Usual Adult Dose for Obesity

Extended-release: 105 mg orally once a day, 30 to 60 minutes before morning meal

Immediate-release: 35 mg orally 2 or 3 times a day, one hour before meals

• Dosage should be individualized to obtain an adequate response with the lowest effective dose; for some patients, 17.5 mg per dose may be adequate

• For use as monotherapy only; indicated for short term use, e.g. a few weeks.

• an initial BMI of 30 kg/m2 or greater OR
• an initial BMI of 27 kg/m2 or greater in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia) who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.

Usual Pediatric Dose for Obesity

Extended-release (17 years and older): See Adult Dose

Renal Dose Adjustments

Data not available; Use with caution.

Liver Dose Adjustments

Data not available

Dose Adjustments

Elderly: Dose selection should be cautious

When Tolerance to Anorectic Effect Develops (usually occurs within a few weeks):

• Discontinue treatment; maximum recommended dose should not be exceeded.

Precautions

Extended-release: Safety and efficacy have not been established in patients younger than 17 years.

Immediate-release: Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule III

Dialysis

Data not available

Other Comments

Administration Advice:

• Immediate-release tablet: Take orally 2 or 3 times a day 1 hour before meals
• Extended-release capsules: Take orally 30 to 60 minutes before morning meal

• This drug should be used as monotherapy; efficacy with other anorectic agents has not been studied and the combine use may have the potential for serious cardiac problems.

• Patients should be instructed to read the patient labeling.