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ADIPEX-P (PHENTERMINE HCL): PRESCRIBING INFORMATION
DESCRIPTION
Phentermine Hydrochloride has the chemical name of Alpha,Alpha-Dimethylphenethylamine Hydrochloride. The chemical structural formula is as follows: C10H15N x HCl (M.W. 185.7).
Phentermine HCl is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.
Adipex-P, an anorectic agent for oral administration, is available as a capsule or tablet containing 37.5 mg of Phentermine Hydrochloride (equivalent to 30 mg of Phentermine Base).
Adipex-P capsules contain the inactive ingredients gelatin, corn starch, lactose monohydrate, titanium dioxide, magnesium stearate, black iron oxide, FD&C Blue #1, FD&C Red #40 and D&C Red #33.
Adipex-P tablets contain the inactive ingredients lactose anhydrous, corn starch, magnesium stearate, pregelatinized starch, microcrystalline cellulose, sucrose, and FD&C Blue #1.
CLINICAL PHARMACOLOGY
Adipex-P clinical pharmacology
INDICATIONS AND USAGE
Adipex-P (Phentermine HCl) 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).
The limited usefulness of agents of this class 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.
Adipex-P (Phentermine HCl) is not recommended for use in patients sixteen (16) years of age and under.
CONTRAINDICATIONS
Cardiovascular disease, advanced arteriosclerosis, moderate to severe hypertension, hyperthyroidism, glaucoma, known hypersensitivity or idiosyncrasy to the sympathomimetic amines.
Agitated states.
Patients with a history of drug abuse.
During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).
WARNINGS
Adipex-P warnings
DRUG ABUSE AND DEPENDENCE
Adipex-P drug abuse and dependence
PRECAUTIONS
Adipex-P precautions
ADVERSE REACTIONS
Adipex-P adverse reactions
OVERDOSAGE
Adipex-P overdosage
HOW SUPPLIED
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" 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 and 1000.
Capsules are packaged in bottles of 100.
Store Adipex-P (Phentermine Hydrochloride) at controlled room temperature 15°-30°C (59°-86°F).
Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
Manufactured and distributed by: Teva and Gate Pharmaceuticals companies.
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