Phendimetrazine Tartrate 24 HR phendimetrazine tartrate 105 MG Extended Release Oral Capsule
INDICATIONS AND USAGE Phendimetrazine tartrate extended-release capsules 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 in patients with an initial body mass index (BMI) of greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia) 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 × 0.0254 = meters BODY MASS INDEX (BMI), kg/m 2 Height (feet, inches) The 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. Phendimetrazine tartrate is indicated for use as monotherapy only. BMI Table
Eon Labs, Inc.
CAPSULE BROWN E5254
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HOW SUPPLIED Packed in bottles of 100 and 1000 capsules. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. DISPENSE IN A TIGHT CONTAINER AS DEFINED IN THE USP. 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 Manufactured for Sandoz Inc. Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 Revised February 2012 MF5254REV02/12 OS7715 MG#10805
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