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We collect facts from name-brand reference titles for you, for free. http://www.answers.com [today's views: 1] Drug Strength Quantity Price Status Pharmacy Info PHENTERMINE 30 mg 30 * $69.00 In Stock PHENTERMINE 30 mg 60 * $87.00 In Stock PHENTERMINE 30 mg 90 * $103.00 In Stock * indicates generic Additional Information Why is this medication prescribed Phentermine is used, in combination with diet and exercise, to help you lose weight. It works by decreasing your appetite. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information. What other information should I know Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to phentermine. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. In case of emergency overdose In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911. Copyright 2005 © BestMedValues All rights reserved The products mentioned are trademarks of their respective owners and are not affiliated with or owned by BestMedValues or any of it's affiliated companies. Privacy Policy (as of 04/10/2006) | Terms Of Use Phentermine From Wikipedia, the free encyclopedia Jump to: navigation, search Phentermine Systematic (IUPAC) name 2-methyl-1-phenyl-propan-2-amine Identifiers CAS number 122-09-8 ATC code A08AA01 C01CA11 PubChem 4771 DrugBank APRD00093 Chemical data Formula C10H15N Mol. weight 149.233 g/mol Pharmacokinetic data Bioavailability Peak plasma levels occur within 1 to 3 hours. Absorption is usually complete by 4 to 6 hours Protein binding Approximately 96.3% Metabolism hepatic Half life 16 to 31 hours Excretion Urinary elimination Therapeutic considerations Pregnancy cat. C(United States); ? (Australia) Legal status C-IV (US) Routes Oral Phentermine is a phenethylamine primarily used as an appetite suppressant. It is typically prescribed for individuals who are at increased medical risk because of their weight, as opposed to cosmetic weight loss. Phentermine is sold either as an immediate-release formulation (Adipex®) or as a slow-release resin (Ionamin®, Duromine® in Australia and New Zealand). Contents [hide] 1 History 2 Mechanism of action 3 Clinical use 4 Side effects 5 Contraindications 6 Internet Notoriety 7 Related Article 8 External links 9 References and End Notes [edit] History Phentermine is one of two drugs in the Fen-phen anti-obesity medication, the other being fenfluramine or dexfenfluramine. Fenfluramine was withdrawn from the U.S. market in 1997 after reports of valvular heart disease and pulmonary hypertension. Phentermine is still available by itself in most countries, including the U.S. However, because it is similar to the amphetamines, individuals may develop an addiction to it. Hence, it is classified as a controlled substance in many countries. Internationally, phentermine is a schedule IV drug under the Convention on Psychotropic Substances (PDF file). In the United States, it is classified as a Schedule IV controlled substance under the Controlled Substances Act. [edit] Mechanism of action Phentermine, as many other prescription drugs, works with neurotransmitters in the brain. It is a centrally-acting stimulant chemically related to the amphetamines. It stimulates neuron bundles to release a particular group of neurotransmitters known as catecholamines; these include dopamine, epinephrine (also known as adrenalin), and norepinephrine (noradrenaline). The anorectic activity seen with these compounds would thus seem likely due to this effect on Central Nervous System, which is consistent with current knowledge about Central Nervous System systems and feeding behavior. This is the same mechanism of action as other stimulant appetite suppresants such as diethylpropion, and phendimetrazine. The neurotransmitters signal a fight-or-flight response in the body which, in turn, puts a halt to the hunger signal. As a result, it causes a loss in appetite because the brain does not receive the hunger message. [edit] Clinical use Generally, it is recommended by the Food and Drug Administration (FDA) that phentermine should be used short-term (usually interpreted as 'up to 12 weeks'), while following nonpharmacological approaches to weight loss such as healthy dieting and exercise. However, recommendations limiting its use for short-term treatment may be controversial. One reason given behind limiting its use to 12 weeks is drug tolerance, whereby phentermine loses its appetite-suppressing effects after the body adjusts to the drug. On the contrary, it has been shown that phentermine did not lose effectiveness in a 36-week trial (PMID 11054601). Due to the risk of insomnia, it is generally recommended that the drug be taken either before breakfast or 1-2 hours after breakfast. [edit] Side effects Generally, phentermine appears to be relatively well tolerated.[1] It can produce side effects consistent with its chycardia]], increased alertness, but the incidence and magnitude of these appear to be less than with the amphetamines. Because phentermine acts through sympathomimetic pathways, the drug ug on a long-term basis may develop euphoria and a psychological addiction [edit] Contraindications Phentermine should generally be avoided in patients with: Agitation Allergy/Hypersensitivity to other sympathomimetic amines Atherosclerosis Cardiovascular disease Glaucoma High blood pressure Hyperthyroidism Previous history of drug abuse Additionally, this drug should not be used at the same time or within 14 days following the use of monoamine oxidase inhibitors. [edit] Internet Notoriety Recently, phentermine has drawn the ire of many internet users. The medication is one of the most commonly used terms in spam e-mails and bulletin board postings by bots. [edit] Related Article Obesity Anti-obesity drug [edit] External links MedLine Plus - Phentermine International Programme on Chemical Safety - Phentermine DrugBank:Phentermine TOXNET phentermine on pharmacywebsearch.com Link page to external chemical sources. 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Do not take it more often or longer than directed. MISSED DOSE If you miss a dose of Phentermine, do not double the next dose. Instead, skip the missed dose and resume your usual dosing schedule. NOTES Appetite suppressants are not a substitute for proper diet. For maximum effects, this must be used in conjunction with a diet and exercise program. Do not share this medication with others. PRECAUTIONS Tell your doctor your complete medical history especially if you have high blood pressure, an over-active thyroid, glaucoma, diabetes or emotional problems. Consult with your doctor if you think you are pregnant or before breast-feeding. Alcohol can increase unwanted side effects of dizziness. Limit alcohol use. This drug is not recommended for use in children. Consult your doctor or pharmacist for further information. SIDE EFFECTS Dry mouth, sleeplessness, irritability, stomach upset or constipation may occur the first few days as your body adjusts to Phentermine. If these effects persist or become bothersome, inform your doctor. STORAGE Store at room temperature away from sunlight and moisture. Keep this and all medications out of the reach of children. DISCLAIMER This information is not intended to substitute for professional medical advice. Be sure to contact your physician, pharmacist or other health care provider for more information about this medication. Get Your Cheap Phentermine Prescription Here! Phentermine is an appetite suppressant designed for use as a short term weight loss aid in conjunction with proper diet and exercise. If you are looking to loose weight, Phentermine can be a good solution for you. Through the comprehensive information listed at RxTank, you can find the right pharmacy to buy generic Phentermine online and order a cheap Phentermine prescription at the right price. We can help you find the best pharmacy to buy the medications you rely on. We've have the most comprehensive generic prescription medication listing on the web. Sign up with our membership and from our list of available pharmacies, you can buy generic Phentermine online. Use our price and quantity comparison list below and receive top quality care at affordable prices. To get started in your search, click the first letter of the product in the alphabetic list. If you know the correct spelling of the medication you need, type the product name in the search box. It is that easy to get started… Why is this medication prescribed?Return to top Phentermine is used, in combination with diet and exercise, to help you lose weight. It works by decreasing your appetite. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information. How should this medicine be used?Return to top Phentermine comes in tablets and extended-release capsules. It usually is taken as a single daily dose in the morning or three times a day 30 minutes before meals. