Phenytoin Sodium Injection

Product Description

Indications:

Phenytoin Sodium Injection USP is indicated for the control of status epilepticus of the grand mal type, and prevention and treatment of seizures occurring during neurosurgery.

Dosage & Administration:

The addition of Phenytoin Sodium Injection USP to intravenous infusion is not recommended due to lack of solubility and resultant precipitation.

Not to exceed 50 mg per minute, intravenously in adults, and not exceeding 1 - 3 mg/kg/min in neonates.

Status Epilepticus

In adults, a loading dose of 10 to 15 mg/kg should be administered slowly intravenously, at a rate not exceeding 50 mg per minute. The loading dose should be followed by maintenance doses of 100 mg orally or intravenously every 6-8 hours.

Neurosurgery

Prophylactic dosage 100 to 200 mg intramuscularly at approximately 4-hour intervals during surgery and continued during the postoperative period.

Contraindications:

Phenytoin is contraindicated in patients with a history of hypersensitivity to hydantoin products. Because of its effect on ventricular automaticity, phenytoin is contraindicated in sinus bradycardia, sino-atrial block, second and third degree A-V block, and patients with Adams-Stokes syndrome.

Warnings:

Intravenous administration should not exceed 50 mg per minute in adults. In neonates, the drug should be administered at a rate not exceeding 1 - 3 mg/kg/min.

Severe cardiotoxic reactions and fatalities have been reported with atrial and ventricular conduction depression and ventricular fibrillation. Severe complications are most commonly encountered in elderly or gravely ill patients.