SIBUTRAMINE WEIGHT LOSS & WEIGHT MANAGEMENT INFORMATION

What is Sibutramine? Sibutramine was withdrawn from the U.S. market in October 2010. Sibutramine affects chemicals in the brain that affect weight maintenance. Sibutramine is used together with diet and exercise to treat obesity that may be related to diabetes, high cholesterol, or high blood pressure. Sibutramine may also be used for other purposes not listed in this medication guide.

In This Section:

What is the most important information I should know about Sibutramine? What should I discuss with my healthcare provider before taking Sibutramine? How much does Sibutramine cost? What conditions might Sibutramine treat? What does Sibutramine look like?

What is the most important information I should know about Sibutramine? Sibutramine was withdrawn from the U.S. market in October 2010. Do not use sibutramine if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use sibutramine before the MAO inhibitor has cleared from your body. You should not take sibutramine if you are allergic to it, or if you have severe or uncontrolled high blood pressure, an eating disorder (anorexia or bulimia), if you are taking stimulant diet pills, or if you have a history of coronary artery disease, stroke, or heart disease.

Before taking sibutramine, tell your doctor if you have glaucoma, high blood pressure, liver or kidney disease, depression, underactive thyroid, seizures, a bleeding disorder, a history of gallstones, or if you are older than 65 or younger than 16. Tell your doctor about all prescription and over-the-counter medications you use, especially antidepressants, cold or allergy medication, narcotic pain medicine, or migraine headache medicines. Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks along with a low calorie diet.

What should I discuss with my healthcare provider before taking Sibutramine? Do not use sibutramine if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use sibutramine before the MAO inhibitor has cleared from your body. You should not take this medication if you are allergic to sibutramine, or if you have:

severe or uncontrolled hypertension (high blood pressure) an eating disorder (anorexia or bulimia) a history of coronary artery disease (atherosclerosis) a history of heart disease (congestive heart failure, heart rhythm disorder) a history of heart attack or stroke; or if you are taking stimulant diet pills If you have any of these other conditions, you may need a sibutramine dose adjustment or special tests:

glaucoma high blood pressure liver disease kidney disease depression

underactive thyroid epilepsy or seizure disorder a bleeding or blood clotting disorder a history of gallstones; or if you are older than 65 or younger than 16

FDA pregnancy category C. It is not known whether sibutramine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using sibutramine. It is not known whether sibutramine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone younger than 16 years old.

GENERIC NAME: sibutramine BRAND NAME: Meridia NOTE: On October 8, 2010, Meridia (sibutramine) was withdrawn from the market due to the risk of serious cardiovascular events. DRUG CLASS AND MECHANISM: Sibutramine is a medication that assists with weight-loss by altering neurotransmitters within the brain. Neurotransmitters are chemicals that are produced and released by nerves in order to communicate with other nerves. Released neurotransmitters may attach to other nerves or they may be taken up again by the nerves that release them, a process termed reuptake. Sibutramine blocks the reuptake of the neurotransmitters dopamine, norepinephrine, and serotonin. Blocking the reuptake of neurotransmitters alters the balance of neurotransmitters within the nerve cells and thereby affect nerve function and interaction.

Patients taking sibutramine may achieve a 5-10% reduction from their baseline weight. Additionally, sibutramine-assisted weight loss has been accompanied by improvement in blood lipids (e.g, cholesterol). Sibutramine was approved by the FDA in 1997.

GENERIC AVAILABLE: No

PRESCRIPTION: Yes

PREPARATIONS: Capsules: 5mg (blue and yellow); 10mg (blue and white); 15mg (white and yellow)

STORAGE: Capsules should be stored at 25C (77F). Brief periods at higher or lower temperatures, i.e., 15-30C (59-86F) are permitted. The medication should be stored in a tight, light-resistant container. The capsules should be protected from heat and moisture.

PRESCRIBED FOR: Sibutramine is used for weight loss in conjunction with a low calorie diet. Specific populations for whom the medication is recommended are those with an initial body mass index of more than 30 kg/m2 (27 mg/m2 if they also have other risk factors such as diabetes mellitus, high cholesterol or hypertension).

DOSING: Sibutramine is taken once daily, generally in the morning. Therapy usually is started with one 10mg tablet per day. The dose may be increased to 15mg by the physician after several weeks to achieve the desired effect. Doses of up to 60mg have been studied. Sibutramine may be taken with or without food.

DRUG INTERACTIONS: Sibutramine must be converted in the liver to its active form. This conversion is inhibited by ketoconazole (Nizoral), cimetidine (Tagamet) and erythromycin (Erytab, Eryc, Ilosone), and use of these drugs can result in decreased conversion and effectiveness of sibutramine. Several other drugs may have a similar effect. These other drugs include clarithromycin (Biaxin), danazol (Danocrine), diltiazem (Cardizem, Tiazac, Dilacor), fluconazole (Diflucan), fluoxetine (Prozac), itraconazole (Sporanox), propoxyphene (Darvon), troleandomycin (Tao) and verapamil (Verelan, Covera, Calan, Isoptin).