DrugBuyers.Com: Tenuate - Diethylpropion

TENUATE® (diethylpropion hydrochloride USP) immediate-release 25 mg tablets
TENUATE® DOSPAN® (diethylpropion hydrochloride USP) controlled-release 75 mg tablets
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: corn starch, lactose, magnesium stearate, pregelatinized corn starch, talc, and tartaric acid.

The inactive ingredients in each controlled-release tablet are: carbomer 934P, mannitol, povidone, tartaric acid, zinc stearate.

Diethylpropion hydrochloride 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.

INDICATIONS

TENUATE 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. 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.

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) controlledrelease:

One controlled-release 75 mg tablet daily, swallowed whole, in midmorning.

HOW SUPPLIED

25 mg immediate-release tablets in bottles of 100

NDC 0068-0697-61

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.

75 mg controlled-release tablets in bottles of 100

NDC 0068-0698-61

75 mg controlled-release tablets in bottles of 250

NDC 0068-0698-62

Each white, capsule-shaped tablet is debossed TENUATE 75 or MERRELL 698 Keep tightly closed. Store at room temperature, below 86° F.

PATIENT INFORMATION

The patient should be cautioned about concomitant use of alcohol or other CNS-active drugs and TENUATE or TENUATE DOSPAN. (See WARNINGS.)

The patient should be advised to observe caution when driving or engaging in any potentially hazardous activity.

WARNINGS

If tolerance develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued. TENUATE or TENUATE DOSPAN may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

When central nervous system active agents are used, consideration must always be given to the possibility of adverse interactions with alcohol.

PRECAUTIONS

General

Caution is to be exercised in prescribing TENUATE or TENUATE DOSPAN for patients with hypertension or with symptomatic cardiovascular disease, including arrhythmias. TENUATE or TENUATE DOSPAN should not be administered to patients with severe hypertension.

Reports suggest that diethylpropion hydrochloride may increase convulsions in some epileptics. Therefore, epileptics receiving TENUATE or TENUATE DOSPAN should be carefully monitored. Titration of dose or discontinuance of TENUATE or TENUATE DOSPAN may be necessary.

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Laboratory Test: None

Carcinogenesis, Mutagenesis, and Impairment of Fertility

No long-term animal studies have been done to evaluate diethylpropion hydrochloride for carcinogenicity. Mutagenicity studies have not been conducted. Animal reproduction studies have revealed no evidence of impairment of fertility (see Pregnancy, below).

Pregnancy

Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 9 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diethylpropion hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Non-Teratogenic Effects: Abuse with diethylpropion hydrochloride during pregnancy may result in withdrawal symptoms in the human neonate.

Nursing Mothers

Since diethylpropion hydrochloride and/or its metabolites have been shown to be excreted in human milk, caution should be exercised when TENUATE or TENUATE DOSPAN is administered to a nursing woman.

Pediatric Use

Since safety and effectiveness in children below the age of 12 have not been established, TENUATE or TENUATE DOSPAN is not recommended for use in children under 12 years of age.

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