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ADIPEX-P® 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., controlled hypertension, diabetes, hyperlipidemia).
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, including ADIPEX-P , [see CLINICAL PHARMACOLOGY] should be measured against possible risk factors inherent in their use such as those described below.
DOSAGE AND ADMINISTRATION
Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is one capsule (37.5 mg) daily as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast for appetite control.
The usual adult dose is one tablet (37.5 mg) daily, as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient's need. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day.
ADIPEX-P® is not recommended for use in pediatric patients ≤ 16 years of age.
Late evening medication should be avoided because of the possibility of resulting insomnia.
Dosage Forms And Strengths
Capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).
Tablets containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).
Storage And Handling
Available in tablets and capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base). Each blue and white, oblong, speckled, scored tablet is debossed with “ADIPEX-P” and “9”-“9”. The #3 capsule has an opaque white body and an opaque bright blue cap. Each capsule is imprinted with “ADIPEX-P” - “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).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured In Croatia By: PLIVA HRVATSKA d.o.o., Zagreb, Croatia. Manufactured For: Teva Select Brands , Horsham, PA 19044, Division of Teva Pharmaceuticals USA, Inc. Revised: July 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/16/2016
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