Acute overdosage with amphetamines may result in restlessness, tremor, tachypnea, confusion, assaultiveness and 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. Hyperpyrexia and rhabdomyolysis have been reported and can lead to a number of associated complications. Fatal poisoning is usually preceded by convulsions and coma.
(See WARNINGS) — Information concerning the effects of overdosage with benzphetamine hydrochloride tablets is extremely limited. The following is based on experience with other anorexiants.
Management of acute amphetamine intoxication is largely symptomatic and includes sedation with a barbiturate. If hypertension is marked, the use of a nitrite or rapidly acting alpha receptor blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard.
Acidification of the urine increases amphetamine excretion.
The oral LD50 is 174 mg/kg in mice and 104 mg/kg in rats. The intraperitoneal LD50 in mice is 153 mg/kg.
Dosage should be individualized according to the response of the patient. The suggested dosage ranges from 25 to 50 mg one to three times daily. Treatment should begin with 25 to 50 mg once daily with subsequent increase in individual dose or frequency according to response. A single daily dose is preferably given in mid-morning or mid-afternoon, according to the patient’s eating habits. In an occasional patient it may be desirable to avoid late afternoon administration. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.
Benzphetamine hydrochloride tablets, 50 mg are supplied as pink, round tablets, debossed “BENZ” on one side and “5” score “0” on the other side in bottles of 100 tablets, NDC 46672-844-10, and 500 tablets, NDC 46672-844-50.
Store at controlled room temperature 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].
Atlanta, GA 30318
| BENZPHETAMINE HYDROCHLORIDE |
benzphetamine hydrochloride tablet
|Labeler — Mikart, Inc. (030034847)|
|Registrant — Mikart, Inc. (030034847)|
Revised: 11/2011 Mikart, Inc.
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