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ACETAMINOPHEN; TRAMADOL (Ultracet(reg)) is a combination analgesic that is used to relieve moderate, acute pain such as pain following surgical procedures, including dental surgery. Acetaminophen; tramadol may be used for other types of pain as determined by your health care provider. Generic acetaminophen; tramadol tablets are not yet available. What should my health care professional know before I take acetaminophen; tramadol? They need to know if you have any of these conditions:; an alcohol or drug abuse problem; blood disease, such as anemia; breathing difficulty or asthma; drink more than 3 alcohol-containing drinks per day; drive or operate machinery or perform hazardous activities; head injury or brain tumor; kidney disease; liver disease; receiving drugs that lower your ability to fight infection; seizures (convulsions) or seizure disorder (epilepsy); stomach or intestinal problems; an unusual or allergic reaction to acetaminophen, tramadol, codeine, other pain medicines, foods, dyes, or preservatives; pregnant or trying to get pregnant; breast-feeding How should I take this medicine? Take acetaminophen; tramadol tablets by mouth. Follow the directions on the prescription label. Swallow the tablets with a drink of water. If acetaminophen; tramadol upsets your stomach, take it with food or milk. Do not take more than 2 tablets at a time or more than 8 tablets per day. Higher doses may cause severe side effects, do not take more medication than your prescriber has instructed. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. Older patients (> 60 years of age) may have a stronger reaction to this medicine, especially if they have kidney or liver disease. What if I miss a dose? If it is almost time for your next dose, take only that dose. Do not take double or extra doses. What drug(s) may interact with acetaminophen; tramadol?; alcohol; antacids; antihistamines (commonly found in allergy or cold products); bulsulfan; bupropion; cocaine; diflunisal; digoxin; droperidol; drugs to regulate heart rhythm such as amiodarone, propafenone, quinidine; furazolidone; imatinib; isoniazid, INH; linezolid; medicines called MAO inhibitors-phenelzine (Nardil(reg)), tranylcypromine (Parnate(reg)), isocarboxazid (Marplan(reg)), selegiline (Eldepryl(reg)); medicines for anxiety, depression, or sleeping problems; medicines for nausea or vomiting; medicines for Parkinson's disease such as entacapone, pramipexole, ropinirole or tolcapone; medicines for mental problems like schizophrenia; muscle relaxants; naloxone; other medicines for pain such as codeine, morphine, nalbuphine, pentazocine, or propoxyphene; procarbazine; rifampin; ritonavir; seizure medicines; stimulants such as amphetamine or dextroamphetamine; St. John's wort; sulfinpyrazone; warfarin Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from taking acetaminophen; tramadol? Side effects that you should report to your prescriber or health care professional as soon as possible: Rare or uncommon:; changes in vision; difficulty breathing, shortness of breath; fast or irregular heartbeat; hallucinations (seeing and hearing things that are not really there); not passing urine as often as usual; redness, blistering, peeling or loosening of the skin, including inside the mouth; skin rash, itching; seizures (convulsions); yellow tint to your skin or whites of your eyes More common:; anxiety, agitation; vomiting Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):; constipation or diarrhea; difficulty sleeping; dizziness, drowsiness; dry mouth; false sense of well being, feeling of unreality, mood changes; headache; indigestion; itching; nausea; sweating or flushing What should I watch for while taking acetaminophen; tramadol? Tell your prescriber or health care professional if your pain does not go away. Do not drive, use machinery, or do anything that needs mental alertness until you know how acetaminophen; tramadol affects you. Be careful taking other medicines which may also make you tired. This effect may be worse when taking these medicines with acetaminophen; tramadol. Alcohol can increase possible drowsiness, dizziness, confusion and affect your breathing. Do not drink alcoholic beverages while taking tramadol. Your mouth may get dry. Chewing sugarless gum, sucking hard candy and drinking plenty of water will help. If you are going to have surgery, tell your prescriber or health care professional that you are taking Ultracet(reg). Many non-prescription medicines contain acetaminophen as an ingredient. Additional acetaminophen taken with Ultracet(reg) can be dangerous. Always read the labels carefully to avoid taking an accidental overdose of acetaminophen. Report any possible overdose of acetaminophen; tramadol promptly to your health care provider. Acetaminophen can affect the results from some blood-sugar tests used by diabetic patients. Check with your prescriber or health care professional before you change your diet or the dose of your diabetic medicine. Where can I keep my medicine? Keep out of reach of children in a container that small children cannot open. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date. Ultracet This page contains drug information on Ultracet. The information provided includes the following: what is Ultracet the possible side effects of Ultracet what happens if you miss a dose of Ultracet what happens if you overdose with Ultracet the most important information about Ultracet how to use Ultracet other drugs that may affect Ultracet what to avoid while using Ultracet Ultracet Tablets Manufacturer: Ortho-McNeil Prescribing Information DESCRIPTION ULTRACET® (tramadol hydrochloride/acetaminophen) Tablets combines two analgesics, tramadol 37.5 mg and acetaminophen 325 mg. The chemical name for tramadol hydrochloride is (±) cis -2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. ULTRACET tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, starch, purified water, magnesium stearate, OPADRY® Light Yellow, and carnauba wax. CLINICAL PHARMACOLOGY The following information is based on studies of tramadol alone or acetaminophen alone, except where otherwise noted: Pharmacodynamics Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to µ-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to µ-opioid receptors. In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in µ-opioid binding. Tramadol-induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound (see CLINICAL PHARMACOLOGY , Pharmacokinetics ). Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of tramadol. Apart from analgesia, tramadol administration may produce a constellation of symptoms (including dizziness, somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids. Acetaminophen Acetaminophen is a non-opiate, non-salicylate analgesic. Pharmacokinetics Tramadol is administered as a racemate and both the [-] and [+] forms of both tramadol and M1 are detected in the circulation. The pharmacokinetics of plasma tramadol and acetaminophen following oral administration of one ULTRACET tablet are shown in Table 1. Tramadol has a slower absorption and longer half-life when compared to acetaminophen. single dose pharmacokinetic study of ULTRACET® in volunteers showed no drug interactions between tramadol and acetaminophen. Upon multiple oral dosing to steady state, however, the bioavailability of tramadol and metabolite M1 was lower for the combination tablets compared to tramadol administered alone. The decrease in AUC was 14% for (+)-tramadol, 10.4% for (-)-tramadol, 11.9% for (+)-M1 and 24.2% for (-)-M1. The cause of this reduced bioavailability is not clear. Following single or multiple dose administration of ULTRACET, no significant change in acetaminophen pharmacokinetics was observed when compared to acetaminophen given alone. Absorption : The absolute bioavailability of tramadol from ULTRACET tablets has not been determined. Tramadol hydrochloride has a mean absolute bioavailability of approximately 75% following administration of a single 100 mg oral dose of ULTRAM® tablets. The mean peak plasma concentration of racemic tramadol and M1 after administration of two ULTRACET tablets occurs at approximately two and three hours, respectively, post-dose. Peak plasma concentrations of acetaminophen occur within one hour and are not affected by co-administration with tramadol. Oral absorption of acetaminophen following ad-ministration of ULTRACET occurs primarily in the small intestine. Food Effects: When ULTRACET was administered with food, the time to peak plasma concentration was delayed for approximately 35 minutes for tramadol and almost one hour for acetaminophen. However, peak plasma concentration or the extent of absorption of either tramadol or acetaminophen were not affected. The clinical significance of this difference is unknown. Distribution: The volume of distribution of tramadol was 2.6 and 2.9 L/kg in male and female subjects, respectively, following a 100 mg intravenous dose. The binding of tramadol to human plasma proteins is approximately 20% and binding also appears to be independent of concentration up to 10 µg/mL. Saturation of plasma protein binding occurs only at concentrations outside the clinically relevant range. Acetaminophen appears to be widely distributed throughout most body tissues except fat. Its apparent volume of distribution is about 0.9 L/kg. A relative small portion (~20%) of acetaminophen is bound to plasma protein. Metabolism: Following oral administration, tramadol is extensively metabolized by a number of pathways, including CYP2D6 and CYP3A4, as well as by conjugation of parent and metabolites. Approximately 30% of the dose is excreted in the urine as unchanged drug, whereas 60% of the dose is excreted as metabolites. The major metabolic pathways appear to be N - and O -demethylation and glucuronidation or sulfation in the liver. Metabolite M1 ( O -desmethyltramadol) is pharmacologically active in animal models. Formation of M1 is dependent on CYP2D6 and as such is subject to inhibition, which may affect the therapeutic response (see PRECAUTIONS , Drug Interactions ). Approximately 7% of the population has reduced activity of the CYP2D6 isoenzyme of cytochrome P450. These individuals are "poor metabolizers" of debrisoquine, dextromethorphan, tricyclic antidepressants, among other drugs. Based on a population PK analysis of Phase 1 studies in healthy subjects, concentrations of tramadol were approximately 20% higher in "poor metabolizers" versus "extensive metabolizers," while M1 concentrations were 40% lower. In vitro drug interaction studies in human liver microsomes indicates that inhibitors of CYP2D6 such as fluoxetine and its metabolite norfluoxetine, amitriptyline and quinidine inhibit the metabolism of tramadol to various degrees. The full pharmacological impact of these alterations in terms of either efficacy or safety is unknown. Concomitant use of SEROTONIN re-uptake INHIBITORS and MAO INHIBITORS may enhance the risk of adverse events, including seizure (see WARNINGS ) and serotonin syndrome. Acetaminophen is primarily metabolized in the liver by first-order kinetics and involves three principal separate pathways: conjugation with glucuronide; conjugation with sulfate; and oxidation via the cytochrome, P450-dependent, mixed-function oxidase enzyme pathway to form a reactive intermediate metabolite, which conjugates with glutathione and is then further metabolized to form cysteine and mercapturic acid conjugates. The principal cytochrome P450 isoenzyme involved appears to be CYP2E1, with CYP1A2 and CYP3A4 as additional pathways. In adults, the majority of acetaminophen is conjugated with glucuronic acid and, to a lesser extent, with sulfate. These glucuronide-, sulfate-, and glutathione-derived metabolites lack biologic activity. In premature infants, newborns, and young infants, the sulfate conjugate predominates. Elimination: Tramadol is eliminated primarily through metabolism by the liver and the metabolites are eliminated primarily by the kidneys. The plasma elimination half-lives of racemic tramadol and M1 are approximately 5-6 and 7 hours, respectively, after administration of ULTRACET. The apparent plasma elimination half-life of racemic tramadol increased to 7-9 hours upon multiple dosing of ULTRACET. The half-life of acetaminophen is about 2 to 3 hours in adults. It is somewhat shorter in children and somewhat longer in neonates and in cirrhotic patients. Acetaminophen is eliminated from the body primarily by formation of glucuronide and sulfate conjugates in a dose-dependent manner. Less than 9% of acetaminophen is excreted unchanged in the urine. Special Populations Renal: The pharmacokinetics of ULTRACET® in patients with renal impairment have not been studied. Based on studies using tramadol alone, excretion of tramadol and metabolite M1 is reduced in patients with creatinine clearance of less than 30 mL/min, adjustment of dosing regimen in this patient population is recommended. (See DOSAGE AND ADMINISTRATION .) The total amount of tramadol and M1 removed during a 4-hour dialysis period is less than 7% of the administered dose based on studies using tramadol