INDICATIONS AND USAGE
PHENTERMINE hydrochloride 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.
Advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.
Patients with a history of drug abuse.
During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).
DOSAGE AND ADMINISTRATION
Dosage should be individualized to obtain an adequate response with the lowest effective dose.
CAPSULES: The usual adult dose is one capsule (37.5 mg) daily, administered before breakfast or 1-2 hours after breakfast.
TABLETS: The usual adult dose is one tablet (37.5 mg) daily, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient's need. For some patients ½ tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give ½ tablet (18.75 mg) two times a day.
PHENTERMINE hydrochloride is not recommended for use in patients 16 years of age and under.
HOW IT'S SUPPLIED
Mutual Pharmaceutical (manufature)
PHENTERMINE hydrochloride tablets USP 37.5 mg (equivalent to 30 mg PHENTERMINE base) are white with blue specks, oval shaped, scored on one side and debossed MP 273 on the other side.
KVK-TECH INC. (manufacture)
PHENTERMINE hydrochloride capsules, USP 37.5 mg are supplied as bright blue opaque cap, white opaque body with black imprint "K29" on both cap and body, filled with powder.
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.
Apotheca, Inc. (Repackager and Distributer)
PHENTERMINE HCl 37.5 mg tablets USP (white with blue specks) are available as follows:
- NDC 12634-687-91 Blister Pack UD
- NDC 12634-687-97 Bottle of 7
- NDC 12634-687-84 Bottle of 14
- NDC 12634-687-85 Bottle of 15
- NDC 12634-687-78 Bottle of 28
- NDC 12634-687-71 Bottle of 30
- NDC 12634-687-60 Bottle of 60
PHENTERMINE HCl 37.5 mg capsules USP (bright blue cap with white opaque body) are available as follows:
- NDC 12634-553-91 Blister Pack UD
- NDC 12634-553-97 Bottle of 7
- NDC 12634-553-84 Bottle of 14
- NDC 12634-553-85 Bottle of 15
- NDC 12634-553-78 Bottle of 28
- NDC 12634-553-71 Bottle of 30
- NDC 12634-553-60 Bottle of 60