Usual Adult Dose for Obesity

IMMEDIATE-RELEASE: 25 mg orally 3 times a day, 1 hour before meals, and in mid-evening if desired to overcome night hunger.

CONTROLLED-RELEASE: 75 mg orally once a day in mid-morning, swallowed whole.

Comments:

• Indicated for monotherapy use only.
• Treatment should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (e.g., weight loss of at least 4 pounds or as determined by the physician and patient).
• Discontinue treatment if tolerance develops; do not exceed the recommended dose in an attempt to increase the effect.

Use: Management of exogenous obesity as a short-term adjunct (a few weeks) on a regimen of weight reduction based on caloric restriction in patients with an initial BMI of 30 kg/m2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.

Usual Pediatric Dose for Obesity

Over 16 years of age:
IMMEDIATE-RELEASE: 25 mg orally 3 times a day, 1 hour before meals, and in mid-evening if desired to overcome night hunger.

CONTROLLED-RELEASE: 75 mg orally once a day in mid-morning, swallowed whole.

Comments:

• Indicated for monotherapy use only.
• Treatment should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (e.g., weight loss of at least 4 pounds or as determined by the physician and patient).
• Discontinue treatment if tolerance develops; do not exceed the recommended dose in an attempt to increase the effect.

Use: Management of exogenous obesity as a short-term adjunct (a few weeks) on a regimen of weight reduction based on caloric restriction in patients with an initial BMI of 30 kg/m2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 16 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Data not available

Other Comments

General:

• The possibility of abuse should be kept in mind when evaluating the desirability of including this drug as part of a weight reduction program. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, personality changes, and psychosis.
• Management of acute overdosage is largely symptomatic and includes lavage and sedation with a barbiturate. IV phentolamine may be considered if severe hypertension occurs. Experience with hemodialysis and peritoneal dialysis is inadequate in this regard.
• Prolonged use may induce dependence with withdrawal syndrome once treatment is discontinued.

Monitoring:

• Cardiovascular: Cardiac evaluation (baseline/prior to treatment initiation). echocardiogram (during and after treatment), blood pressure
• Metabolic: Weight, waist circumference
• Renal: Renal function (in elderly patients and patients with renal impairment)

Patient advice:

• This drug may cause symptoms including dizziness, drowsiness, and vision problems; avoid driving and other activities such as operating machinery until you know how this drug affects you.
• Avoid drinking alcohol while taking this drug.