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take phentermine exactly as directed. Most people take the drug for 3-6 weeks; the length of treatment depends on how you respond to the medication. Phentermine can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to. To prevent side effects, phentermine should be taken with meals. If you are taking an extended-release (long-acting) product, do not chew or crush the tablet. There are some tablets that can be crushed and mixed with food. What special precautions should I follow?Return to top Before taking phentermine, tell your doctor and pharmacist if you are allergic to phentermine or any other drugs. tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially fluoxetine (Prozac), fluvoxamine (Luvox), guanethidine, insulin, MAO inhibitors [phenelzine (Nardil) and tranylcypromine (Parnate)] even if you stopped taking them within the past 2 weeks, medications for weight loss and depression, paroxetine (Paxil), sertraline (Zoloft),and vitamins. tell your doctor if you have or have ever had heart disease, high blood pressure, arteriosclerosis (narrowing of the arteries), hyperthyroidism (overactive thyroid gland), diabetes, glaucoma, or a history of drug abuse. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking phentermine, call your doctor. you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you. remember that alcohol can add to the drowsiness caused by this drug. if you have diabetes, you may need a larger dose of insulin while taking phentermine. Call your doctor if you have questions or problems. What special dietary instructions should I follow?Return to top Follow the diet and exercise program your doctor has given you. Phentermine works best in combination with a diet program. What should I do if I forget a dose?Return to top Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. What side effects can this medication cause?Return to top Phentermine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: dry mouth unpleasant taste diarrhea constipation vomiting If you experience any of the following symptoms, call your doctor immediately: increased blood pressure heart palpitations restlessness dizziness tremor insomnia shortness of breath chest pain dizziness swelling of the legs and ankles difficulty doing exercise that you have been able to do If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088]. What storage conditions are needed for this medicine?Return to top Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication. In case of emergency/overdoseReturn to top In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911. What other information should I know?Return to top Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to phentermine. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. Phentermine is used as an appetite suppressant. It is used in conjunction with an overall diet plan to reduce weight. how to take phentermine Phentermine is best taken on an empty stomach one-half hour before breakfast. Because taking it may cause sleeplessness, avoid taking a dose late in the day. Take phentermine as prescribed. Do not take phentermine more often or longer than directed. phentermine side effects Dry mouth, sleeplessness, irritability, stomach upset or constipation may occur the first few days as your body adjusts to the medication. If these effects persist or become bothersome, inform your doctor. phentermine precautions Tell your doctor your complete medical history especially if you have high blood pressure, an over-active thyroid, glaucoma, diabetes or emotional problems. Consult with your doctor if you think you are pregnant or before breast-feeding. Alcohol can increase unwanted side effects of dizziness. Limit alcohol use. Phentermine is not recommended for use in children. Consult your doctor or pharmacist for further information. phentermine interactions Inform your doctor about all the medicines you use, (prescription and nonprescription) especially if you take high blood pressure medicine or MAO inhibitors (e.g., furazolidone, phenelzine, selegiline, tranylcypromine) or any other weight loss medicine. Decongestants are commonly found in over-the-counter cough and cold medicine. phentermine general notes Appetite suppressants are not a substitute for proper diet. For maximum effects, this must be used in conjunction with a diet and exercise program. Do not share these pills with others. missed dosage of phentermine If you miss a dose, do not double the next dose. Instead, skip the missed dose of phentermine and resume your usual dosing schedule. phentermine storage Store phentermine at room temperature away from sunlight and moisture. Keep this and all medications out of the reach of children. Phentermine is not a substitute for a healthy lifestyle Phentermine is a helper. Have you ever thought about your food habits? Perhaps you have some that don't allow you to lose weight? Try to answer the following questions: Do you think you have to eat everything that is on the plate? When at someone's place, do you ask for more just to please the host? Do you often have meals while walking? Are you feeling like eating when in a bad mood? Do you sometimes take more meals even when you are full? Do you eat more than usual when annoyed or excited? Do you have snacks while reading, or watching TV, or surfing the web? Do you finish your meals fast? Looking in the fridge when nothing to do? Can you name all of your yesterday meals? It's not hard to tell that positive answers to all the above (except the last question) prove your habits to be disastrous. You are eating not because you are hungry. E.g. "Yes" to the second and the fifth question mean that you eat when full to please the others. Be strong; remember that friends indeed would always support you in your quest for loosing weight. If you have answered "yes" to the first question then you can't trash the food. You must be often trying the dishes while cooking or just without any schedule. Take a "Carrot or Cookie" test. Ask yourself, what are you feeling like more? If you are really hungry neither would get a favor. Choose a carrot then. If you have positive answers to the third, seventh and eighth question you have to change the style of having meals: when you eat fast or while walking or doing other stuff, it is hard for you to track the amount of food consumed. Serve the table, sit down, relax and start... slowly. "Yes" to #4, #6 and #9 mean that you are ruled by your mood, not your appetite. You better move to get rid of boredom or anxiety. Walking, biking, tennis will help you to relax. There is also another way: warm bathing. And finally, having "No" for the tenth question, you have to think about yesterday menu. Perhaps you had too many tasty things you'd prefer to forget about? Remember them as your yesterday weakness, it'll help you to be more reasonable in your meals today. Do you see now how having an appetite suppressant such as phentermine can help you benefit in loosing weight? Do you see now that it will take some efforts from you too? Starting an Exercise Plan along with phentermine course Beginning and exercise plan can take a little planning on your part if you have not been exercising for some time now. If you are overweight, or if you want to tone your body, starting an exercise plan is always a great topic to think about. If you want to start an exercise plan, and lose weight, Phentermine is a diet aid that works wonders in controlling your appetite, giving you extra energy, and it has a way of keeping you on track focusing on your exercise plan. First, you need to sit down and think about what you want to accomplish. If it has been a long time since you have done any type of exercising you will want to start out slowly and then build up to more exercises and more demanding exercises to get your body moving. It is important to start out slowly because your body is not accustomed to movements and stress. The additional movements and stress on your body urge your muscles to work, and in turn, you will burn calories. Through diet and exercise, your body will burn calories and will help you slim down, losing weight to hit the goals you have set for yourself. No one can do the exercise for you, this is something you have to plan and follow through with. Setting goals for an exercise plan can boost your health for years to come! A combination of exercise and the use of Phentermine does produce results. It is important to realize there is no magic pills that will help you lose weight without adding exercise to your plan. Exercise is a major fundamental in burning