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TENUATE AND TENUATE DOSPAN (DIETHYLPROPION/AMFEPRAMONE): PRESCRIBING INFORMATION

DESCRIPTION

Tenuate is available for oral administration in immediate-release tablets containing 25 mg diethylpropion hydrochloride and in controlled-release tablets containing 75 mg diethylpropion hydrochloride. The inactive ingredients in each immediate-release tablet are: lactose, corn starch, magnesium stearate, talc, pregelatinized corn starch, and tartaric acid. The inactive ingredients in each controlled-release tablet are: mannitol, carbomer 934P, povidone, zinc stearate, tartaric acid. Diethylpropion HCl is a sympathomimetic agent. The chemical name for diethylpropion hydrochloride is 1-phenyl-2-diethyl-amino-1-propanone hydrochloride.

In Tenuate Dospan tablets, diethylpropion hydrochloride is dispersed in a hydrophilic matrix. On exposure to water, the diethylpropion hydrochloride is released at a relatively uniform rate as a result of slow hydration of the matrix. The result is controlled release of the anorectic agent.


CLINICAL PHARMACOLOGY

Tenuate and Tenuate Dospan clinical pharmacology


INDICATIONS AND USAGE

Tenuate (Diethylpropion Hydrochloride) and Tenuate 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.

The usefulness of agents of this class should be measured against possible risk factors inherent in their use such as those described below. Tenuate (Diethylpropion Hydrochloride) tablets and Tenuate Dospan are indicated for use as monotherapy only.


CONTRAINDICATIONS

Pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma, severe hypertension.

Agitated states.

Patients with a history of drug abuse.

Usage of Tenuate (Diethylpropion HCl) or Tenuate Dospan in combination with other anorectic agents is contraindicated.

During or within 14 days following the administration of monoamine oxidase inhibitors, hypertensive crises may result.


WARNINGS

Tenuate and Tenuate Dospan warnings


PRECAUTIONS

Tenuate and Tenuate Dospan precautions


ADVERSE REACTIONS

Tenuate and Tenuate Dospan adverse reactions


DRUG ABUSE AND DEPENDENCE

Tenuate (Diethylpropion Hydrochloride) tablets and Tenuate Dospan are schedule IV controlled substances. Diethylpropion HCl has some chemical and pharmacologic similarities to the amphetamines and other related stimulant drugs that have been extensively abused. There have been reports of subjects becoming psychologically dependent on diethylpropion. The possibility of abuse should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with varying degrees of psychologic dependence and social dysfunction which, in the case of certain drugs, may be severe. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.


OVERDOSAGE

Tenuate and Tenuate Dospan overdosage


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.

Geriatric use:

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.


HOW SUPPLIED

Tenuate 25 mg immediate-release tablets in bottles of 100.

Each white, round tablet is debossed TENUATE 25 or MERRELL 697.

Keep tightly closed, store at room temperature, preferably below 86°F.

Protect from excessive heat.

Tenuate 75 mg controlled-release tablets in bottles of 100.

Tenuate controlled-release tablets in bottles of 250.

Each Tenuate and Tenuate Dospan (Diethylpropion Hydrochloride) white, capsule-shaped tablet is debossed TENUATE 75 or MERRELL 698.

Keep tightly closed. Store at room temperature, below 86°F.

Rx only

Manufactured and distributed by Sanofi-Aventis, Patheon Pharmaceuticals, Merrell Pharmaceuticals companies.

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