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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.