Sanbetoin

Phenytoin Na

Control of status epilepticus of the tonic-clonic (grand mal) type & prevention & treatment of seizures occurring during or following neurosurgery. Treatment of trigeminal neuralgia. XR cap: Control of complex partial (psychomotor, temporal lobe) seizures. Inj: Prevention & treatment of seizures occurring during or following severe head injury. Treatment of migraine, & certain psychoses; cardiac arrhythmias, digitalis intoxication, & post-event treatment of MI.

XR cap: Individualized dosage. Adult Patients who have received no previous treatment Initially 300 mg daily in 3 divided doses. Maintenance dose: 300-400 mg daily in 3-4 divided doses. Max: 600 mg daily. Non-emergency oral loading dose in patients who require rapid steady state serum levels & for whom IV administration is not desirable Loading dose: 1 g in 3 divided doses (400 mg, 300 mg, 300mg) given at 2-hr intervals. Maintenance dose: Instituted 24 hr after the loading dose w/ frequent serum level determinations. Childn Initially 5 mg/kg/day in 2-3 divided doses. Maintenance dose: 4-8 mg/kg daily. Max: 300 mg daily. Childn & adolescents >6 yr Min: 300 mg daily. Inj: Status epilepticus Loading dose: 10-15 mg/kg by slow IV at 50 mg/min rate. Maintenance dose: 100 mg PO or IV every 6-8 hr. Childn & neonates Loading dose: 15-20 mg/kg by slow IV at 1-3 mg/kg/min. Neurosurgery Prophylactic dose: 100-200 mg IM at 4-hr intervals during & post-op. Cardiac arrhythmia 3.5-5 mg/kg repeated once if necessary by slow administration of 30-50 mg/min. Total daily dose: 700-1,000 mg.

XR cap: Should be taken with food.

Hypersensitivity to phenytoin or other hydantoins. Co-administration w/ delavirdine. Inj: Sinus bradycardia, SA block, 2nd & 3rd degree AV block, Adams-Stoke syndrome.

Not for absence (petit mal) seizures; seizures due to hypoglycemia or other metabolic causes. Avoid abrupt discontinuation. Discontinue if an alternative etiology for hypersensitivity syndrome/DRESS cannot be established; acute toxicity occurs. Acute alcoholic intake may increase phenytoin serum levels, while chronic alcoholic use may decrease serum levels. Increased fraction of unbound phenytoin in patients w/ renal or hepatic disease, or in those w/ hypoalbuminemia. Suicidal ideation & behavior. Immediately evaluate patients w/ signs & symptoms of hypersensitivity syndrome/DRESS. Black patients, patients who have experienced hypersensitivity/DRESS in the past (w/ phenytoin or other anticonvulsants), who have a family history of this syndrome & immunosuppressed patients. Exfoliative dermatitis, SJS, & TEN. Follow-up observation in all cases of lymphadenopathy for an extended period. Porphyria exacerbation. May raise serum glucose levels in diabetic patients. May affect ability to drive & use machines. Impaired liver function. Pregnancy. Not recommended in nursing mothers. Elderly or who are gravely ill. XR cap: Discontinue treatment if rash appears. Toxic hepatitis & liver damage; hematopoietic complications including thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis & pancytopenia w/ or w/o bone marrow suppression. Phenytoin serum levels sustained above the optimal range may produce confusional states eg, delirium, psychosis, or encephalopathy, or rarely irreversible cerebellar dysfunction &/or cerebellar atrophy. Vit D deficiency. Prenatal exposure may increase risks for congenital malformations & other adverse development outcomes. May result in failure of hormonal contraceptives therapeutic effect. Advise women of childbearing potential who are not planning a pregnancy to use effective contraception during treatment. Inj: IM route is not recommended for the treatment of status epilepticus. Careful cardiac (including resp) monitoring is needed when administering IV loading doses. Hypotension &/or severe myocardial insufficiency. Avoid improper administration including SC or perivascular inj.

