Dilantin Oral

Dilantin Oral

phenytoin

Manufacturer:

Pfizer USA

Distributor:

Viatris
Concise Prescribing Info
Contents
Phenytoin (cap: Na)
Indications/Uses
Control of generalized tonic-clonic (grand mal) & complex partial (psychomotor, temporal lobe) seizures. Prevention & treatment of seizures occurring during or following neurosurgery.
Dosage/Direction for Use
Individualized dosage. Cap Seizures Adult w/ no previous treatment Initially 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 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 Initially 125 mg (5 mL) tid, may increase to 625 mg (25 mL) daily if necessary. Cap/oral susp Seizures Childn Initially 5 mg/kg daily in 2 or 3 equally divided doses, w/ subsequent individualized dosage. Max: 300 mg daily. Maintenance: 4-8 mg/kg. Childn >6 yr & adolescent Min: 300 mg daily.
Administration
Should be taken with food: Swallow whole, do not open/chew/crush. For patients on nasogastric or other enteral feeds, do not administer feeds 2 hr before or after a dose. Be consistent throughout therapy in relation to feed times.
Contraindications
Hypersensitivity to phenytoin or other hydantoins. Co-administration w/ delavirdine or to the class of NNRTIs.
Special Precautions
Hypersensitivity syndrome (HSS)/DRESS. Not effective for absence (petit mal) seizures. Not indicated for seizures due to hypoglycemic or other metabolic causes. Avoid abrupt discontinuation due to the possibility of increased seizure frequency including status epilepticus. Polymorphism. May increase phenytoin serum levels w/ acute alcohol intake, while chronic alcohol intake may decrease serum levels. Suicidal ideation & behavior. Bradycardia & asystole/cardiac arrest. Exfoliative dermatitis, SJS, TEN & DRESS. Angioedema. Toxic hepatitis & liver damage. Thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis & pancytopenia w/ or w/o bone marrow suppression. Delirium, psychosis or encephalopathy, irreversible cerebellar dysfunction (rarely) &/or cerebellar atrophy. Exacerbation of porphyria. Hyperglycemia. Risk of osteomalacia, bone fractures, osteoporosis, hypocalcemia & hypophosphatemia in chronically treated epileptic patients. 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. May affect ability to drive or operate machinery. Women of childbearing potential. Pregnancy & lactation. Elderly (lower or less frequent dosing may be required).
Adverse Reactions
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, enlargement of the lips, 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.
Drug Interactions
May increase serum levels 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. May decrease serum levels 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 antacids containing Ca. May either increase/decrease serum levels w/ ciprofloxacin; carbamazepine, phenobarb, Na valproate, valproic acid; antineoplastics; 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. May precipitate seizures w/ TCAs. Increased risk of valproate-associated hyperammonemia. Lower than expected plasma levels w/ enteral feeding prep &/or related nutritional supplements.
MIMS Class
Anticonvulsants
ATC Classification
N03AB02 - phenytoin ; Belongs to the class of hydantoin derivatives antiepileptics.
Presentation/Packing
Form
Dilantin Oral cap 100 mg
Packing/Price
100's (P3,381.44/pack)
Form
Dilantin oral susp 125 mg/5 mL
Packing/Price
120 mL x 1's (P712.12/bottle)
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