calories. Burning calories is going to help you to shed weight and it will tone your muscles. As you begin your exercise program you may feel the need to eat more but Phentermine controls that hunger so you eat less, and burn more calories during your exercise routines. The second step in a successful exercise plan is to form goals such as when you will exercise, what exercises you will be doing, and how you are going to track yourself. When you will exercise, can be any time of the day. If you need to make more time, make more time! Exercise can be something you perform, in your home, in the office, in the gym or even at a friend's house. Exercise should become a regular part of your day, even if it is just for ten minutes a day - which will be all you need it you stick to it. Now you have set times when you are going to exercise. This could be three times a week, four times a week or even every day depending on how long you are going to exercise. Exercising shorter amounts of time will require you to exercise more days per week. If you were to dedicate twenty minutes three times a week you can stick to that three days a week and lose weight, meeting your goals. Setting goals is another thing you should do when starting an exercise plan. What you will do is set your goal at a good pace. Say, three pounds a week, or so many hours a week, or you want to be down a size per month. Phentermine controls your appetite, so when you exercise you are burning calories from your body, which is how the overall plan of diet and exercise works together to help you meet your exercise goals. Exercise can be done right in your home or in your office. Stretching exercises are simple exercises that will help you stay loose, tone muscles, and you will feel more energetic as you will be pushing the blood through your body just by stretching and more oxygen gets to the portions of your body that will make you feel more awake. Exercise can be done right in your home. Simple additions to your day like toe touches, waist bends and even sit-ups are a great start. No one is going to start off doing aerobics, or running for miles, that comes months later as you rebuild the muscles in your body for a great calorie burning start. Exercise is something you will do in small steps building up your endurance and your abilities. Get on the move, set goals for your exercise plan and start meeting them using phentermine and exercise in combination to control your hunger while you burn calories. Your goals will be easier to meet, you will find more energy in your day and you will feel great all the while! Thousands and thousands of overweight people, who are obese are looking for the cure needed to lose weight for their fit future. With no confidence to approach the doctor, one can never lose the weight needed to be healthy. Having phentermine available on the internet they can purchase drugs online without facing embarrassing (yes, embarrassing!) conversations in person. It is much more cheaper on the internet sites than it is at the pharmacy next street. Phentermine is a drug that can be very dear per tablet but with the competition between online drugstores the prices are being kept low as possible. You need not to pay more for the same pillpack onlin. The OPs (which is common abbreviation for "online pharmacies") regulated by the FDA (Federal Drug Association) and run by licensed pharmacists are offering more savings and confidence for those who really want to lose weight. How does Phentermine work best for your personal needs? Phentermine helps you to control your hunger yet it helps provide you with additional energy so you can exercise. Exercising is a vital part of the diet process for everyone. Toning your body and making use of the muscles your body has, prevents additional problems that many who are overweight also suffer. Phentermine is the right choice for those who find they need the extra motivation to lose weight, and to do it in a manner that shows you results faster. We are a society that wants results now, faster which is what Phentermine does provide you when combined with exercise and your personal motivation to lose weight for a healthy you!

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So what is the next step? 1 - view our success stories 2 - spend some time in the Phentermine forums 3 - go for it... life is too short! And, if you like this site ...tell a friend Weight loss forums In our Phentermine.com forums, meet Phentermine users & non-users and share your Phentermine & weight loss experience with 24,649 members. These forums are a valuable community meeting place for members who are striving to lose weight, who all give and receive support and information on Phentermine and weight loss. Go to any forum here! - Phentermine ... My experience with... Success Stories New Members The Best Of... - Phendimetrazine... My experience with... Success Stories - Supporting & Motivating... Challenges The Buddy Board - Meeting each Other... Phen Events Chat Rooms... - Helping each Other... The Swap Shop Recipe Exchange Doctors, Nutritionists... Solidarity Forum - Overweight and Your Health... Obesity and Other Illnesses Side-Effects of Phentermine Side-Effects of Other... 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Or, download our customized Phentermine.com screensavers, wallpapers or Winamp Skin. Overweight vs. Obesity The CDC calls obesity a growing epidemic; 61% of American adults are overweight or obese. Are you? Visit Overweight vs. Obesity. Their favorite quotes "Being hungry is like being in love: If you don't know, you're probably not" Geneen Roth. Contributed by Forum Member mommy of twins Phentermine History | Phentermine Overview | Phentermine Pictures | Phentermine FAQ's | Prescribing Info | Overweight? Are you at Risk? | Obesity meds | Find a Doctor | Phen Tools | Phentermine Forums | Phentermine Chat Rooms Phentermine Success Stories | Our Story | Privacy Policy | Legal Disclaimer WhichDatingSite.com | Phentermine.info | WhichDrugstore.com | WhichPetstore.com Phentermine.com is intended solely for U.S. audiences; products described here may be subject to different medical and/or regulatory requirements in other countries. This site is for educational purposes only; information contained within should not be used to diagnose or treat a health problem regarding your medical condition. Phentermine.com - Copyright© 1999-2004. All Rights Reserved. Phentermine is a phenethylamine primarily used as an appetite suppressant. It is typically prescribed for individuals who are at increased medical risk because of their weight, as opposed to cosmetic weight loss. Phentermine is sold either as an immediate-release formulation (Adipex®) or as a slow-release resin (Ionamin®, Duromine® in Australia and New Zealand). Phentermine is one of two drugs in the Fen-phen anti-obesity medication, the other being fenfluramine or dexfenfluramine. Fenfluramine was withdrawn from the U.S. market in 1997 after reports of valvular heart disease and pulmonary hypertension. Phentermine is still available by itself in most countries, including the U.S. However, because it is similar to the amphetamines, individuals may develop an addiction to it. Hence, it is classified as a controlled substance in many countries. Internationally, phentermine is a schedule IV drug under the Convention on Psychotropic Substances (PDF file). In the United States, it is classified as a Schedule IV controlled substance under the Controlled Substances Act. [edit] Mechanism of action Phentermine, as many other prescription drugs, works with neurotransmitters in the brain. It is a centrally-acting stimulant chemically related to the amphetamines. It stimulates neuron bundles to release a particular group of neurotransmitters known as catecholamines; these include dopamine, epinephrine (also known as adrenalin), and norepinephrine (noradrenaline). The anorectic activity seen with these compounds would thus seem likely due to this effect on Central Nervous System, which is consistent with current knowledge about Central Nervous System systems and feeding behavior. This is the same mechanism of action as other stimulant appetite suppresants such as diethylpropion, and phendimetrazine. The neurotransmitters signal a fight-or-flight response in the body which, in turn, puts a halt to the hunger signal. As a result, it causes a loss in appetite because the brain does not receive the hunger message. [edit] Clinical use Generally, it is recommended by the Food and Drug Administration (FDA) that phentermine should be used short-term (usually interpreted as 'up to 12 weeks'), while following nonpharmacological approaches to weight loss such as healthy dieting and exercise. However, recommendations limiting its use for short-term treatment may be controversial. One reason given behind limiting its use to 12 weeks is drug tolerance, whereby phentermine loses its appetite-suppressing effects after the body adjusts to the drug. On the contrary, it has been shown that phentermine did not lose effectiveness in a 36-week trial (PMID 11054601). Due to the risk of insomnia, it is generally recommended that the drug be taken either before breakfast or 1-2 hours after breakfast. [edit] Side effects Generally, phentermine appears to be relatively well tolerated.