Sibutramine

This drug has been withdrawn from the US and Canadian markets due to problems with safety (increased risk of heart attack and stroke). Talk with your doctor about stopping sibutramine now and about other treatment options. This medication is used along with a low-calorie diet to help people with obesity lose weight. Reducing excess weight helps to prevent or control complications such as heart disease, diabetes, and joint pain. Sibutramine works by affecting the area in your brain that controls hunger, providing you with a sense of fullness and satisfaction. Discuss the risks and benefits of sibutramine with your doctor. This drug should not be used in adults 65 years or older.

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 the dose to catch up.

Read the Medication Guide provided by your pharmacist before you start using sibutramine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth, usually once daily with or without food, or as directed by your doctor. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Dosage is based on your medical condition and response to therapy. Do not increase your dose, take it more frequently, or use it for a longer period of time than prescribed. Do not suddenly stop using this drug without your doctor's approval. Your dose may need to be gradually reduced, especially if you have been taking this medication for a long time. Consult your doctor or pharmacist for more details. When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well. Since this medication can increase your blood pressure and heart rate (pulse), it is important to have regular check-ups to monitor these readings before starting and during treatment with sibutramine. Your doctor will also monitor your weight loss progress and check for side effects (usually checking after 4 weeks, and then after 3-6 months of treatment or as directed) to decide if continued treatment is safe and effective for you.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first. This drug should not be used with the following medications because very serious interactions may occur: certain other weight loss medicines (e.g., diethylpropion, phentermine). If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting sibutramine. Avoid taking MAO inhibitors (isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antidepressants (e.g., citalopram, fluoxetine, venlafaxine), certain antipsychotics (phenothiazines such as chlorpromazine, thioridazine), dextromethorphan, drugs used to treat migraine headaches (e.g., sumatriptan, ergotamine), ketoconazole, lithium, certain narcotic pain medications (e.g., fentanyl, meperidine, pentazocine), tryptophan. This medication may rarely increase your risk for serious bleeding, especially if you take other drugs such as "blood thinners" (e.g., warfarin) or anti-platelet drugs (e.g., aspirin, clopidogrel). Sibutramine is generally not used in patients with heart disease, however, if you are prescribed any of these drugs for heart attack or stroke prevention, continue taking them and consult your doctor on how to minimize your risk of bleeding. Check the labels on all your medicines (e.g., cough-and-cold products, diet aids, herbal products) because they may contain ingredients that could increase your heart rate or blood pressure. These ingredients include pseudoephedrine, ephedrine, ephedra, and ma huang, among others. Ask your pharmacist about the safe use of these products. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas). Caffeine can increase the side effects of this medication (e.g., increase your heart rate). This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Do not share this medication with others. It is against the law. Have your blood pressure and heart rate (pulse) checked regularly while taking this medication. You can learn how to monitor your own blood pressure and pulse. Discuss this with your doctor. For best results, this medication should be used along with an exercise program and reduced calorie diet as approved by your doctor. Behavior change counseling is also helpful. Consult your doctor for details.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

Before taking sibutramine, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: eating disorders (e.g., anorexia nervosa, bulimia nervosa), uncontrolled or poorly controlled high blood pressure, heart or blood vessel disease (e.g., coronary artery disease, history of heart attack or angina, congestive heart failure, abnormal heart rhythms, poor circulation in the arms/legs), stroke or TIA (transient ischemic attack). Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, glaucoma (narrow angle type), untreated underactive thyroid disease, liver disease, kidney disease, gallstones, seizure disorder, bleeding disorders, depression, drug abuse. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Children may be at a greater risk for mental/mood changes (including rare thoughts of suicide) while using this drug. This medication is not recommended for use during pregnancy. Women of child-bearing age should use effective birth control while taking this medication. Consult your doctor for more details. It is not known whether this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Store at room temperature (77 degrees F or 25 degrees C) away from heat and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Dry mouth, increased appetite, nausea, strange taste in the mouth, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding/irregular heartbeat, numbness/tingling of the hands or feet, mental/mood changes (e.g., excitement, restlessness, confusion, depression, rare thoughts of suicide). Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount or color of urine, easy or unusual bruising/bleeding, black stools, vomit that looks like coffee grounds, yellowing eyes or skin, unexplained fever, shaking, unusual sweating, swelling of the arms/legs. Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, chest pain, weakness on one side of the body, vision changes, trouble breathing. Sibutramine may rarely cause a very serious condition called serotonin syndrome. Taking sibutramine with "triptans" used to treat migraine headaches (e.g., sumatriptan, eletriptan) or certain antidepressants including SSRIs (e.g., citalopram, fluoxetine, paroxetine) and NSRIs (e.g., duloxetine, venlafaxine) increases the risk of this reaction. Before taking sibutramine, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: severe mental/mood changes (e.g., hallucinations, unusual restlessness), loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitchy muscles. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.