PHENTERMINE HYDROCHLORIDE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Camber Pharmaceuticals, Inc.

INN (שם בינלאומי):

PHENTERMINE HYDROCHLORIDE

הרכב:

PHENTERMINE HYDROCHLORIDE 37.5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Phentermine hydrochloride tablets 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. - History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive

leaflet_short:

Phentermine hydrochloride tablets USP 37.5 mg contains phentermine hydrochloride (equivalent to 30 mg phentermine base). Available in white with blue specks, modified capsule shaped, biconvex tablets debossed with I on the left side of bisect and G on the right side of bisect on one side and 359 on the other. Supplied in bottles of 30s (NDC 31722-359-30), 100’s (NDC 31722-359-01) and 1000s (NDC 31722-359-10). 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.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

PHENTERMINE HYDROCHLORIDE- PHENTERMINE HYDROCHLORIDE TABLET
CAMBER PHARMACEUTICALS, INC.
----------
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 C IV 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/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 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)
Late evening administration should be avoided (risk of insomnia). (2)
Phentermine hydrochloride tablets can be taken with or without food.
(12.3)
DOSAGE FORMS AND STRENGTHS
Tablets 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 and efficacy of combination not
established). (5.1)
Rare cases of primary pulmonary hypertension have