GENERIC AVAILABLE: No
PREPARATIONS: Capsules: 5mg (blue and yellow); 10mg (blue and white); 15mg (white and yellow)
STORAGE: Capsules should be stored at 25°C (77°F). Brief periods at higher or lower temperatures, i.e., 15-30°C (59-86°F) are permitted. The medication should be stored in a tight, light-resistant container. The capsules should be protected from heat and moisture.
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).
In patients receiving one of the drugs from a class of drugs known as selective serotonin reuptake inhibitors (SSRIs), for example, fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft)--at the same time as monoamine oxidase inhibitor drugs (MAO inhibitors), there have been reports of serious reactions (serotonin syndrome). The serotonin syndrome may include one or more of the following: agitation, anxiety, dizziness, confusion, excessive sweating, disorientation, painful joints, vomiting, hyperexcitement, fever, loss of coordination, loss of consciousness, shivering, fast heart rate, tremor, and weakness. As discussed previously, sibutramine, like the SSRIs, blocks the reuptake of serotonin and may also cause the serotonin syndrome. Therefore, sibutramine should not be used with MAO inhibitors, and there should be at least a 2-week interval between stopping an MAO inhibitor and starting sibutramine. Similarly, there should be at least a 2-week interval after stopping sibutramine and starting an MAO inhibitor. Serotonin syndrome also has been reported with the use of SSRIs at the same time as medications used for migraines such as sumatriptan (Imitrex), zolmitriptan (Zomig) and dihydroergotamine (DHE), as well as dextromethorphan (found in many cough medications such as Robitussin-DM), meperidine (Demerol), pentazocine (Talwin) and fentanyl (Duragesic), or lithium (Eskalith). Therefore, these drugs should not be used with sibutramine.
PREGNANCY: No adequate studies with sibutramine have been done in pregnant women. The use of sibutramine during pregnancy, therefore, is not recommended. Women who could become pregnant should use adequate contraception while taking sibutramine.
NURSING MOTHERS: It is unknown whether sibutramine or its active products accumulate in breast milk. Sibutramine, therefore, is not recommended for nursing mothers.
Medically reviewed by Eni Williams, PharmD
Reference: FDA Prescribing Information
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