[1] It can produce side effects consistent with its tachycardia, increased alertness, but the incidence and magnitude of these appear to be less than with the amphetamines. Because phentermine acts through sympathomimetic pathways, the drug ug on a long-term basis may develop euphoria and a psychological addiction PDR Drug information for PHENTERMINE RESIN Manufacturer: Celltech R523A Rev. 3/03 DESCRIPTION IONAMIN `15' and IONAMIN `30' contain 15 mg and 30 mg respectively of phentermine as the cationic exchange resin complex. Phentermine is (alpha), (alpha)-dimethyl phenethylamine (phenyl-tertiary-butylamine). Inactive Ingredients: D&C Yellow No. 10, dibasic calcium phosphate, FD&C Yellow No. 6, gelatin, iron oxides (15 mg capsules only), lactose, magnesium stearate, titanium dioxide. ACTIONS IONAMIN is a sympathomimetic amine with pharmacologic activity similar to the prototype drug of this class used in obesity, amphetamine (d- and d|Sj-amphetamine). Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects may be involved. Adult obese subjects instructed in dietary management and treated with "anorectic" drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks' or months' duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited. The bioavailability of IONAMIN has been studied in humans in which blood levels of phentermine were measured by a gas chromatography method. Blood levels obtained with the 15 mg and 30 mg resin complex formulations indicated slower absorption with a reduced but prolonged peak concentration and without a significant difference in prolongation of blood levels when compared with the same doses of phentermine hydrochloride. The clinical significance of these differences is not known. In clinical trials establishing the efficacy of IONAMIN, a single daily dose produced an effect comparable to that produced by other regimens of "anorectic" drug therapy. INDICATION IONAMIN Capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification, and caloric restriction in the management of exogenous obesity for patients with an initial body mass index >/=30 kg/m 2 , or >/=27 kg/m 2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ? 2.2 = kg; inches ? 0.0254 = meters. BODY MASS INDEX (BMI), kg/m 2 Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 The limited usefulness of agents of this class (see ACTIONS ) should be measured against possible risk factors inherent in their use such as those described below. CONTRAINDICATIONS Advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity, or idiosyncrasy to the sympathomimetic amines, glaucoma. Agitated states. Patients with a history of drug abuse. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result). WARNINGS IONAMIN Capsules are indicated only as short-term monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss, including selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, the coadministration of these drug products for weight loss is not recommended. Primary Pulmonary Hypertension (PPH)-- a rare, frequently fatal disease of the lungs--has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of phentermine alone cannot be ruled out. The initial symptom of PPH is usually dyspnea. Other initial symptoms include: angina pectoris, syncope, or lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope, or lower extremity edema. Valvular Heart Disease: Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss. The etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. If tolerance to the "anorectic" effect develops, the recommended dose should not be exceeded in an attempt to increase the effect: rather, the drug should be discontinued. IONAMIN may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly. When using CNS active agents, consideration must always be given to the possibility of adverse interactions with alcohol. Drug Dependence: IONAMIN is related chemically and pharmacologically to amphetamine (d- and d|Sj-amphetamine) and other stimulant drugs that have been extensively abused. The possibility of abuse of IONAMIN should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamine (d- and d|Sj-amphetamine) and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of some of these drugs to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable fromschizophrenia. Usage in Pregnancy: Safe use in pregnancy has not been established. Use of IONAMIN by women who are or may become pregnant requires that the potential benefit be weighed against the possible hazard to mother and infant. Pediatric Use: IONAMIN® Capsules (phentermine resin) are not recommended for use in pediatric patients under 16 years of age. PRECAUTIONS Caution is to be exercised in prescribing IONAMIN for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of IONAMIN and the concomitant dietary regimen. IONAMIN may decrease the hypotensive effect of adrenergic neuron blocking drugs. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Geriatric Use: Clinical studies of IONAMIN did not include sufficient numbers of subjects aged 65 or over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. ADVERSE REACTIONS Cardiovascular: Primary pulmonary hypertension (see WARNINGS ), palpitation, tachycardia, elevation of blood pressure. phentermine Drug information Generic Name: phentermine (FEN ter meen) Brand Names: Adipex-P, Fastin, Ionamin, Obenix, Obephen, Oby-Cap, Oby-Trim, Panshape M, Phentercot, Phentride, Pro-Fast HS, Pro-Fast SA, Pro-Fast SR, Teramine, Zantryl What is the most important information I should know about phentermine? • Use caution when driving, operating machinery, or performing other hazardous activities. Phentermine may cause dizziness, blurred vision, or restlessness, and it may hide the symptoms of extreme tiredness. If you experience these effects, avoid hazardous activities. • Phentermine 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" phentermine tablets or capsules. Swallow them whole. What is phentermine? • Phentermine is a sympathomimetic amine, which is similar to an amphetamine. It is also known as an "anorectic" or "anorexigenic" drug. Phentermine stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite. • Phentermine is used as a short-term supplement to diet and exercise in the treatment of obesity. • Phentermine may also be used for purposes other than those listed in this medication guide. Who should not take phentermine? • You cannot take phentermine 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 phentermine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above. • It is not known whether phentermine will harm an unborn baby. Do not take phentermine without first talking to your doctor if you are pregnant. • It is also not known whether phentermine passes into breast milk. Do not take phentermine without first talking to your doctor if you are breast-feeding a baby. How should I take phentermine? • Take phentermine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. • Take each dose with a full glass of water. • Phentermine is usually taken once or twice a day before a meal on an empty stomach. • Do not take phentermine in the evening because it may cause insomnia. • Do not crush, chew or open any "once-daily" phentermine tablets or capsules. Swallow them whole. • Never take more of this medication than is prescribed for you. Too much phentermine could be very dangerous to your health. • Store phentermine at room temperature away from moisture and heat. What happens if I miss a dose? • 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? • Seek emergency medical attention. • Symptoms of a phentermine overdose include restlessness, tremor, rapid breathing, confusion, hallucinations, panic, aggressiveness, nausea, vomiting, diarrhea, an irregular heartbeat, and seizures. What should I avoid while taking phentermine? • Use caution when driving, operating machinery, or performing other hazardous activities. Amphetamine 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 phentermine late in the day. A dose taken too late in the day can cause insomnia. What are the possible side effects of phentermine? • If you experience any of the following serious side effects, stop taking phentermine 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 phentermine 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. • Phentermine 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. 