alone. Hepatic: The pharmacokinetics and tolerability of ULTRACET in patients with impaired hepatic function has not been studied. Since tramadol and acetaminophen are both extensively metabolized by the liver, the use of ULTRACET in patients with hepatic impairment is not recommended (see PRECAUTIONS and DOSAGE AND ADMINISTRATION ). Geriatric: A population pharmacokinetic analysis of data obtained from a clinical trial in patients with chronic pain treated with ULTRACET which included 55 patients between 65 and 75 years of age and 19 patients over 75 years of age, showed no significant changes in pharmacokinetics of tramadol and acetaminophen in elderly patients with normal renal and hepatic function (see PRECAUTIONS , Geriatric Use ). Gender: Tramadol clearance was 20% higher in female subjects compared to males on four phase I studies of ULTRACET in 50 male and 34 female healthy subjects. The clinical significance of this difference is unknown. Pediatric: Pharmacokinetics of ULTRACET tablets have not been studied in pediatric patients below 16 years of age. Clinical Studies Single Dose Studies for Treatment of Acute Pain In pivotal single-dose studies in acute pain, two tablets of ULTRACET® administered to patients with pain following oral surgical procedures provided greater relief than placebo or either of the individual components given at the same dose. The onset of pain relief after ULTRACET was faster than tramadol alone. Onset of analgesia occurred in less than one hour. The duration of pain relief after ULTRACET was longer than acetaminophen alone. Analgesia was generally comparable to that of the comparator, ibuprofen. INDICATIONS AND USAGE ULTRACET® is indicated for the short-term (five days or less) management of acute pain. CONTRAINDICATIONS ULTRACET® should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, acetaminophen, any other component of this product or opioids. ULTRACET is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. ULTRACET may worsen central nervous system and respiratory depression in these patients. WARNINGS Seizure Risk Administer ULTRACET® cautiously in patients at risk for respiratory depression. In these patients, alternative non-opioid analgesics should be considered. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipi-tate seizures (see WARNINGS , Seizure Risk and OVERDOSAGE ). Interaction With Central Nervous System (CNS) Depressants ULTRACET® should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. Tramadol increases the risk of CNS and respiratory depression in these patients. Increased Intracranial Pressure or Head Trauma ULTRACET® should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from tramadol may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patients if they are receiving ULTRACET (see Respiratory Depression ). Use in Ambulatory Patients Tramadol may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly. Use With MAO Inhibitors and Serotonin Re-uptake Inhibitors Use ULTRACET® with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration of MAO inhibitors and tramadol. Concomitant use of tramadol with MAO inhibitors or SSRI's increases the risk of adverse events, including seizure and serotonin syndrome. Use With Alcohol ULTRACET® should not be used concomitantly with alcohol consumption. The use of ULTRACET in patients with liver disease is not recommended. Use With Other Acetaminophen-containing Products Due to the potential for acetaminophen hepatotoxicity at doses higher than the recommended dose, ULTRACET® should not be used concomitantly with other acetaminophen-containing products. Withdrawal Withdrawal symptoms may occur if ULTRACET® is discontinued abruptly. (See DRUG ABUSE AND DEPENDENCE .) These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been seen less frequently with ULTRACET discontinuation include: panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be avoided by tapering ULTRACET at the time of discontinuation. Physical Dependence and Abuse Tramadol may induce psychic and physical dependence of the morphine-type (µ-opioid). (See DRUG ABUSE AND DEPENDENCE .) Tramadol should not be used in opioid-dependent patients. Tramadol has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids. Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug are not limited to those patients with prior history of opioid dependence. Risk of Overdosage Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment. (See OVERDOSAGE .) Serious potential consequences of overdosage with acetaminophen are hepatic (centrilobular) necrosis, leading to hepatic failure and death. Emergency help should be sought immediately and treatment initiated immediately if overdose is suspected, even if symptoms are not apparent. PRECAUTIONS General The recommended dose of ULTRACET® should not be exceeded. Do not co-administer ULTRACET with other tramadol or acetaminophen-containing products. (See WARNINGS , Use With Other Acetaminophen-containing Products and Risk of Overdosage .) Pediatric Use The safety and effectiveness of ULTRACET® has not been studied in the pediatric population. Geriatric Use In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy. Acute Abdominal Conditions The administration of ULTRACET® may complicate the clinical assessment of patients with acute abdominal conditions. Use in Renal Disease ULTRACET® has not been studied in patients with impaired renal function. Experience with tramadol suggest that impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. In patients with creatinine clearances of less than 30 mL/min, it is recommended that the dosing interval of ULTRACET be increased not to exceed 2 tablets every 12 hours. Use in Hepatic Disease ULTRACET® has not been studied in patients with impaired hepatic function. The use of ULTRACET in patients with hepatic impairment is not recommended (see WARNINGS, Use With Alcohol ). Information for Patients ULTRACET® may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. ULTRACET should not be taken with alcohol containing beverages. The patient should be instructed not to take ULTRACET in combination with other tramadol or acetaminophen-containing products, including over-the-counter preparations. ULTRACET should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics. The patient should be instructed to inform the physician if they are pregnant, think they might become pregnant, or are trying to become pregnant (see PRECAUTIONS , Labor and Delivery ). The patient should understand the single-dose and 24-hour dose limit and the time interval between doses, since exceeding these recommendations can result in respiratory depression, seizures, hepatic toxicity and death. There are no adequate and well-controlled studies in pregnant women. ULTRACET® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported with tramadol hydrochloride during post-marketing. Labor and Delivery ULTRACET® should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn. (See DRUG ABUSE AND DEPENDENCE .) Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor. The effect of ULTRACET, if any, on the later growth, development, and functional maturation of the child is unknown. Nursing Mothers ULTRACET® is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hours post-dose was 100 µg of tramadol (0.1% of the maternal dose) and 27 µg of M1. ADVERSE REACTIONS Table 2 reports the incidence rate of treatment-emergent adverse events over five days of ULTRACET® use in clinical trials (subjects took an average of at least 6 tablets per day). Incidence at least 1%, causal relationship at least possible or greater: the following lists adverse reactions that occurred with an incidence of at least 1% in single-dose or repeated-dose clinical trials of ULTRACET. Body as a Whole --Asthenia, fatigue, hot flushes Central and Peripheral Nervous System --Dizziness, headache, tremor Gastrointestinal System --Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting Psychiatric Disorders --Anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence Skin and Appendages --Pruritus, rash, increased sweating. Selected Adverse events occurring at less than 1%: the following lists clinically relevant adverse reactions that occurred with an incidence of less than 1% in ULTRACET clinical trials. Body as a Whole --Chest pain, rigors, syncope, withdrawal syndrome Cardiovascular Disorders --Hypertension, aggravated hypertension, hypotension Central and Peripheral Nervous System --Ataxia, convulsions, hypertonia, migraine, aggravated migraine, involuntary muscle contractions, stupor, vertigo Gastrointestinal System --Dysphagia, melena, tongue edema Hearing and Vestibular Disorders --Tinnitus Heart Rate and Rhythm Disorders --Arrhythmia, palpitation, tachycardia Liver and Biliary System --Hepatic function abnormal Metabolic and Nutritional Disorders --Weight decrease Psychiatric Disorders --Amnesia, depersonalization, depression, drug abuse, emotional lability, hallucination, impotence, paroniria, abnormal thinking Red Blood Cell Disorders --Anemia Respiratory System --Dyspnea Urinary System --Albuminuria, micturition disorder, oliguria, urinary retention Buy Ultracet on the web and save. Minor surgery, joint pain flare-ups, the soreness and bruised feeling after an accident…all of these can cause acute pain, and Ultracet is designed to treat exactly this kind of pain. Acute pain is the kind of discomfort that is acutely painful and short-term in duration, such as the pain in the days immediately after surgery or an accident. Sometimes you may experience joint pain flare-up if you suffer form arthritis as well. This isn’t the long-term, dull pain associated with a chronic condition, but the more intense, short term pain that can really get you down. Ultracet is uniquely designed to treat intense, short-term pain that lasts less than five days. Many people who have osteoarthritis can successfully control the chronic pain with other pain medications, but when they have a joint pain flare, movement and pain control may be nearly impossible. That’s where Ultracet comes in. The unique combination of tramadol and acetaminophen found in Ultracet makes it one of the most effective analgesics prescribed today for acute pain relief. The mix of both of these ingredients means Ultracet goes to work relieving pain more quickly and last longer, a powerful combination you. Ultracet is even safe for those who are using high blood pressure medication or have kidney problems, making it an excellent pain reliever for older persons and those with a history of kidney or blood pressure problems. Many other pain relievers don’t meet this standard and can’t be used. The side effects to Ultracet are mild, including headache, dizziness and drowsiness. You can get your Ultracet online now Drug Uses Ultracet is a unique pain medication. It is used to relieve moderate, acute pain such as pain following surgical procedures, including dental surgery. Ultracet may be used for other types of pain as determined by your health care provider. How Taken Take Ultracet tablets by mouth. Follow the directions on the prescription label. Swallow the tablets with a drink of water. If Ultracet upsets your stomach, take it with food or milk. Do not take more than 2 tablets at a time or more than 8 tablets per day. Higher doses may cause severe side effects, do not take more medication than your prescriber has instructed. Warnings/Precautions DO NOT TAKE Ultracet IF YOU HAVE HAD SEVERE ALLERGIC REACTION to codeine. A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. IF YOU EXPERIENCE difficulty breathing, tightness of chest, swelling of eyelids, face or lips or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of Ultracet unless your doctor tells you to do so. DO NOT EXCEED THE RECOMMENDED DOSE or take Ultracet for longer than prescribed. Ultracet MAY BE HABIT FORMING. Use caution driving or operating machinery. DO NOT DRINK ALCOHOL while taking Ultracet. DO NOT TAKE other products containing acetaminophen (check labels closely) while you are taking Ultracet. IF DIZZINESS OCCURS, sit or stand up slowly. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor that you are taking Ultracet. IF YOU EXPERIENCE WITHDRAWAL SYMPTOMS (nervousness, sweating, nausea, diarrhea, tremor, trouble sleeping), check with your doctor. FOR WOMEN: Discuss with your doctor is you are planning on getting pregnant. Ultracet IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking Ultracet. Missed Dose If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Possible Side Effects Side effects that you should report to your prescriber or health care professional as soon as possible: Rare or uncommon:; changes in vision; difficulty breathing, shortness of breath; fast or irregular heartbeat; hallucinations (seeing and hearing things that are not really there); not passing urine as often as usual; redness, blistering, peeling or loosening of the skin, including inside the mouth; skin rash, itching; seizures (convulsions); yellow tint to your skin or whites of your eyes. More common:; anxiety, agitation; vomiting. Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome); constipation or diarrhea; difficulty sleeping; dizziness, drowsiness; dry mouth; false sense of well being, feeling of unreality, mood changes; headache; indigestion; itching; nausea; sweating or flushing. Storage Keep out of reach of children in a container that small children cannot open. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date. Overdose Seek emergency medical attention. Symptoms of a Ultracet overdose include nausea; vomiting; sweating; difficulty breathing; shallow, weak breathing; and seizures. More Information Use caution when driving, operating machinery, or performing other hazardous activities. Ultracet may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Do not take other prescription or over-the-counter medicines that contain acetaminophen (Tylenol, pain relievers, cold and flu medicines, others) during treatment with Ultracet. Taking too much acetaminophen may be harmful. Avoid sleeping pills, tranquilizers, sedatives and antihistamines except under the supervision of your doctor. Ultracet may cause drowsiness and these agents may worsen this effect. Disclaimer This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information American Journal Of Surgery Study Shows ULTRACET® (acetaminophen/tramadol hydrochloride) Effective And Well Tolerated For Post-Surgical Pain Raritan, NJ (April 5, 2004) A new study published in the latest edition of a leading medical journal has shown that treatment with ULTRACET® (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets) demonstrates similar efficacy and better tolerability than TYLENOL® with Codeine No. 3 when each is compared to placebo. Study results published in the April issue of American Journal of Surgery found that pain associated with orthopedic or abdominal surgery was successfully reduced following treatment with ULTRACET®, a leading combination pain reliever marketed by Ortho-McNeil Pharmaceutical, Inc. In an overall review, 69 percent of patients taking ULTRACET® rated it as very good or good compared with 62 percent of patients who were prescribed TYLENOL® (acetaminophen) with Codeine No. 3. "Treating pain following surgery with narcotics including TYLENOL® with Codeine No. 3 has long been the preferred method of health care professionals, but this often leaves patients in a state of immobility due to narcotic side effects, like fatigue, nausea or abdominal discomfort," said Adam B. Smith, D.O., Department of Surgery, University of North Texas Health Science Center, Fort Worth, Texas. "This study found that ULTRACET® delivers efficacy but with fewer side effects." The rate of constipation for patients treated with ULTRACET® was less than half the rate experienced by patients treated with TYLENOL® with Codeine No. 3, (4.1 percent versus 10.1 percent). Also, patients treated with ULTRACET® experienced less vomiting (9.2 percent versus 14.7 percent) and discontinuation due to adverse events (8.2 percent versus 10.1 percent) than in patients treated with TYLENOL® with Codeine No. 3. This multicenter, randomized, double-blind, placebo-controlled trial evaluated ULTRACET in 153 orthopedic patients (arthroscopic procedure of the knee or shoulder) and 152 abdominal surgery patients (inguinal or ventral hernia repair) for post-surgical pain. Patients with moderate pain or greater were treated with ULTRACET®, TYLENOL® with Codeine No. 3 or placebo. Outcome measures were pain relief and pain intensity. The study was supported by Ortho-McNeil Pharmaceutical, Inc. ULTRACET® combines tramadol, a leading prescription pain reliever, with acetaminophen, the most commonly recommended nonprescription pain treatment. Single-dose dental pain studies demonstrated that the ULTRACET® combination of tramadol and acetaminophen provides faster onset, longer duration and better pain relief over either medication alone. ULTRACET® is indicated for the short-term (five days or less) management of acute pain. ULTRACET® is contraindicated in any situation where opioids are contraindicated. Seizures have been reported in patients receiving tramadol. The risk of seizures is increased with doses of tramadol above the recommended range. Tramadol increases the seizure risk in patients taking certain medications (e.g., tricyclic antidepressants, SSRIs, opioids). Tramadol may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or other drugs that reduce the seizure threshold or in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). See WARNINGS in full Prescribing Information. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive ULTRACET®. ULTRACET® should not be used concomitantly with alcohol consumption. The use of ULTRACET® in patients with liver disease is not recommended. Withdrawal symptoms may occur if ULTRACET® is discontinued abruptly. ULTRACET® should not be used concomitantly with other acetaminophen-containing products. Tramadol may induce psychic and physical dependence of the morphine type (mu - opioid). Cases of abuse and dependence on tramadol have been reported. Tramadol should not be used in opioid-dependent patients. Since tramadol can reinitiate physical dependence, ULTRACET® is not recommended for patients with a tendency to drug abuse, a history of drug dependence, or chronically using opioids. The most frequently reported side effects experienced with ULTRACET® were constipation, somnolence and sweating. For more information on warnings, precautions, and additional adverse reactions that may occur, regardless of drug relationship, please see the full U.S. Prescribing Information available upon request or at www.ultracet.com or www.ortho-mcneil.com. Ortho-McNeil Pharmaceutical, Inc., is a Johnson & Johnson company. Ortho-McNeil Pharmaceutical, Inc., markets prescription drugs in the areas of women's health, infectious disease, central nervous system, pain treatment, urology and migraine headaches. # # # Important: Due to State and Federal Regulations, we are not able to ship Ultracet into Kentucky. We apologize for the incovenience. Ultracet® Uses This medicine is an analgesic combination used to treat or prevent pain for a short period of time (usually 5 days or less). Ultracet is an invaluable medicine for many patients. However it is also abused by a few patients. To control abuse of this medicine, our patients are limited to two bottles every 30 days of any of the following medications - Ultram, Generic Ultram, Soma, Fioricet, Ultracet, Robaxin, Flexeril or Parafon Forte. For example, a patient who orders one bottle of Flexeril on the 1st of the month will not be able to order any of the other medicines in the above list until the 15th of the month. A patient who orders one bottle of Flexeril and one bottle of Parafon Forte on the 1st of the moth will not be able to order any of the above medications until the 1st of the next month. Before Using It is important that you mention all prescription and over-the-counter medicines in our medical questionnaire and any medical conditions you may have including allergies, pregnancy, or breast-feeding. DO NOT TAKE THIS MEDICINE if you are also taking carbamazepine, cyclobenzaprine, an amphetamine, opiate analgesic, tricyclic antidepressant, serotonin reuptake inhibitor (SSRI), monoamine oxidase inhibitor (MAOI), promethazine, or medicine for appetite suppression, sleep, or a nervous, mood, or behavior condition. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITIONS may be needed if you are taking isoniazid, guanidine, or an oral anticoagulant. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have liver disease or high levels of alcohol, depressants, stimulants, or other analgesics in your blood. Directions THIS MEDICINE MAY BE TAKEN on an empty stomach or with food. Side effects you may experience while taking this medicine include drowsiness, dizziness, and constipation. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE IF you develop a skin rash, itching, confusion, changes in mood or behavior, hallucinations, dark urine or pale stools, yellowing of the skin or eyes, or unusual tiredness. CONTACT YOUR DOCTOR IMMEDIATELY IF you experience seizures, difficulty breathing or swallowing, or swelling of face or mouth. Store this medicine at room temperature in a tightly-closed container away from heat and light. IF YOU MISS A DOSE OF THIS MEDICINE and you are taking it regularly, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT TAKE TWO DOSES AT ONCE. If your symptoms do not improve or become worse, check with your doctor. Cautions DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD A SEVERE ALLERGIC REACTION to codeine, hydrocodone, dihydrocodeine, oxycodone (such as Tylox, Tylenol with Codeine, Vicodin). A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. IF YOU EXPERIENCE difficulty breathing, tightness of chest, swelling of eyelids, face, or lips, or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of this medicine unless your doctor tells you to do so. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed. THIS MEDICINE MAY BE HABIT FORMING. Use caution driving or operating machinery. DO NOT DRINK ALCOHOL while taking this medicine. DO NOT TAKE other products containing acetaminophen (check labels closely) while you are taking this medicine. IF DIZZINESS OCCURS, sit or stand up slowly. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor that you are taking this medicine. IF YOU EXPERIENCE WITHDRAWAL SYMPTOMS (nervousness, sweating, nausea, diarrhea, tremor, trouble sleeping), check with your doctor . FOR WOMEN: Discuss with your doctor is you are planning on getting pregnant. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine. Overdose If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include nausea, vomiting, sweating, unusual drowsiness, slowed breathing, seizures, stomach pain, dark urine, deep sleep or loss of consciousness, coma and death. FDA Approves Ultracet (Tramadol/Acetominophen) For Acute Pain RARITAN, NJ -- August 20, 2001 -- The U.S. Food and Drug Administration has approved Ultracet™ (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets), a new centrally acting prescription pain medication. Ultracet provides long-lasting pain relief and flexible dosing. Ortho-McNeil Pharmaceutical, Inc. will market the product in the United States. Ultracet combines Ultram® (tramadol hydrochloride), a leading prescription pain reliever, with acetaminophen, the most commonly recommended nonprescription pain treatment. Clinical trials demonstrated that the combination offers better pain relief over either medication alone. In the trials, Ultracet consistently began working faster than tramadol alone, and pain relief with Ultracet lasted significantly longer than with acetaminophen alone. Ultracet is indicated for the short-term (five days or less) management of acute pain. "Pain is one of the most prevalent medical symptoms in the United States," said Warren A. Katz, MD, chief of Rheumatology at Presbyterian Medical Center/University of Pennsylvania Healthcare System in Philadelphia. "Millions of people suffer from acute pain without relief, in part because their medications don't work or have side-effects that interfere with treatment. With Ultracet, we have a product that offers effective relief and a positive side-effect profile." Ultracet™ is a centrally acting analgesic that controls pain via different mechanisms of action than non-steroidal anti-inflammatory drugs (NSAIDs), the most commonly used pain medications. Ultracet is not an NSAID, and is not associated with potentially life-threatening gastrointestinal ulcers or bleeding that can occur with NSAIDs and the newer COX-2 NSAIDs. In addition, Ultracet does not compromise the efficacy of certain antihypertensive agents, like NSAIDs and COX-2 NSAIDs. Ultracet can also be prescribed in sulfa-sensitive patients. The most frequently reported side effects with Ultracet were constipation, somnolence (sleepiness) and increased sweating. Ultracet should not be used concomitantly with alcohol. The use of Ultracet in patients with liver disease is not recommended. In addition, acetaminophen may cause liver damage. Cases of abuse and dependence on tramadol have been reported. Tramadol should not be used in opioid-dependent patients. Since tramadol can reinitiate physical dependence, Ultracet is not recommended for patients with a tendency to drug or alcohol abuse, a history of drug or alcohol dependence or a history of chronic opioid use. Patients with a history of severe, life-threatening allergic (anaphylactoid) reactions to codeine and other opioids may be at increased risk and therefore should not receive Ultracet. Seizures have been reported in patients receiving tramadol. The risk of seizures is increased with doses of tramadol above the recommended range. Tramadol increases the seizure risk in patients taking certain medications (e.g., tricyclic antidepressants, selective serotonin reuptake inhibitors, opioids) and may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or other drugs that reduce the seizure threshold or in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, and CNS infections). See WARNINGS in the full Prescribing Information. SOURCE: Ortho-McNeil Pharmaceutical, Inc. The following information is a summary of Ultracet medication. It is not intended to replace a doctor's instructions. Tablets Chemical Name: Chemical Name: TRAMADOL (TRA-ma-doll) and ACETAMINOPHEN (a-seat-a-MIN-oh-fen) Common uses for Ultracet Medication This medicine is an analgesic combination used to treat or prevent pain for a short period of time (usually 5 days or less). Ultracet is a unique pain medication that combines Tramadol, a leading prescription pain reliever, and acetaminophen, the most commonly recommended over-the-counter analgesic in the U.S. Ultracet provides powerful relief from many kinds of acute pain, including joint pain, strains and sprains, post-operative recuperation, joint pain flares (i.e., associated with osteoarthritis) and muscle aches. Ultracet Medication Directions Ultracet may be taken on an empty stomach or with food. Side effects you may experience while taking Ultracet include drowsiness, dizziness, and constipation. