Pharmacia and Upjohn


Concise Prescribing Info
Fosphenytoin Na
Control of generalized convulsive status epilepticus, prevention & treatment of seizures occurring during neurosurgery.
Dosage/Direction for Use
Adult Status epilepticus loading dose of 15-20 mg PE/kg administered at 100-150 mg PE/min. Rate should not >150 mg PE/min. Non-emergent situation & maintenance dosing 10-20 mg PE/kg given IV or IM as loading dose. Rate should not be >150 mg PE/min. Maintenance dose: 4-6 mg PE/kg/day.
Hypersensitivity to fosphenytoin or other hydantoins. Patients w/ sinus bradycardia, sinoatrial block, second & third-degree AV block, & Adams-Stokes syndrome. Concomitant use w/ delavirdine or to class of NNRTIs.
Special Precautions
Do not make any adjustment in the recommended doses when substituting fosphenytoin for phenytoin Na. Do not confuse the amount of drug to be given in PE w/ the conc of the drug in the vial. Risk of adverse CV reactions associated w/ rapid administration (>150 mg PE/min). Not to be used for absence (petit mal) seizures, seizures due to hypoglycemic or other metabolic causes. Patients w/ renal and/or hepatic disease, or w/ hypoalbuminemia. Potential to lower serum folate levels. May increase risk of suicidal ideation and/or behavior, all patients should be routinely evaluated for depression, anxiety, & suicidality. Hypotension may occur especially after IV administration at high doses & high rates; severe CV reactions (eg, atrial & ventricular conduction depression & ventricular fibrillation). Patients w/ hypotension & severe myocardial insufficiency. Purple glove syndrome may develop. May develop hypersensitivity syndrome or drug reaction w/ eosinophilia & systemic symptoms, the syndrome may be more severe in previously sensitized individuals. Patients at higher risk for developing HSS/DRESS eg, Black patients, patients who have experienced syndrome in the past (w/ phenytoin, fosphenytoin or other anticonvulsants), patients w/ family history of syndrome & immunosuppressed patients. Severe cutaneous adverse reactions eg, acute generalized exanthematous pustulosis, exfoliative dermatitis, SJS, TEN & DRESS. Discontinue treatment if rash appears; if rash of a milder type (measles-like or scarlatiniform), therapy may be resumed after the rash has completely disappeared. Discontinued immediately if symptoms of angioedema, eg, facial, perioral, or upper airway swelling occur; acute hepatotoxicity. Impaired liver function, or those who are gravely ill may show early signs of toxicity. Hematopoietic complications eg, thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, & pancytopenia w/ or w/o bone marrow suppression. May develop lymphadenopathy (local or generalized), including benign lymph node hyperplasia, pseudolymphoma, lymphoma & Hodgkin's disease. May produce confusional states. Exacerbation of porphyria; hyperglycemia. May impair ability to drive or operate machinery. Pregnancy. Not recommended for breastfeeding woman. Elderly.
Adverse Reactions
CV collapse &/or CNS depression. Nystagmus & dizziness; pruritus. Tinnitus, ear disorder, vertigo; visual impairment, vision blurred; nausea, dry mouth, vomiting; pain, asthenia, inj site pain, chills; paresthesia, somnolence, ataxia, headache, tremor, abnormal coordination, dysgeusia, stupor, dysarthia; euphoric mood; ecchymosis; hypotension, vasodilatation.
Drug Interactions
May increase serum levels w/ acute alcohol intake, azapropazone, phenylbutazone, salicylates, halothane, chloramphenicol, erythromycin, INH, sulfadiazine, sulfamethizole, co-trimoxazole, sulfaphenazole, sulfisoxazole, sulfonamides, felbamate, oxcarbazepine, Na valproate, succinimides, topiramate, amphotericin B, fluconazole, itraconazole, ketoconazole, miconazole, voriconazole, fluorouracil, capecitabine, chlordiazepoxide, diazepam, disulfiram, methylphenidate, trazodone, viloxazine, amiodarone, dicumarol, diltiazem, nifedipine, ticlodipine, cimetidine, fluvastatin, estrogens, tacrolimus, tolbutamide, omeprazole, fluoxetine, fluvoxamine, sertraline.
MIMS Class
ATC Classification
N03AB05 - fosphenytoin ; Belongs to the class of hydantoin derivatives antiepileptics.
Aurantin soln for inj 75 mg/mL
10 mL x 10 × 1's
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