WARNINGS
If tolerance develops, the recommended dose should not be exceeded in an attempt to increase the effect: rather, the drug should be discontinued.
PRECAUTIONS
General Precautions:
Caution is to be exercised in prescribing Diethylpropion hydrochloride for patients with hypertension or with symptomatic cardiovascular disease, including arrhythmias. They should not be administered to patients with severe hypertension. Reports suggest that Diethylpropion hydrochloride may increase convulsions in some epileptics. Therefore, epileptics receiving them should be carefully monitored. Titration of dose or discontinuance of drug may be necessary. The least amount feasible should be prescribed or dispensed at one time to minimize the possibility of an overdose.
Information for Patients:
Diethylpropion hydrochloride may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore by cautioned accordingly. When central nervous system-active agents are used, consideration must always be given to the possibility of adverse interactions with alcohol.
Drug Interactions:
Antidiabetic drug requirements, i.e., insulin, may be altered in association with the use of Diethylpropion hydrochloride and the concomitant dietary regimen. Concurrent use with general anesthetics may result in arrhythmias. The presser 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
Diethylpropion hydrochloride has not been evaluated for carcinogenicity, mutagenicity, or impairment of fertility.
Pregnancy: Teratogenic Effects: - Pregnancy Category B:
Reproduction studies have been performed in rats at doses up to nine times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diethylpropion hydrochloride. However, no adequate and well-controlled studies have been conducted 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.
Pregnancy: Nonteratogenic Effects:
Abuse during pregnancy may result in withdrawal symptoms in the neonate.
Labor and Delivery:
Diethylpropion hydrochloride has no recognized use during labor and delivery, and its effect during these processes are unknown. Diethylpropion and /or its active metabolites are believed to cross the placenta.
Nursing Mothers:
It is not known whether diethylpropion is excreted in human milk. Because many drugs are excreted in human milk, caution should be used when Diethylpropion hydrochloride is administered to a nursing woman.
Pediatric Use:
Safety and effectiveness in pediatric patients below the age of 16 have not been established.
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