PHENDIMETRAZINE TARTRATE TABLETS, USP

Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S.3S)-3, 4-Dimethyl-2-phenylmorpholine L-(*)-tartrate (1.1). Its molecular weight is 341.36.

Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene.

Each tablet, for oral administration, contains 35mg of phendimetrazine tartrate. In addition, each tablet contains the following inactive ingredients: Lactose USP, Magnesium Stearate NF, Colloidal Silicon Dioxide, Microcrystalline Cellulose NF, Starch NF (Modified Corn Starch).

Additional inactive ingredients are present as follows: Phendimetrazine 35mg Gray Tablet Contains: Activated Charcoal USP. Sterotex Food Grade.

Phendimetrazine 35mg Pink Tablet contains: FD&C Red #3.

Phendimetrazine 35mg Speckled Tablet contains: Calcium Stearate NF, FD&C Blue #1, FD&C Yellow #5, and sucrose.

Phendimetrazine 35mg Yellow Tablet contains: FD&C Yellow #5, Calcium Stearate NF.

Phendimetrazine 35mg Blue Tablet contains: FD&C Blue #1.

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. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.

WARNINGS

Tolerance to the anorectic effect usually develops within a few weeks. When this occurs the recommended dose should not be exceeded in an attempt to increase the effect rather, the drug should be discontinued.

Use of phendimetrazine within 14 days following the administration of monoamine oxidase inhibitors may result in a hypertensive crisis. Abrupt cessation of administration following prolonged high dosage results in extreme fatigue and depression. Because of the effect on the central nervous system phendimetrazine tartrate may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle. The patient should therefore be cautioned accordingly.

PRECAUTIONS

Caution is to be exercised in prescribing phendimetrazine for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of phendimetrazine and the concomitant dietary regimen.

Phendimetrazine may decrease the hypotensive effect of guanethidine. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Phendimetrazine tartrate 35 mg Yellow and Speckled tablets contain FD& C Yellow #5 (tartrazine) which may cause allergic type reactions (including bronchial asthma) in certain susceptible persons, although the overall incidence of FD& C Yellow #5 (tartrazine) sensitivity in the general population is low. It is frequently seen in patients who also have aspirin hypersensitivity.

Usage In Pregnancy

Safe use in pregnancy has not been established. Until more information is available, phendimetrazine tartrate should not be taken by women who are or may become pregnant unless, in the opinion of the physician, the potential benefits outweigh the possible hazards.

Usage In Children

Phendimetrazine tartrate is not recommended for use in Children Under 12 years of age.