Dilantin Infatabs Generic Name & Formulations
Legal Class
Rx
General Description
Phenytoin 50mg; chewable tabs.
Pharmacological Class
Hydantoin.
See Also
How Supplied
Caps 30mg—100; 100mg—100, 1000; Tabs—100; Susp—8oz
Manufacturer
Generic Availability
YES
Dilantin Infatabs Indications
Indications
Tonic-clonic, psychomotor and neurosurgically induced seizures.
Dilantin Infatabs Dosage and Administration
Adult
May be chewed or swallowed whole. Initially 2 tabs 3 times daily. Maintenance dose: 6–8 tabs daily in divided doses; may increase to 12 tabs daily if necessary.
Children
Initially 5mg/kg per day in 2–3 equally divided doses. Increase weekly if needed. Usual maintenance: 4–8mg/kg per day; max 300mg daily.
Dilantin Infatabs Contraindications
Contraindications
History of prior acute hepatotoxicity due to phenytoin. Concomitant delavirdine.
Dilantin Infatabs Boxed Warnings
Not Applicable
Dilantin Infatabs Warnings/Precautions
Warnings/Precautions
Suicidal tendencies (monitor). Diabetes. Discontinue if acute hepatotoxicity occurs; do not restart. Monitor serum levels when switching between sodium salt of phenytoin (caps) and free acid form (suspension, Infatabs). Discontinue and evaluate at the 1st sign of a rash. Increased risk of SJS/TEN if positive for HLA-B*1502 or in CYP2C9*3 carriers (esp. Asian ancestry); consider avoiding as an alternative for carbamazepine. Adjust dose gradually. Angioedema. Underlying cardiac disease. Use proper dental hygiene. Hormonal contraception. Monitor bone mineral density with chronic use. Porphyria. Intermediate or poor CYP2C9 metabolizers. Renal and/or hepatic impairment. Hypoalbuminemia. Elderly. Debilitated. Pregnancy: avoid. Nursing mothers: not recommended.
Dilantin Infatabs Pharmacokinetics
See Literature
Dilantin Infatabs Interactions
Interactions
Potentiated by acute alcohol ingestion, amiodarone, antiepileptic agents (eg, ethosuximide, felbamate, oxcarbazepine, methsuximide, topiramate), azoles (eg, fluconazole, ketoconazole, itraconazole, miconazole, voriconazole), benzodiazepines (eg, chlordiazepoxide, diazepam), capecitabine, chloramphenicol, disulfiram, estrogens, fluorouracil, fluoxetine, fluvastatin, fluvoxamine, halothane, H2-blockers (eg, cimetidine), isoniazid, methylphenidate, omeprazole, phenothiazines, salicylates, sertraline, succinamides (eg, ethosuximide), sulfonamides, ticlopidine, tolbutamide, trazodone, warfarin. Antagonized by anticancer drugs (eg, bleomycin, carboplatin, cisplatin, doxorubicin, methotrexate), chronic alcohol ingestion, carbamazepine, diazepam, folic acid, fosamprenavir, nelfinavir, reserpine, rifampin, ritonavir, St. John’s wort, sucralfate, theophylline, vigabatrin. Antagonizes anticoagulants (eg, apixaban, dabigatran, edoxaban, rivaroxaban), antiepileptic agents (eg, carbamazepine, felbamate, lacosamide, lamotrigine, topiramate, oxcarbazepine), atorvastatin, fluvastatin, simvastatin, ticagrelor, antivirals (eg, efavirenz, lopinavir/ritonavir, indinavir, nelfinavir, ritonavir, saquinavir), albendazole, chlorpropamide, clozapine, cyclosporine, digoxin, disopyramide, folic acid, methadone, mexiletine, nifedipine, nimodipine, nisoldipine, praziquantel, quetiapine, verapamil. Reduces efficacy of concomitant azoles, corticosteroids, doxycycline, estrogens, furosemide, irinotecan, oral contraceptives, paclitaxel, paroxetine, quinidine, rifampin, sertraline, teniposide, theophylline, vitamin D, warfarin. Concomitant fosamprenavir/ritonavir may potentiate amprenavir. Concomitant neuromuscular blockers (eg, pancuronium, vecuronium, rocuronium, cisatracurium); may need higher infusion rate. Variable effects with phenobarbital, valproic acid, sodium valproate. Absorption decreased by calcium, antacids. Increased risk of hyperammonemia with concomitant valproate; monitor.
Dilantin Infatabs Adverse Reactions
Adverse Reactions
Nystagmus, ataxia, slurred speech, decreased coordination, somnolence, mental confusion, headaches, dizziness, cerebellar atrophy, nausea, vomiting, constipation, gingival hyperplasia, osteomalacia, blood dyscrasias, lymphadenopathy, cardiac effects, hepatic disease, hyperglycemia, SLE, hypertrichosis, lab test abnormality; rare: serious dermatologic reactions (eg, SJS, TEN, AGEP, DRESS), multiorgan hypersensitivity (may be fatal).
Dilantin Infatabs Clinical Trials
See Literature
Dilantin Infatabs Note
Notes
To enroll in the North American Antiepileptic Drug Pregnancy Registry call (888) 233-2334.
Dilantin Infatabs Patient Counseling
See Literature