SUPRENZA phentermine hydrochloride tablet orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akrimax Pharmaceuticals, LLC

INN (International Name):

PHENTERMINE HYDROCHLORIDE

Composition:

PHENTERMINE HYDROCHLORIDE 37.5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

SUPRENZA- PHENTERMINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING
AKRIMAX PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUPRENZA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SUPRENZA
SUPRENZA (PHENTERMINE HYDROCHLORIDE) ORALLY DISINTEGRATING TABLET
C IV
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Suprenza 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 Suprenza,
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)
Late evening administration should be avoided (risk of insomnia). (2)
Suprenza can be taken with or without food (12.3)
DOSAGE FORMS AND STRENGTHS
Orally disintegrating tablets containing 15 mg, 30 mg, or 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 and efficacy of combination not
established). (5.1)
Rare cases of primary pulmonary hypertension have been reported.
Suprenza should