Phentermine HCL C-IV

FDA Drug Profile — Phentermine HCL C-IV

Drug Details

Generic Name
Phentermine HCL C-IV
Brand Names
Phentermine HCL C-IV
Application Number
ANDA205019
Sponsor
Direct_Rx
NDC Codes
2
Dosage Forms
CAPSULE, TABLET
Routes
ORAL
Active Ingredients
PHENTERMINE HYDROCHLORIDE

Indications and Usage

Phentermine hydrochloride capsules are indicated as a 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 ≥ 30 kg/m2, or ≥ 27 kg/m2 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. BODY MASS INDEX (BMI), kg/m2 [BMI] The limited usefulness of agents of this class, including phentermine, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.