Online Meridia

What is Meridia? Meridia® (sibutramine hydrochloride monohydrate) is the first FDA approved medication of its class for the treatment of weight loss and weight maintenance. Sibutramine is an equipotent serotonin and norepinephrine reuptake inhibitor (SNRI), which means it has an equal effect on serotonin (a brain neurotransmitter which generally promotes a calming feeling) and norepinephrine (a stimulant). Research indicates that these brain chemicals have an effect on appetite and satiety. Meridia® is available in 5 mg, 10 mg, and 15 mg capsules (see photo). The recommended starting dose is 10 mg which may be increased to 15 mg if the 10 mg capsule is ineffective. The 5 mg capsule can be used as an adjunct to the 10 mg dose; it is not intended to be used as a starting dose. Graphic: Knoll Pharmaceuticals. Studies have shown that Meridia® is moderately effective in producing weight loss in obese individuals, with 85 percent losing at least 5 percent of body weight and 57 percent at least 10 percent. In the majority of studies it has not been shown to be as effective as the combination of fenfluramine and phentermine ("phen/fen") which enhances the release of norepinephrine and serotonin. Subjects in studies by Weintraub and Wadden lost an average of 15.9 percent of body weight. However, with the withdrawal of fenfluramine from the market in 1997, the combination is no longer available. Animals given sibutramine have shown an increase in metabolic rate, but human studies have not been conclusive. The reasons for the difference between animals and humans is not clear but may be due to the small number of subjects tested and the small effect of the drug on energy expenditure. However, even small increases in thermogenesis could be clinically significant in weight loss and weight maintenance. For further information, see: Sibutramine: Its impact on long term metabolic rate. February 2000, subscribers. More on sibutramine and thermogenesis. May 1999, subscribers. Does sibutramine promote thermogenesis in humans? January 1999, subscribers. Meridia goes to market. February 1998, subscribers. -------------------------------------------------------------------------------- What does Meridia cost? Meridia® is priced at $3 for the 5 and 10 mg capsules, and $4 for the 15 mg capsules. Dosing is once a day. The cost is $90 for one month's supply of the 5 or 10 mg capsules, and $120 for the 15 mg capsules. Many pharmacies discount the price well below the retail prices listed above, so shop around. -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- Meridia is not approved where I live. Is it legal for me to import Meridia? It depends on the laws of your country. If the country you live in doesn't prohibit the import of unapproved drugs, and isn't specifically prohibiting the importation of Meridia®, you may be able to import it. You should investigate the specific laws in your country. If you live in the United States it is not legal to import Meridia®. For more information about drug import laws, check out the OMR FAQ on importing medications for personal use. If your country does allow drug imports, you should be able to mail order medication with a doctor's prescription from any of the prescription mail order pharmacies on the OMR web site. I do not know the specific policies of any of these pharmacies regarding out of country orders. You'll have to check directly with the pharmacies. US subscribers interested in Meridia® should see a doctor and get a prescription. If you would like to see how successful other patients have been on Meridia®, I suggest taking a look at the OMR Meridia® survey which went on line in January 1999. The survey results rate the success of 339 patients who took this medication for up to 40 weeks. -------------------------------------------------------------------------------- What impact does Meridia's scheduling as a controlled medication have on me? It really has very little effect on the consumer. Every doctor is issued a Drug Enforcement Administration number. That number is entered by pharmacists into a computer database when controlled substances are prescribed. Unless irregularities are found in a physician's prescribing practices, no other action is taken other than the recordkeeping. This is an overview of the schedule of drugs: Certain drugs which are determined to have abuse potential, are controlled by the US Drug Enforcement Administration. Schedule 1: illegal substances with no medical use. Schedule 2: drugs with high abuse potential, including narcotics, amphetamines and some depressants. There are no anorectic medications controlled under schedule 2. Schedule 3: drugs with less abuse potential than schedule 2 medications. Phendimetrazine is controlled under schedule 3. Schedule 4: drugs with less abuse potential than schedule 3 medications. Most anorectic medications including phentermine, fenfluramine, dexfenfluramine, diethylpropion are schedule 4 medications. Schedule 5: drugs with relatively low abuse potential. Ephedrine is controlled under schedule 5 by some individual states. The DEA uses a specific process and criteria when deciding whether or not to control a drug. -------------------------------------------------------------------------------- Could Meridia give me heart valve damage or other problems associated with fenfluramine? Heart valve damage, pulmonary hypertension and neurotoxicity (the depletion of brain neurotransmitters) are linked to fenfluramine and dexfenfluramine use. It is unlikely that Meridia® would cause these diseases, since the drug only works on clearance of serotonin. Fenfluramine and dexfenfluramine also enhance its release. Recently, a new theory has been proposed that serotonin releasing drugs, like fenfluramine and dexfenfluramine, which activate the 5-HT2B receptor, may contribute to the development of heart valve disease. For further information, see: Mechanism for fenfluramine associated heart valve damage proposed. Dec 2000/Jan 2001, subscribers. -------------------------------------------------------------------------------- Where can I learn more about Meridia? OBESITY MEDS AND RESEARCH NEWS has published numerous articles about Meridia® since 1997 when it was approved. In addition, of interest is our January 1999 primer on Serotonin, eating disorders and obesity. Many OMR articles are only available to subscribers, but some are available to the general public. Our article index has a listing of all OMR Meridia® coverage by year, which can be browsed by all site visitors. In addition, Knoll Pharmaceuticals has a web site on Meridia®, which can be accessed from the OMR Meridia page. A copy of the Meridia prescribing information, and the results of our Meridia survey are also available. The OMR family of web sites: Obesity Meds and Research News, Obesity 101, and Obesity Update. OBESITY MEDS AND RESEARCH NEWS is a publication of Hirsch Communications. An on-line subscription is $104.00 per year, payable in advance by check, money order, American Express, Discover, VISA or Mastercard. Subscribing is simple using our secure on-line subscription form. OMR also accepts fax orders at 703/960-7462 and mail orders at PO Box 19316, Alexandria, VA 22320-0316. Copyright 1997-2006, all rights reserved. IMPORTANT: All information in this publication is believed to be accurate and true. Publisher is not liable for omissions or inaccuracies. Information in this newsletter is for educational purposes only and should not be construed as medical advice, or be used in lieu of consultation with a health care provider. Sibutramine (Meridia® in the USA, Reductil® in Europe), usually as sibutramide hydrochloride monohydrate, is an orally administered agent for the treatment of obesity. It is a centrally-acting stimulant chemically related to amphetamine, methamphetamine, and phentermine (one of the drugs in the Fen-Phen combination). Sibutramine is classified as a Schedule IV controlled substance in the Directions The medication is taken once daily with or without food. The usual starting dose is 10mg daily and can be increased to 15mg daily if no significant weight loss is observed. Patient information Do not take more frequently than prescribed. Side effects include dry mouth, insomnia, constipation, runny nose, and headaches. Precautions It is important that the doctor has your complete medical history. Consult with your doctor if you have a history of anorexia, cardiovascular problems, glaucoma, under productive thyroid, kidney problems, pregnant, history of drug abuse or misuse, pulmonary hypertension, seizures, gallstones, take liver function tests, a mental disease, pregnant or breast-feeding. Drug interactions Inform your doctor about all the medicines you use, especially other weight reducing agents (e.g., diethylpropion), drugs that can raise blood pressure such as decongestants (e.g., pseudoephedrine), cough suppressants (e.g., dextromethorphan), antidepressants (e.g., nefazodone, fluoxetine, paroxetine, sertraline, fluvoxamine, venlafaxine), lithium, psychiatric medications (e.g., MAO Inhibitors such as selegiline, furazolidone, phenelzine, tranylcypromine), drugs for migraines (e.g., dihydroergotamine, sumatriptan), tryptophan, certain narcotic pain relievers (e.g., meperidine, pentazocine, fentanyl), ketoconazole, erythromycin, high blood pressure medicine or any drugs which can cause drowsiness, including certain antihistamines (e.g., diphenhydramine), sedatives and anti-seizure drugs. Antihistamines and decongestants may be found in many over the counter drugs for cough and cold. Consult your pharmacist. MAO Inhibitors (see above) and this drug should not be taken together. If an MAO Inhibitor or this drug is stopped, wait 2 weeks before starting the other drug. You should not use herbal or over the counter weight loss products while taking this medication. Many people who lose weight and remain on Meridia maintain their weight loss. When fen phen was recalled in 1997, dieters anxiously awaited the new diet pill despite the high number of deaths and serious, life-threatening side effects it caused, and Meridia’s 1998 approval was just that. To date, there has failed to exist a diet pill that has been considered safe and effective, but Meridia was still successful with nearly two million prescriptions written for the diet pill in just one year alone. Meridia was approved one year after the FDA’s own advisory committed voted against the approval of Meridia 5-4 because of the risks associated to the diet pill. Immediately, marketing strategies emerged that focused on differentiating Meridia from fen phen. Despite claims of a safer diet pill, reports of serious and deadly Meridia side effects were made, leading the Public Citizen watchdog group to file a petition to the FDA requesting Meridia be removed from the market in March 2002. There have been at least 29 Meridia related deaths as well as cardiovascular problems. From February 1998 to September 2001 alone, there were nearly 400 serious Meridia adverse reactions reported. The reports of Meridia side effects did not seem to influence the popularity of the drug with around 8.5 million people worldwide using Meridia. Some critics feel drug companies have taken advantage of one of the most eager and large consumer groups when promoting diet pills with deadly side effects like Meridia. The FDA demanded Meridia manufacturer Abbott Laboratories make changes in advertising and promotional materials because they suggested Meridia was more effective than evidence shows. For more information on Meridia and Meridia side effects, please contact us to learn