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Redux

"The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical act"...

Redux

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Indications
Dosage
How Supplied

INDICATIONS

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

 Weight (pounds) Height (feet, inches)
5'0" 5'3" 5'6" 5'9" 6'0" 6'3"
140 27 25 23 21 19 18
150 29 27 24 22 20 19
160 31 28 26 24 22 20
170 33 30 28 25 23 21
180 35 32 29 27 25 23
190 37 34 31 28 26 24
200 39 36 32 30 27 25
210 41 37 34 31 29 26
220 43 39 36 33 30 28
230 45 41 37 34 31 29
240 47 43 39 36 33 30
250 49 44 40 37 34 31

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).

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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.

Indications
Dosage
How Supplied
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