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE IF you develop a skin rash, itching, confusion, changes in mood or behavior, hallucinations, dark urine or pale stools, yellowing of the skin or eyes, or unusual tiredness. CONTACT YOUR DOCTOR IMMEDIATELY IF you experience seizures, difficulty breathing or swallowing, or swelling of face or mouth. Store Ultracet drug products at room temperature in a tightly-closed container away from heat and light. If your symptoms do not improve or become worse, check with your doctor. Ultracet Drug Side Effects SIDE EFFECTS that may occur while taking an Ultracet drug include drowsiness, dizziness, and constipation. If they continue or are bothersome, check with your doctor. Ultracet Precautions DO NOT TAKE ULTRACET IF YOU HAVE HAD A SEVERE ALLERGIC REACTION to codeine, hydrocodone, dihydrocodeine, oxycodone (such as Tylox, Tylenol with Codeine, Vicodin). A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. IF YOU EXPERIENCE difficulty breathing, tightness of chest, swelling of eyelids, face, or lips, or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of Ultracet unless your doctor tells you to do so. DO NOT EXCEED THE RECOMMENDED DOSE or take Ultracet for longer than prescribed. ULTRACET MAY BE HABIT FORMING. Use caution driving or operating machinery. DO NOT DRINK ALCOHOL while taking Ultracet. DO NOT TAKE other products containing acetaminophen (check labels closely) while you are taking Ultracet. IF DIZZINESS OCCURS, sit or stand up slowly. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor that you are taking Ultracet. IF YOU EXPERIENCE WITHDRAWAL SYMPTOMS (nervousness, sweating, nausea, diarrhea, tremor, trouble sleeping), check with your doctor . FOR WOMEN: Discuss with your doctor is you are planning on getting pregnant. ULTRACET IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking Ultracet. Drug Interactions with Ultracet DO NOT TAKE ULTRACET if you are also taking carbamazepine, cyclobenzaprine, an amphetamine, opiate analgesic, tricyclic antidepressant, serotonin reuptake inhibitor (SSRI), monoamine oxidase inhibitor (MAOI), promethazine, or medicine for appetite suppression, sleep, or a nervous, mood, or behavior condition. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITIONS may be needed if you are taking isoniazid, guanidine, or an oral anticoagulant. Ultracet Overdose If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of Ultracet overdose may include nausea, vomiting, sweating, unusual drowsiness, slowed breathing, seizures, stomach pain, dark urine, deep sleep or loss of consciousness, coma and death. ssed Dose of Ultracet IF YOU MISS A DOSE OF ULTRACET and you are taking it regularly, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT TAKE TWO DOSES OF ULTRACET AT ONCE

Pharmacy (from the Greek ???????? = drug) is a chemical science and profession charged with ensuring the safe use of medication. Traditionally, pharmacists have compounded and dispensed medications on the orders of physicians. More recently, pharmacy has come to include other services related to patient care including clinical practice, medication review, and drug information. Some of these new pharmaceutical roles are now mandated by law in various legislatures. Pharmacists, therefore, are drug therapy experts, and the primary health professionals who optimise medication management to produce positive health-outcomes. The symbols most commonly associated with pharmacy are the mortar and pestle and the ? (recipere) character. Pharmacy organisations often employ other elements, such as the Bowl of Hygieia, conical measures, and caduceuses in their logos. Other symbols are common in different countries such as the green Greek cross in France and Great Britain, the increasingly-rare Gaper in The Netherlands, and a red stylised letter A in Germany. complex clinical medication management issues whereas pharmacists in community pharmacies often have more complex business and customer relations issues. Because of the complexity of the medication use system, many pharmacists practicing in hospitals gain more education and training after pharmacy school through a pharmacy practice residency and sometimes followed by another residency in a specific area. Hospital pharmacies can usually be found within the premises of the hospital. Hospital pharmacies usually stock a larger range of medications, including more specialized medications, than would be feasible in the community setting. Most hospital medications are unit-dose, or a single dose of medicine. Hospital pharmacists and trained pharmacy technicians compound sterile products for patients including total parenteral nutrition (TPN), and other medications given intravenously. This is a complex process that requires adequate training of personnel, quality assurance of products, and adequate facilities. Some hospital pharmacies have decided to outsource high risk preparations and some other compounding functions to companies who specialize in compounding. [edit] Internet pharmacy Recently, a number of pharmacies have begun operating over the internet. Many such pharmacies are, in some ways, similar to community pharmacies; the primary difference is the method by which the medications are requested and received. Some customers consider this to be more convenient than traveling to a community drugstore. Some internet pharmacies sell prescription drugs without requiring a prescription. Some customers order drugs from such pharmacies to avoid the "inconvenience" of visiting a doctor or to obtain medications which their doctors were unwilling to prescribe. However, this practice has been criticized as potentially dangerous, especially by those who feel that only doctors can reliably assess contraindications, risk/benefit ratios, and an individual's overall suitability for use of a medication. There have also been reports of such pharmacies dispensing substandard products. In the United States, there has been a push to legalize importation of medications from Canada and other countries, in order to reduce consumer costs. Although importation of prescription medication currently violates Food and Drug Administration (FDA) regulations and federal laws, enforcement is generally targeted at international drug suppliers, rather than consumers. [edit] The future of pharmacy In the coming decades, pharmacists are expected to become more integral within the health care system. Rather than simply dispensing medication, pharmacists expect to be paid for their cognitive skills. This paradigm shift has already commenced in some countries; for instance, pharmacists in Australia receive remuneration from the Australian Government for conducting comprehensive Home Medicines Reviews. In Great Britain, pharmacists (and nurses) who undertake additional training are obtaining prescribing rights. In the United States, consultant pharmacists, who traditionally operated primarily in nursing homes are now expanding into direct consultation with patients, under the banner of "senior care pharmacy." Many universities are altering their programs to increase emphasis in fields such as pharmacotherapeutics, clinical pharmacy, nuclear pharmacy, disease state management, etc. Access to student services by website, phone, and mail CanadaDrugs.comTM is Canada's largest International Prescription Service ("Internet") Pharmacy. Since opening in April of 2001, Canada DrugsTM has earned many pharmacy accreditations and become one of the most trusted Canadian discount pharmacies on the Internet. With over 250 full time staff, and over 3,000 prescriptions filled every day and shipped safely to patients internationally. You can trust us with your prescription drug purchase. Canada DrugsTM is located at: 24 Terracon Place, Winnipeg, MB, Canada, R2J 4G7. [full contact information] CanadaDrugs.comTM is licensed by the Manitoba Pharmaceutical Association: License # 32195. Canada DrugsTM is a Canadian pharmacy of choice for purchasing your discount prescription drugs and medication. At Canada DrugsTM, buying from an online Canadian pharmacy has never been easier. You can order prescription drugs and medication from Canada DrugsTM at discount prices by supplying a valid, prescription from a licensed physician. Our international online pharmacy also offers convenient prescription refills. At Canada DrugsTM, we maintain the highest standards in patient safety of any Canadian online pharmacy. We believe access to essential prescription drugs should be safe, convenient, and affordable for all. Canada DrugsTM is proud to be the first Canadian pharmacy to receive accreditation from IMPAC (Internet and Mailorder Pharmacy Accreditation Commission). Canada DrugsTM is also a certified member of the Canadian Internet Pharmacy Association (CIPA), the Better Business Bureau (BBB), VeriSign and is a 5 star rated pharmacy from Pharmacy Checker.com. As a premiere Canadian Internet-based and mail order pharmacy, Canada DrugsTM pharmacy is licensed by the Manitoba Pharmaceutical Association to distribute prescription medication. * All prices are subject to change at any time. Exchange rates under license from XE.com. For questions regarding pricing and availability of products from CanadaDrugs.comTM you may call 1-800-CAN-DRUG (1-800-226-3784). CanadaDrugs.comTM is presently licensed in the province of Manitoba by the Manitoba Pharmaceutical Association. License Number 32195 CanadaDrugs.comTM is located at: 24 Terracon Place, Winnipeg, Manitoba, Canada, R2J 4G7 Copyright © 2006 CanadaDrugs.comTM. All rights reserved. "Canada Drugs" and "CanadaDrugs.com" are registered trademarks used under exclusive license by CanadaDrugs.comTM. All rights reserved The College of Pharmacy is situated in the foothills of the Wasatch Mountains in L.S. Skaggs Hall, which houses college and departmental offices. The College of Pharmacy is part of the Health Sciences Center which incorporates the University of Utah Hospital and Clinics, The School of Medicine, the Colleges of Health, Nursing, and Pharmacy as well as the Eccles Health Sciences Library. The College of Pharmacy has state-of-the-art facilities to train students in all areas of the biomedical sciences and professional practice. Adjacent facilities for research and instruction include the Biomedical Polymers Research Building, University Research Park and University Hospital. Clinical clerkships, post-graduate residency and fellowship training is also available in a variety of professional practice settings. The student/faculty ratio in all programs is small so students receive concentrated, individual attention. The faculty, many of whom are recognized authorities in their areas of specialization, are committed to providing each student with a valuable educational experience. Since the college is located within the Health Sciences Center, pharmacy students can interact on a daily basis with students who are training in the other health professions and sciences such as medicine, nursing or physician assistants. Student professional organizations are active on campus and provide students with the opportunity to participate in extracurricular service and social activities. General Information The application deadline for 2007 will be January 10, 2007. The application will be online and available after October 1, 2006. Students are required to make an application to the Doctor of Pharmacy Program and an application to the Graduate School of the University of Utah. Applications not meeting the January 10th deadline will not be reviewed. Advanced Placement Scores accepted by the Admissions Committee Calculus: a score of 4 or 5 on either the AB or BC waives only the first semester of calculus. Chemistry: a score of 4 or 5 waives only the first semester of general chemistry. Physics: a score of 4 or 5 on the physic B; C:MECH; C:E&M waives only the first semester of any physics series. Pre-professional GPA Students must have a pre-professional grade point average of 2.75 or higher in the pre-required science course work. The Admissions Committee reviews every time you take a course; and if a course is repeated the second repeat grade is used in the pre-professional grade point calculation. The average pre-professional GPA for the accepted students for the past 4 years