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Bontril® PDM (phendimetrazine tartrate) is indicatedin the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. 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 kilograms (kg), divided bythe patient's height,inmeters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.
BODY MASS INDEX (BMI), kg/m2
Height (feet, inches)
Phendimetrazine tartrate is indicated for use as monotherapy only.
DOSAGE AND ADMINISTRATION
Usual Adult Dosage: 1 tablet (35 mg) twice a day or three times a day one hour before meals.
Dosage should be individualized to obtain an adequate response with the lowest effective dosage. In some cases, 1/2 tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets three times a day.
Three-layered green, white and yellow tablet with “B 35” on the scored side and the letter “V” on the other. Bontril® PDM tablets containing 35 mg of phendimetrazine tartrate are available in bottles of 100 (NDC 0187-0497-01) and 1000 (NDC 0187-0497-02).
Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).
DEA Order Form Required.
Distributed by: Valeant Pharmaceuticals North America. One Enterprise, Aliso Viejo, CA 92656 USA. Manufactured by: Mallinckrodt, Inc. Hobart, NY 13788.
Last reviewed on RxList: 3/25/2009
This monograph has been modified to include the generic and brand name in many instances.
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