Sibutramine is no longer available in the U.S. The manufacturer has decided to stop producing sibutramine based on information from a recent clinical study. In this study, people taking sibutramine had an increased risk of cardiovascular events such as heart attack and stroke. If you are currently taking sibutramine, you should stop taking this medication and call your doctor to discuss switching to another treatment for weight loss or maintenance of weight loss.
WHY is this medicine prescribed?
Sibutramine is used in combination with a reduced calorie diet and exercise to help people who are overweight lose weight and maintain their weight loss. Sibutramine is in a class of medications called appetite suppressants. It works by acting on appetite control centers in the brain to decrease appetite.
HOW should this medicine be used?
Sibutramine comes as a capsule to take by mouth. It is usually taken with or without food once a day. To help you remember to take sibutramine, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sibutramine exactly as directed. Sibutramine can be habit forming. Do not take more or less of it or take it more often or for a longer time than prescribed by your doctor.
Your doctor may start you on a low dose of sibutramine and increase your dose, after you have been taking sibutramine for at least 4 weeks. Your doctor may decrease your dose if you experience certain side effects while you are taking your starting dose.
You will probably lose weight soon after you begin taking sibutramine and following your diet and exercise program. Be sure to monitor your weight, and call your doctor if you do not lose at least 4 pounds (1.8 kilograms) during your first 4 weeks of therapy. Your doctor may wish to change your dose of sibutramine.
Sibutramine may not work for everybody. Tell your doctor how much weight you lose during your treatment with sibutramine. Your doctor may tell you to stop taking sibutramine if you do not lose a certain amount of weight during the first 3 to 6 months of your treatment.
You may not continue to lose weight after your first 6 months of treatment. However, you should continue to take sibutramine even if you have stopped losing weight. If you stop taking sibutramine, you may gain weight. Do not stop taking sibutramine without talking to your doctor.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking sibutramine,
- tell your doctor and pharmacist if you are allergic to sibutramine or any other medications.
- tell your doctor if you are taking monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or have stopped taking them within the past 2 weeks. Your doctor may tell you not to take sibutramine. Do not start taking these drugs for at least 2 weeks after you stop taking sibutramine.
- tell your doctor if you are taking other prescription or nonprescription medications, herbal products or nutritional supplements to help you lose weight such as benzphetamine (Didrex), methamphetamine (Desoxyn), phendimetrazine (Adipost, Bontril, others), and phentermine (Adipex-P, Phentride, others). Your doctor may tell you not to take sibutramine.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: amiodarone (Cordarone); anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); caffeine-containing products including NoDoz, and Vivarin; cancer chemotherapy medications; clarithromycin (Biaxin, Prevpac); clopidogrel (Plavix); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); fentanyl (Actiq, Duragesic); gold salts such as auranofin (Ridaura) and aurothioglucose (Solganal); heparin; HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Fortovase, Invirase); isoniazid (INH, Nydrazid); lithium (Eskalith, Lithobid); medications for allergies, coughs, and colds; medications for depression; medications for high blood pressure; medications for migraine headaches such as almotriptan (Axert), dihydroergotamine mesylate (Migranal), eletriptan (Relpax), ergoloid mesylates (Gerimal, Hydergine), ergonovine (Ergotrate, Methergine), ergotamine (Bellamine, Cafergot, others), frovatriptan (Frova), methysergide (Sansert), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); medications for nausea such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran) and palonosetron (Aloxi); medications for anxiety, mental illness, seizures, and pain; meperidine (Demerol, Mepergan); metronidazole (Flagyl); muscle relaxants; pentazocine (Talcen, Talwin); quinine; quinidine (Quinidex); salicylate pain relievers such as aspirin, choline magnesium trisalicylate, choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic); sedatives; sleeping pills; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine, paroxetine (Paxil), and sertraline (Zoloft); selective serotonin/norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta) and venlafaxine (Effexor); sulfa antibiotics such as sulfadiazine, sulfamethizole (Urobiotic), sulfamethoxazole and trimethoprim (Bactrim, Septra), sulfasalazine (Azulfidine), and sulfisoxazole (Gantrisin, Pediazole); ticlopidine (Ticlid); tranquilizers; troleandomycin (TAO); tryptophan; verapamil (Calan, Covera, Isoptin, Verelan); or zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or ever had an eating disorder such as anorexia nervosa (abnormal focus on being thin that causes you to eat very little and exercise excessively) or bulimia nervosa (eating large amounts of food and then removing the food from the body using diuretics (water pills), laxatives, or vomiting), angina (chest pain), congestive heart failure (heart is unable to pump blood well enough), a heart attack, high blood pressure, irregular heartbeat, peripheral arterial disease (PAD; narrowing of the blood vessels outside of your heart), or a stroke or ministroke. Your doctor will probably tell you not to take sibutramine.
- tell your doctor if you have or have ever had cancer; depression; gallstones (clumps of hardened material that can block the passages from the liver to intestine); glaucoma (an eye disease); hemophilia or other bleeding problems; migraine headaches; osteoporosis (thinning and weakening of the bones); Parkinson's disease (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance); seizures; pulmonary hypertension (high pressure in the vessel that moves blood from the heart to the lungs); or kidney, liver, or thyroid disease. Also tell your doctor if you have ever used street drugs or overused prescription medications.
- tell your doctor if you are pregnant or are breast-feeding. You should use effective birth control to be sure you do not become pregnant while you are taking sibutramine. Ask your doctor if you need help choosing a method of birth control.
- talk to your doctor about the risks and benefits of taking this medication if you are 65 years of age or older. Older adults should not usually take sibutramine.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sibutramine.
- you should know that sibutramine may make you drowsy and may affect your judgment, your ability to think, and your coordination. Do not drive a car or operate machinery until you know how this medication affects you.
- remember that alcohol can add to the drowsiness caused by this medication. Ask your doctor about the safe use of alcoholic beverages while you are taking sibutramine.
- ask your doctor about drinking coffee, tea, or caffeinated beverages while taking sibutramine. Caffeine may make the side effects from sibutramine worse.
What SPECIAL DIETARY instructions should I follow?
Follow the diet and exercise program your doctor has given you.
Talk to your doctor about drinking grapefruit juice while taking this medicine.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Sibutramine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- change in appetite
- dry mouth
- back pain
- difficulty falling asleep or staying asleep
- runny nose
- flu-like symptoms
- painful menstrual periods
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
- fast or pounding heartbeat
- chest pain
- shortness of breath
- stomach pain
- extreme excitement
- uncoordinated or abnormal movement
- muscle stiffness
- shaking hands that you cannot control
- excessive sweating
- sore throat
- large pupils (black area in center of eyes)
- change in vision
- eye pain
- skin rash
- difficulty speaking, breathing, or swallowing
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- unusual bleeding or bruising
Sibutramine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom) and light. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
What OTHER INFORMATION should I know?
Keep all appointments with your doctor. Your doctor will monitor your blood pressure and heart rate (pulse) frequently while you are taking sibutramine.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
¶This branded product is no longer on the market. Generic alternatives may be available.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: November 20, 2012.