Dexfenfluramine is indicated for the management of obesity including weight loss and maintenance of weight loss in patients on a reduced calorie diet. Dexfenfluramine hydrochloride is recommended for obese patients with an initial body mass index ³30 kg/m², or ³27 kg/m² in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia).

The safety and effectiveness of dexfenfluramine beyond 1 year have not been determined at this time.

Below is a chart of Body Mass Index (BMI) based on various heights and weights.

BMI is calculated by taking the patient's weight, in kg, divided by the patient's height, in meters, squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

TABLE 1 - BODY MASS INDEX (BMI), kg/m²

Patients with BMI values ³30 may be candidates for dexfenfluramine therapy.

Patients with BMI values of 27-29 may be candidates for dexfenfluramine therapy if they also have a concomitant risk factor (e.g., hypertension, diabetes, hyperlipidemia).

The usual dosage is one 15-mg capsule twice daily, with meals. Doses above 30 mg per day are not recommended.

Analysis of numerous variables has indicated that about 60% of patients who lose at least 4 pounds in the first 4 weeks of treatment with dexfenfluramine in combination with a reduced-calorie diet lose at least 10% of their initial body weight by the end of 1 year of treatment. If a patient has not lost at least 4 pounds in the first 4 weeks of treatment, the physician should consider reevaluation of therapy which may include discontinuation of dexfenfluramine.

The safety and effectiveness of dexfenfluramine beyond 1 year have not been determined at this time.

Infrequently, symptoms (e.g., abdominal pain, anxiety, asthenia, delusion, depression, diarrhea, dizziness, hypertension, insomnia, nausea and vomiting) have occurred within several days following cessation of dexfenfluramine. If the physician notes such symptoms, clinical judgment should guide the treatment, which may include tapering the dose (15 mg once daily) for 2 weeks prior to complete discontinuation.

Redux (dexfenfluramine hydrochloride capsules) 15 mg, is supplied in number 3, white, opaque, hard-gelatin capsules. Each capsule is marked with "Redux (dexfenfluramine (fda removed from us market 9/15/97)) " and three black vertical bands.

Storage: Store at room temperature, between 15°C and 30°C (59°F and 86°F).

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.