has been a 3.55 (ranging from a 2.77 to a 4.0). Pharmacy College Admissions Test (PCAT) Applicants to the University of Utah College of Pharmacy are required to take the PCAT. Information concerning the PCAT and registration can be found at: www.pcatweb.info. For students applying for admission starting fall semester 2007 the latest PCAT scores accepted will be the October, 2006 test. A composite score above the 65th percentile must be obtained before the Admissions Committee will review an application. For the past 4 years the average composite score for those students accepted has been the 91st percentile. Pharmacy Experience is Required Students need pharmacy experience. If you are a technician you will be asked to provide a copy of your current technician license and complete the pharmacy experience block that will be part of the application. If you are interested in becoming a technician the following website has a list of State Board of Pharmacy approved technician training programs: http://www.dopl.utah.gov/licensing/pharmacy.html If you have not worked as a technician the Admissions Committee recommends shadowing pharmacists in various practice settings for a minimum of 40 hours. A shadowing form must be completed by the pharmacist you shadowed and mailed directly from the pharmacist to the Admissions Committee. The form is available here. Recommendations For the upcoming 2007 application three (3) recommendation forms will be required. One - from a professor you have taken a course with; one - from a supervisor you have worked under; and, one - from a volunteer/community service supervisor. The recommendation form will be available after October 1, 2006. Community Services/Leadership As part of the application you will be requested to provide the Admissions Committee with a summary of your community service activities and any leadership roles you have held. Community service is defined as work you do as a volunteer whether with a church or school organization or something you do on your own. TOEFL Internet-based test For students whose first language is not English the TOEFL iBT must be taken. This test has four components: reading, listening, speaking and writing. A minimum score of 25 must be obtained for the speaking component and a total score of 61 must be obtained for all sections in order to make an application to the Doctor of Pharmacy Professional Program. Information on the TOEFL iBt can be found at: www.ets.org. Statistics from the last application process The Admissions Committee interviewed 130 applicants out of an applicant pool of 240 for the entering class of 2006. Forty-eight students were accepted. The average pre-professional GPA for the entering class is: 3.56. The average composite PCAT score for the entering class is: the 90th percentile. For questions regarding Admission or Applications please contact Marion Lennberg at (801) 581-7503 in the College of Pharmacy Admissions Office or send email to: PharmD.Admissions@pharm.utah.edu Thank you for your interest in the University of Utah College of Pharmacy About.com: Buying Prescription Drugs in Mexico - Offers the pros and cons and further considerations including bringing the medications back through customs. Argus Health Systems, Inc. - Provides pharmacy information technology, value-added administration, and claims processing. Learn about Argus, its products, services, and career information. Assorted ACPE Acredited Pharmacy CE - Comprehensive database of free online ACPE-accredited Pharmacy Continuing Education(CE); database contains more than 10 years worth of free ACPE credits; fee CE's also included. Baker APS - Pharmacy automation products, from pill counting to robotic systems and from design services to pharmacy workflow software. Brookcare Pharmacy Services - Provides over the counter and prescription drug pharmacy services to Assisted Living residences, Alzheimer's Care residences and skilled nursing facilities. Comprehensive Pharmacy Services - The Nations Leading Pharmacy Management Company. Since 1971 Comprehensive Pharmacy Services has provided our clients the highest level of pharmacy services throughout the continuum of the overall healthcare system. Dr. Ahmed Elgarhi - Egyptian pharmacist offers data on drug interaction , precautions in pregnancy and pharmacy education in U.S.A. Drug Store News - Information about the drug store industry, trends, news articles, links. DrugInfoNet.com - The Internet source for healthcare information. Provides both information and links to areas on the web concerning healthcare and pharmaceutical-related topics. This free service is brought to you to improve your education as consumers and healthcare professionals. FutureRx.com - A community with discussion forums that focus on future prescription drugs in the pipelines for various diseases. Health Central: People's Pharmacy - Provides drug and health information to consumers. Articles, drug and herb libraries, home remedies, in-depth guides, answers to frequently asked questions, and summaries of radio programs. The Hospital Pharmacist Journal - Full text of Hospital Pharmacist plus jobs in hospital pharmacy. InPharm.com - The leading pharmaceutical resource on the Internet - healthcare industries; news, views, jobs, directories of agencies, professional organisations and freelancers, along with thousands of links out into the Internet. Irish Pharmacy Pages - News and views about Irish Pharmacy with particular interest to community pharmacists. Johnston Rorke - Pharmacy Services - Accountant specialising in Pharmacy Advice. Over 150 pharmacy clients. The Journal of Pharmacy Technology - For both pharmacists and technicians, jPT provides valuable information for those interested in the entire body of pharmacy practice. Maxor - Maxor is committed to the cost-effective delivery of quality products and services through our pharmacy benefit management, specialty injectables, and other services. Meditec Pty., Ltd. - Delivering automation products to pharmacists around the world. Mypharmacy - Health Advice - A UK pharmacist shares his knowledge and experience on keeping healthy, and what to do when you are not so well. National Co-op Pharmacy Branches - Health advice and NCC store locator. Numark Pharmacists - Advice about diseases and conditions, herbal remedies and homeopathy. Ask the pharmacist a question, shop online or just find your local Numark Pharmacist. Paramount Data, LLC - Software for pharmacists involved with extemporaneous pharmaceutical compounding (CompoundIt(r)) and other clinical pharmacy related software. Paul Hsiao, PharmD's Clinical Pharmacy Center - Offers pharmacy/medical related news. PDR.net - Offers healthcare information tailored to physicians, nurses, pharmacists, physicians assistants and consumers. Pharm Vision - Providing quality pharmacy and health information to empower consumers to make better informed healthcare decisions. PharmaCE - Pharmacist & Technician Continuing Education - ACPE-approved continuing education from the publisher of The Annals of Pharmacotherapy and the Journal of Pharmacy Technology. The PharmaChannel - Web-based information services designed to inform and connect the Canadian Pharmacy community, and anyone with an interest and role in this important sector of the healthcare industry. Pharmacist.com - Source for pharmacy news, drug information, jobs, continuing education, books and resources. Pharmacist's Guide to Drug and Medical Information on the Internet - Clinical Pharmacist's web page containing links to helpful and informative drug and medical information sites. Drug databases are available. PharmacoEthics - Dedicated to the exploration of ethical issues related to the development, promotion, sales, prescription, and use of pharmaceuticals. Includes articles, news stories, organizations and links. Pharmacy Choice - Provides online pharmacy news, continuing education, career services, drug resources and pharmacy business solutions for today's pharmacists and pharmacy related industries. Pharmacy Compounding Customizes Prescription Drugs - FDA Consumer magazine feature article on pharmacy compounding laws. Pharmacy OneSource - The "one" source for information and resources for the pharmacy profession. The Pharmacy Student's Guide to Life - A place for students to get guidance and support. PharmaSource.com - Provides customized pharmacy management services to hospitals and health care systems including staffing, clinical programs, regulatory compliance and inventory control. PharmaSYST - Pharmacy with an Engineering Focus - Designed to blend the professions of pharmacy and industrial engineering and explore the possibilities of pharmacy informatics. PharmCatalyst - For retail pharmacists, technicians, and pharmacy students needing information on pharmacists continuing education, technician CE, jobs, drugs, herbs and diseases. Pharmex.com - Since 1954, Pharmex has worked with pharmacies to develop products and services designed to improve efficiency and enhance pharmacy operations. Products include pharmacy opening kits, prescription laser and thermal forms, warning labels, fonts, and other pharmacy and business supplies. Physician's Pharmilink - A one-stop resource for ordering free pharmaceutical samples from leading manufacturers - 24 hours a day, 7 days a week. Exclusively for physicians. Prodigy Data Systems, Inc. - Specializing in pharmacy management software. Proxymed Pharmacies Solutions and Services - Online service that allows pharmacy staff to process physician prescriptions and refill requests, check formularies and drug interactions, and file claims for reimbursement. Rx30 Pharmacy Management Systems - Pharmacy software available on the medical market. Rx Tech School - Offers review courses and manuals for pharmacy technicians who need to pass the PTCB exam. RxAmerica - A leading Pharmacy Benefits Management provider, offering proven solutions and tools to improve the health of your members while reducing overall benefits cost. Includes FAQs, news, careers and contact details. RxDesktop - Includes metric to standard conversions, common medical abbreviations, and a rebate program. Presented by Taro Pharmaceuticals U.S.A. Inc. RXinsider - Free pharmacy training programs, pharmacy news, Spanish for pharmacists, career opportunities, CE's, and industry stocks. RxRelay.com - Provides medical information delivery services for doctors, pharmacies, patients, and healthcare organizations free of charge. RxSystems, Inc. - Established in 1979 by Richard Jensen, is a privately-owned company specializing in the manufacturing and distribution of pharmacy-related products. Student Doctor Network - Pharmacy Forums - Online discussions for pharmacy students and practitioners. Synthetica - Located in Oslo and is an efficient, flexible, and independent synthesis laboratory. Broad experience in the synthesis of organic compounds of wide structural variety. US FDA: Buying Medicines and Medical Products Online - FAQ on health concerns and legal aspects of buying medications over the Internet and from foreign sources. -------------------------------------------------------------------------------- Do you envision a career helping people understand the effects of medication on their body? Do you see yourself collaborating with health care professionals to determine effective drug therapy for patients? With the Doctor of Pharmacy (Pharm.D.) degree from USP, you'll gain a competitive edge in one of the fastest-growing professions in health care. Why USP? USP is the only place to study pharmacy. You won't do any better than nearly 200 years of experience in the profession. In 1821, we established the first college of pharmacy in North America. Philadelphia College of Pharmacy's long tradition of educating pharmacists to be leaders in health care is built on our unique combination of: A broad curriculum that integrates liberal arts and sciences courses with pharmacy and health sciences courses. You'll study the complex nature of drugs and their effects, the regulatory and administrative aspects of contemporary pharmacy practice, and applications of information technology in health care. In addition, you'll learn to interact with other health care professionals and educate patients and consumers regarding medication use. Capstone courses in human disorders and medication through which you'll explore drug therapy in the management and prevention of many disease states, work directly with data systems records that simulate those used in pharmacy practice, and develop drug therapy regimens using data from actual patients in our Center for Advanced Pharmacy Studies (CAPS). Clerkship experiences in a variety of pharmacy practice settings in community and hospital pharmacies, clinics and managed care organizations, pharmaceutical industry sites, regulatory agencies, and research laboratories. Faculty who are leading scientists, researchers, and practicing pharmacists. Many have held elected leadership positions in the most prominent pharmacy and scientific organizations, authored nationally renowned textbooks, and received prestigious awards for their teaching and professional accomplishments. Opportunities