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TENUATE AND TENUATE DOSPAN (DIETHYLPROPION/AMFEPRAMONE): PRECAUTIONS

General

Caution is to be exercised in prescribing Tenuate (Diethylpropion HCl) or Tenuate Dospan tablets for patients with hypertension or with symptomatic cardiovascular disease, including arrhythmias. Tenuate (Diethylpropion Hydrochloride) 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 (Diethylpropion Hydrochloride) tablets or Tenuate Dospan should be carefully monitored. Titration of dose or discontinuance of these drugs may be necessary.

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

Information for Patient

The patient should be cautioned about concomitant use of alcohol or other CNS-active drugs and Tenuate or Tenuate Dospan (Diethylpropion HCl). The patient should be advised to observe caution when driving or engaging in any potentially hazardous activity.

Laboratory Tests

None

Drug Interactions

Because Tenuate and Tenuate Dospan (Diethylpropion HCl) tablets are monoamines, hypertension may result when either agent is used with monoamine oxidase (MAO) inhibitors. Efficacy of diethylpropion with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems; therefore, the concomitant use with other anorectic agents is contraindicated.

Antidiabetic drug requirements (i.e., insulin) may be altered. Concurrent use with general anesthetics may result in arrhythmias. The pressor effects of diethylpropion and those of other drugs may be additive when the drugs are used concomitantly; conversely, diethylpropion may interfere with antihypertensive drugs (i.e., guanethidine, a-methyldopa). Concurrent use of phenothiazines may antagonize the anorectic effect of diethylpropion.

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.

Pregnancy

Teratogenic Effects

Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 1.6 times the human dose (based on mg/m2) 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.

Spontaneous reports of congenital malformations have been recorded in humans, but no causal relationship to diethylpropion has been established.

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 (Diethylpropion Hydrochloride) tablets is administered to a nursing woman.

Geriatric Use

Clinical studies of Tenuate (Diethylpropion HCl) or Tenuate Dospan did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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.

Pediatric Use

Since safety and effectiveness in pediatric patients below the age of 16 have not been established, Tenuate (Diethylpropion HCl) tablets or Tenuate Dospan is not recommended for use in pediatric patients 16 years of age and under.

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