your legal rights and options. Health Canada reports back to public on safety profile of MERIDIA® (sibutramine) OTTAWA - Health Canada is updating the public on safety information regarding sibutramine, a prescription drug sold as MERIDIA® in Canada. Health Canada has completed this review and has concluded that MERIDIA® (sibutramine) continues to meet the requirements for sale in Canada. MERIDIA® (sibutramine) received Health Canada's approval for sale on December 28, 2000, for the treatment of obesity. On March 27, 2002, Health Canada issued a public health advisory informing Canadians that it was conducting a review of the safety profile of the marketed drug in light of international regulatory action and adverse reactions reported in Canada and elsewhere. Last year's advisory explained that Italian authorities had temporarily suspended market authorisation of all drugs containing sibutramine in that country, primarily because of concerns regarding cardiovascular events and two deaths. The Committee for Proprietary Medicinal Products (CPMP) in Europe reassessed sibutramine in June 2002 and concluded that the benefit/risk balance of sibutramine-containing products was favourable. The Italian Ministry of Health revoked the temporary suspension of sibutramine on August 28, 2002, thus reinstating marketing approval in Italy. There were 53 reports of adverse reactions associated with the use of MERIDIA® (sibutramine) reported to Health Canada from March 1, 2002 and November 13, 2002. No deaths have been reported. These reports are consistent with the known adverse reactions of MERIDIA® (sibutramine), which can include an increase in blood pressure and heart rate, and disturbances of the visual system such as eye pain and eye hemorrhage. Patients should not take MERIDIA® (sibutramine) while taking medications that can affect the level of serotonin in the brain, such as antidepressants. Patients should be monitored by their physicians while using MERIDIA® (sibutramine). SIBUTRAMINE (Meridia®) is used to control hunger in patients who are overweight. Sibutramine is prescribed along with a reduced-calorie diet and, if appropriate, an exercise program. Do not share this medicine with anyone else. Generic sibutramine capsules are not yet available. Visit your prescriber regularly to have your blood pressure and heart rate checked. Contact your prescriber if you think you are experiencing any unusual side effects. Keep in mind that sibutramine was intended to be used in addition to a healthy diet and appropriate exercise. The best results are achieved this way. Do not increase or in any way change your dose without consulting your prescriber. A weight-loss of 4 pounds or more during your first month of treatment is a good indicator of success with sibutramine. Most of the weight you will lose will be lost gradually during 6—12 months. Many people who lose weight and remain on sibutramine therapy maintain their weight loss. You should not use herbal or over-the-counter weight-loss products while taking sibutramine. Non-drug nutritional supplements, like vitamins, minerals, and proteins or amino acids (with the exception of tryptophan), can be used with sibutramine. You should make sure your prescriber knows what nutritional supplements you are taking and why you are taking them. Meridia has now been associated with 29 deaths, including 19 due to adverse cardiovascular effects. The diet drug was first approved in 1997, one year after the FDA advisory committee voted 5-4 that the benefits of Meridia did not outweigh the risks. Meridia had received a review from an FDA medical officer concluding that a non-approval was recommended due to the significant increase in blood pressure and heart rate in many people. Until this March, Meridia appeared to be a total success to Abbott Laboratories, the drug’s maker. Meridia is found in 70 countries and has been used by 8.5 million people worldwide. But the sales success of Meridia has turned into a safety question. After two cardiovascular deaths occurred in Italy, the use of Meridia was suspended so that a safety review could be performed. This Meridia suspension in Italy was the first country movement to investigate the safety of the weight loss pill that led to a Europe-wide review of the drug. France and Great Britain have had a total of 103 serious Meridia side effects reported, including the deaths of two people in Great Britain. The worldwide reports of potentially life threatening adverse effects has prompted the consumer advocacy group Public Citizen to file a petition to the FDA for the immediate ban of Meridia. Abbott Laboratories continues to dispute Public Citizen’s petition, claiming the diet drug Meridia, despite any risk associated to the drug, is an overall aid to the risk that any obese person has. Studies performed on the diet drug Meridia show that there is an average 6.5 lbs lost in a year’s time, and during the second year the majority of people regain the weight and gain the entire weight back if stopping drug use. While Abbott claims that any weight loss Meridia can provide an obese patient would be expected to decrease the risk of heart disease and death, Sidney Wolfe of Public Citizen claims, “There is no evidence that this drug has prolonged the life of a single patient, or reduced the risks of strokes or heart attacks tied to obesity,” (WebMD, 3-22-02). Meridia Side Effects The difference in reported adverse Meridia side effects verses the real number of Meridia side effects is estimated to be tenfold higher. The FDA is currently reviewing the safety implications that have been associated with Meridia in response to Public Citizen’s petition. Public Citizen has petitioned for the removal of four other FDA approved drugs since 1996 and three of the drugs ended up being banned and one severely restricted. The end of March introduced the first lawsuits against Abbott on behalf of Meridia patients. 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The information in the MediResource Drug and Disease Databases is for informational purposes only and must not be used or relied upon for making a diagnosis or treatment decision. Always seek the advice of your physician or other qualified healthcare provider regarding any questions you may have about a medical condition. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. It should not be construed to indicate that the use of a particular drug is safe, appropriate or effective for you. It should not be relied upon or interpreted as a recommendation for any specific treatment plan, product or course of action. The information on the site is not intended as a substitute of any kind for professional medical advice, diagnosis or treatment. Speak to your healthcare professional before taking any product, changing your lifestyle, or beginning or discontinuing any course of treatment. If you suspect that you are ill or may have a medical emergency, contact a physician, a health professional or call 911 immediately Meridia is a weight loss drug that was approved by the Food and Drugs Administration in the late 1990s. Manufactured by Abbot Laboratories, this weight loss and diet drug has received a great deal of negative attention lately, having been linked to over 25 deaths in the United States. Across the globe, Meridia is thought to have been taken by up to nine million people, although in truth it has been at the center of controversy even before it received approval from the Food and Drugs Administration. Meridia works by inhibiting certain neurotransmitters, including monamine, norepinephrine, and 5-HT. This in turn helps to reduce appetite and depression, and can therefore aid weight loss. An FDA Advisory Committee tried to persuade the agency not to approve Meridia in September 1996. Thos followed research that showed a number of side effects that could stem from taking Meridia, including high blood pressure. However, the Food and Drugs Administration went ahead and approved the drug anyway, which resulted in Meridia being issued to millions of people worldwide and resulting in some undesirable and often dangerous side effects. Some years later, in 2002, a petition was filed by consumer health group Public Citizen. The petition called for the immediate recall of Meridia from the United States market by the Food and Drugs Administration. This came four years after the diet drug had received initial FDA approval, and Public Citizen also provided details of 29 deaths that had occurred since the approval of Meridia and that had been associated with the drug. Public Citizen also provided details on the side effects that had been associated with the diet drug, and it pointed out that over a three year period since it’s approval Meridia had been associated with over four hundred serious adverse reactions. Public Citizen also went on to state that Meridia had not made any significant contribution to prolonging a patient’s life or reducing the risk of heart attacks or strokes linked to obesity. It also went on to state that Meridia had instead contributed to cardiovascular problems, and left patients with an increased risk of injury and death. Some of the side effects associated with Meridia include: Increased blood pressureIncreased heart rateHeart diseaseSeizuresStroke Mental disorders You can now find specialist lawyers that deal with Meridia cases and other types of drug litigation, and anyone that has taken the drug and suffered side effects is urged to seek both medical and legal assistance. An experienced Meridia lawyer can help you to get compensation for harm or injury caused by taking this diet drug. If you are related to someone that has been seriously debilitated or has died through taking Meridia, you can also seek legal assistance. You can get your initial consultation for free with many Meridia lawyers, so even if you are unsure as to whether you have grounds to make a claim, you can find this out from an experienced lawyer without having to pay a cent up-front. An experienced Meridia lawyer can evaluate the facts and circumstances surrounding your case, and can determine whether you have a viable case to claim for compensation. An experienced lawyer will also put together as solid a case as possible, in order to try and maximize on your chances of a successful claim against the manufacturer of Meridia. An experienced Meridia lawyer will know all about the symptoms and implication involved in taking Meridia. He or she will also have established links with other groups and resources, enabling you to receive support and to lend your lawsuit extra weight. A Meridia lawyer will also gather the relevant information, and will aim to put together as solid a lawsuit as possible in order to maximize on the chances of a successful claim. You could get compensation for medical expenses incurred as a result of taking Meridia, as well as compensation for pain, suffering, loss of income, and if you are claiming on behalf of someone that has passed away, wrongful death. Take by mouth exactly as directed by your doctor, usually once daily. The full effect on weight may require four to six weeks. Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. Also, if used for a longer period of time, do not suddenly stop using this drug without your doctor's approval. Over time, this drug may not work as well as it did at the beginning. Consult your doctor if weight increases. Tell your doctor of all nonprescription and prescription medication you may use, especially other weight reducing agents (e.g., diethylpropion), drugs that can raise blood pressure such as decongestants (e.g., pseudoephedrine, phenylpropanolamine), cough suppressants (e.g., dextromethorphan), antidepressants (e.g., nefazodone, fluoxetine, paroxetine, sertraline, fluvoxamine, venlafaxine), lithium, psychiatric medications (e.g., MAO Inhibitors such as selegiline, moclobemide, furazolidone, phenelzine, tranylcypromine), drugs for migraines (e.g., dihydroergotamine, sumatriptan), tryptophan, certain narcotic pain relievers (e.g., meperidine, pentazocine, fentanyl), ketoconazole, erythromycin, high blood pressure medicine or any drugs which can cause drowsiness, including certain antihistamines (e.g., diphenhydramine), sedatives and anti-seizure drugs. Antihistamines and decongestants may be found in many nonprescription drugs for cough and cold. Consult your pharmacist. MAO Inhibitors (see above) and this drug should not be taken together. If an MAO Inhibitor or this drug is stopped, wait 2 weeks before starting the other drug. Directions The medication is taken once daily with or without food. The usual starting dose is 10mg daily and can be increased to 15mg daily if no significant weight loss is observed. Patient information Do not take more frequently than prescribed. Side effects include dry mouth, insomnia, constipation, runny nose, and headaches. Precautions It is important that the doctor has your complete medical history. Consult with your doctor if you have a history of anorexia, cardiovascular problems, glaucoma, under productive thyroid, kidney problems, pregnant, history of drug abuse or misuse, pulmonary hypertension, seizures, gallstones, take liver function tests, a mental disease, pregnant or breast-feeding. Drug interactions Inform your doctor about all the medicines you use, especially other weight reducing agents (e.g., diethylpropion), drugs that can raise blood pressure such as decongestants (e.g., pseudoephedrine), cough suppressants (e.g., dextromethorphan), antidepressants (e.g., nefazodone, fluoxetine, paroxetine, sertraline, fluvoxamine, venlafaxine), lithium, psychiatric medications (e.g., MAO Inhibitors such as selegiline, furazolidone, phenelzine, tranylcypromine), drugs for migraines (e.g., dihydroergotamine, sumatriptan), tryptophan, certain narcotic pain relievers (e.g., meperidine, pentazocine, fentanyl), ketoconazole, erythromycin, high blood pressure medicine or any drugs which can cause drowsiness, including certain antihistamines (e.g., diphenhydramine), sedatives and anti-seizure drugs. Antihistamines and decongestants may be found in many over the counter drugs for cough and cold. Consult your pharmacist. MAO Inhibitors (see above) and this drug should not be taken together. If an MAO Inhibitor or this drug is stopped, wait 2 weeks before starting the other drug. You should not use herbal or over the counter weight loss products while taking this medication. Many people who lose weight and remain on Meridia maintain their weight loss. Storage: Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture. Keep this and all medications out of the reach of children. Buy Meridia on sale now. Order Sibutramine at Discount Prices. Links to Generic & brand name Meridia with great prices and superior service. 5, 10 & 15mg sizes. http://www.bigonlinepharmacy.com/meridia.html Buy Meridia on sale now. Order Sibutramine at Discount Prices. Links to Generic & brand name Meridia with great prices and superior service. 5, 10 & 15mg sizes Buy Meridia on sale now. Order Sibutramine at Discount Prices. Links to Generic & brand name Meridia with great prices and superior service. 5, 10 & 15mg sizes. Why pay more for your Meridia Medication than you have to? Some pharmacies charge over $100 more for the same prescription!! We also offer Next day shipping so you get your order quickly. Why do so many people turn to Meridia as a crucial part of the weight loss process? With a proper diet, the right supplements, and an appetite suppressant, you can become more comfortable with yourself as you are able to lose those extra pounds. Meridia works to influence the appetite control center in your brain. You simply take one capsule a day. The active ingredient in Meridia has been tested and proven! More than 8 million people around the world have taken it, and more than 100,000 U.S. doctors have prescribed Meridia for their patients. It has been tested in clinical studies over 100 times, with over 12,000 study participants. We know that obtaining your medication the old way can be inconvenient and expensive. That’s why here at Meridia Online we provide a service to you that allows you to save time and money while getting the medication you need on our website. From the time you place your order until you receive your medication is just a couple of days. And, even better, you don’t have to run all over town to the doctor and pharmacist to get it. We Fed-Ex it right to you! In most cases, Meridia is both a safe and effective treatment. Of course, no prescriptions are ever filled until one of our U.S. Licensed physicians reviews your medical history. For this reason, we ask you to provide us complete and honest information when you fill out the consultation form. This is important for our records, but it is much more important for your safety and long-term health, (order Meridia) Order Online and Save! When you order your Meridia online from us, you will save both time and money. You can be sure you’ll get exactly the right prescription and your medical consultation is always FREE! Meridia-Online helps consumers obtain Meridia safely, inexpensively, and legally from our U.S. based pharmacies. We are not directly affiliated with the manufacturer of Meridia, Knoll Pharmaceutical Company. For more information about Meridia directly from the manufacturer, please visit 4meridia.com. Generic Meridia (Sibutramine) blocks the re-uptake of the brain chemicals (serotonin and norepinephrine) which help regulate the sense of fullness. Fullness is your signal to stop eating. Having a sense of fullness, or satiety, means you may feel satisfied with less food. Generic Meridia (Sibutramine) should be used in conjunction with a reduced calorie diet. Always consult your physician before beginning any diet or exercise program. Sibutramine, the active ingredient in generic Meridia (Sibutramine), has been extensively studied throughout the world. It has been studied in more than 100 clinical trials involving more than 12,000 patients. Approximately 14 million patients in more than 75 countries have used generic Meridia (Sibutramine) for the treatment of obesity since it was approved in 1997. In studies, generic Meridia (Sibutramine) in combination with diet and exercise was effective in producing and maintaining significant weight loss in the majority of obese patients compared to diet and exercise alone Generic Meridia (Sibutramine) works by acting on the appetite control center in the brain. Studies have shown that using Generic Meridia (Sibutramine), along with a reduced-calorie diet and exercise, helped patients lose weight and maintain weight loss for up to two years. The active ingredient in Generic Meridia (Sibutramine) works in the area of the brain that signals the sense of fullness (satiety). Generic Meridia (Sibutramine) does not suppress appetite, which is your signal to start eating Generic Meridia (Sibutramine) substantially increases blood pressure or heart rate in some patients and should not be given to patients with uncontrolled or poorly controlled hypertension, history of heart disease, stroke, severe liver or kidney disease, pregnant women or nursing mothers. Generic Meridia (Sibutramine) should be used cautiously in patients with a history of hypertension, glaucoma or seizures. All patients being treated with generic Meridia (Sibutramine) should see their doctor as directed for regular monitoring of blood pressure and heart rate. It is important that you tell your health care provider about all current and past medical problems. Do not take other medicines with generic Meridia (Sibutramine) unless your doctor has told you that it is okay to do so. Talk to your doctor about all medications (including prescriptions for depression, and those which may increase risk of bleeding), over- the-counter medicines, such as cough and cold, and herbal products that you are currently taking or have recently taken. Sibutramine affects chemicals in the body that are related to weight maintenance. Sibutramine is used as a short-term supplement to diet and exercise in the treatment of obesity. Sibutramine is indicated for people who need to lose 30 pounds or more depending on height, and should be used in conjunction with a reduced-calorie diet. Sibutramine is not for everyone including persons who are allergic to any of the ingredients of Sibutramine, those with anorexia nervosa , bulimia nervosa, or who are taking monoamine oxidase inhibitors (MAOIs ) or other weight loss medications that act on the brain. Sibutramine substantially increases blood pressure or heart rate in some patients and should not be given to patients with uncontrolled or poorly controlled hypertension, history of heart disease, stroke, severe liver or kidney disease, pregnant women or nursing mothers. Sibutramine should be used cautiously in patients with a history of hypertension, glaucoma or seizures. All patients being treated with Sibutramine should see their doctor as directed for regular monitoring of blood pressure and heart rate. It is important that you tell your health care provider about all current and past medical problems. Do not take other medicines with Sibutramine unless your doctor has told you that it is okay to do so. Talk to your doctor about all medications (including prescriptions for depression, and those which may increase risk of bleeding ), over- the-counter medicines, such as cough and cold, and herbal products that you are currently taking or have recently taken. Sibutramine is a controlled substance that might be abused, or might cause physical or psychological dependence. The most common side effects include headache, dry mouth, anorexia, constipation and insomnia. This drug is taken by mouth as needed 45min before sexual activity Once a man has completed sexual activity, blood flow to his penis should decrease and his erection should go away Paroxetine has also been used to treat a severe form of premenstrual syndrome (premenstrual dysphoric disorder- PMDD), sexual function problems in men (premature ejaculation), nerve problems associated with diabetes (diabetic neuropathy), chronic headaches, or post-traumatic stress disorder (PTSD) Rabeprazole works by blocking acid production in the stomach Assessments were done by looking at photographic enlargements of sections of the scalp g Atorvastatin works by blocking an enzyme in the liver that your body uses to make cholesterol The amount or how often Atorvastatin is taken should never be changed without consulting your healthcare professional If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you 0% of men taking this medicine CAN I TAKE CELEBREX IF I AM TAKING OTHER MEDICATIONS? , diphenhydramine) • Swallow the regular tablets with a glass of water Follow the directions for taking this medicine provided by your doctor or pharmacist What is Atorvastatin? • Take this medication exactly as directed by your doctor If you are one of the many people who take low-dose aspirin for the prevention of heart attack or stroke, you can still take CELEBREX • Your doctor may want you to have blood pressure checks, blood tests, or other medical evaluations during treatment with losartan to monitor progress and side effects Atorvastatin is used with diet changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol and certain fatty substances in your blood It is used to treat acid-related stomach/intestinal and throat (esophagus) problems (e Cialis works along with sexual stimulation to help achieve an erection Tell your doctor your medical history, especially of: any liver or kidney disease, blood disorders, porphyria, asthma, any allergies • Losartan can be taken with or without food Vardenafil (Levitra) helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity • Take cephalexin at evenly spaced intervals to keep a constant level of drug in the body If needed, antacids may be taken along with this medication · numbness, tingling, or pain; Rabeprazole works by blocking acid production in the stomach Atorvastatin works by blocking an enzyme in the liver that your body uses to make cholesterol Limit alcohol intake while taking this medication Increased HDL cholesterol, the "good" cholesterol, by 5-9% Your doctor may prescribe this medicine for other conditions as well · nasal irritation Tell your doctor your medical history, especially of: any liver or kidney disease, blood disorders, porphyria, asthma, any allergies Intestinal side effects (e PROPECIA through its inhibitory action serves to reverse this process by decreasing the amount of DHT in the hair follicle and in blood • Other, less serious side effects may be more likely to occur It is available in 2 Intestinal side effects (e • Do not stop taking montelukast without first talking to your doctor Xenical should not be used if you have anorexia nervosa or bulemia-type eating disorders This medication is used to treat male sexual function problems (erection problems) g If you experience any of the following serious side effects, stop taking losartan and contact your doctor immediately or seek emergency medical treatment Talk to your doctor about any side effect that seems unusual or that is especially bothersome CELEBREX provides relief through the day and through the night • Store the tablets and capsules at room temperature away from moisture and heat · mucous or blood in the stool; or Do not crush or chew them or the sustained activity of the drug will be destroyed and the chances of side effects occurring may be increased Do not double doses Use caution engaging in activities requiring alertness (such as driving) if this drug makes you dizzy or drowsy Fosamax/Alendronate is used to prevent and treat postmenopausal osteoporosis (bone weakening) or Paget's disease Leukotrienes are substances in the body that are associated with the inflammation and constriction of airway muscles and the accumulation of fluid in the lungs, all of which occur during an asthma attack Because of the potential risk to the infant, breast-feeding while using Xenical is not recommended Always take Atorvastatin as directed by your healthcare professional • Store the suspension in the refrigerator Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture Do not suck or chew the Fosamax/Alendronate tablet; swallow the Fosamax tablet whole Take montelukast exactly as directed by your doctor Paxil works by helping to restore the balance of certain natural chemicals in the brain Standing or sitting upright helps you get the full dose and decreases heartburn or the risk of injury to your esophagus If a meal is occasionally missed or contains no fat, skip that dose of the medication This medication may be taken with food or immediately after meals to prevent stomach upset PROPECIA through its inhibitory action serves to reverse this process by decreasing the amount of DHT in the hair follicle and in blood What are the effects of Atorvastatin tablets? Standing or sitting upright helps you get the full dose and decreases heartburn or the risk of injury to your esophagus Atorvastatin can be taken any time of the day, with or without food A net increase in scalp hair count and hair regrowth was seen in over 80% of men for whom it was prescribed Propecia is a pill taken by mouth that is a new and effective treatment for male pattern baldness - If you have had an allergic reaction to aspirin or other NSAIDs How does Atorvastatin work?? 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Generic Name: sibutramine (oral) (sih BYOO tra meen) Brand Names: Meridia What is the most important information I should know about sibutramine? • Sibutramine has been reported to cause increased blood pressure in some patients. It is important to have your blood pressure and pulse monitored regularly while taking sibutramine. • Use caution when driving, operating machinery, or performing other hazardous activities. Sibutramine may cause dizziness, difficulty concentrating, or restlessness. If you experience these effects, avoid hazardous activities. • Do not take any other prescription or over-the-counter medicines without first talking to your doctor, especially weight-loss products, tryptophan (L-tryptophan, 5-HTP), decongestants, antidepressants, cough suppressants, lithium (Eskalith, Lithobid, Lithonate, others), and migraine medicines. What is sibutramine? • Sibutramine affects chemicals in the body that are related to weight maintenance. • Sibutramine is used as a short-term supplement to diet and exercise in the treatment of obesity. • Sibutramine may also be used for purposes other than those listed in this medication guide. What should I discuss with my healthcare provider before taking sibutramine? • Do not take sibutramine without first talking to your doctor if you · have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the last 14 days; · are or have been depressed; · have bleeding problems; · have anorexia nervosa; · are taking an appetite suppressant; · have high blood pressure; · have heart disease, irregular heartbeats, congestive heart failure, or a history of stroke; · have epilepsy or another seizure disorder; · have gallstones; · have glaucoma; · have liver disease; or · have kidney disease. • You may not be able to take sibutramine, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above. • Sibutramine may interact with other medicines and cause a condition called Serotonin Syndrome. This syndrome requires immediate medical attention and may include one or more of the following symptoms: anxiety, restlessness, loss of consciousness, confusion, weakness, tremor, poor coordination, fever, shivering, sweating, vomiting, a fast heartbeat, and others. Do not take any other prescription or over-the-counter medicines without first talking to your doctor, especially weight-loss products, tryptophan (L-tryptophan, 5-HTP), decongestants, antidepressants, cough suppressants, lithium (Eskalith, Lithobid, Lithonate, others), or migraine medicines. • Sibutramine is in the FDA pregnancy category C. This means that it is not known whether sibutramine will harm an unborn baby. Do not take sibutramine without first talking to your doctor if you are pregnant or could become pregnant during treatment. • It is not known whether sibutramine passes into breast milk. Do not take sibutramine without first talking to your doctor if you are breast-feeding a baby. • The safety and effectiveness of sibutramine have not been studied in children younger than 16 years of age. How should I take sibutramine? • Take sibutramine 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. • Sibutramine is usually taken once a day. Follow your doctor's instructions. • Sibutramine can be taken with or without food. • Never take more of this medication than is prescribed for you. Too much sibutramine could be dangerous. • Sibutramine has been reported to cause increased blood pressure in some patients. It is important to have your blood pressure and pulse monitored regularly while taking sibutramine. • Store sibutramine 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 the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication. What happens if I overdose? • Seek emergency medical attention. • Symptoms of a sibutramine overdose are not known. What should I avoid while taking sibutramine? • Use caution when driving, operating machinery, or performing other hazardous activities. Sibutramine may cause dizziness, difficulty concentrating, or restlessness. If you experience these effects, avoid hazardous activities. • Do not take any other prescription or over-the-counter medicines without first talking to your doctor, especially weight-loss products, tryptophan (L-tryptophan, 5-HTP), decongestants, antidepressants, cough suppressants, lithium (Eskalith, Lithobid, Lithonate, others), and migraine medicines. What are the possible side effects of sibutramine? • If you experience any of the following serious side effects, stop taking sibutramine and seek emergency medical attention or contact your doctor immediately: · an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); · easy bleeding, bruising under the skin , bloody gums, or blood in your urine or stool; · new or worsening shortness of breath; · an irregular heartbeat; · high blood pressure (severe headache, blurred vision); or · seizures. • Other, less serious side effects may be more likely to occur. Continue to take sibutramine and talk to your doctor if you experience · restlessness or tremor, · nervousness or anxiety, · mild headache or dizziness, · insomnia, · dry mouth or an unpleasant taste in your mouth, or · constipation. • Sibutramine may interact with other medicines and cause a condition called Serotonin Syndrome. This syndrome requires immediate medical attention and may include one or more of the following symptoms: anxiety, restlessness, loss of consciousness, confusion, weakness, tremor, poor coordination, fever, shivering, sweating, vomiting, a fast heartbeat, and others. Do not take any other prescription or over-the-counter medicines without first talking to your doctor, especially weight-loss products, tryptophan (L-tryptophan, 5-HTP), decongestants, antidepressants, cough suppressants, lithium (Eskalith, Lithobid, Lithonate, others), or migraine medicines. • 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 sibutramine? • Do not take sibutramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the last 14 days. A dangerous drug interaction may occur. • Before taking this medication, tell your doctor if you are taking · lithium (Lithobid, Eskalith, Lithonate, others); · almotriptan (Axert), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), eletriptan (Relpax), frovatriptan (Frova), or zolmitriptan (Zomig); · venlafaxine (Effexor), duloxetine (Cymbalta), nefazodone (Serzone), mirtazapine (Remeron), or thioridazine (Mellaril); · citalopram (Celexa), fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), or fluvoxamine (Luvox); · amitriptyline (Elavil, Endep), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil); · dihydroergotamine (D.H.E.); · an oral anticoagulant or drugs that may increase bleeding such as warfarin (Coumadin), ticlopidine (Ticlid), clopidogrel (Plavix), pentoxifylline (Trental) , aspirin, and others; · dextromethorphan (in many cough medicines); · meperidine (Demerol); · fentanyl (Duragesic); or · pentazocine (Talacen, Talwin). • Sibutramine may interact with the medicines listed above and cause a condition called Serotonin Syndrome. This syndrome requires immediate medical attention and may include one or more of the following symptoms: anxiety, restlessness, loss of consciousness, confusion, weakness, tremor, poor coordination, fever, shivering, sweating, vomiting, a fast heartbeat, and others. Do not take any other prescription or over-the-counter medicines without first talking to your doctor, especially weight-loss products, tryptophan (L-tryptophan, 5-HTP), decongestants, antidepressants, cough suppressants, lithium (Eskalith, Lithobid, Lithonate, others), or migraine medicines. • Drugs other than those listed here may also interact with sibutramine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines including vitamins, minerals, and herbal products. Where can I get more information? • Your pharmacist has more information about sibutramine 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, check with your doctor, nurse or pharmacist. Sibutramine (si-BYOO-tra-meen) is used together with a reduced-calorie diet to help you lose weight and to help keep the lost weight from returning. Sibutramine is thought to work by increasing the activity of certain chemicals, called norepinephrine and serotonin, in the brain. This medicine is approved for use only in people who are very overweight. This medicine is available only with your doctor's prescription, in the following dosage form: Oral Capsules (U.S.) -------------------------------------------------------------------------------- Before Using This Medicine In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sibutramine, the following should be considered: Allergies-Tell your doctor if you have ever had any unusual or allergic reaction to sibutramine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. Pregnancy-Sibutramine has not been studied in pregnant women. However, studies in animals have shown that sibutramine causes birth defects when used in doses many times higher than the usual human dose. