PHENTERMINE HYDROCHLORIDE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

DirectRx

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2 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. BMI Index The limited usefulness of agents of this class, including Phentermine hydrochloride, [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 arter

Toote kokkuvõte:

Available in tablets and capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg Phentermine base). Phentermine hydrochloride capsules, USP 37.5 mg are supplied as bright blue opaque cap, white opaque body with black imprint “K 29” on both the cap and body, filled with powder. Bottles of 30, NDC Bottles of 100, NDC Bottles of 1000, NDC Phentermine hydrochloride tablets, USP 37.5 mg (equivalent to 30 mg phentermine base), are supplied as blue and white mottled oval tablets debossed “K” left to bisect “25” on one side and plain on the other side. Bottles of 30, NDC Bottles of 100, NDC Bottles of 1000, NDC Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light resistant container as defined in the USP/NF, with a child-resistant closure (as required). Keep out of the reach of children

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

PHENTERMINE HYDROCHLORIDE- PHENTERMINE HYDROCHLORIDE TABLET
DIRECTRX
----------
PHENTERMINE
Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or
equal to 27
kg/m 2 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.
BMI Index
The limited usefulness of agents of this class, including Phentermine
hydrochloride, [see
CLINICAL PHARMACOLOGY ( 12.1, 12.2) ] should be measured against
possible risk
factors inherent in their use such as those described below.
2.1 Exogenous Obesity
Dosage should be individualized to obtain an adequate response with
the lowest
effective dose.
The usual adult dose is one tablet (37.5 mg) or one capsule (37.5 mg)
daily, as
prescribed by the physician, administered before breakfast or 1 to 2
hours after
breakfast. The dosage may be adjusted to the patient’s need. For
some patients, half
tablet (18.75 mg) daily may be adequate, while in some cases it may be
desirable to give
half-tablets (18.75 mg) two times a day.
Phentermine is not recommended for use in pediatric patients ≤ 16
years of age.
Late Evening medication should be avoided because of the possibility
of resulting
insomnia.
2.2 Dosage in Patients With Renal Impairment
The recommended maximum dosage of phentermine hydrochloride is 15 mg
daily for
patients with severe renal impairments (eGFR 15 to 29 mL/min/1.73 m
2). Avoid use of
phentermine hydrochloride in patients with eGFR less than 15
mL/min/1.73 m 2 or end-
stage renal disease