ADIPEX-P- phentermine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 greater than or equal to 30 kg/m 2 , or greater than or equal to 27 kg/m 2 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 ADIPEX-P ® , [ see Clinical Pharmacology ( 12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described belo

Product summary:

ADIPEX-P ® Tablets are available for oral administration containing 37.5 mg phentermine hydrochloride, USP (equivalent to 30 mg phentermine base). Each white, oblong, scored tablet is debossed with “ADIPEX-P” and “9”-“9”. Tablets are packaged in bottles of 30 (NDC 72789-175-30) . Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ADIPEX-P- PHENTERMINE HYDROCHLORIDE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADIPEX-P SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADIPEX-P
.
ADIPEX-P (PHENTERMINE HYDROCHLORIDE) TABLETS, FOR ORAL USE CIV
ADIPEX-P (PHENTERMINE HYDROCHLORIDE) CAPSULES, FOR ORAL USE CIV
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
ADIPEX-P
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 greater than or equal to 30
kg/m
, or greater than or equal to 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 ADIPEX-P
, 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)
ADIPEX-P
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: 37.5 mg phentermine hydrochloride. ( 3)
Tablets: 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 weig