Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP)
SUNRISE PHARMACEUTICAL, INC.
PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE 37.5 mg
ORAL
PRESCRIPTION DRUG
Phentermine hydrochloride 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 ≥ 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, [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 hyper
Available in tablets and capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base). Each white with blue specks, capsule shaped tablet is debossed with “N” on the left side of bisect and “4” on the right side of bisect on one side and plain on the other side, having a functional score. The capsule has an opaque white body and an opaque blue cap. Each powder filled capsule is imprinted with “N3” on both the cap and body. Tablets are packaged in bottles of 30 (NDC 11534-160-30), 100 (NDC 11534-160-01) and 1,000 (NDC 11534-160-03) Capsules are packaged in bottles of 30 (NDC 11534-159-30), 100 (NDC 11534-159-01) and 1,000 (NDC 11534-159-03). 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 THIS AND ALL MEDICATIONS OUT OF THE REACH OF THE CHILDREN.
Abbreviated New Drug Application
PHENTERMINE HYDROCHLORIDE- PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE- PHENTERMINE HYDROCHLORIDE CAPSULE SUNRISE PHARMACEUTICAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PHENTERMINE HYDROCHLORIDE TABLETS AND CAPSULES, USP 37.5 MG SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PHENTERMINE HYDROCHLORIDE TABLETS AND CAPSULES, USP 37.5 MG. PHENTERMINE HYDROCHLORIDE CAPSULES USP, FOR ORAL USE CIV PHENTERMINE HYDROCHLORIDE TABLETS USP, FOR ORAL USE CIV 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, 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 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/1.73m )- (2.2) DOSAGE FORMS AND STRENGTHS Capsules containing 37.5 mg phentermine hydrochloride. (3) Tablets with a functional score 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) Hi Прочитайте повний документ