PHENTERMINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

PHENTERMINE HYDROCHLORIDE

Composition:

PHENTERMINE HYDROCHLORIDE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phentermine hydrochloride capsules are 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.  BODY MASS INDEX (BMI), kg/m2 Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3"  140  27  25  23  21  19  18  150  29  27  24  22  20  19  160  31  28  26  24  22  20  170  33  30  28  25  23  21  180  35  32  29  27  25  23  190  37  34  31  28  26  24  200  39  36  32  30  27  25  210  41  37  34  31  29  26  220  43

Product summary:

Phentermine hydrochloride capsules are supplied as: 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 out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHENTERMINE HYDROCHLORIDE- PHENTERMINE HYDROCHLORIDE CAPSULE
PREFERRED PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENTERMINE HYDROCHLORIDE CAPSULES, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PHENTERMINE
HYDROCHLORIDE CAPSULES, USP.
PHENTERMINE HYDROCHLORIDE CAPSULES, 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 FORMS AND STRENGTHS
•
•
•
CONTRAINDICATIONS
•
•
•
•
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
Adverse events have been reported in the cardiovascular, central
nervous, gastrointestinal, allergic, and endocrine systems. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LANNETT COMPANY, INC.
AT 1-800-325-9994 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
•
2
2
Dosage should be individualized to obtain an adequate response with
the lowest effective dose. (2)
Late evening administration should be avoided (risk of insomnia). (2)
Phentermine hydrochloride capsules can be taken with or without food
(12.3)
Powder-filled capsules containing 15 mg phentermine hydrochloride. (3)
Powder-filled capsules containing 30 mg phentermine hydrochloride. (3)
Pellet-filled capsules containing 30 mg phentermine hydrochloride. (3)
History of cardiovascular disease