Anaphylactoid reaction & anaphylaxis; connective tissue, GI, hematopoietic, dermatology system; CNS; immunologic; taste perversion. XR cap: Bone fractures & osteomalacia w/ long term use (>10 yr), osteoporosis & other bone metabolism disorder eg, hypocalcemia, hypophosphatemia & decreased level of vit D metabolites. Inj: CV system; inj site reactions; thyroid function test abnormal.

Alcohol (acute intake), analgesics/anti-Inflammatory agents (azapropazone, phenylbutazone, salicylates), anesth (halothane), antibacterial agents (chloramphenicol, erythromycin, INH, sulfadiazine, sulfamethizole, sulfamethoxazole-trimethoprim, sulfaphenazole, sulfisoxazole sulfonamides), anticonvulsants (felbamate, oxcarbazepine, Na valproate, succinimides, topiramate), antifungal agents (amphotericin B, fluconazole, itraconazole, ketoconazole, miconazole, voriconazole), antineoplastic agents (fluorouracil, capecitabine), benzodiazepines/psychotropic agents (chlordiazepoxide, diazepam, disulfiram, methylphenidate, trazodone, viloxazine), Ca channel blockers/CV agents (amiodarone, dicumarol, diltiazem, nifedipine, ticlonidine), H₂ antagonist (cimetidine), HMG-CoA reductase inhibitor (fluvastatin), hormones (estrogen), immunosuppressant drugs (tacrolimus), oral hypoglycaemics (tolbutamide), PPIs (omeprazole), serotonin re-uptake inhibitors (fluoxetine, fluvoxamine, sertraline) may increase phenytoin serum levels. Alcohol (chronic intake), antibacterial agents (rifampin, ciprofloxacin), anticonvulsants (vigabatrin), antineoplastic agents (bleomycin, carboplatin, cisplatin, doxorubicin, MTX), antiretrovirals (fosamprenavir, nelfinafir, ritonavir), bronchodilators (theophylline), CV agents (reserpine), folic acid, hyperglycemic agents (diazoxide), St. John's wort may decrease phenytoin serum levels. Antibacterial agents (ciprofloxacin), anticonvulsants (carbamazepine, phenobarb, Na valproate, valproic acid), antineoplastic agents (teniposide), psychotropic agents (chlordiazepoxide, diazepam, phenothiazines) may increase or decrease phenytoin serum levels. May alter serum levels &/or effects of antibacterial agents (doxycycline, rifampicin, tetracycline), anticonvulsants (carbamazepine, lamotigrine, phenobarb, Na valproate, valproic acid), antifungal agents (azole, posaconazole, voriconazole), anthelmintics (albendazole, praziquantel), antineoplastic agent (teniposide), antiretrovirals (delavirdine, efavirenz, fosamprenavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir), bronchodilators (theophylline), Ca channel blockers/CV agents (digitoxin, disopyramide, digoxin, mexiletine, nicardipine, nimodipine, nisoldipine, quinidine, verapamil), corticosteroids, coumarin anticoagulants (warfarin), cyclosporine, diuretics (furosemide), HMG-CoA reductase inhibitors (atorvastatin, fluvastatin, simvastatin), hormones (estrogen, OC), hyperglycemic agents (diazoxide), neuromuscular blocking agents (alcuronium, cisatracurium, paricuronium, rocuronium, vecuronium), opioid analgesics (methadone), oral hypoglycemic agents (chlorpropamide, glyburide, tolbutamide), psychotropic agents/antidepressant (clozapine, paroxetine, quetiapine, sertraline), vit D, folic acid. May decrease serum levels of protein-bound iodine (PBI). May produce lower than normal values for dexamethasone or metyrapone tests. May increase serum levels of glucose, alkaline phosphatase, & γ-glutamyltranspeptidase (GGT). May affect Ca & blood sugar metabolism tests. XR cap: Antiulcer agents (sucralfate) may decrease phenytoin serum levels. May alter serum levels &/or effects of immunosuppressants. Lower than expected plasma levels in patients who have received enteral feeding prep &/or related nutritional supplements.

Anticonvulsants

N03AB02 - phenytoin ; Belongs to the class of hydantoin derivatives antiepileptics.

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