to develop mentoring relationships with pharmacists from all types of practice settings who participate extensively in professional courses on our campus. Preparation to sit for the licensing examination. Licensure is required to enter the pharmacy profession. Your Life as a Pharmacist Pharmacists work in a variety of settings such as community pharmacies, hospitals, or clinics. Other possibilities include home health care agencies, government settings, and industry settings where you might work on drug discovery and development, clinical trials, sales and marketing, production, quality assurance, drug information, or regulatory affairs. Pharmacists work closely with other health professionals to select appropriate drug therapy for patients, evaluate the success of the therapy, and ensure that patients understand their medications. Your Future in Pharmacy Increased medication and health care needs of an older population, more effective drugs to treat and prevent diseases, and a growing population have resulted in a shortage of pharmacists nationwide. The employment outlook for pharmacists is “very good,” according to the U.S. Department of Labor. New opportunities are emerging for pharmacists in managed-care organizations and for pharmacists trained in research, disease management, and pharmacoeconomics, the science of determining the costs and benefits of different drug therapies. As a USP Pharm.D. graduate, you will be recognized as a highly competent professional, and in demand among employers because of the thorough science, clinical, and research background you'll acquire. More than 90 percent of recent graduates are placed in positions before graduation. Hands-on Learning at USP Throughout the Pharm.D. program, you'll apply the knowledge and skills you develop. You'll use the latest information technology to solve complex drug information questions, prepare specialized dosage forms in our laboratories, and assess a patient's response to drug therapy by doing physical exams and interpreting laboratory results from blood tests and other types of tests. Many USP Pharm.D. students work in pharmacies during semester breaks and summers. Whether you are interested in working at a community or hospital pharmacy or exploring diverse opportunities within the pharmaceutical industry, the Public Health Service, or a variety of community health initiatives, we will help you find positions that offer an interesting and rewarding start to your career. In your final year, you will put your skills to work during a clerkship in a variety of pharmacy practice settings including some of the nation's leading hospitals, retail pharmacy chains and independent pharmacies, clinics, pharmaceutical companies, managed care organizations, drug information centers, regulatory agencies, and research organizations. Learn from the Best Preparing well-educated and experienced Pharm.D. graduates requires the best faculty in the industry. You'll learn from people like: Steve Sheaffer, Pharm.D., a past president of the American Society of Health-system Pharmacists, one of the nation's largest and most respected professional organizations for pharmacists who practice in hospitals, clinics, and other types of institutions. After graduating from PCP/USP, Dr. Sheaffer completed additional training at the Crozer Health System. After many years of practice and administrative experience, he returned to USP to coordinate our clerkship and experiential learning program. He is also the advisor for our student chapter of ASHP. Sarah Spinler, Pharm.D., who completed her Pharm.D. degree at the University of Minnesota and post-doctoral training at the University of Illinois. Dr. Spinler is a nationally known expert on cardiovascular pharmacotherapy and investigates ways to improve long-term survival and quality of life after heart attacks. Joan Tarloff, Ph.D., who holds a pharmacy degree from the University of Toledo College of Pharmacy and a Ph.D. from the Medical College of Ohio. After post-doctoral training and experience in the pharmaceutical industry, Dr. Tarloff established a research program at USP to study ways to improve cancer drugs. She teaches pharmacology and physiology courses. Lisa Davis, Pharm.D., BCPS, BCOP, one of about only 300 board-certified oncology pharmacy specialists in the country. Dr. Davis trained at the University of Arizona and the University of Kentucky before coming to USP in 1986. Together, with other leading cancer researchers in Philadelphia, she works on developing new drugs to treat all types of cancers. She shares her experience and insight with students in the classroom, her research laboratory, and through her practice at one of the area's top cancer centers. William McGhan, Pharm.D.,Ph.D., recognized worldwide as a leader in the area of pharmacoeconomics, the field that studies the cost-effectiveness and economic impact of drug therapy. Cathy Poon, Pharm.D., who received her pharmacy degree from St. John's University and completed post-doctoral training at the Medical University of South Carolina and the University of Oklahoma where she developed expertise in pediatric pharmacotherapy. Dr. Poon coordinates one of the capstone courses, teaches most of the pediatric course material, and maintains an active clinical practice in a pediatric intensive care unit. Pardeep Gupta, Ph.D., who holds a pharmacy degree from Panjab University in India and a Ph.D. in pharmaceutics from the University of Wisconsin. Dr. Gupta has an active research program in which he is developing ways to administer high-tech, protein-based drug products. He teaches in the pharmaceutics courses and labs. The USP Pharmacy Curriculum Note: Curriculum information below is for students entering USP in Fall 2006 and beyond. For students enrolled in the PharmD program prior to Fall 2006, please see the University Catalog, your advisor, or refer to the most recent publication of the Polonius for a description of the curriculum. Our intensive Doctor of Pharmacy (Pharm.D.) program is built upon a strong foundation in the physical, biological, chemical, and social sciences, and the liberal arts. After completing all required courses at USP with a cumulative G.P.A. of 2.70 or greater and a cumulative natural science/math G.P.A. of 2.30 or greater, you will progress to the first professional year (third year) of the curriculum. The professional pharmacy curriculum includes courses in: Pharmaceutical sciences, including pharmacology and pharmaceutics, which is the study of dosage formulations and drug stability. Clinical pharmacy, emphasizing patient assessment skills and application of rational drug therapy. Pharmacy practice and management, including evaluation of drug information, regulatory and ethical issues related to pharmacy practice, and basic management and administrative skills. You will participate in an introductory pharmacy practice experience. This will begin in your first professional year and continue through your second and third professional years. Forty weeks of clinical training will occur in your final year. As a student in the Pharm.D. program, you will learn how to: Educate patients on the use, composition, and effects of drugs. Dispense drugs prescribed by physicians and other health practitioners. Counsel patients about medications and their uses. Advise physicians and other health practitioners on the selection, dosages, interactions, and side effects of medications. First Year General Biology I and II General Chemistry I and II Chemistry Lab College Composition Mathematical Analysis I and II Pharmacy Orientation Physical Education Social Science Fundamental Requirement Second Year Human Anatomy/Histology Organic Chemistry I and II Organic Chemistry Lab Intellectual Heritage I and II Physics I Social Science Fundamental Requirement Introduction to Pharmacy & Healthcare Core Distribution Requirements Microbiology Third Year Physiology I and II Core Distribution Requirement Introduction to Communications Biostatistics/research design Biochemistry Physiology II Professional Experience I Introduction to Clinical Pharmacy Skills Immunology Molecular Biology Pharmaceutical Calculations Fourth Year Professional Experience II Drug Information/Literature Evaluation I Pharmaceutics I and II Pharmacology/Medicinal Chemistry I and II Pharmacotherapeutics/Human Diseases I and II Practice Lab & Case Studies I and II OTC Medications and Devices Pharmacy Management Fifth Year Professional Experience III Pharmacology/Medicinal Chemistry III Pharmacotherapeutics/Human Diseases III and IV Practice Lab & Case Studies III and IV Law, Ethics Applied Pharmacoeconomics Literature Evaluation II Free Elective Professional Electives Clinical Pharmacokinetics Professional Seminar Sixth Year Advanced Pharmacy Practice Experience (eight rotations/five weeks in length) Total credits: 211 Professional Connections in Pharmacy Through involvement in student pharmacy organizations, you'll have an unprecedented opportunity to learn more about careers in all types of pharmacy practice while networking with your peers from our pharmacy school and others across the nation. In addition, our faculty advisors, alumni, and other practitioners will help you develop the leadership and teamwork skills that will accelerate your career and make you even more competitive in the field. Our professional pharmacy organizations include: American Pharmacist Association/Academy of Students of Pharmacy Student Chapter, Academy of Managed Care Pharmacy Student Chapter of Pennsylvania Society of Health-System Pharmacists/American Society of Health-System Pharmacists Student Chapter of the National Community Pharmacists Association In addition, you'll have many more opportunities to network with USP alumni and working professionals through our career pathways program and other activities. Doctor of Pharmacy Program Frequently Asked Questions 1) How long is the program? 2) What are the requirements for admission? 3) Don't computers/pharm techs do all the things a pharmacist can do? 4) Can you describe the sixth-year rotations? In what areas of pharmacy will I be working? Answers: 1) The Doctor of Pharmacy program is six years in duration if you enter as a first year student. 2) The most important item reviewed by the Admission Committee is the high school transcript. A strong math and science background provides an excellent foundation for professional study. The average GPA for admitted students is 3.5. The average SAT score for students admitted to the University is 1100, while the ACT average is 25. Students applying for the third year of the program must complete the Pharmacy College Admission Test (PCAT). 3) No, all questions related to prescriptions, health matters, or drug information must be referred to the licensed pharmacist. Such counseling cannot be done by either pharmacy technicians or by computers. 4) Specialty areas of practice include nuclear pharmacy, infectious diseases, oncology, psychiatry, pediatrics, nutrition, and geriatrics. You will gain experience in hospitals, clinics, retail settings, laboratories, and a variety of other settings. For more information……… Diploma - Pharmacy Technician In the pharmacy technician program, you'll learn to work closely with pharmacists to provide medication and health care products to patients. Study includes: Receiving prescriptions from doctors and hospitals Preparing prescriptions for patients Verifying insurance and prescription information Assisting the pharmacist with everyday duties With the right credentials, you can: Work for a retail pharmacy, local druggist, grocery store, or hospital. Be an important part of a rewarding profession. Demand for pharmacy technicians will rise 29% by 2012. Because of expansion of retail pharmacies and other employment settings, good job opportunities are expected for full-time and part-time pharmacy technicians with formal training. That means more employment opportunity for you Questions Related to Pharmacy Technician Registration What are the prerequisites for being eligible for registration? A pharmacy technician must either hold current certification from the Pharmacy Technician Certification Board (PTCB) or satisfactorily complete a Virginia Board of Pharmacy approved training program and pass a Board of Pharmacy approved examination. An applicant must also submit an application form with fee to the board for review. Where can I get an application form? Applications on our website on the applications and forms page or by contacting the board office at 804-662-9911. What is the fee for registration? A person who wishes to register as a pharmacy technician must submit a completed application and a $25 fee to the Board of Pharmacy. Checks are to be made payable to the “Treasurer of Virginia”. The application will usually be reviewed and verified, and processed within 7 to 10 business days. A pharmacy technician must maintain their registration in order to continue performing technician tasks. This requires a $15 annual renewal fee and the completion of 5 hours of pharmacy continuing education annually. How do I know if the board has approved a training program? Approved training programs may be