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ADIPEX-P®, an anorectic agent for oral administration, is available as a capsule or tablet containing 37.5 mg ofphentermine hydrochloride (equivalent to 30 mg ofphentermine base). ADIPEX-P® Capsules contain the inactive ingredients Corn Starch, Gelatin, Lactose Monohydrate, Magnesium Stearate, Titanium Dioxide, Black Iron Oxide, FD&C Blue #1, FD&C Red #40 and D&C Red #33. ADIPEX-P® Tablets contain the inactive ingredients Corn Starch, Lactose (Anhydrous), Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Sucrose, and FD&C Blue #1. CLINICAL PHARMACOLOGY ADIPEX-P® is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved, for example. Adult obese subjects instructed in dietary management and treated with "anorectic" drugs lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks' duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited. INDICATIONS AND USAGE ADIPEX-P® (phentermine hydrochloride) is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index >/=30 kg/m 2 , or >/=27 kg/m 2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ? 2.2 = kg; inches ? 0.0254 = meters.

The relative benefits of selegeline hydrochloride (2 x 5 mg, 2 x 10 mg selegeline) were studied in 30 narcoleptic patients using a randomized, double-blind, placebo-controlled design. Patients were randomly assigned to three groups (placebo and 2 x 5 mg and 2 x 10 mg selegeline). After a 2-week washout period for previous anticataplectic and stimulant medication, the study started with a 2-day period of placebo intake for each group, continued by 14 days of medication, ending with a 2-day placebo period. Outcome was measured by comparison of four polysomnographies and four multiple sleep latency tests (MSLTs) performed during the initial and the final placebo and medication period. Each MSLT day included acoustic and visual vigilance tests. Blood pressure and pulse rate were monitored daily. Patients reported daily about mood, concentration, subjective sleep time, nocturnal awakenings, nocturnal wake times, number of naps, and occurrence of symptoms of the narcoleptic tetrad. Selegeline caused dose-dependent REM suppression during nighttime sleep and naps and increase of sleep and REM latency. Under selegeline, daytime sleepiness improved significantly and the number of sleep attacks and naps as well as the frequency of cataplexy were reduced. Selegeline at a dose of a least 20 mg/day is a potent drug for the treatment of all narcoleptic symptoms. SELEGILINE HYDROCHLORIDE Manufacturer: Somerset DESCRIPTION ELDEPRYL (selegiline hydrochloride) is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl. The chemical name is: (R)-(-)- N,2 -dimethyl- N-2 -propynylphenethylamine hydrochloride. It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.75. The structural formula is as follows: Each aqua blue capsule is band imprinted with the Somerset logo on the cap and "Eldepryl 5 mg" on the body. Each capsule contains 5 mg selegiline hydrochloride. Inactive ingredients are anhydrous citric acid, lactose, magnesium stearate, and microcrystalline cellulose. CLINICAL PHARMACOLOGY The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of Parkinson's disease are not fully understood. Inhibition of monoamine oxidase, type B, activity is generally considered to be of primary importance; in addition, there is evidence that selegiline may act through other mechanisms to increase dopaminergic activity. Selegiline is best known as an irreversible inhibitor of monoamine oxidase (MAO), an intracellular enzyme associated with the outer membrane of mitochondria. Selegiline inhibits MAO by acting as a `suicide' substrate for the enzyme; that is, it is converted by MAO to an active moiety which combines irreversibly with the active site and/or the enzyme's essential FAD cofactor. Because selegiline has greater affinity for type B rather than for type A active sites, it can serve as a selective inhibitor of MAO type B if it is administered at the recommended dose. MAOs are widely distributed throughout the body; their concentration is especially high in liver, kidney, stomach, intestinal wall, and brain. MAOs are currently subclassified into two types, A and B, which differ in their substrate specificity and tissue distribution. In humans, intestinal MAO is predominantly type A, while most of that in brain is type B. In CNS neurons, MAO plays an important role in the catabolism of catecholamines (dopamine, norepinephrine and epinephrine) and serotonin. MAOs are also important in the catabolism of various exogenous amines found in a variety of foods and drugs. MAO in the GI tract and liver (primarily type A), for example, is thought to provide vital protection from exogenous amines (e.g., tyramine) that have the capacity, if absorbed intact, to cause a `hypertensive crisis,' the so-called `cheese reaction.' (If large amounts of certain exogenous amines gain access to the systemic circulation - e.g., from fermented cheese, red wine, herring, over-the-counter cough/cold medications, etc. - they are taken up by adrenergic neurons and displace norepinephrine from storage sites within membrane bound vesicles. Subsequent release of the displaced norepinephrine causes the rise in systemic blood pressure, etc.) In theory, since MAO A of the gut is not inhibited, patients treated with selegiline at a dose of 10 mg a day should be able to take medications containing pharmacologically active amines and consume tyramine-containing foods without risk of uncontrolled hypertension. Although rare, a few reports of hypertensive reactions have occurred in patients receiving Eldepryl at the recommended dose, with tyramine-containing foods. In addition, one case of hypertensive crisis has been reported in a patient taking the recommended dose of selegiline and a sympathomimetic medication, ephedrine. The pathophysiology of the `cheese reaction' is complicated and, in addition to its ability to inhibit MAO B selectively, selegiline's relative freedom from this reaction has been attributed to an ability to prevent tyramine and other indirect acting sympathomimetics from displacing norepinephrine from adrenergic neurons. However, until the pathophysiology of the cheese reaction is more completely understood, it seems prudent to assume that selegiline can ordinarily only be used safely without dietary restrictions at doses where it presumably selectively inhibits MAO B (e.g., 10 mg/day). In short, attention to the dose dependent nature of selegiline's selectivity is critical if it is to be used without elaborate restrictions being placed on diet and concomitant drug use although, as noted above, a few cases of hypertensive reactions have been reported at the recommended dose. (See WARNINGS and PRECAUTIONS ). It is important to be aware that selegiline may have pharmacological effects unrelated to MAO B inhibition. As noted above, there is some evidence that it may increase dopaminergic activity by other mechanisms, including interfering with dopamine re-uptake at the synapse. Effects resulting from selegiline administration may also be mediated through its metabolites. Two of its three principal metabolites, amphetamine and methamphetamine, have pharmacological actions of their own; they interfere with neuronal uptake and enhance release of several neurotransmitters (e.g., norepinephrine, dopamine, serotonin). However, the extent to which these metabolites contribute to the effects of selegiline are unknown. Rationale for the Use of a Selective Monoamine Oxidase Type B Inhibitor in Parkinson's Disease: Many of the prominent symptoms of Parkinson's disease are due to a deficiency of striatal dopamine that is the consequence of a progressive degeneration and loss of a population of dopami-nergic neurons which originate in the substantia nigra of the midbrain and project to the basal ganglia or striatum. Early in the course of Parkinson's Disease, the deficit in the capacity of these neurons to synthesize dopamine can be overcome by administration of exogenous levodopa, usually given in combination with a peripheral decarboxylase inhibitor (carbidopa). With the passage of time, due to the progression of the disease and/or the effect of sustained treatment, the efficacy and quality of the therapeutic response to levodopa diminishes. Thus, after several years of levodopa treatment, the response, for a given dose of levodopa, is shorter, has less predictable onset and offset (i.e., there is `wearing off'), and is often accompanied by side effects (e.g., dyskinesia, akinesias, on-off phenomena, freezing, etc.). This deteriorating response is currently interpreted as a manifestation of the inability of the ever decreasing population of intact nigrostriatal neurons to synthesize and release adequate amounts of dopamine. MAO B inhibition may be useful in this setting because, by blocking the catabolism of dopamine, it would increase the net amount of dopamine available (i.e., it would increase the pool of dopamine). Whether or not this mechanism or an alternative one actually accounts for the observed beneficial effects of adjunctive selegiline is unknown. Selegiline's benefit in Parkinson's disease has only been documented as an adjunct to levodopa/carbidopa. Whether or not it might be effective as a sole treatment is unknown, but past attempts to treat Parkinson's disease with non-selective MAOI monotherapy are reported to have been unsuccessful. It is important to note that attempts to treat Parkinsonian patients with combinations of levodopa and currently marketed non-selective MAO inhibitors were abandoned because of multiple side effects including hypertension, increase in involuntary movement, and toxic delirium. Pharmacokinetic Information (Absorption, Distribution, Metabolism and Elimination--ADME): The absolute bioavailability of selegiline following oral dosing is not known; however, selegiline undergoes extensive metabolism (presumably attributable to presystemic clearance in gut and liver). The major plasma metabolites are N-desmethylselegiline, L-amphetamine and L-methamphetamine. Only N-desmethylselegiline has MAO-B inhibiting activity. The peak plasma levels of these metabolites following a single oral dose of 10 mg are from 4 to almost 20 times greater than that of the maximum plasma concentration of selegiline [1 ng/mL]. The maximum concentrations of amphetamine and methamphetamine, however, are far below those ordinarily expected to produce clinically important effects. Single oral dose studies do not predict multiple dose kinetics, however. At steady state the peak plasma level of selegiline is 4 fold that obtained following a single dose. Metabolite concentrations increase to a lesser extent, averaging 2 fold that seen after a single dose. The bioavailability of selegiline is increased 3 to 4 fold when it is taken with food. The extent of systemic exposure to selegiline at a given dose varies considerably among individuals. Estimates of systemic clearance of selegiline are not available. Following a single oral dose, the mean elimination half-life of selegiline is two hours. Under steady state conditions the elimination half-life increases to ten hours. Because selegiline's inhibition of MAO-B is irreversible, it is impossible to predict the extent of MAO-B inhibition from steady state plasma levels. For the same reason, it is not possible to predict the rate of recovery of MAO-B activity as a function of plasma levels. The recovery of MAO-B activity is a function of de novo protein synthesis; however, information about the rate of de novo protein synthesis is not yet available. Although platelet MAO-B activity returns to the normal range within 5 to 7 days of selegiline discontinuation, the linkage between platelet and brain MAO-B inhibition is not fully understood nor is the relationship of MAO-B inhibition to the clinical effect established (see CLINICAL PHARMACOLOGY ). Special Populations: Renal Impairment: No pharmacokinetic information is available on selegiline or its metabolites in renally impaired subjects. Hepatic Impairment: No pharmacokinetic information is available on selegiline or its metabolites in hepatically impaired subjects. Age: Although a general conclusion about the effects of age on the pharmacokinetics of selegiline is not warranted because of the size of the sample evaluated (12 subjects greater than 60 years of age, 12 subjects between the ages of 18 to 30), systemic exposure was about twice as great in older as compared to a younger population given a single oral dose of 10 mg. Gender: No information is available on the effects of gender on the pharmacokinetics of selegiline. INDICATIONS AND USAGE ELDEPRYL is indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy. Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of `off' time, and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state). CONTRAINDICATIONS ELDEPRYL is contraindicated in patients with a known hypersensitivity to this drug. ELDEPRYL is contraindicated for use with meperidine (DEMEROL & other trade names). This contraindication is often extended to other opioids. (See Drug Interactions.) WARNINGS Selegiline should not be used at daily doses exceeding those recommended (10 mg/day) because of the risks associated with nonselective inhibition of MAO. (See CLINICAL PHARMACOLOGY ). The selectivity of selegiline for MAO B may not be absolute even at the recommended daily dose of 10 mg a day. Rare cases of hypertensive reactions associated with ingestion of tyramine-containing foods have been reported in patients taking the recommended daily dose of selegiline. The selectivity is further diminished with increasing daily doses. The precise dose at which selegiline becomes a non-selective inhibitor of all MAO is unknown, but may be in the range of 30 to 40 mg a day. Severe CNS toxicity associated with hyperpyrexia and death have been reported with the combination of tricyclic antidepressants and non-selective MAOIs (NARDIL, PARNATE). A similar reaction has been reported for a patient on amitriptyline and ELDEPRYL. Another patient receiving protriptyline and ELDEPRYL developed tremors, agitation, and restlessness followed by unresponsiveness and death two weeks after ELDEPRYL was added. Related adverse events including hypertension, syncope, asystole, diaphoresis, seizures, changes in behavioral and mental status, and muscular rigidity have also been reported in some patients receiving ELDEPRYL and various tricyclic antidepressants. Serious, sometimes fatal, reactions with signs and symptoms that may include hyperthermia, rigidity, myoclonus, autonomic instability with rapid fluctuations of the vital signs, and mental status changes that include extreme agitation progressing to delirium and coma have been reported with patients receiving a combination of fluoxetine hydrochloride (PROZAC) and non-selective MAOIs. Similar signs have been reported in some patients on the combination of ELDEPRYL (10 mg a day) and selective serotonin reuptake inhibitors including fluoxetine, sertraline and paroxetine. Since the mechanisms of these reactions are not fully understood, it seems prudent, in general, to avoid this combination of ELDEPRYL and tricyclic antidepressants as well as ELDEPRYL and selective serotonin reuptake inhibitors. At least 14 days should elapse between discontinuation of ELDEPRYL and initiation of treatment with a tricyclic antidepressant or selective serotonin reuptake inhibitors. Because of the long half-lives of fluoxetine and its active metabolite, at least five weeks (perhaps longer, especially if fluoxetine has been prescribed chronically and/or at higher doses) should elapse between discontinuation of fluoxetine and initiation of treatment with ELDEPRYL. PRECAUTIONS General: Some patients given selegiline may experience an exacerbation of levodopa associated side effects, presumably due to the increased amounts of dopamine reaction with super sensitive, post-synaptic receptors. These effects may often be mitigated by reducing the dose of levodopa/carbidopa by approximately 10 to 30%. The decision to prescribe selegiline should take into consideration that the MAO system of enzymes is complex and incompletely understood and there is only a limited amount of carefully documented clinical experience with selegiline. Consequently, the full spectrum of possible responses to selegiline may not have been observed in pre-marketing evaluation of the drug. It is advisable, therefore, to observe patients closely for atypical responses. Information for Patients: Patients should be advised of the possible need to reduce levodopa dosage after the initiation of ELDEPRYL therapy. Patients (or their families if the patient is incompetent) should be advised not to exceed the daily recommended dose of 10 mg. The risk of using higher daily doses of selegiline should be explained, and a brief description of the `cheese reaction' provided. Rare hypertensive reactions with selegiline at recommended doses associated with dietary influences have been reported. Consequently, it may be useful to inform patients (or their families) about the signs and symptoms associated with MAOI induced hypertensive reactions. In particular, patients should be urged to report, immediately, any severe headache