PHENTERMINE HYDROCHLORIDE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Keltman Pharmaceuticals Inc.

INN (International Name):

PHENTERMINE HYDROCHLORIDE

Sammensætning:

PHENTERMINE HYDROCHLORIDE 37.5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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., 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 (see CLINICAL PHARMACOLOGY ) should be measured against possible risk factors inherent in their use such as those described below. Advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma. Agita

Produkt oversigt:

Phentermine hydrochloride tablets USP 37.5 mg (equivalent to 30 mg phentermine base) are white with blue specks, oval shaped, scored on one side and debossed MP 273 on the other side. They are supplied by Keltman Pharmaceuticals Inc. as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

PHENTERMINE HYDROCHLORIDE - PHENTERMINE HYDROCHLORIDE TABLET
KELTMAN PHARMACEUTICALS INC.
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PHENTERMINE
HYDROCHLORIDE
TABLETS USP, 37.5 MG CIV
RX ONLY
DESCRIPTION
Phentermine hydrochloride USP has the chemical name of α,
α-Dimethylphenethylamine hydrochloride.
The structural formula is as follows:
C H N•HCL M.W. 185.7
Phentermine hydrochloride is a white, odorless, hygroscopic,
crystalline powder which is soluble in
water and lower alcohols, slightly soluble in chloroform and insoluble
in ether.
Phentermine hydrochloride, an anorectic agent for oral administration,
is available as a tablet containing
37.5 mg of phentermine hydrochloride (equivalent to 30 mg of
phentermine base).
Phentermine hydrochloride tablets contain the inactive ingredients:
crospovidone, dibasic calcium
phosphate dihydrate, magnesium stearate, povidone, propylene glycol,
FD&C Blue #1 Aluminum Lake,
shellac glaze, and titanium dioxide.
CLINICAL PHARMACOLOGY
Phentermine hydrochloride is a sympathomimetic amine with
pharmacologic activity similar to the
prototype drugs of this class used in obesity, the amphetamines.
Actions include central nervous system
stimulation and elevation of blood pressure. Tachyphylaxis and
tolerance have been demonstrated with
all drugs of this class in which these phenomena have been looked for.
Drugs of this class used in obesity are commonly known as "anorectics"
or "anorexigenics". It has not
been established that the action of such drugs in treating obesity is
primarily one of appetite
suppression. Other central nervous system actions, or metabolic
effects, may be involved, for example.
Adult obese subjects instructed in dietary management and treated with
"anorectic" drugs, lose more
weight on the average than those treated with placebo and diet, as
determined in relatively short-term
clinical trials.
The magnitude of increased weight loss of drug-treated patients over
placebo-treated patients is only a
fraction of a pound a week. The rate of weight loss is greatest in the
first weeks of therapy fo