PHENTERMINE HYDROCHLORIDE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Bryant Ranch Prepack

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 × 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [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 heart failure, uncontrolled

Tóm tắt sản phẩm:

Product: 63629-8201 NDC: 63629-8201-1 30 TABLET in a BOTTLE

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

PHENTERMINE HYDROCHLORIDE- PHENTERMINE HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
----------
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, 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 m ) (2.2)
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 ef