PHENTERMINE HYDROCHLORIDE tablet PHENTERMINE HYDROCHLORIDE capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

SUNRISE PHARMACEUTICAL, INC.

INN (الاسم الدولي):

PHENTERMINE HYDROCHLORIDE

تركيب:

PHENTERMINE HYDROCHLORIDE 37.5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

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.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

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