PHENYTOIN SODIUM- phenytoin sodium injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)

Available from:

X-GEN Pharmaceuticals, Inc.

INN (International Name):

PHENYTOIN SODIUM

Composition:

PHENYTOIN SODIUM 50 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Parenteral Phenytoin Sodium Injection is indicated for the control of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. Parenteral phenytoin should be used only when oral phenytoin administration is not possible. Phenytoin is contraindicated in patients with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins. 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. Coadministration of phenytoin is contraindicated with delavirdine due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.

Product summary:

Phenytoin Sodium Injection, USP - 100 mg/2 mL (50 mg/mL) – in 2 mL vials (NDC 39822-4050-2) packaged in cartons of 25 (NDC 39822-4050-3) Phenytoin Sodium Injection, USP - 250 mg/5 mL (50 mg/mL) – in 10 mL vials (NDC 39822-4050-5) packaged in cartons of 25 (NDC 39822-4050-6)  Federal law prohibits dispensing without prescription.  Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: X-GEN Pharmaceuticals Big Flats, NY 14814 Revised: 05/2013 PY-PI-03

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHENYTOIN SODIUM- PHENYTOIN SODIUM INJECTION, SOLUTION
X-GEN PHARMACEUTICALS, INC.
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PHENYTOIN SODIUM INJECTION, USP
BOXED WARNING
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION THE
RATE OF INTRAVENOUS PHENYTOIN ADMINISTRATION SHOULD NOT EXCEED 50 MG
PER MINUTE IN ADULTS
AND 1-3 MG/KG/MIN (OR 50 MG PER MINUTE, WHICHEVER IS SLOWER) IN
PEDIATRIC PATIENTS BECAUSE
OF THE RISK OF SEVERE HYPOTENSION AND CARDIAC ARRHYTHMIAS. CAREFUL
CARDIAC MONITORING IS
NEEDED DURING AND AFTER ADMINISTERING INTRAVENOUS PHENYTOIN. ALTHOUGH
THE RISK OF
CARDIOVASCULAR TOXICITY INCREASES WITH INFUSION RATES ABOVE THE
RECOMMENDED INFUSION RATE,
THESE EVENTS HAVE ALSO BEEN REPORTED AT OR BELOW THE RECOMMENDED
INFUSION RATE.
REDUCTION IN RATE OF ADMINISTRATION OR DISCONTINUATION OF DOSING MAY
BE NEEDED (SEE
WARNINGS AND DOSAGE AND ADMINISTRATION).
DESCRIPTION
Phenytoin Sodium Injection, USP is a ready-mixed solution of phenytoin
sodium in a vehicle containing
40% propylene glycol and 10% alcohol in water for injection, adjusted
to pH 12 with sodium
hydroxide.
Phentoin sodium is related to the barbiturates in chemical structure,
but has a five-membered ring. The
chemical name is sodium 5,5-diphenyl-2, 4-imidazolidinedione
represented by the following structural
formula:
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Phenytoin is an anticonvulsant which may be useful in the treatment of
generalized tonic-clonic status
epilepticus. The primary site of action appears to be the motor cortex
where spread of seizure activity
is inhibited. Possibly by promoting sodium efflux from neurons,
phenytoin tends to stabilize the
threshold against hyperexcitability caused by excessive stimulation or
environmental changes capable
of reducing membrane sodium gradient. This includes the reduction of
posttetanic potentiation at
synapses. Loss of posttetanic potentiation prevents cortical seizure
foci from detonating adjacent
cortical areas. Phenytoin reduces the maximal activity of brain stem
centers responsible for the tonic
phase of generalized