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TENUATE (diethylpropion) and TENUATE (diethylpropion) DOSPAN are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of BMI based on various heights and weights. BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds divided by 2.2 = kg; inches x 0.0254 = meters.
|Body Mass Index (BMI), kg/m2|
|Weight (pounds)||Height (feet, inches)|
The usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below. TENUATE (diethylpropion) and TENUATE (diethylpropion) DOSPAN are indicated for use as monotherapy only.
DOSAGE AND ADMINISTRATION
TENUATE (diethylpropion hydrochloride) immediate-release:
One immediate-release 25 mg tablet three times daily, one hour before meals, and in midevening if desired to overcome night hunger.
TENUATE DOSPAN (diethylpropion hydrochloride) controlled-release: One controlled-release 75 mg tablet daily, swallowed whole, in midmorning.
This drug in known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See PRECAUTIONS, Geriatric Use.)
25 mg immediate-release tablets in bottles of 100
Each white, round tablet is debossed TENUATE (diethylpropion) 25 or MERRELL 697
Keep tightly closed, store at room temperature, preferably below 86°F.
Protect from excessive heat.
75 mg controlled-release tablets in bottles of 100
75 mg controlled-release tablets in bottles of 250
Each white, capsule-shaped tablet is debossed TENUATE (diethylpropion) 75 or MERRELL 698
Keep tightly closed. Store at room temperature, below 86°F.
Rev. November 2003. Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45215 USA. Manufactured for: Merrell Pharmaceuticals Inc. FDA Rev date: 9/3/2004
Last reviewed on RxList: 12/21/2007
This monograph has been modified to include the generic and brand name in many instances.
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