phentermine hydrochloride

FDA Drug Profile — Phentermine Hydrochloride, Phentermine hydrochloride

Drug Details

Generic Name
phentermine hydrochloride
Brand Names
Phentermine Hydrochloride, Phentermine hydrochloride
Application Number
ANDA205019
Sponsor
Bryant Ranch Prepack
NDC Codes
36
Dosage Forms
CAPSULE, TABLET
Routes
ORAL
Active Ingredients
PHENTERMINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Phentermine hydrochloride, USP 37.5 mg is indicated as short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m 2 , or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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. The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY ( 12.1 , 12.2 ) ] should be measured against possible risk factors inherent in their use such as those described below. Phentermine Hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m 2 , or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). ( 1 ) The limited usefulness of agents of this class, including Phentermine hydrochloride, should be measured against possible risk factors inherent in their use. ( 1 ) BMI Index