PHENTERMINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP)

Available from:

Lannett Company, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. The limited usefulness of agents of this class, including phentermine,  [seeClinical Pharmacology (12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below. - History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled

Product summary:

Phentermine Hydrochloride Capsules, USP are supplied as 37.5 mg powder-filled capsules, light turquoise blue opaque/white opaque; imprinted logo LANNETT on the cap and 1743 on the body, in bottles of 30 (NDC 0527-1743-30), bottles of 100 (NDC 0527-1743-01) and 1000 (NDC 0527-1743-10) capsules. 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 out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHENTERMINE HYDROCHLORIDE- PHENTERMINE HYDROCHLORIDE CAPSULE
LANNETT COMPANY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENTERMINE HYDROCHLORIDE CAPSULES,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PHENTERMINE HYDROCHLORIDE CAPSULES, USP.
PHENTERMINE HYDROCHLORIDE CAPSULES, USP FOR ORAL USE
CIV
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
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 ≥ 30
kg/m , or ≥ 27 kg/m 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)
DOSAGE AND ADMINISTRATION
Dosage should be individualized to obtain an adequate response with
the lowest effective dose. (2.1)
Late evening administration should be avoided (risk of insomnia).
(2.1)
Phentermine hydrochloride capsules can be taken with or without food
(2.1)
Limit the dosage to 15 mg daily for patients with severe renal
impairment (eGFR 15 to 29 mL/min/1.73 m ). (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules containing 37.5 mg phentermine hydrochloride. (3)
CONTRAINDICATIONS
History of cardiovascular disease (e.g., coronary artery disease,
stroke, arrhythmias, congestive heart failure,
uncontrolled hypertension) (4)
During or within 14 days following the administration of monoamine
oxidase inhibitors (4)
Hyperthyroidism (4)
Glaucoma (4)
Agitated states (4)
History of drug abuse (4)
Pregnancy (4, 8.1)
Nursing (4, 8.3)
Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines
(4)
WARNINGS AND PRECAUTIONS
Coadministration with other drugs for weight loss is not recommended
(safety