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:

Solco Healthcare U.S., LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phentermine hydrochloride tablets, USP 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 hydrochloride tablets, USP [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below. Teratogenic Effects Pregnancy category X Phentermine is contraindicated during pregnancy beca

Product summary:

Available in tablets containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base). Each phentermine hydrochloride tablet for oral administration is white with blue specks, capsule shaped, bisected and debossed “5030” on one side and debossed “V” on the reverse side. Tablets are packaged in bottles of 30 (NDC 43547-404-03), 100 (NDC 43547-404-10) and 1000 (NDC 43547-404-11). You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 TABLET
SOLCO HEALTHCARE U.S., LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENTERMINE HYDROCHLORIDE
TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR PHENTERMINE HYDROCHLORIDE
TABLETS, USP.PHENTERMINE HYDROCHLORIDE TABLETS, USP
CIV FOR ORAL USE
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/m2, or ≥ 27 kg/m2 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 tablets, USP, 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 tablets 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 m2) (2.2)
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adverse events have been reported in the cardiovascular, central
nervous, gastrointestinal, allergic, and endocrine
Tablets containing 37.5 mg phentermine hydrochloride. (3)
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 st