Phendimetrazine (Phendimetrazine Tartrate) - Indications and Dosage

INDICATIONS AND USAGE

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 follow: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

BODY MASS INDEX (BMI), kg/m 2 Height (feet, inches)
Weight	5’0”	5’3”	5’6”	5’9”	6’0”	6’3”
(pounds)
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 the 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.

HOW SUPPLIED

Phendimetrazine Tartrate Tablets, USP 35 mg are available as Yellow, round, biconvex tablets debossed “A 327” on bisected side. Available in bottles of 100’s and 1000’s.

Store at 20(to 25(C (68(to 77(F) [See USP Controlled Room Temperature].

DEA Order Form Required.

Manufactured by: Actavis Totowa LLC

990 Riverview Drive, Totowa, NJ 07512 USA

8664-02
11/07