DIMENHYDRINATE Solution for injection Ref.[10838] Active ingredients: Dimenhydrinate

Source: FDA, National Drug Code (US)  Revision Year: 2019 

3. Indications and Usage

Dimenhydrinate Injection, USP is indicated for the prevention and treatment of nausea, vomiting, or vertigo of motion sickness.

10. Dosage and Administration

Dimenhydrinate in the injectable form is indicated when the oral form is impractical.

Adults

Nausea or vomiting may be expected to be controlled for approximately 4 hours with 50 mg, and prevented by a similar dose every 4 hours. Its administration may be attended by some degree of drowsiness in some patients, and 100 mg every 4 hours may be given in conditions in which drowsiness is not objectionable or is even desirable.

For intramuscular administration, each milliliter (50 mg) of solution is injected as needed, but for intravenous administration, each milliliter (50 mg) of solution must be diluted in 10 mL of 0.9% Sodium Chloride Injection, USP and injected over a period of 2 minutes.

Pediatric

For intramuscular administration, 1.25 mg/kg of body weight or 37.5 mg/m² of body surface area is administered four times daily. The maximum dose should not exceed 300 mg daily (see CONTRAINDICATIONS).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

9. Overdosage

Drowsiness is the usual clinical side effect. Convulsions, coma, and respiratory depression may occur with massive overdosage. No specific antidote is known. If respiratory depression occurs, mechanically assisted respiration should be initiated and oxygen should be administered. Convulsions should be treated with appropriate doses of diazepam. Phenobarbital (5 to 6 mg/kg) may be given to control convulsions in pediatric patients.

The oral LD50 in mice and rats is 203 mg/kg and 1320 mg/kg, respectively. The intraperitoneal LD50 in mice is 149 mg/kg.

12. Storage and Handling

Protect from light.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Vial stoppers do not contain natural rubber latex.

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