What is the most important information I should know about sibutramine?

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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.

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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.

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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?

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Sibutramine affects chemicals in the body that are related to weight maintenance.

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Sibutramine is used as a short-term supplement to diet and exercise in the treatment of obesity.

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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?

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Do not take sibutramine without first talking to your doctor if you

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have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the last 14 days;

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have anorexia nervosa;

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are taking an appetite suppressant;

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have high blood pressure;

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have heart disease, irregular heartbeats, congestive heart failure, or a history of stroke;

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have epilepsy or another seizure disorder;

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have gallstones;

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have glaucoma;

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have liver disease; or

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have kidney disease.

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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.

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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.

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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.

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The safety and effectiveness of sibutramine have not been studied in children younger than 16 years of age.

How should I take sibutramine?

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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.

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Take each dose with a full glass of water.

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Sibutramine is usually taken once a day. Follow your doctor's instructions.

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Sibutramine can be taken with or without food.

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Never take more of this medication than is prescribed for you. Too much sibutramine could be dangerous.

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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.

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Store sibutramine at room temperature away from moisture and heat.

What happens if I miss a dose?

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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?

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Seek emergency medical attention.

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Symptoms of a sibutramine overdose are not known.

What should I avoid while taking sibutramine?

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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.

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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?

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If you experience any of the following serious side effects, stop taking sibutramine and seek emergency medical attention or contact your doctor immediately:

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an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

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an irregular heartbeat;

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high blood pressure (severe headache, blurred vision); or

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seizures.

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Other, less serious side effects may be more likely to occur. Continue to take sibutramine and talk to your doctor if you experience

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restlessness or tremor,

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nervousness or anxiety,

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mild headache or dizziness,

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insomnia,

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dry mouth or an unpleasant taste in your mouth, or

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constipation.

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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?

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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.

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Before taking this medication, tell your doctor if you are taking

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lithium (Lithobid, Eskalith, Lithonate, others);

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almotriptan (Axert), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), or zolmitriptan (Zomig);

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citalopram (Celexa), fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), or fluvoxamine (Luvox);

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venlafaxine (Effexor), nefazodone (Serzone), mirtazapine (Remeron), or thioridazine (Mellaril);

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amitriptyline (Elavil, Endep), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil);

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dihydroergotamine (D.H.E.);

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dextromethorphan (in many cough medicines);

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meperidine (Demerol);

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fentanyl (Duragesic); or

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pentazocine (Talacen, Talwin).

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Sibutramine may interact with the medicines listed above and cause anxiety, restlessness, loss of consciousness, confusion, weakness, tremor, poor coordination, fever, shivering, sweating, vomiting, a fast heartbeat, and other symptoms. These reactions can be very dangerous and require medical attention. 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.

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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.

Where can I get more information?

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Your pharmacist has more information about sibutramine written for health professionals that you may read.

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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