Phentermine Hydrochloride 37.5 MG Oral Capsule
1 INDICATIONS AND USAGE 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 described below. 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 2 , or greater than or equal to 27 kg/m 2 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 ) BMI Index
kvk-tech, inc.
CAPSULE WHITE K 29
K 29 CAPSULE WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 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 10702-029-03 Bottles of 100, NDC 10702-029-01 Bottles of 1000, NDC 10702-029-10
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 10702-025-03 Bottles of 100, NDC 10702-025-01 Bottles of 1000, NDC 10702-025-10 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
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