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant. Breast-feeding-It is not known whether sibutramine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. A mother who is taking this medicine and who wishes to breast-feed should discuss this with her doctor. Children-Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of sibutramine in children with use in other age groups. Older adults-Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of sibutramine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults. Other medicines-Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking sibutramine, it is especially important that your health care professional know if you are taking any of the following: Appetite suppressants, other (benzphetamine [e.g., Didrex], diethylpropion [e.g., Tenuate], mazindol [e.g., Sanorex], phendimetrazine [e.g., Phendiet], phentermine [e.g., Ionamin])-The effects of using sibutramine in combination with another appetite suppressant are not known Bromocriptine (e.g., Parlodel) or Buspirone (e.g., BuSpar) or Certain tricyclic antidepressants (amitriptyline [e.g., Elavil], clomipramine [e.g., Anafranil], imipramine [e.g., Tofranil]) or Dextromethorphan (cough medicine) or Levodopa (e.g., Sinemet) or Lithium (e.g., Eskalith) or Meperidine (e.g., Demerol) or Nefazodone (e.g., Serzone) or Pentazocine (e.g., Talwin) or Selective serotonin reuptake inhibitors (citalopram [e.g., Celexa], fluoxetine [e.g., Prozac], fluvoxamine [e.g., Luvox], paroxetine [e.g., Paxil], sertraline [e.g., Zoloft]) or Street drugs (LSD, MDMA [e.g., ecstasy], marijuana) or Sumatriptan (e.g., Imitrex) or Tramadol (e.g., Ultram) or Trazodone (e.g., Desyrel) or Tryptophan or Venlafaxine (e.g., Effexor)-Using these medicines with sibutramine may increase the chance of developing a rare, but very serious, unwanted effect known as the serotonin syndrome. Symptoms of this syndrome include confusion, diarrhea, fever, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, or twitching. If you develop these symptoms, contact your doctor as soon as possible Moclobemide (e.g., Manerex)-Taking moclobemide and sibutramine together or less than 3 days apart may increase the chance of developing serious unwanted effects, including the serotonin syndrome, and is not recommended Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])- Do not take sibutramine while you are taking or within 2 weeks of taking an MAO inhibitor, and do not take an MAO inhibitor within 2 weeks of taking sibutramine . If you do, you may develop severe seizures, extremely high blood pressure, or the serotonin syndrome. Allow at least 2 weeks to pass between taking one of these medicines (sibutramine or an MAO inhibitor) and taking the other Other medical problems-The presence of other medical problems may affect the use of sibutramine. Make sure you tell your doctor if you have any other medical problems, especially: Anorexia nervosa (an eating disorder) or Glaucoma, narrow angle or High blood pressure (or history of)-Sibutramine may make these conditions worse Brain disease or damage, or mental retardation or Seizures (history of)-Sibutramine may increase the chance of having seizures Gallstones (or history of)-Weight loss may make this condition worse Heart disease (or history of) or Stroke (or history of)-Increased blood pressure or heart rate caused by sibutramine may make these conditions worse Kidney disease (severe) or Liver disease (severe)-Higher blood levels of sibutramine may occur, increasing the chance of having unwanted effects -------------------------------------------------------------------------------- Proper Use of This Medicine Take this medicine only as directed . Do not take more of it, do not take it more often, and do not take it for a longer time than directed by your doctor. To do so may increase the chance of developing unwanted effects, such as high blood pressure. Follow a reduced-calorie diet while taking sibutramine, as directed by your doctor. Sibutramine may be taken with or without food, on a full or empty stomach. However, if your doctor tells you to take it in a certain way, take it as directed. You must follow a reduced-calorie diet while taking sibutramine in order to lose weight and keep the lost weight from returning. Dosing-The dose of sibutramine will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of sibutramine. If your dose is different, do not change it unless your doctor tells you to do so. The number of capsules that you take depends on the strength of the medicine. For oral dosage form (capsules): For weight loss: Adults-At first, 10 milligrams (mg) one time a day, usually in the morning. Your doctor may increase or decrease your dose if needed. However, the dose is usually not more than 15 mg a day. Children-Use and dose must be determined by the doctor. Missed dose-If you miss a dose of sibutramine and you remember it within 2 to 3 hours, take it as soon as possible. If you do not remember the missed dose until later, skip the missed dose and return to your regular dosing schedule. Do not double doses. Storage-To store this medicine: Keep out of the reach of children. Store away from heat and direct light. Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down. Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children. -------------------------------------------------------------------------------- Precautions While Using This Medicine It is important that your doctor check your progress at regular visits . Sibutramine may increase blood pressure or heart rate and your doctor will check for these effects. Your doctor may need to adjust your dose. If sibutramine does not seem to be working well, do not increase your dosage . Check with your doctor. Do not take sibutramine while you are taking or within 2 weeks of taking medicines with monoamine oxidase (MAO) inhibitor activity , such as isocarboxazid (e.g., Marplan), phenelzine (e.g., Nardil), procarbazine (e.g., Matulane), selegiline (e.g., Eldepryl), or tranylcypromine (e.g., Parnate). Do not take an MAO inhibitor within 2 weeks of taking sibutramine . To do so may cause severe seizures, extremely high blood pressure, or a life-threatening adverse effect called the serotonin syndrome. Do not drink excess alcohol while taking sibutramine. Notify your doctor as soon as possible if you develop a skin rash, hives, or other allergic symptoms . Sibutramine may cause dizziness, drowsiness, or poor judgment. Be sure you know how you react to this medicine before you drive, operate machinery, or do other things that could be dangerous if you are not alert and able to think clearly . Sibutramine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections. -------------------------------------------------------------------------------- Side Effects of This Medicine Along with its needed effects, a medicine may cause some unwanted effects. Some of these effects, such as high blood pressure, may not have signs or symptoms that you can see or feel. While you are taking sibutramine, your doctor will check your blood pressure and heart rate at regular visits. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor as soon as possible if any of the following side effects occur: Less common Achiness; chills; fast or irregular heartbeat; increased blood pressure; mental depression; painful menstruation; swelling of body or of feet and ankles Rare Bruising or red spots or patches on skin; convulsions (seizures); excessive bleeding following injury; headache (severe); rapidly changing moods; skin rash; weight gain (unusual) Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome: More common Anxiety; constipation; dizziness; dryness of mouth; headache; irritability or unusual impatience; nervousness; stuffy or runny nose; trouble in sleeping Less common Abdominal pain; back pain; burning, itching, prickling, or tingling of skin; change in sense of taste; diarrhea; drowsiness; increase in appetite; increased sweating; increased thirst; indigestion; nausea; unusual warmth or flushing of skin Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor. -------------------------------------------------------------------------------- Developed: 04/26/1999 The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products. The health information contained herein is provided for informational purposes only and is not intended to replace a discussion with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider and consider the unique characteristics of each patient. The information contained in MERIDIA.net is intended for use only by United States residents. Countries outside of the United States may have regulatory requirements, data measurements, or medical practices that may differ from those in the United States. Therefore, this information may not be appropriate for use outside the United States. Used to reduce excess body weight (Sibutramine - Oral) Uses This medication is used to reduce excess body weight (obesity). How to take this medication Take by mouth exactly as directed by your doctor, usually once daily. The full effect on weight may require four to six weeks. Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. Also, if used for a longer period of time, do not suddenly stop using this drug without your doctor's approval. Over time, this drug may not work as well as it did at the beginning. Consult your doctor if weight increases. Side effects Dry mouth, drowsiness, constipation and difficulty sleeping may occur. If these effects persist or worsen, notify your doctor promptly. Precautions Before using Meridia, tell your doctor your entire medical history, including any allergies (especially drug allergies), liver or kidney disease, high blood pressure or heart disease, history of stroke or seizures, certain eating disorders (e.g., anorexia nervosa), glaucoma (narrow angle), or history of gallstones. Limit alcohol intake, as it may worsen certain side effects of this medication. It is recommended that women of child-bearing age should use effective birth control while taking this medication. This drug is not recommended for use during pregnancy. Consult your doctor before using this drug. It is not known whether this drug is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using Meridia is not recommended. Consult your doctor before breast-feeding. Elderly patients may be more sensitive to the effects of this drug. Use cautiously. Drug interactions Tell your doctor of all nonprescription and prescription medication you may use, especially other weight reducing agents (e.g., diethylpropion), drugs that can raise blood pressure such as decongestants (e.g., pseudoephedrine, phenylpropanolamine), cough suppressants (e.g., dextromethorphan), antidepressants (e.g., nefazodone, fluoxetine, paroxetine, sertraline, fluvoxamine, venlafaxine), lithium, psychiatric medications (e.g., MAO Inhibitors such as selegiline, moclobemide, furazolidone, phenelzine, tranylcypromine), drugs for migraines (e.g., dihydroergotamine, sumatriptan), tryptophan, certain narcotic pain relievers (e.g., meperidine, pentazocine, fentanyl), ketoconazole, erythromycin, high blood pressure medicine or any drugs which can cause drowsiness, including certain antihistamines (e.g., diphenhydramine), sedatives and anti-seizure drugs. Antihistamines and decongestants may be found in many nonprescription drugs for cough and cold. Consult your pharmacist. MAO Inhibitors (see above) and Meridia should not be taken together. If an MAO Inhibitor or this drug is stopped, wait 2 weeks before starting the other drug. Notes Do not share this medication with others. This medication should be used in addition to a reduced calorie diet. Blood pressure and pulse may be measured and laboratory tests performed to monitor side effects. Miss dose If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not "double- up" the dose to catch up. Storage Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture. Keep this and all medications out of the reach of children. Meridia is indicated for people who need to lose 30 pounds or more depending on height, and should be used in conjunction with a reduced-calorie diet. Meridia is not for everyone, including people who are allergic to any of the ingredients of Meridia, those with anorexia nervosa, bulimia nervosa, or who are taking monoamine oxidase inhibitors (MAOIs) or weight loss medications to control your appetite. Meridia substantially increases blood pressure or heart rate in some patients and should not be given to patients with uncontrolled or poorly controlled hypertension, history of heart disease, stroke, severe liver or kidney disease, pregnant women or nursing mothers. Meridia should be used cautiously in patients with a history of hypertension, glaucoma, seizures, or mild to moderate kidney disease. All patients being treated with Meridia should see their doctor as directed for regular monitoring of blood pressure and heart rate. It is important that you tell your healthcare provider about all current and past medical problems. Do not take other medicines with Meridia unless your doctor has told you that it is okay to do so. Talk to your doctor about all medications (including prescriptions for depression, and those which may increase risk of bleeding), over-the-counter medicines, such as cough and cold, and herbal products that you are currently taking or have recently taken. Meridia is a controlled substance (CIV). This means that Meridia can be a target for people who abuse prescription medicines. The most common side effects include headache, dry mouth, anorexia, constipation, and insomnia. Meridia is recommended for overweight people with an initial body mass index (BMI) of 30 or higher, or for overweight people with a BMI of 27 or higher if they have medical risk factors such as high blood pressure, diabetes, or high cholesterol. Your doctor can determine your BMI and will decide if you meet these criteria. How Is It Used? Take orally exactly as directed by your doctor - usually once daily. Results may take 4-6 weeks to appear. Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed, as this drug can be habit-forming. If taken over a long period of time, do not suddenly stop taking this medication without your doctor's approval. This drug may become less effective over time. Consult your doctor if weight increases. You can take Meridia on an empty stomach or after a meal. Are There Possible Side Effects? Dry mouth, drowsiness, constipation and difficulty sleeping may occur. If these effects persist or worsen, notify your doctor immediately. Read more here. Do not share this medication with others. This medication should be used in conjunction with a reduced calorie diet. Blood pressure and pulse may be measured and laboratory tests performed to monitor side effects. Is It Safe? Tell your doctor of your entire medical history, including any allergies (especially drug allergies), liver or kidney disease, high blood pressure, heart disease, history of stroke or seizures, certain eating disorders (e.g., anorexia nervosa), glaucoma (narrow angle), or gallstones. Limit alcohol intake, as it may worsen certain side effects of this medication. It is recommended that women of childbearing age discuss their use of birth control methods with their doctor. This drug is not recommended for use during pregnancy. Because of potential risk to infants, breast-feeding while taking this medication is not recommended. Elderly patients may be more sensitive to the effects of this drug. Use cautiously. What About Interactions With Other Drugs? Inform your doctor of all nonprescription and prescription medication you use, particularly other weight reducing agents (e.g., diethylpropion), drugs that can raise blood pressure, such as decongestants like: pseudoephedrine, phenylpropanolamine. Inform your doctor if you use cough suppressants such as (dextromethorphan), antidepressants (nefazodone, fluoxetine, paroxetine, sertraline, fluvoxamine, venlafaxine), lithium, psychiatric medications, (e.g., MAO Inhibitors such as selegiline, moclobemide, furazolidone, phenelzine, tranylcypromine). Also inform your doctor if you use drugs for migraines (e.g., dihydroergotamine, sumatriptan), tryptophan, certain narcotic pain relievers (e.g., meperidine, pentazocine, fentanyl), ketoconazole, erythromycin, high blood pressure medicine or any drugs, which can cause drowsiness, including certain antihistamines (e.g., diphenhydramine), sedatives and anti-seizure drugs. Antihistamines and decongestants may be found in many nonprescription drugs for cough and cold. Consult your pharmacist. MAO Inhibitors (see above) and this drug should not be taken together. If an MAO Inhibitor or this drug is stopped, wait 2 weeks before starting the other drug. What If I Miss A Dose? If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your regular dosing schedule. Do not "double-up" the dose to catch up. How Should It Be Stored? Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture. Keep this medication out of reach of children. Anything Else I Should Know? Do not share this medication with others. This medication should be used in conjunction with a reduced calorie diet. Blood pressure and pulse may be measured and laboratory tests performed to monitor side effects. The FDA approved the use of the Meridia diet drug against the wishes of its advisory committee that actually voted against its approval by a 5 to 4 vote. The concern of the committee was that the health risks associated with the use of Meridia for treatment of obesity outweighed the potential benefits. Since Meridia was first sold In February of 1998, until September 2001, there have been 397 adverse reactions reported to the FDA, including 152 hospitalizations, and 29 deaths. How Can I Manage My Weight Once I'm Off This Medication? More On Weight Loss NOTE: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product. Please note: at times products might be shipped loose and not in blister packs due to high demand or lack of stock and in order to allow for the best possible prices. Please note: At times products might be shipped loose and not in blister packs due to high demand or lack of stock and in order to allow for the best possible prices. Take by mouth exactly as directed by your doctor, usually once daily. The full effect on weight may require four to six weeks. Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. Also, if used for a longer period of time, do not suddenly stop using this drug without your doctor's approval. Over time, this drug may not work as well as it did at the beginning. Consult your doctor if weight increases. side effects Dry mouth, drowsiness, constipation and difficulty sleeping may occur. If these effects persist or worsen, notify your doctor promptly. precautions Before using this drug, tell your doctor your entire medical history, including any allergies (especially drug allergies), liver or kidney disease, high blood pressure or heart disease, history of stroke or seizures, certain eating disorders (e.g., anorexia nervosa), glaucoma (narrow angle), or history of gallstones. Limit alcohol intake, as it may worsen certain side effects of this medication. It is recommended that women of child-bearing age should use effective birth control while taking this medication. This drug is not recommended for use during pregnancy. Consult your doctor before using this drug. It is not known whether this drug is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. Elderly patients may be more sensitive to the effects of this drug. Use cautiously. drug interactions Tell your doctor of all nonprescription and prescription medication you may use, especially other weight reducing agents (e.g., diethylpropion), drugs that can raise blood pressure such as decongestants (e.g., pseudoephedrine, phenylpropanolamine), cough suppressants (e.g., dextromethorphan), antidepressants (e.g., nefazodone, fluoxetine, paroxetine, sertraline, fluvoxamine, venlafaxine), lithium, psychiatric medications (e.g., MAO Inhibitors such as selegiline, moclobemide, furazolidone, phenelzine, tranylcypromine), drugs for migraines (e.g., dihydroergotamine, sumatriptan), tryptophan, certain narcotic pain relievers (e.g., meperidine, pentazocine, fentanyl), ketoconazole, erythromycin, high blood pressure medicine or any drugs which can cause drowsiness, including certain antihistamines (e.g., diphenhydramine), sedatives and anti-seizure drugs. Antihistamines and decongestants may be found in many nonprescription drugs for cough and cold. Consult your pharmacist. MAO Inhibitors (see above) and this drug should not be taken together. If an MAO Inhibitor or this drug is stopped, wait 2 weeks before starting the other drug. notes Do not share this medication with others. This medication should be used in addition to a reduced calorie diet. Blood pressure and pulse may be measured and laboratory tests performed to monitor side effects. missed dosage If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not "double- up" the dose to catch up. storage Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture. Keep this and all medications out of the reach of children. Meridia - Free FedEx Meridia - 10mg x30 $93.99 All orders processed. USA Pharmacy SafeUSmeds.com Meridia at Wholesale Smart shoppers buy Meridia at wholesale prices. No membership. www.pillsavers.com Meridia - Free FedEx Meridia - 10mg x30 $93.92 1-800 Support. All orders processed USMedCenter.com IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug. SIBUTRAMINE - ORAL (sye-BYOU-truh-meen) COMMON BRAND NAME(S): Meridia USES: This medication is used to reduce excess body weight (obesity). HOW TO USE: Take by mouth exactly as directed by your doctor, usually once daily. The full effect on weight may require four to six weeks. Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. Also, if used for a longer period of time, do not suddenly stop using this drug without your doctor's approval. Over time, this drug may not work as well as it did at the beginning. Consult your doctor if weight increases. SIDE EFFECTS: Dry mouth, drowsiness, constipation, difficulty sleeping, or headache may occur. If any of these effects persist or worsen, notify your doctor promptly. Report promptly: dizziness, back pain, arthritis, increased appetite, stomach pain, mood/mental changes, persistent sore throat, sinus congestion. Unlikely but report promptly: chest pain, fast or irregular heartbeat, flushing or fever, increased thirst, arm or leg swelling, muscle pain or weakness, leg cramps, numbness, vision changes, one-sided weakness, sweating, painful menstruation. Very unlikely but report promptly: seizures, bruising, change in frequency/amount/color of urine, painful urination, yellowing skin or eyes. In the unlikely event you have an allergic reaction to this drug, seek medical attention immediately. Symptoms of an allergic reaction include: rash, itching, swelling, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist. PRECAUTIONS: Before using this drug, tell your doctor your entire medical history, including: any allergies (especially drug allergies), liver or kidney disease, high blood pressure, heart disease, history of stroke or seizures, certain eating disorders (e.g., anorexia nervosa), glaucoma (narrow angle), history of gallstones. Limit alcohol intake, as it may worsen certain side effects of this medication. Since this drug may cause dizziness or fatigue, use extreme caution if operating machinery or performing hazardous tasks (e.g., driving). It is recommended that women of child-bearing age should use effective birth control while taking this medication. This drug is not recommended for use during pregnancy. Consult your doctor before using this drug. It is not known whether this drug is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. Elderly patients may be more sensitive to the effects of this drug. Use cautiously. DRUG INTERACTIONS: Tell your doctor of all nonprescription and prescription drugs you may use, especially: other weight reducing agents (e.g., diethylpropion), drugs that can raise blood pressure such as decongestants (e.g., pseudoephedrine, phenylpropanolamine), cough suppressants (e.g., dextromethorphan), antidepressants (e.g., nefazodone, fluoxetine, paroxetine, sertraline, fluvoxamine, venlafaxine), lithium, psychiatric medications (e.g., MAO inhibitors such as selegiline, moclobemide, furazolidone, phenelzine, tranylcypromine, procarbazine, linezolid), drugs for migraines (e.g., dihydroergotamine, sumatriptan), tryptophan, certain narcotic pain relievers (e.g., meperidine, pentazocine, fentanyl), ketoconazole, erythromycin, high blood pressure medicine. Tell your doctor if you take drugs that cause drowsiness: medicine for sleep, sedatives, tranquilizers, anti-anxiety drugs (e.g., diazepam), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines or tricyclics), anti- seizure drugs (e.g., carbamazepine), muscle relaxants, antihistamines that cause drowsiness (e.g., diphenhydramine). Antihistamines and decongestants may be found in many nonprescription drugs for cough and cold. Consult your pharmacist. MAO inhibitors (see above) and this drug should not be taken together. If an MAO inhibitor or this drug is stopped, wait 2 weeks before starting the other drug. Do not start or stop any medicine without doctor or pharmacist approval. OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include fast heartbeat. NOTES: Do not share this medication with others. This medication should be used in addition to a reduced calorie diet. 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New: Paxil Linked to Birth Defects Paxil SSRI Side Effects Lawsuits: Suicide Claims If you or someone you know has been prescribed Paxil and have suffered serious side effects such as attempted suicide or birth defects, get the facts. Please review the information on our site and contact us for legal assistance. Paxil (paroxetine) is subject to FDA warnings, that state Paxil may cause suicide and violence in some children and teenagers. Other studies have shown that self harm and suicidal behavior may increase in some people taking this widely prescribed medication. New studies show that pregnant woman taking Paxil are at greater risk to having a child with rare birth defects. People who have been victims of these types of serious Paxil side effects may have possible claims against the drug maker. Our lawyers are interesting in speaking to people who may have been harmed by serious Paxil side effects. Contact us if you or a loved one has committed or attempted suicide, or if a child has birth defects you believe are related to Paxil use. Paxil Birth Defects Free Legal Consultation | Paxil Facts | Withdrawal Symptoms | Paxil Suicide Side Effects | Lawsuits If you need immediate attention for a Paxil Suicide or Birth Defects related matter please call 1-800-942-2056 This site is NOT authorized by Glaxo Smithkline Corporation: the manufacturers of Paxil and is not an Official Site of Paxil" All images are used for the purposes of dramatization. No Paxil claim is the same and results may vary. Call us for information about your legal rights Paxil Birth Defects, Paxil Side Effects and Infant Death On September 27, 2005, the FDA announced an alert to healthcare professionals and consumers as GlaxoSmithKline changed their warning label on Paxil (paroxetine) to include the risk of birth defects. The results of a recent study conducted by the two entities points to an increased risk of babies born with birth defects, specifically cardiovascular defects or congenital malformations, in instances where the mother was taking Paxil during the first trimester of pregnancy. Congenital malformations are physical defects present at birth and may involve the brain, heart, lungs, liver, bones, or intestinal tract. Congenital malformations are currently the leading cause of infant deaths in the U.S.; some examples include heart defects, cleft lip, cleft palate, Down syndrome, spina bifida, or limb defects. Paxil, an antidepressant drug, is used by millions of people worldwide and generates more than $1 billion USD in annual sales. Paxil has been in the news previously for complaints of severe withdrawal symptoms and risks of suicidal behavior and increased violence in children and adolescents. Paxil is known as a Selective Serotonin Reuptake Inhibitor (SSRI); other SSRI drugs include Prozac, Zoloft, Celexa and Lexapro. The FDA warns physicians to carefully weigh the potential risks and benefits of prescribing or renewing Paxil prescriptions to women during pregnancy or while breast-feeding. It is important that all patients are aware of the side effects, risks, and treatment alternatives. Paxil Category Warning too late for My Baby Paxil: A Mother's Warning GlaxoSmithKline Sued over Paxil Birth Defects Paxil Warning: Baby at Risk How Paxil can Ruin Lives Paxil and Birth Defects Paxil and Paxil Birth Defects in the News Jul-30-06: Parents of son born with severe heart defects sues Paxil makers GlaxoSmitKline. [NEWS RELEASE WIRE] Jul-20-06: Using Paxil or other SSRI's during pregnancy can cause pulmonary hypertension in newborns. [MEDACAPE] Jul-19-06: FDA healthcare professional alert on the increased risk of Neonatal Persistent Pulmonary Hypertension to mothers who took Paxil (Paroxetine). [FDA] Jul-19-06: Babies have risk of Persistent Pulmonary Hypertension (PPHN) if mothers take Paxil during pregnancy. [PHARMA LIVE] Jul-11-06: Authors, paid as consultants to drug makers, claim there is no danger to foetus when taking Paxil during pregnancy. [POST-GAZETTE] Apr-04-06: Study shows that use of SSRIs during pregnancy causes premature delivery, underweight babies, stillbirths and seizures in newborns. [CHRONICLE HERALD] Feb-23-06: Health Tip: Paxil and Pregnancy Don't Mix [FORBES] Feb-06-06: New study confirms baby’s risk when mother took Paxil, an SSRI antidepressant, while pregnant. Results show that the newborn may suffer from withdrawal symptoms such as seizures, tremors, gastrointestinal problems, and sleep disturbances immediately but the long term effects are still unknown. [FORBES] Dec-08-05: The Food and Drug Administration said that the warning label on GlaxoSmithKline's widely prescribed anxiety drug Paxil has again been revised to advise the drug may cause heart defects in babies. [MARKET WATCH] Sep-27-05: The FDA announces a Paxil label change and warning to physicians regarding the risk of major congenital malformations in infants born to women taking Paxil during the first trimester of pregnancy. [FDA] Sep-27-05: A joint study conducted by the FDA and the maker of Paxil reviewed medical records of 3,581 infants born to women who took Paxil or other antidepressants during the first trimester of pregnancy. A preliminary analysis found infants born to women who took Paxil were more likely to be born with an abnormality than babies born to women who took another antidepressant. [ABC NEWS] Register your Paxil / Paxil Birth Defect Complaint If you or a loved one has suffered from a newborn’s death or birth defect and the mother was prescribed Paxil during pregnancy, please fill in the form below for a free case evaluation by a Paxil lawyer, or call 1-866-886-5529 toll free. Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of PAXIL CR or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PAXIL CR is not approved for use in pediatric patients. (See WARNINGS and PRECAUTIONS -- Pediatric Use.) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4,400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials. DESCRIPTION PAXIL CR (paroxetine hydrochloride) is an orally administered psychotropic drug with a chemical structure unrelated to other selective serotonin reuptake inhibitors or to tricyclic, tetracyclic, or other available antidepressant or antipanic agents. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans -4 R -(4'-fluorophenyl)-3 S -[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19 H 20 FNO 3 ·HCl·1/2H 2 O. The molecular weight is 374.8 (329.4 as free base). Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Distribution: Paroxetine distributes throughout the body, including the CNS, with only 1% remaining in the plasma. Protein Binding: Approximately 95% and 93% of paroxetine is bound to plasma protein at 100 ng/mL and 400 ng/mL, respectively. Under clinical conditions, paroxetine concentrations would normally be less than 400 ng/mL. Paroxetine does not alter the in vitro protein binding of phenytoin or warfarin. Renal and Liver Disease: Increased plasma concentrations of paroxetine occur in subjects with renal and hepatic impairment. The mean plasma concentrations in patients with creatinine clearance below 30 mL/min. was approximately 4 times greater than seen in normal volunteers. Patients with creatinine clearance of 30 to 60 mL/min. and patients with hepatic functional impairment had about a 2-fold increase in plasma concentrations (AUC, C max ). The initial dosage should therefore be reduced in patients with severe renal or hepatic impairment, and upward titration, if necessary, should be at increased intervals (see DOSAGE AND ADMINISTRATION ). Elderly Patients: In a multiple-dose study in the elderly at daily doses of 20, 30, and 40 mg of the immediate-release formulation, C min concentrations were about 70% to 80% greater than the respective C min concentrations in non-elderly subjects. Therefore the initial dosage in the elderly should be reduced (see DOSAGE AND ADMINISTRATION ). Clinical Trials Major Depressive Disorder: The efficacy of PAXIL CR controlled-release tablets as a treatment for major depressive disorder has been established in two 12-week, flexible-dose, placebo-controlled studies of patients with DSM-IV Major Depressive Disorder. One study included patients in the age range 18 to 65 years, and a second study included elderly patients, ranging in age from 60 to 88. In both studies, PAXIL CR was shown to be significantly more effective than placebo in treating major depressive disorder as measured by the following: Hamilton Depression Rating Scale (HDRS), the Hamilton depressed mood item, and the Clinical Global Impression (CGI)-Severity of Illness score. A study of outpatients with major depressive disorder who had responded to immediate-release paroxetine tablets (HDRS total score <8) during an initial 8-week open-treatment phase and were then randomized to continuation on immediate-release paroxetine tablets or placebo for 1 year demonstrated a significantly lower relapse rate for patients taking immediate-release paroxetine tablets (15%) compared to those on placebo (39%). Effectiveness was similar for male and female patients. Panic Disorder: The effectiveness of PAXIL CR in the treatment of panic disorder was evaluated in three 10-week, multicenter, flexible-dose studies (Studies 1, 2, and 3) comparing paroxetine controlled-release (12.5 to 75 mg daily) to placebo in adult outpatients who had panic disorder (DSM-IV), with or without agoraphobia. These trials were assessed on the basis of their outcomes on 3 variables: (1) the proportions of patients free of full panic attacks at endpoint; (2) change from baseline to endpoint in the median number of full panic attacks; and (3) change from baseline to endpoint in the median Clinical Global Impression Severity score. For Studies 1 and 2, PAXIL CR was consistently superior to placebo on 2 of these 3 variables. Study 3 failed to consistently demonstrate a significant difference between PAXIL CR and placebo on any of these variables. For all 3 studies, the mean dose of PAXIL CR for completers at endpoint was approximately 50 mg/day. Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of age or gender. Long-term maintenance effects of the immediate-release formulation of paroxetine in panic disorder were demonstrated in an extension study. Patients who were responders during a 10-week double-blind phase with immediate-release paroxetine and during a 3-month double-blind extension phase were randomized to either immediate-release paroxetine or placebo in a 3-month double-blind relapse prevention phase. Patients randomized to paroxetine were significantly less likely to relapse than comparably treated patients who were randomized to placebo. Social Anxiety Disorder: The efficacy of PAXIL CR as a treatment for social anxiety disorder has been established, in part, on the basis of extrapolation from the established effectiveness of the immediate-release formulation of paroxetine. In addition, the effectiveness of PAXIL CR in the treatment of social anxiety disorder was demonstrated in a 12-week, multicenter, double-blind, flexible-dose, placebo-controlled study of adult outpatients with a primary diagnosis of social anxiety disorder (DSM-IV). In the study, the effectiveness of PAXIL CR (12.5 to 37.5 mg daily) compared to placebo was evaluated on the basis of (1) change from baseline in the Liebowitz Social Anxiety Scale (LSAS) total score and (2) the proportion of responders who scored 1 or 2 (very much improved or much improved) on the Clinical Global Impression (CGI) Global Improvement score. PAXIL CR demonstrated statistically significant superiority over placebo on both the LSAS total score and the CGI Improvement responder criterion. For patients who completed the trial, 64% of patients treated with PAXIL CR compared to 34.7% of patients treated with placebo were CGI Improvement responders. Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of gender. Subgroup analyses of studies utilizing the immediate-release formulation of paroxetine generally did not indicate differences in treatment outcomes as a function of age, race, or gender. Premenstrual Dysphoric Disorder: The effectiveness of PAXIL CR for the treatment of PMDD utilizing a continuous dosing regimen has been established in 2 placebo-controlled trials. Patients in these trials met DSM-IV criteria for PMDD. In a pool of 1,030 patients, treated with daily doses of PAXIL CR 12.5 or 25 mg/day, or placebo the mean duration of the PMDD symptoms was approximately 11 ± 7 years. Patients on systemic hormonal contraceptives were excluded from these trials. Therefore, the efficacy of PAXIL CR in combination with systemic (including oral) hormonal contraceptives for the continuous daily treatment of PMDD is unknown. In both positive studies, patients (N = 672) were treated with 12.5 mg/day or 25 mg/day of PAXIL CR or placebo continuously throughout the menstrual cycle for a period of 3 menstrual cycles. The VAS-Total score is a patient-rated instrument that mirrors the diagnostic criteria of PMDD as identified in the DSM-IV, and includes assessments for mood, physical symptoms, and other symptoms. 12.5 mg/day and 25 mg/day of PAXIL CR were significantly more effective than placebo as measured by change from baseline to the endpoint on the luteal phase VAS-Total score. In a third study employing intermittent dosing, patients (N = 366) were treated for the 2 weeks prior to the onset of menses (luteal phase dosing, also known as intermittent dosing) with 12.5 mg/day or 25 mg/day of PAXIL CR or placebo for a period of 3 months. 12.5 mg/day and 25 mg/day of PAXIL CR, as luteal phase dosing, was significantly more effective than placebo as measured by change from baseline luteal phase VAS total score. There is insufficient information to determine the effect of race or age on outcome in these studies. INDICATIONS AND USAGE Major Depressive Disorder: PAXIL CR is indicated for the treatment of major depressive disorder. The efficacy of PAXIL CR in the treatment of a major depressive episode was established in two 12-week controlled trials of outpatients whose diagnoses corresponded to the DSM-IV category of major depressive disorder (see CLINICAL PHARMACOLOGY -- Clinical Trials ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least 5 of the following 9 symptoms during the same 2-week period: Depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The antidepressant action of paroxetine in hospitalized depressed patients has not been adequately studied. PAXIL CR has not been systematically evaluated beyond 12 weeks in controlled clinical trials; however, the effectiveness of immediate-release paroxetine hydrochloride in maintaining a response in major depressive disorder for up to 1 year has been demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY-- Clinical Trials ). The physician who elects to use PAXIL CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Panic Disorder: PAXIL CR is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of PAXIL CR controlled-release tablets was established in two 10-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IV category of panic disorder (see CLINICAL PHARMACOLOGY -- Clinical Trials ). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Long-term maintenance of efficacy with the immediate-release formulation of paroxetine was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to immediate-release paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY -- Clinical Trials ). Nevertheless, the physician who prescribes PAXIL CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Social Anxiety Disorder: PAXIL CR is indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in DSM-IV (300.23). Social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of PAXIL CR as a treatment for social anxiety disorder has been established, in part, on the basis of extrapolation from the established effectiveness of the immediate-release formulation of paroxetine. In addition, the efficacy of PAXIL CR was established in a 12-week trial, in adult outpatients with social anxiety disorder (DSM-IV). PAXIL CR has not been studied in children or adolescents with social phobia (see CLINICAL PHARMACOLOGY -- Clinical Trials ). The effectiveness of PAXIL CR in long-term treatment of social anxiety disorder, i.e., for more than 12 weeks, has not been systematically evaluated in adequate and well-controlled trials. Therefore, the physician who elects to prescribe PAXIL CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Premenstrual Dysphoric Disorder: PAXIL CR is indicated for the treatment of PMDD. The efficacy of PAXIL CR in the treatment of PMDD has been established in 3 placebo-controlled trials (see CLINICAL PHARMACOLOGY -- Clinical Trials ). The essential features of PMDD, according to DSM-IV, include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating, and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following the onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of PAXIL CR in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use PAXIL CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. CONTRAINDICATIONS Concomitant use in patients taking either monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated (see WARNINGS and PRECAUTIONS ). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS ). PAXIL CR is contraindicated in patients with a hypersensitivity to paroxetine or to any of the inactive ingredients in PAXIL CR. WARNINGS Clinical Worsening and Suicide Risk: Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients. Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Pooled analyses of short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with MDD, OCD, or other psychiatric disorders (a total of 24 trials involving over 4,400 patients) have revealed a greater risk of adverse events representing suicidal behavior or thinking (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. There was considerable variation in risk among drugs, but a tendency toward an increase for almost all drugs studied. The risk of suicidality was most consistently observed in the MDD trials, but there were signals of risk arising from some trials in other psychiatric indications (obsessive compulsive disorder and social anxiety disorder) as well. No suicides occurred in any of these trials. It is unknown whether the suicidality risk in pediatric patients extends to longer-term use, i.e., beyond several months. It is also unknown whether the suicidality risk extends to adults. All pediatric patients being treated with antidepressants for any indication should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Such observation would generally include at least weekly face-to-face contact with patients or their family members or caregivers during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks. Additional contact by telephone may be appropriate between face-to-face visits. Adults with MDD or co-morbid depression in the setting of other psychiatric illness being treated with antidepressants should be observed similarly for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms (see PRECAUTIONS and DOSAGE AND ADMINISTRATION -- Discontinuation of Treatment With PAXIL CR , for a description of the risks of discontinuation of PAXIL CR). Families and caregivers of pediatric patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for