Benzphetamine Hydrochloride (Page 3 of 3)

OVERDOSAGE

Manifestations of Overdosage

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.

Treatment of Overdosage

(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 AND ADMINISTRATION

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.

HOW SUPPLIED

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].

Manufactured by:

Mikart, Inc.

Atlanta, GA 30318

Code 1025Z00

Rev. 11/10

PRINCIPAL DISPLAY PANEL

100 count bottle label
(click image for full-size original)

BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46672-844
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE) BENZPHETAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
D&C RED NO. 30
SORBITOL
STARCH, CORN
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code BENZ;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46672-844-10 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:46672-844-50 500 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090473 11/01/2011
Labeler — Mikart, Inc. (030034847)
Registrant — Mikart, Inc. (030034847)

Revised: 11/2011 Mikart, Inc.

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