or other atypical or unusual symptoms not previously experienced. Laboratory Tests: No specific laboratory tests are deemed essential for the management of patients on ELDEPRYL. Periodic routine evaluation of all patients, however, is appropriate. Drug Interactions: The occurrence of stupor, muscular rigidity, severe agitation, and elevated temperature has been reported in some patients receiving the combination of selegiline and meperidine. Symptoms usually resolve over days when the combination is discontinued. This is typical of the interaction of meperidine and MAOIs. Other serious reactions (including severe agitation, hallucinations, and death) have been reported in patients receiving this combination (see CONTRAINDICATIONS ). Severe toxicity has also been reported in patients receiving the combination of tricyclic antidepressants and ELDEPRYL and selective serotonin reuptake inhibitors and ELDEPRYL. (See WARNINGS for details). One case of hypertensive crisis has been reported in a patient taking the recommended doses of selegiline and a sympathomimetic medication (ephedrine). Carcinogenesis, Mutagenesis, and Impairment of Fertility: Assessment of the carcinogenic potential of selegiline in mice and rats is ongoing. Selegiline did not induce mutations or chromosomal damage when tested in the bacterial mutation assay in Salmonella typhimurium and in an in vivo chromosomal aberration assay. While these studies provide some reassurance that selegiline is not mutagenic or clastogenic, they are not definitive because of methodological limitations. No definitive in vitro chromosomal aberration or in vitro mammalian gene mutation assays have been performed. The effect of selegiline on fertility has not been adequately assessed. Pregnancy: Pregnancy Category C: No teratogenic effects were observed in a study of embryo-fetal development in Sprague-Dawley rats at oral doses of 4, 12, and 36 mg/kg or 4, 12 and 35 times the human therapeutic dose on a mg/m 2 basis. No teratogenic effects were observed in a study of embryo-fetal development in New Zealand White rabbits at oral doses of 5, 25, and 50 mg/kg or 10, 48, and 95 times the human therapeutic dose on a mg/m 2 basis; however, in this study, the number of litters produced at the two higher doses was less than recommended for assessing teratogenic potential. In the rat study, there was a decrease in fetal body weight at the highest dose tested. In the rabbit study, increases in total resorptions and % post-implantation loss, and a decrease in the number of live fetuses per dam occurred at the highest dose tested. In a peri- and postnatal development study in Sprague-Dawley rats (oral doses of 4, 16, and 64 mg/kg or 4, 15, and 62 times the human therapeutic dose on a mg/m 2 basis), an increase in the number of stillbirths and decreases in the number of pups per dam, pup survival, and pup body weight (at birth and throughout the lactation period) were observed at the two highest doses. At the highest dose tested, no pups born alive survived to Day 4 postpartum. Postnatal development at the highest dose tested in dams could not be evaluated because of the lack of surviving pups. The reproductive performance of the untreated off-spring was not assessed. There are no adequate and well-controlled studies in pregnant women. Selegiline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether selegiline hydrochloride is excreted in human milk. Because many drugs are excreted in human milk, consideration should be given to discontinuing the use of all but absolutely essential drug treatments in nursing women. Pediatric Use: The effects of selegiline hydrochloride in children have not been evaluated. ADVERSE REACTIONS Introduction: The number of patients who received selegiline in prospectively monitored pre-marketing studies is limited. While other sources of information about the use of selegiline are available (e.g., literature reports, foreign post-marketing reports, etc.) they do not provide the kind of information necessary to estimate the incidence of adverse events. Thus, overall incidence figures for adverse reactions associated with the use of selegiline cannot be provided. Many of the adverse reactions seen have also been reported as symptoms of dopamine excess. Moreover, the importance and severity of various reactions reported often cannot be ascertained. One index of relative importance, however, is whether or not a reaction caused treatment discontinuation. In prospective pre-marketing studies, the following events led, in decreasing order of frequency, to discontinuation of treatment with selegiline: nausea, hallucinations, confusion, depression, loss of balance, insomnia, orthostatic hypotension, increased akinetic involuntary movements, agitation, arrhythmia, bradykinesia, chorea, delusions, hypertension, new or increased angina pectoris, and syncope. Events reported only once as a cause of discontinuation are ankle edema, anxiety, burning lips/mouth, constipation, drowsiness/lethargy, dystonia, excess perspiration, increased freezing, gastrointestinal bleeding, hair loss, increased tremor, nervousness, weakness, and weight loss. Experience with ELDEPRYL obtained in parallel, placebo controlled, randomized studies provides only a limited basis for estimates of adverse reaction rates. The following reactions that occurred with greater frequency among the 49 patients assigned to selegiline as compared to the 50 patients assigned to placebo in the only parallel, placebo controlled trial performed in patients with Parkinson's disease are shown in the following Table. None of these adverse reactions led to a discontinuation of treatment. Selegiline: No specific information is available about clinically significant overdoses with ELDEPRYL. However, experience gained during selegiline's development reveals that some individuals exposed to doses of 600 mg of d,l-selegiline suffered severe hypotension and psychomotor agitation. Since the selective inhibition of MAO B by selegiline hydrochloride is achieved only at doses in the range recommended for the treatment of Parkinson's disease (e.g., 10 mg/day), overdoses are likely to cause significant inhibition of both MAO A and MAO B. Consequently, the signs and symptoms of overdose may resemble those observed with marketed non-selective MAO inhibitors [e.g., tranylcypromine (PARNATE), isocarboxazide (MARPLAN), and phenelzine (NARDIL)]. Overdose with Non-Selective MAO Inhibition: NOTE: This section is provided for reference; it does not describe events that have actually been observed with selegiline in overdose. Characteristically, signs and symptoms of non-selective MAOI overdose may not appear immediately. Delays of up to 12 hours between ingestion of drug and the appearance of signs may occur. Importantly, the peak intensity of the syndrome may not be reached for upwards of a day following the overdose. Death has been reported following overdosage. Therefore, immediate hospitalization, with continuous patient observation and monitoring for a period of at least two days following the ingestion of such drugs in overdose, is strongly recommended. The clinical picture of MAOI overdose varies considerably; its severity may be a function of the amount of drug consumed. The central nervous and cardiovascular systems are prominently involved. Signs and symptoms of overdosage may include, alone or in combination, any of the following: drowsiness, dizziness, faintness, irritability, hyperactivity, agitation, severe headache, hallucinations, trismus, opisthotonos, convulsions, and coma; rapid and irregular pulse, hypertension, hypotension and vascular collapse; precordial pain, respiratory depression and failure, hyperpyrexia, diaphoresis, and cool, clammy skin. Treatment Suggestions For Overdose: NOTE: Because there is no recorded experience with selegiline overdose, the following suggestions are offered based upon the assumption that selegiline overdose may be modeled by non-selective MAOI poisoning. In any case, up-to-date information about the treatment of overdose can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians' Desk Reference (PDR). Treatment of overdose with non-selective MAOIs is symptomatic and supportive. Induction of emesis or gastric lavage with instillation of charcoal slurry may be helpful in early poisoning, provided the airway has been protected against aspiration. Signs and symptoms of central nervous system stimulation, including convulsions, should be treated with diazepam, given slowly intravenously. Phenothiazine derivatives and central nervous system stimulants should be avoided. Hypotension and vascular collapse should be treated with intravenous fluids and, if necessary, blood pressure titration with an