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Phenytoin Injection Generic Name & Formulations
Legal Class
Rx
General Description
Phenytoin 50mg/mL; contains alcohol, propylene glycol.
Pharmacological Class
Hydantoin.
How Supplied
Contact supplier.
Manufacturer
Phenytoin Injection Indications
Indications
Status epilepticus (tonic-clonic). Seizure prophylaxis and treatment in neurosurgery.
Phenytoin Injection Dosage and Administration
Adult
Status epilepticus: IV not to exceed 50mg/min. Loading dose: 10–15mg/kg followed by maintenance doses of 100mg orally or IV every 6–8 hrs. Do not dilute solution in IV fluids. Neurosurgical procedures: see full labeling.
Children
Status epilepticus: IV not to exceed 1–3mg/kg/min. Loading dose: 15–20mg/kg. Neurosurgical procedures: see full labeling.
Phenytoin Injection Contraindications
Contraindications
History of prior acute hepatotoxicity due to phenytoin. Heart block and sinus bradycardia. Adams-Stokes syndrome. Concomitant delavirdine.
Phenytoin Injection Boxed Warnings
Not Applicable
Phenytoin Injection Warnings/Precautions
Warnings/Precautions
Increased cardiovascular risk associated with rapid infusion; monitor during and after therapy; rate reduction or discontinuation may be needed. Hypotension. Severe myocardial insufficiency. Monitor ECG, BP, respiration, phenytoin levels. Diabetes. Change dose gradually. Monitor for signs/symptoms of serious dermatological reactions; discontinue if rash develops. Maintain proper dental hygiene. Oral contraception. Porphyria. Renal and/or hepatic impairment. Hypoalbuminemia. Elderly. Debilitated. Pregnancy (see full labeling). Nursing mothers.
Phenytoin Injection Pharmacokinetics
See Literature
Phenytoin Injection Interactions
Interactions
See Contraindications. Potentiated by acute alcohol ingestion, amiodarone, benzodiazepines (eg, chlordiazepoxide, diazepam), chloramphenicol, dicumarol, disulfiram, estrogens, fluoxetine, halothane, H2 blockers (eg, cimetidine), isoniazid, methylphenidate, phenothiazines, phenylbutazone, salicylates, succinamides (eg, ethosuximide), sulfonamides, tolbutamide, trazodone, others. Antagonized by chronic alcohol ingestion, carbamazepine, reserpine, others. Antagonizes tricyclic antidepressants, oral anticoagulants, oral contraceptives, estrogens, corticosteroids, doxycycline, digitoxin, furosemide, theophylline, rifampin, quinidine, vitamins D and K, others. Variable effects with phenobarbital, valproic acid, divalproex, others. Absorption decreased by calcium.
Phenytoin Injection Adverse Reactions
Adverse Reactions
Nystagmus, drowsiness, dizziness, insomnia, dyskinesias, ataxia, GI disturbances, gingival hyperplasia, osteomalacia, blood dyscrasias, atrial and ventricular conduction depression, slurred speech, lymphadenopathy, hepatic disease, rash, hyperglycemia, SLE, hypertrichosis, immunoglobulin abnormalities; DRESS, multiorgan hypersensitivity (may be fatal), local toxicity (eg, purple glove syndrome).
Phenytoin Injection Clinical Trials
See Literature
Phenytoin Injection Note
Not Applicable
Phenytoin Injection Patient Counseling
See Literature
