Aurantin

Aurantin

fosphenytoin

Manufacturer:

Pharmacia and Upjohn

Distributor:

Pfizer
Concise Prescribing Info
Contents
Fosphenytoin Na
Indications/Uses
Control of generalized convulsive status epilepticus. Prevention & treatment of seizures occurring during neurosurgery. It can be substituted (short-term) for oral phenytoin.
Dosage/Direction for Use
Adult Status epilepticus Loading dose: 15-20 mg phenytoin Na equiv (PE)/kg administered at 100-150 mg PE/min followed by maintenance doses of either parenteral fosphenytoin or oral/parenteral phenytoin. Do not administer rate >150 mg PE/min. Non-emergent loading & maintenance dosing Loading dose: 10-20 mg PE/kg given as IV or IM. Do not administer IV rate >150 mg PE/min. Initial daily maintenance dose: 4-6 mg PE/kg/day. IM or IV substitution for oral phenytoin therapy Same total daily dose. Ped Status epilepticus Loading dose: 15 mg PE/kg. Infusion rate: 2 mg PE/kg/min. Administer not faster >150 mg PE/min. Non-emergent loading & maintenance dosing Loading dose: 10-15 mg PE/kg. Infusion rate: 1-2 mg PE/kg/min. Initial maintenance dose: 2-4 mg PE/kg given 12 hr after the loading dose then continue 4-8 mg PE/kg/day every 12 hr at a rate of 1-2 mg PE/kg/min (no faster >100 mg PE/min).
Contraindications
Hypersensitivity to fosphenytoin, phenytoin or other hydantoin. Patients w/ sinus bradycardia, SA block, 2nd- & 3rd-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 or vice versa. 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. Not indicated for absence (petit mal) seizures, seizures due to hypoglycemic or other metabolic causes. Do not discontinue abruptly due to possible increased seizure frequency including status epilepticus; dose reduction, discontinuation, or substitution should be done gradually. Renal &/or hepatic disease, or w/ hypoalbuminemia. May increase risk of suicidal ideation &/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). Monitor (including resp) carefully when administering IV loading doses. Patients w/ hypotension & severe myocardial insufficiency. Local toxicity including purple glove syndrome. Higher risk for developing hypersensitivity syndrome (HSS) or DRESS in black patients, those who have experienced this syndrome in the past (w/ phenytoin, fosphenytoin or other anticonvulsants), those w/ family history of this 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. Discontinue immediately if symptoms of angioedema, eg, facial, perioral, or upper airway swelling occur; acute hepatotoxicity. 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 affect ability to drive & use machines. Impaired liver function. Use effective contraception during treatment in women of childbearing potential. Not recommended during lactation. Elderly.
Adverse Reactions
CV collapse &/or CNS depression; hypotension. Nystagmus, dizziness; pruritus. Tinnitus, ear disorder, vertigo; visual impairment, blurred vision; nausea, dry mouth, vomiting; pain, asthenia, inj site reaction/pain, chills; paresthesia, somnolence, ataxia, headache, tremor, abnormal coordination, dysgeusia, stupor, dysarthria; euphoric mood; ecchymosis; hypotension, vasodilatation.
Drug Interactions
May increase the unbound fraction w/ drugs highly bound to albumin. May increase phenytoin 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, ticlopidine, cimetidine, fluvastatin, estrogens, tacrolimus, tolbutamide, omeprazole, fluoxetine, fluvoxamine, sertraline. May decreased phenytoin serum levels w/ chronic alcohol intake, rifampin, ciprofloxacin, vigabatrin, bleomycin, carboplatin, cisplatin, doxorubicin, MTX, fosamprenavir, nelfinavir, ritonavir, theophylline, reserpine, folic acid, diazoxide, St. John's wort. May increase or decrease phenytoin serum levels w/ ciprofloxacin, carbamazepine, phenobarb, Na valproate, valproic acid, antineoplastic agents, chlordiazepoxide, diazepam, phenothiazines. Potential loss of virologic response & possible resistance to delavirdine.
MIMS Class
Anticonvulsants
ATC Classification
N03AB05 - fosphenytoin ; Belongs to the class of hydantoin derivatives antiepileptics.
Presentation/Packing
Form
Aurantin soln for inj 75 mg/mL
Packing/Price
10 mL x 10 × 1's
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