Dilantin Oral

Control of generalized tonic-clonic (grand mal) & complex partial (psychomotor, temporal lobe) seizures. Prevention & treatment of seizures occurring during or following neurosurgery.

Individualized dosage. Cap Seizures Adult w/ no previous treatment May be started 300 mg daily, to be taken in 3 equally divided doses. Maintenance: 300-400 mg daily, to be taken in 3-4 equally divided doses. May be increased up to 600 mg daily if necessary. Non-emergency oral loading dose Adult 1 g of phenytoin divided into 3 doses (400 mg, 300 mg, & 300 mg) administered at 2-hr intervals. Normal maintenance dosage is then instituted 24 hr after the loading dose, w/ frequent serum level determinations. Oral susp Seizures Adult w/ no previous treatment May be started 125 mg (5 mL) tid, may be increased to 625 mg (25 mL) daily if necessary. Cap/oral susp Seizures Childn Initially 5 mg/kg/day in 2 or 3 equally divided doses, w/ subsequent individualized dosage. Max: 300 mg daily. Maintenance: 4-8 mg/kg. Childn >6 yr & adolescent May require min adult dose: 300 mg daily.

Should be taken with food: Cap: Swallow whole, do not open/chew/crush.

Hypersensitivity to phenytoin or other hydantoins. Co-administration w/ delavirdine or to the class of NNRTIs.

Not effective for absence (petit mal) seizures. Not indicated for seizures due to hypoglycemic or other metabolic causes. Should not be abruptly discontinued due to possibility of increased seizure frequency including status epilepticus. Rapid substitution of alternative therapy may be necessary in the event of an allergic or hypersensitivity reaction. Slow drug metabolism in some individuals. Acute alcohol intake may increase phenytoin serum levels, while chronic alcohol use may decrease serum levels. Reports of suicidal ideation & behavior; bradycardia & asystole/cardiac arrest; hypersensitivity syndrome or DRESS; serious dermatologic reactions; angioedema; acute hepatotoxicity, including infrequent cases of acute hepatic failure; hematopoietic complications eg, thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis & pancytopenia w/ or w/o bone marrow suppression; hyperglycemia. Discontinue immediately if symptoms of angioedema eg, facial, perioral, or upper airway swelling occur. Serum phenytoin levels sustained above the optimal range may produce confusional states eg, delirium, psychosis or encephalopathy, or irreversible cerebellar dysfunction (rarely) &/or cerebellar atrophy. Caution in patients w/ exacerbation of porphyria. May lead to Vit D deficiency & heightened risk of osteomalacia, bone fractures, osteoporosis, hypocalcemia & hypophosphatemia in chronically treated epileptic patients. Advise patient not to drive a car or operate potentially dangerous machinery until effect on ability to engage in these activities is known. Caution in interpreting total phenytoin plasma conc in patients w/ renal or hepatic disease, or w/ hypoalbuminemia due to increased fraction of unbound phenytoin in these patients. Women of childbearing potential who are not planning a pregnancy should use effective contraception during treatment. May cause fetal harm when administered to a pregnant woman. Prenatal exposure to phenytoin may increase risks for congenital malformations & other adverse development outcomes. Should only be used in women of childbearing potential & pregnant women if potential benefit outweighs the risk. Breast-feeding is not recommended during treatment. Slightly decreased clearance in elderly; lower or less frequent dosing may be required.

Anaphylactoid reaction, anaphylaxis; nystagmus, ataxia, slurred speech, decreased coordination, mental confusion; cerebellar atrophy; dizziness, vertigo, insomnia, transient nervousness, motor twitchings, headache, paresthesia, somnolence; sensory peripheral polyneuropathy (long-term therapy); coarsening of the facial features, lips enlargement, gingival hyperplasia, hypertrichosis, Peyronie's disease; acute hepatic failure, toxic hepatitis, liver damage, vomiting, nausea, constipation; thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, pancytopenia w/ or w/o bone marrow suppression; macrocytosis, megaloblastic anemia; lymphadenopathy including benign lymph node hyperplasia, pseudolymphoma, lymphoma, Hodgkin's disease; pure red cell aplasia; hypersensitivity syndrome/DRESS, SLE, polyarteritis nodosa, Ig abnormalities; angioedema; abnormal thyroid function test; dermatological manifestations including scarlatiniform or morbilliform rashes; bullous, exfoliative or purpuric dermatitis, lupus erythematosus, acute generalized exanthematous pustulosis, SJS, TEN; urticaria; taste perversion; bone fractures & osteomalacia (long-term use >10 yr) in patients w/ chronic epilepsy; osteoporosis & other bone metabolism disorders eg, hypocalcemia, hypophosphatemia & decreased vit D metabolites level.

Serum levels may be increased w/ acute alcohol intake; azapropazone, phenylbutazone, salicylates; halothane; chloramphenicol, erythromycin, INH, sulfadiazine, sulfamethizole, sulfamethoxazole-trimethoprim, sulfaphenazole, sulfisoxazole, sulfonamides; felbamate, oxcarbazepine, Na valproate, succinimides, topiramate; amphotericin B, fluconazole, itraconazole, ketoconazole, miconazole, voriconazole; capecitabine, fluorouracil; chlordiazepoxide, diazepam, disulfiram, methylphenidate, trazodone, viloxazine; amiodarone, dicumarol, diltiazem, nifedipine, ticlopidine; cimetidine; fluvastatin; estrogens; tacrolimus; tolbutamide; omeprazole; fluoxetine, fluvoxamine, sertraline. Serum levels may be decreased w/ chronic alcohol intake; ciprofloxacin, rifampin; vigabatrin; bleomycin, carboplatin, cisplatin, doxorubicin, MTX; sucralfate; fosamprenavir, nelfinavir, ritonavir; theophylline; reserpine; folic acid; diazoxide; St. John's wort. Interfered absorption w/ molindone HCl. Absorption problems w/ Ca prep, including antacid prep containing Ca. Serum levels may either be increased/decreased w/ ciprofloxacin; carbamazepine, phenobarb, Na valproate, valproic acid; antineoplastic agents; chlordiazepoxide, diazepam, phenothiazines. May alter serum levels &/or effects of doxycycline, rifampin, tetracycline; warfarin, apixaban, dabigatran, edoxaban, rivaroxaban; carbamazepine, lamotrigine, phenobarb, Na valproate, valproic acid, lacosamide; azoles, posaconazole, voriconazole; albendazole, praziquantel; teniposide; ticagrelor; delavirdine, efavirenz, fosamprenavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir; theophylline; digitoxin, digoxin, disopyramide, mexiletine, nicardipine, nimodipine, nisoldipine, quinidine, verapamil; corticosteroids; cyclosporine; furosemide; atorvastatin, fluvastatin, simvastatin; estrogens, OCs; diazoxide; immunosuppressants; alcuronium, cisatracurium, pancuronium, rocuronium, vecuronium; methadone; chlorpropamide, glyburide, tolbutamide; clozapine, paroxetine, quetiapine, sertraline; vit D; folic acid. TCAs may precipitate seizures in susceptible patients & phenytoin dosage may need to be adjusted. Concomitant administration w/ valproate has been associated w/ increased risk of valproate-associated hyperammonemia. Lower than expected plasma levels w/ enteral feeding prep &/or related nutritional supplements. May decrease serum levels of protein-bound iodine. May produce lower than normal values for dexamethasone or metyrapone tests. May increase serum levels of glucose, alkaline phosphatase, & γ-glutamyl transpeptidase. May affect blood Ca & sugar metabolism rates.

Anticonvulsants

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

Rx