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Suprenza 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 greater than or equal to 30 kg/m² , or greater than or equal to 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)|
The limited usefulness of agents of this class, including Suprenza, [see CLINICAL PHARMACOLOGY] should be measured against possible risk factors inherent in their use such as those described below.
DOSAGE AND ADMINISTRATION
Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is one tablet as prescribed by the physician, administered in the morning, with or without food. Suprenza is not recommended for use in pediatric patients less than or equal to 16 years of age.
Late evening medication should be avoided because of the possibility of resulting insomnia.
With dry hands, gently remove the Suprenza (phentermine hydrochloride ODT) tablet from the bottle. Immediately place the Suprenza tablet on top of the tongue where it will dissolve, then swallow with or without water.
Dosage Forms And Strengths
Orally disintegrating tablets (ODT) containing 15 mg, 30 mg, or 37.5 mg phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg phentermine base, respectively). The tablets are not scored. The 15 mg ODT is a yellow with blue spots round tablet embossed with AX4 on one side. The 30 mg ODT is a yellow round tablet embossed with AX7 on one side. The 37.5 mg ODT is a white with blue spots round tablet embossed with AX8 on one side.
Storage And Handling
Available as orally disintegrating tablets (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg phentermine base, respectively). The tablets are not scored. The 15 mg ODT is a yellow with blue spots round tablet embossed with AX4 on one side. The 30 mg ODT is a yellow round tablet embossed with AX7 on one side. The 37.5 mg ODT is a white with blue spots round tablet embossed with AX8 on one side.
Suprenza is available as described in Table 2.
Table 2: Suprenza Orally Disintegrating Tablet
|Tablet Strength||Tablet Color/Shape||Tablet Markings||NDC Code|
|15 mg||Round, embossed tablets Yellow with blue spots||AX4 on one side||NDC:24090 720|
|30 mg||Round, embossed tablets Yellow||AX7 on one side||NDC:24090 721|
|37.5 mg||Round, embossed tablets White with blue spots||AX8 on one side||NDC:24090 722|
Suprenza 15 mg, 30 mg, and 37.5 mg ODT are packaged in bottles of 30.
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.
Manufactured for Akrimax Pharmaceuticals, LLC Cranford, NJ 07016. by: Alpex Pharma SA, Lugano, Switzerland. Marketed and Distributed by: Akrimax Pharmaceuticals, LLC Cranford, NJ 07016. Revised: 06/2013
Last reviewed on RxList: 7/2/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Suprenza Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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