identified by checking our website for a listing. Click on the “Technicians” link then on “List of Approved Pharmacy Technician Training Programs.” A person who has completed a training program prior to board approval need not retake the entire program after it is approved provided there have been no significant changes in the program or provided the person receives additional training on the portion that has been changed. How do I request to take the PTCB test? Information about applying to take the PTCB can be found at www.ptcb.org. How do I sign up for the Virginia examination? The Virginia Pharmacy Technician Exam can be scheduled by contacting LaserGrade at 1-800-211-2754 to register for the exam. A Study Guide for the exam can be downloaded from the www.advancepharmacy.org website. Where and how often will the Virginia examination be offered? Testing for the Virginia examination will be held at a LaserGrade Computer Testing, Inc. facility. There are currently 11 testing locations in Virginia offering exams six days a week during normal business hours; some offer exams on Sundays and some evenings as well. As a general rule, an exam will be scheduled within 10-14 days of receiving the application. The link on the Board of Pharmacy website will allow you to locate the testing facility closest to you. What is the cost to take the PTCB or the Virginia examination? Check the PTCB website for current fee information for their exam. The cost for the Virginia examination is $55. Do persons newly hired to be pharmacy technicians have a “grace period” before they need to be registered with the Board of Pharmacy? Provided a person is enrolled in an approved pharmacy technician training program, that person can work as a pharmacy technician for up to nine months while going through the process to become registered. After the nine months, registration is required in order to continue working as a pharmacy technician. Every pharmacy using such a person shall have documentation on site and available for inspection showing that the person is currently enrolled in an approved training program, and the start date for the training. The pharmacist to technician ratio must be considered in this scenario. The new ratio is 1 pharmacist to 4 technicians. Of the 4 technicians only 2 may be “technicians in training” as described above. May I work in a pharmacy as a technician if I plan to take the PTCB exam in the future? Applying to take the PTCB is not considered to be enrollment in a Board approved training program. You may not work as a pharmacy technician unless you are registered or enrolled in a Board approved training program (see above). If you want to work while waiting to take the PTCB, you must be enrolled in an approved program. What are the requirements for continuing education? Guide to Continuing Pharmacy Education Requirements for Pharmacy Technicians Registered Pharmacy Technicians are required to obtain a minimum of 5 contact hours of continuing pharmacy education (CPE) per calendar year in order to maintain an active registration. This brochure is intended to help pharmacy technicians to better understand the CPE requirements. The Board of Pharmacy prepared this document as a guide in order to promote compliance with the statutes and regulations concerning CPE. Q. What is the minimum number of CPE hours required? When do I have to take them? A. The law requires a minimum of 5 contact hours per calendar year. You should receive all your certificates prior to sending in the license renewal in order to properly attest that you have met the requirements. The certificates should be dated between January 1 and December 31, inclusive, of the calendar year they are used. Q. May I carry over my extra hours to next year? What if I’m licensed in another state? A. No. The law does not allow any carryover. Although some states permit courses to be taken over a two-year period, Virginia does not. This means a pharmacy technician registered in Virginia must obtain at least 5 CPE hours each and every calendar year. Q. May I get an extension? A. Yes. A one-time extension may be possible if the request is made in writing to the Board prior to renewal. Q. I obtained my license in Virginia earlier this year. Do I need CPE credits now to renew my license for next year? A. Yes. Q. Do I have to obtain credits from any particular providers? A. Yes. In order to meet the CPE requirements, courses must be either ACPE approved or certain Category 1 CME or a program approved by the Virginia Board of Pharmacy. Any credits taken that do not meet these requirements cannot be used to satisfy CPE hours. Q. I’ve lost my certificates. What should I do? A. You should obtain a replacement from the course provider. ACPE approved providers must keep this information for at least five years. Some providers make it possible to print duplicates from their web sites. Q. Do I have to keep my certificates at work? A. No. Pharmacy technicians must keep their original certificates at their address of record. Pharmacy technicians are encouraged to keep an extra copy elsewhere, as a precaution, in the event the originals cannot be located. Q. I’ve taken a course near the end of the year and didn’t get my certificate until the next calendar year. How are the hours applied? A. The date the certificate is issued controls unless it is a “live” course. Live courses are counted on the date of attending the course. Q. What should I do if the Board audits me? A. Whenever the Board may contact you, you should respond promptly. Failure to respond may cause the Board to pursue disciplinary action. If the Board audits your continuing pharmacy education credits, find your original certificates and make a copy for yourself. Send the originals to the Board office by the deadline in the letter. Although not required, you may want to send your response by certified mail so that you have proof of mailing. If you do not have enough credits for the year(s) in question, you may send an explanation to the Board with your certificates. Your explanation will be taken into account when the Board determines whether disciplinary action should be pursued. If you have lost some or all of your certificates, you should immediately contact the respective providers for a replacement certificate and inform the Board of your actions. Current Board guidelines call for a monetary penalty of $100 for each missing hour of CPE, and $300 for each renewal falsely attesting to CPE compliance. Q. What can I do to keep my records better organized? A. Here are some suggestions that may help you to keep your CPE records organized and avoid disciplinary action: 1. Store your original certificates in a safe place where they are unlikely to be thrown out by mistake. 2. Keep a copy of your certificates, or at least a record of the course number, provider and date, in a secondary safe location (not with the originals). These are a back-up if you lose the originals. 3. BEFORE YOU RENEW YOUR LICENSE, look at your original certificates and verify compliance with the CPE requirements: 5 contact hours in pharmacy continuing education (some courses may carry a different number of credits for other professions) ACPE approved (look for the logo), or Category 1 CME courses focused on pharmacy, pharmacology or drug therapy, or a program approved by the Virginia Board of Pharmacy Each of your CPE certificates show a “date issued” on or prior to December 31 for the year in question. Note that it is your responsibility to maintain your CPE records for the current and two previous calendar years. You must complete the hours before you send in the licensure renewal. Top of Page Prescription Blank Requirements In 2003, the General Assembly eliminated the Virginia Voluntary Formulary as the standard for generic substitution for several reasons, and put into place the FDA "Orange Book" as the new standard. For this reason, the prescription blank requirement for a check box "Voluntary Formulary Permitted" had to be removed from law. There is now no set form for a written prescription blank. Because the term "brand medically necessary" is a nationally accepted term and one that is required by Medicaid in order to ensure payment for a branded product, this phrase was adopted in Virginia law as the required term to prohibit generic substitution. The new law did give prescribers three years to use up all their "old" prescription blanks before the new requirement took effect. After July 1, 2006, checking an old "dispense as written" box will not prohibit generic substitution. Below are some frequently asked questions on the subject: Q. When ordering new prescription pads, should the prescriber remove the Dispense as Written and Virginia Voluntary Formulary boxes from new prescription pads? A. Yes. After July 1, 2006, the Dispense as Written box will not prohibit substitution with a therapeutically equivalent drug, and the Virginia Voluntary Formulary is no longer recognized as the standard of therapeutic equivalence. The new standard is FDA's Orange Book which can be found on-line. http://www.fda.gov/cder/ob/default.htm Q. Can the prescriber put the phrase” Brand Medically Necessary” in the form of a check-box on the prescription pad or "stamp" the phrase on the prescription? A. Yes. The law does not state in what form the phrase should appear. However, the prescriber must handwrite the phrase in order to ensure payment for a branded product for Medicaid patients when there are generics available in the marketplace. Q. Can prescribers continue to use and deplete their current stock of the old two-check-box formatted prescription blanks after July 1, 2006? A. Yes. However, after this date, checking the "dispense as written" box will not prevent substitution. Prescribers will still need to indicate “Brand Medically Necessary” on the prescription when they do not want a generic dispensed. Q. Does this law that allows a pharmacist to substitute a "therapeutically equivalent" drug mean that a pharmacist can substitute a different drug within a therapeutic class? A. No. This law refers to what is commonly called generic substitution. The terminology used in the law is somewhat confusing, but the definition of "therapeutically equivalent drug product" in the law means a drug that contains the same active ingredient(s) identical in strength, concentration, and dosage form, and has been evaluated by FDA and deemed to be therapeutically equivalent to the brand name drug. Q. Do prescriptions have to be written on special security paper to assist in preventing forgeries? A. No. Virginia law does not require this at this time. Q. What are other requirements for prescriptions? A. See Board of Pharmacy, Guidance Document 110-35 (word .doc) available on the Board's website under guidance documents. Statutes related to generic substitution requirements with relevant phrases bolded: excerpt from §54.1-3401. Definitions "Therapeutically equivalent drug products" means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the United States Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book." § 54.1-3408.03. Dispensing of therapeutically equivalent drug product permitted. A. A pharmacist may dispense a therapeutically equivalent drug product for a prescription that is written for a brand-name drug product unless (i) the prescriber indicates such substitution is not authorized by specifying on the prescription, "brand medically necessary" or (ii) the patient insists on the dispensing of the brand-name drug product. In the case of an oral prescription, the prescriber's oral dispensing instructions regarding substitution shall be followed. B. Prescribers using prescription blanks printed in compliance with Virginia law in effect on June 30, 2003, having two check boxes and referencing the Virginia Voluntary Formulary, may indicate, until July 1, 2006, that substitution is not authorized by checking the "Dispense as Written" box. If the "Voluntary Formulary Permitted" box is checked on such prescription blanks or if neither box is checked, a pharmacist may dispense a therapeutically equivalent drug product pursuant to such prescriptions. C. If the pharmacist dispenses a drug product other than the brand name prescribed, he shall so inform the purchaser and shall indicate, unless otherwise directed by the prescriber, on both his permanent record and the prescription label, the brand name or, in the case of a therapeutically equivalent drug product, the name of the manufacturer or the distributor. Whenever a pharmacist dispenses a therapeutically equivalent drug product pursuant to a prescription written for a brand-name product, the pharmacist shall label the drug with the name of the therapeutically equivalent drug product followed by the words "generic for" and the brand name of the drug for which the prescription was written. D. When a pharmacist dispenses a drug product other than the drug product prescribed, the dispensed drug product shall be at a lower retail price than that of the drug product prescribed. Such retail price shall not exceed the usual and customary retail price charged by the pharmacist for the dispensed therapeutically equivalent drug product.