intravenous infusion of a dilute pressor agent. It should be noted that adrenergic agents may produce a markedly increased pressor response. Respiration should be supported by appropriate measures, including management of the airway, use of supplemental oxygen, and mechanical ventilatory assistance, as required. Body temperature should be monitored closely. Intensive management of hyperpyrexia may be required. Maintenance of fluid and electrolyte balance is essential. DOSAGE AND ADMINISTRATION ELDEPRYL is intended for administration to Parkinsonian patients receiving levodopa/carbidopa therapy who demonstrate a deteriorating response to this treatment. The recommended regimen for the administration of ELDEPRYL is 10 mg per day administered as divided doses of 5 mg each taken at breakfast and lunch. There is no evidence that additional benefit will be obtained from the administration of higher doses. Moreover, higher doses should ordinarily be avoided because of the increased risk of side effects. After two to three days of selegiline treatment, an attempt may be made to reduce the dose of levodopa/carbidopa. A reduction of 10 to 30% was achieved with the typical participant in the domestic placebo controlled trials who was assigned to selegiline treatment. Further reductions of levodopa/carbidopa may be possible during continued selegiline therapy. selegiline Drug information Generic Name: selegiline (transdermal) (se LE ji lene) Brand Names: Emsam What is the most important information I should know about selegiline transdermal? • You may have an increased risk of suicidal thoughts or behavior at the start of treatment with selegiline transdermal, especially if you are 18 years of age or younger. Talk with your doctor about this risk. While you are using this medication you will need to be monitored for worsening symptoms of depression and/ or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment. • Contact your doctor if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/ or physical hyperactivity), or thoughts of suicide or hurting yourself. • Selegiline transdermal can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. What is selegiline transdermal? • Selegiline prevents the breakdown of chemicals in the brain that are often imbalanced in people with depression. • Selegiline transdermal is used to treat major depressive disorder. • Selegiline may also be used for purposes other than those listed in this medication guide. What should I discuss with my health care provider before using selegiline transdermal? • Do not use selegiline if you are also taking meperidine (Demerol). • Before using this medication, tell your doctor if: · you or anyone in your family has bipolar disorder (manic depression); · you or anyone in your family has ever attempted suicide; · you have heart disease; · you have seizures; or · you have dizzy spells. • You may have an increased risk of suicidal thoughts or behavior at the start of treatment with selegiline transdermal, especially if you are 18 years of age or younger. Talk with your doctor about this risk. While you are using this medication you will need to be monitored for worsening symptoms of depression and/ or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment. • Contact your doctor if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/ or physical hyperactivity), or thoughts of suicide or hurting yourself. • If you need to have surgery, tell the surgeon that you are using selegiline. You may need to briefly stop using the medication before your surgery. • FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. • It is not known whether selegiline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use selegiline transdermal? • Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use more of the skin patches or use them for longer than recommended. • This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. • The patch can be worn on your back, upper arm, upper chest, or upper thigh. Choose a place on your body that is dry, smooth, and hairless. • Before applying a skin patch, wash the skin area with soap and water and dry completely. • Remove the patch from its sealed pouch. Take off one half of the protective liner and press the sticky side of the patch firmly against your skin. Try not to touch the sticky side of the patch with your fingers. As you remove the second half of the protective liner, press the patch firmly into place. • If a patch becomes loose, press it back in place. If a patch falls off, apply a new patch and go back to your regular schedule for patch changes. • Do not cut the skin patch. Do not apply it to a scar, a skin wound, or to irritated skin. Do not wear the patch underneath tight clothing that could cause the patch to rub off. • Remove the patch after 24 hours, taking care not to touch the sticky side with your fingers. Fold the patch in half so that it sticks together. Throw the used patch away where children and pets cannot reach it. A used patch can still have active medicine in it. • Wash your hands with soap and water after applying a patch, and after removing one. Wash your skin after removing a patch, and use baby oil to remove any adhesive that does not wash off. • Use only one patch at a time. While you are wearing the patch, do not expose it to sunlight or other sources of heat such as a heating pad, electric blanket, hot tub, or sauna. • Do not stop using selegiline suddenly or you may have harmful side effects. It may take several weeks of using selegiline transdermal before you start to feel better. Keep using the medication as prescribed. Talk with your doctor before stopping the medication. • Store the skin patches at room temperature away from heat and moisture. What happens if I miss a dose? • Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose. What happens if I overdose? • Seek emergency medical attention if you think you have used too much of this medicine. • Symptoms of a selegiline overdose may include excitement, irritability, nervousness, insomnia, dizziness, severe headache, hallucinations, sweating, light-headedness, fainting, or seizures. What should I avoid while using selegiline transdermal? • Avoid drinking alcohol while using selegiline transdermal. • Your doctor may recommend you avoid certain foods that contain tyramine. Consuming tyramine while you are using selegiline transdermal can cause a serious increase in blood pressure. Foods that contain tyramine include dried meats, improperly stored meats, fava beans, aged cheeses, tap beer, soybeans, tofu, sauerkraut, and yeast extract. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must avoid to prevent serious side effects. • Selegiline transdermal can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. What are the possible side effects of selegiline transdermal? • Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. • Stop using selegiline and call your doctor at once if you have any of these serious side effects: · severe headache, stiff neck, confusion, fast or uneven heartbeat; · feeling light-headed, fainting; · fever or sweating; · feeling restless, agitated, or irritable; · seizure (convulsions); or · tremors, muscle stiffness, or movements you cannot control. • Continue using selegiline and talk with your doctor if you have any of these less serious side effects: · headache; · diarrhea, upset stomach; · sleep problems (insomnia); · dry mouth, sore throat; or · redness or itching where the patch is worn. • 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 selegiline transdermal? • Do not use selegiline if you are also taking meperidine (Demerol). • Before using selegiline transdermal, tell your doctor if you are using any of the following drugs: · antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), paroxetine (Paxil), or sertraline (Zoloft); · antidepressants such as amitriptyline (Elavil), nortriptyline (Pamelor), desipramine (Norpramin), or imipramine (Tofranil); · St. John's wort; · cyclobenzaprine (Flexeril); · carbamazepine (Tegretol) or oxcarbazepine (Trileptal); · buspirone (Buspar); · cold or cough medicine; or · diet pills or stimulants. • If you are using any of these drugs, you may not be able to tuse selegiline transdermal, or you may have to stop using the other drugs for a few weeks before you start using selegiline. • There may be other drugs not listed that can affect selegiline transdermal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Where can I get more information? • Your pharmacist has more information about selegiline transdermal written for health professionals that you may read. -------------------------------------------------------------------------------- • 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, c