Label: tepanil- diethylpropion hydrochloride tablet, extended release

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.

Cardiovascular:

Precordial pain, arrhythmia, ECG changes (one published report described T-wave changes in the ECG of a healthy young male after ingestion of diethylpropion hydrochloride), tachycardia, elevation of blood pressure, palpitation.

Central Nervous System:

In a few epileptics an increase in convulsive episodes has been reported: dyskinesia, blurred vision, overstimulation, nervousness, restlessness, dizziness, jitteriness, insomnia, anxiety, euphoria, depression, dysphoria, tremor, mydriasis, drowsiness, malaise, headache, and rarely, psychotic episodes at recommended doses.

Gastrointestinal:

Vomiting, diarrhea, abdominal discomfort, dryness of the mouth, unpleasant taste, nausea, constipation.

Allergic:

Urticaria, rash, ecchymosis, erythema.

Endocrine:

Impotence, changes in libido, gynecomastia, menstrual upset.

Hematopoietic System:

Bone marrow depression, agranulocytosis, leukopenia.

Other:

Dysuria, dyspnea, hair loss, muscle pain, increased sweating, polyuria.

Controlled Substance:

Diethylpropion is a schedule IV controlled substance.

Abuse:

Diethylpropion has some chemical and pharmacologic similarities to the amphetamines and other related stimulant drugs that have been extensively abused. 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.

Dependence:

There have been reports of subjects becoming psychologically dependent on diethylpropion. 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.

Symptoms:

Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states.

Fatigue and depression usually follow the central stimulation.

Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Overdose of pharmacologically similar compounds has resulted in fatal poisoning, usually terminating in convulsions and coma.

Treatment:

Management of acute Diethylpropion hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard: Intravenous phentolamine (Regitine®) has been suggested on pharmacologic grounds for possible acute, severe hypertension. If this complicates diethylpropion hydrochloride overdosage.