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ADIPEX-P® (phentermine hydrochloride) is 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., 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 Height (feet, inches)
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
Exogenous Obesity: Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is one capsule or tablet (37.5 mg) daily, administered before breakfast or 1-2 hours after breakfast. For tablets, the dosage may be adjusted to the patient's need. For some patients 1/2 tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give 1/2 tablet (18.75 mg) two times a day.
Late evening medication should be avoided because of the possibility of resulting insomnia.
Phentermine is not recommended for use in patients sixteen (16) years of age and under.
Available in tablets and capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base). Each blue and white, oblong, scored tablet is debossed with "ADIPEX-P (phentermine hydrochloride) " and "9"-"9". The #3 capsule has an opaque white body and an opaque bright blue cap. Each capsule is imprinted with "ADIPEX-P (phentermine hydrochloride) " - "37.5" on the cap and two stripes on the body using dark blue ink.
Tablets are packaged in bottles of 30 (NDC 57844-009-56); 100 (NDC 57844-009-01); and 1000 (NDC 57844-009-10).
Capsules are packaged in bottles of 100 (NDC 57844-019-01).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
Manufactured for: GATE PHARMACEUTICALS, Div. of Teva Pharmaceuticals USA, Sellersville, PA 18960. Manufactured by: TEVA PHARMACEUTICALS USA. Sellersville, PA 18960. Rev. 7/2005. FDA Rev date: 10/15/2002
Last reviewed on RxList: 10/29/2008
This monograph has been modified to include the generic and brand name in many instances.
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