Phendimetrazine (Phendimetrazine Tartrate) - Indications and Dosage

INDICATIONS AND USAGE

Phendimetrazine tartrate tablets are 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.

DOSAGE AND ADMINISTRATION

Usual Adult Dose: 1 tablet (35 mg) b.i.d. or t.i.d., 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 t.i.d.

HOW SUPPLIED

Phendimetrazine Tartrate Tablets 35 mg are available in bottles of 100 and 1000 and are supplied as:

a. pink/white/blue speckled, bisected, capsule-shaped tablet; imprinted “E 75”

b. pink, bisected, capsule-shaped tablet; imprinted “E 77”

c. yellow, bisected, round tablet; imprinted “E 76”

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Sandoz Inc.

Princeton, NJ 08540

OS8919

Rev. 12/09

MF4055REV12/09

MG #29012

Manufactured for

Sandoz Inc.

Princeton, NJ 08540

Manufactured by

Epic Pharma, LLC

Laurelton, NY 11413

OS7316

Rev. 10/08