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Bontril PDM (Phendimetrazine Tartrate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Bontril®PDM (phendimetrazine tartrate) is indicated in 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 by the patient's height, in meters (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)
Weight
(pounds)
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

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, ½ tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets three times a day.

HOW SUPPLIED

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

Printed with food grade ink.

MG #20886
Rev. 10/07
Part No. L2BB01

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