Usual Adult Dose for Obesity

Sibutramine was voluntarily withdrawn from the US market by the manufacturer in October, 2010 due to clinical trial data indicating an increased risk of heart attack and stroke. The following dosage information applies to when the drug was available in the US.

Initial Dose: 10 mg orally once a day.

Usual Geriatric Dose for Obesity

Sibutramine was voluntarily withdrawn from the US market by the manufacturer in October, 2010 due to clinical trial data indicating an increased risk of heart attack and stroke. The following dosage information applies to when the drug was available in the US.

Clinical studies of sibutramine did not include sufficient numbers of patients over 65 years of age. Sibutramine is contraindicated in this group of patients.

Usual Pediatric Dose for Obesity

Sibutramine was voluntarily withdrawn from the US market by the manufacturer in October, 2010 due to clinical trial data indicating an increased risk of heart attack and stroke. The following dosage information applies to when the drug was available in the US.

Based on one study (n=60)

14 to 17 years:
Initial Dose: 10 mg orally once a day.

Renal Dose Adjustments

Sibutramine should not be used in patients with severe renal impairment.

Liver Dose Adjustments

If liver dysfunction is severe, use of sibutramine is not recommended. However, the manufacturer has reported that observed differences in patients with mild to moderate liver dysfunction did not warrant dosage adjustments.

Dose Adjustments

If weight loss is inadequate after four weeks, the dose may be titrated to a total of 15 mg once daily. Doses above 15 mg daily are not recommended.

Alternatively, for patients who do not tolerate the 10 mg dose well, either discontinuation of the drug or a dose of 5 mg orally once a day may be appropriate (depending on the severity of the adverse reaction to the 10 mg dose).

Dialysis

The manufacturer of sibutramine does not recommend its use in patients with severe renal dysfunction.

Other Comments

In most clinical trials, doses were given in the morning. Sibutramine may be taken with or without food.

Periodic monitoring of blood pressure is required when prescribing sibutramine. Blood pressure and heart rate changes should be taken into account when making decisions regarding dose titration.