PHENTERMINE HYDROCHLORIDE tablet 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:

Aidarex Pharmaceuticals LLC

INN (International Name):

PHENTERMINE HYDROCHLORIDE

Composition:

PHENTERMINE HYDROCHLORIDE 37.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phentermine hydrochloride, USP 37.5 mg 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 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 artery disease, stroke, arrhythmias, congestive heart fail

Product summary:

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 cap and body, filled with powder. Bottles of 7, NDC 33261-408-07 Bottles of 8, NDC 33261-408-08 Bottles of 14, NDC 33261-408-14 Bottles of 15, NDC 33261-408-15 Bottles of 23, NDC 33261-408-23 Bottles of 28, NDC 33261-408-28 Bottles of 30, NDC 33261-408-30 Bottles of 40, NDC 33261-408-40 Bottles of 45, NDC 33261-408-45 Bottles of 60, NDC 33261-408-60 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 33261-471-07 Bottles of 8, NDC 33261-471-08 Bottles of 14, NDC 33261-471-14 Bottles of 15, NDC 33261-471-15 Bottles of 23, NDC 33261-471-23 Bottles of 28, NDC 33261-471-28 Bottles of 30, NDC 33261-471-30 Bottles of 40, NDC 33261-471-40 Bottles of 45, NDC 33261-471-45 Bottles of 60, NDC 33261-471-60 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 container as defined in the USP/NF, 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 TABLET
PHENTERMINE HYDROCHLORIDE- PHENTERMINE HYDROCHLORIDE CAPSULE
AIDAREX PHARMACEUTICALS LLC
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UNKNOWN TITLE
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENTERMINE HYDROCHLORIDE,
USP 37.5 MG SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR PHENTERMINE
HYDROCHLORIDE, USP 37.5 MG.
PHENTERMINE HYDROCHLORIDE, USP 37.5 MG (PHENTERMINE HYDROCHLORIDE USP)
CIV FOR ORAL USE
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/m2, or ≥ 27 kg/m2 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)
• Late evening administration should be avoided (risk of insomnia).
(2)
• Phentermine hydrochloride can be taken with or without food.
(12.3)
DOSAGE FORMS AND STRENGTHS
• Capsules containing 37.5 mg phentermine hydrochloride. (3)
• Tablets 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)
• History of drug abuse (4)
• Pregnancy (4, 8.1)
• Nursing (4, 8.3)
• Known hypersensitivity, or idiosyncrasy to the sympathomimetic
amines (4)
WARNINGS AND PRECAUTIONS
•