PHENTERMINE HYDROCHLORIDE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Preferred Pharmaceuticals Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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. 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 describ

Περίληψη προϊόντος:

Available in tablets and capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg Phentermine base). 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 7, NDC 68788-7823-1 Bottles of 15, NDC 68788-7823-5 Bottles of 30, NDC 68788-7823-3 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

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PHENTERMINE HYDROCHLORIDE- PHENTERMINE HYDROCHLORIDE TABLET
PREFERRED PHARMACEUTICALS INC.
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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 TABLETS AND CAPSULES, USP 37.5 MG
(PHENTERMINE HYDROCHLORIDE, 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 greater than or equal to 30
kg/m
, or greater than or equal to 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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adverse events have been reported in the cardiovascular, central
nervous, gastrointestinal, allergic, and endocrine systems. ( 6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT KVK-TECH, INC., AT
1-800-862-3895 OR
[e-mail]; OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
2
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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/1.73 m