Phendimetrazine (Bontril®) is a weight loss medication. Phendimetrazine is chemically related to amphetamines and is a Schedule III drug under the Convention on Psychotropic Substances. In the United States, phendimetrazine is a Schedule III controlled substance under the Uniform Controlled Substances Act of 1970. Phendimetrazine is used clinically in the form of phendimetrazine tartrate. Approximately 30% of a given dose of phendimetrazine is metabolized into phenmetrazine, which may account for part of its anorectic effect, and probably also influences abuse potential; individuals who metabolise a greater proportion of phendimetrazine into phenmetrazine are more likely to develop problems with dependence and addiction. Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S.3S)-3, 4-Dimethyl-2-phenylmorpholine L-(*)-tartrate (1.1). Its molecular weight is 341.36. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene. Each tablet, for oral administration, contains 35mg of phendimetrazine tartrate. In addition, each tablet contains the following inactive ingredients: Lactose USP, Magnesium Stearate NF, Colloidal Silicon Dioxide, Microcrystalline Cellulose NF, Starch NF (Modified Corn Starch). Additional inactive ingredients are present as follows: Phendimetrazine 35mg Gray Tablet Contains: Activated Charcoal USP. Sterotex Food Grade. Phendimetrazine 35mg Pink Tablet contains: FD&C Red #3. Phendimetrazine 35mg Speckled Tablet contains: Calcium Stearate NF, FD&C Blue #1, FD&C Yellow #5, and sucrose. What are phendimetrazine capsules or tablets? (Back to top) PHENDIMETRAZINE (Bontril PDM®, Phendiet®, Phenzene®, Plegine®) helps you lose weight. Combined with a reduced calorie diet, it can help you reduce weight by decreasing your appetite. Generic phendimetrazine is available. What should my health care professional know before I take phendimetrazine? (Back to top) They need to know if you have any of these conditions: •diabetes •glaucoma •heart disease •high blood pressure •thyroid disease •taken other medicines to lose weight in the past year •an unusual or allergic reaction to phendimetrazine, other medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should I take this medicine? (Back to top) Take phendimetrazine capsules or tablets by mouth. Follow the specific directions on the prescription label. Swallow the capsules or tablets with a drink of water at least 1 hour before eating. Do not take your medicine more often than directed. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. What if I miss a dose? (Back to top) If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. What drug(s) may interact with phendimetrazine? (Back to top) •linezolid •medicines for blood pressure •medicines for diabetes •medicines for mental depression •other medicines or herbal products for weight loss or to decrease appetite Tell your prescriber or health care professional about all other medicines you are taking, including nonprescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from taking phendimetrazine? (Back to top) Side effects that you should report to your prescriber or health care professional as soon as possible: •breathlessness on exertion •chest pain •depression or severe changes in mood •dry cough •heart palpitations •increased blood pressure •severe dizziness •problems urinating •vomiting Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •a false sense of well being •blurred vision or other eye problems •changes in sexual ability or desire •constipation •diarrhea •difficulty sleeping •dizziness •dry mouth •fatigue •flushing •headache •irritability •nervousness or restlessness •nausea •sweating •unpleasant taste What should I watch for while taking phendimetrazine? (Back to top) Notify your physician immediately if you become short of breath while doing your normal activities. Keep in mind that phendimetrazine was intended to be used in addition to a healthy diet and exercise. The best results are achieved this way. While your prescriber or health care professional will most likely prescribe phendimetrazine for only a few months; however, some people have used it for longer periods. Eventually your weight loss may "level out". At that point, the drug will only help you maintain your new weight. Do not increase or in any way change your dose without consulting your prescriber. Do not drive, use machinery, or do anything that requires mental alertness or physical coordination until you know how phendimetrazine affects you. Alcohol can increase the possibility of experiencing side effects with phendimetrazine. Therefore, it is best to avoid alcoholic drinks. Where can I keep my medicine? (Back to top) Keep out of the reach of children in a container that small children cannot open. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date. Use caution when driving, operating machinery, or performing other hazardous activities. Phendimetrazine may cause dizziness, blurred vision, or restlessness, and it may hide the symptoms of extreme tiredness. If you experience these effects, avoid hazardous activities. • Phendimetrazine is habit forming. You can become physically and psychologically dependent on this medication, and withdrawal effects may occur if you stop taking it suddenly after several weeks of continuous use. Talk to your doctor about stopping this medication gradually. • Do not crush, chew, or open any "once-daily" phendimetrazine tablets or capsules. Swallow them whole. Phendimetrazine is a sympathomimetic amine, which is similar to an amphetamine. It is also known as an "anorectic" or "anorexigenic" drug. Phendimetrazine stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite. • Phendimetrazine is used as a short-term supplement to diet and exercise in the treatment of obesity. • Phendimetrazine may also be used for purposes other than those listed in this medication guide. Cardiovascular - Palpitation, chest pain, tachycardia, arrhythmias and hypertension are common; cardiovascular collapse can occur in severe poisoning. Myocardial ischaemia, infarction and ventricular dysfunction are described. Central Nervous System (CNS) - Stimulation of CNS, tremor, restlessness, agitation, insomnia, increased motor activity, headache, convulsions, coma and hyperreflexia are described. Stroke and cerebral vasculitis have been observed. Gastrointestinal - Vomiting, diarrhoea and cramps may occur. Acute transient ischaemic colitis has occurred with chronic methamphetamine abuse. Genitourinary - Increased bladder sphincter tone may cause dysuria, hesitancy and acute urinary retention. Renal failure can occur secondary to dehydration or rhabdomyolysis. Renal ischaemia may be noted. Dermatologic - Skin is usually pale and diaphoretic, but mucous membranes appear dry. Endocrine - Transient hyperthyroxinaemia may be noted. Metabolism - Increased metabolic and muscular activity may result in hyperventilation and hyperthermia. Weight loss is common with chronic use. Fluid/Electrolyte - Hypo- and hyperkalaemia have been reported. Dehydration is common. Musculoskeletal - Fasciculations and rigidity may be noted. Rhabdomyolysis is an important consequence of severe amphetamine poisoning. Psychiatric - Agitation, confusion, mood elevation, increased wakefulness, talkativeness, irritability and panic attacks are typical. Chronic abuse can cause delusions and paranoia. A withdrawal syndrome occurs after abrupt cessation following chronic use. 2.3 Diagnosis The diagnosis of acute amphetamine poisoning is made on the history of exposure or abuse, and the characteristic features of CNS and cardiovascular stimulation. The presence of amphetamines in urine or blood can support the diagnosis but is not helpful in management. Whilst some patients show signs of toxicity at blood concentrations of 20 µg/L, chronic abusers of amphetamine have been known to have blood concentration of up to 3000 µg/L. 2.4 First aid measures and management principles Management of amphetamine and its complications is essentially supportive. The initial priority is stabilisation of the airway, breathing and circulation. Monitoring of pulse, blood pressure, oxygenation, core temperature and cardiac rhythm should instituted. Supplemental oxygen should be administered. Specific supportive care measures that may be necessary include: maintenance of hydration, control of seizures, relief of agitation, control of hyperthermia, control of hypertension, management of rhabdomyolysis. Decontamination with oral activated charcoal is appropriate if the patient is conscious. There are no suitable methods of enhancing elimination of amphetamine and no specific antidotes. 3. PHYSICO-CHEMICAL PROPERTIES 3.1 Origin of the substance Synthetic 3.2 Chemical structure Phendimetrazine tartrate Chemical name: 3,4-Dimethyl-2-phenyl-morpholine tartrate Other chemical names: D-3,4-Dimethyl-2-phenyl-morpholine tartrate Morpholine, 3,4-dimethyl-2-phenyl-, (+)-, tartrate (1:1) Molecular formula: C12H17NO,C4H6O6 Molecular weight: 341.4 3.3 Physical properties Use caution when driving, operating machinery, or performing other hazardous activities. Phendimetrazine may cause dizziness, blurred vision, or restlessness, and it may hide the symptoms of extreme tiredness. If you experience these effects, avoid hazardous activities. habit Phendimetrazine is habit forming. You can become physically and psychologically dependent on this medication, and withdrawal effects may occur if you stop taking it suddenly after several weeks of continuous use. Talk to your doctor about stopping this medication gradually. nocrush Do not crush, chew, or open any "once-daily" phendimetrazine tablets or capsules. Swallow them whole. What is phendimetrazine? Phendimetrazine is a sympathomimetic amine, which is similar to an amphetamine. It is also known as an "anorectic" or "anorexigenic" drug. Phendimetrazine stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite. Phendimetrazine is used as a short-term supplement to diet and exercise in the treatment of obesity. Phendimetrazine may also be used for purposes other than those listed in this medication guide. Who should not take phendimetrazine? donot You cannot take phendimetrazine if you * have heart disease or high blood pressure; * have arteriosclerosis (hardening of the arteries); * have glaucoma; * have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the last 14 days; or * have a history of drug or alcohol abuse. Before taking this medication, tell your doctor if you have * problems with your thyroid, * an anxiety disorder, * epilepsy or another seizure disorder, or * diabetes. You may not be able to take phendimetrazine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above. nopreg It is not known whether phendimetrazine will harm an unborn baby. Do not take phendimetrazine without first talking to your doctor if you are pregnant. nobrfeed It is also not known whether phendimetrazine passes into breast milk. Do not take phendimetrazine without first talking to your doctor if you are breast-feeding a baby. How should I take phendimetrazine? Take phendimetrazine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. water Take each dose with a full glass of water. stomach Phendimetrazine is usually taken once a day (sustained release formula) or two to three times daily (immediate-release formula) before meals on an empty stomach. Do not take phendimetrazine in the evening because it may cause insomnia. nocrush Do not crush, chew, or open any "once-daily" phendimetrazine tablets or capsules. Swallow them whole. donot Never take more of this medication than is prescribed for you. Too much phendimetrazine could be very dangerous to your health. rt Store phendimetrazine at room temperature away from moisture and heat. What happens if I miss a dose? donot Take the missed dose as soon as you remember. However, if it is almost time for your next dose or if it is already evening, skip the missed dose and take only your next regularly scheduled dose. A dose taken too late in the day will cause insomnia. Do not take a double dose of this medication. What happens if I overdose? emt Seek emergency medical attention. Symptoms of a phendimetrazine overdose include restlessness, tremor, rapid breathing, confusion, hallucinations, panic, aggressiveness, nausea, vomiting, diarrhea, an irregular heartbeat, and seizures. What should I avoid while taking phendimetrazine? dizzy Use caution when driving, operating machinery, or performing other hazardous activities. Phendimetrazine may cause dizziness, blurred vision, or restlessness, and it may hide the symptoms of extreme tiredness. If you experience these effects, avoid hazardous activities. Do not take phendimetrazine late in the day. A dose taken too late in the day can cause insomnia. What are the possible side effects of phendimetrazine? emt If you experience any of the following serious side effects, stop taking phendimetrazine and seek emergency medical attention: * an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); * an irregular heartbeat or very high blood pressure (severe headache, blurred vision); or * hallucinations, abnormal behavior, or confusion. Other, less serious side effects may be more likely to occur. Continue to take phendimetrazine and talk to your doctor if you experience * restlessness or tremor, * nervousness or anxiety, * headache or dizziness, * insomnia, * dry mouth or an unpleasant taste in your mouth, * diarrhea or constipation, or * impotence or changes in your sex drive. habit Phendimetrazine is habit forming. You can become physically and psychologically dependent on this medication, and withdrawal effects may occur if you stop taking it suddenly after several weeks of continuous use. Talk to your doctor about stopping this medication gradually. Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. What other drugs will affect phendimetrazine? You cannot take phendimetrazine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the last 14 days. Changes in insulin and other diabetes drug therapies may be necessary during treatment with phendimetrazine. Phendimetrazine may reduce the effects of guanethidine (Ismelin). This could lead to an increase in blood pressure. Tell your doctor if you are taking guanethidine. Before taking this medication, tell your doctor if you are taking a tricyclic antidepressant such as amitriptyline (Elavil), amoxapine (Asendin), doxepin (Sinequan), nortriptyline (Pamelor), imipramine (Tofranil), clomipramine (Anafranil), protriptyline (Vivactil), or desipramine (Norpramin). These drugs may decrease the effects of phendimetrazine. Drugs other than those listed here may also interact with phendimetrazine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines. Where can I get more information? Your pharmacist has more information about phendimetrazine written for health professionals that you may read. What does my medication look like? Phendimetrazine is available with a prescription under several brand names. The immediate-release formulation is available in 35 mg tablets and capsules. The sustained-release formulation is available in 105 mg capsules. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.


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