Universal Medical Industry
Concise Prescribing Info
Phenytoin Na
Control of tonic-clonic (grand mal) & simple or complex partial (psychomotor or temporal lobe). Treatment of ventricular tachycardia or paroxysmal atrial tachycardia or arrhythmias caused by digitalis intoxication. Prophylactic in neurosurgery. Control of status epilepticus.
Dosage/Direction for Use
Status epilepticus Adult Loading dose: 15-20 mg/kg IV at a rate of ≤50 mg/min. Maintenance dose: 100 mg IV every 6-8 hr. Neonate & childn Loading dose: 15-20 mg/kg or 250 mg/m3 IV at a rate of 1 mg/kg/min & ≤50 mg/min. Neurosurgery prophylaxis 100-200 mg IM at approx 4 hrly intervals during surgery & continued during the post-op period. Cardiac arrhythmias 50-100 mg at a rate of ≤50 mg/min every 10-15 min by slow IV infusion (max 15 mg/kg).
Hypersensitivity to hydantoins. Sinus bradycardia; SA block, 2nd- & 3rd-degree AV block, Adams-Stokes syndrome. Lactation.
Special Precautions
Elderly or gravely ill patients. Hypotension (especially via IV route), severe myocardial insufficiency, liver & kidney disease, porphyria. May impair ability to drive or operate machinery. Pregnancy (may cause teratogenesis). Management of status epilepticus: Continuous monitoring of ECG, BP & serum phenytoin level is essential.
Adverse Reactions
Hypotension (IV infusion rate related), atrial & ventricular depression, ventricular fibrillation, nystagmus, ataxia, slurred speech, decreased coordination, mental confusion, dizziness, insomnia, transient nervousness, motor twitchings, headaches, GIT disturbances. Dermatological manifestations eg, potentially fatal bullous, exfoliative or purpuric dermatitis; lupus erythematosus; Stevens-Johnson syndrome & toxic epidermal necrolysis. Hematopoietic system disturbances, coarsening of the facial features, enlargement of the lips, gingival hyperplasia, hypertrichosis & Peyronie's disease. Inj site reaction.
Drug Interactions
Increase phenytoin serum levels: Acute alcohol intake, dicoumarol, disulfiram, methylphenidate, omeprazole, ticlopidine, viloxazine, NSAID eg, salicylates, halothane, chloramphenicol, erythromycin, INH, sulfonamides, felbamate, succinimides, amphotericin B, fluconazole, ketoconazole, miconazole, itraconazole, benzodiazepines/psychotropic agents, amiodarone, diltiazem, nifedipine, estrogens, tolbutamide, fluoxetine. Decrease phenytoin serum levels: Fluoroquinolones, chronic alcohol abuse, diazoxide, reserpine, sucralfate, theophylline, vigabatrin, Ca-containing prep. Drugs which affect phenytoin: Anticonvulsants, chlordiazepoxide, diazepam. Drugs affected by phenytoin: Clozapine, corticosteroids, coumarin, anticoagulants, cyclosporine, diazoxide, furosemide, paroxetine, theophylline, vit D, doxycycline, rifampicin, praziquantel, tetracycline, OC, neuromuscular-blocking agents, methadone, sulfonylurea antidiabetic drugs.
MIMS Class
ATC Classification
N03AB02 - phenytoin ; Belongs to the class of hydantoin derivatives antiepileptics.
Utoin-250 infusion 50 mg/mL
(amp) 5 mL x 10 × 1's; (vial) 5 mL x 1's
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