Dilantin

Dilantin

phenytoin

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
Phenytoin Na
Indications/Uses
Prevention & treatment of seizures occurring during or following neurosurgery. Treatment of trigeminal neuralgia. SR cap: Control of generalized tonic-clonic (grand mal) & complex partial (psychomotor, temporal lobe) seizures. Inj: Control of status epilepticus of the tonic-clonic (grand mal) type. 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.
Dosage/Direction for Use
Individualized dosage. SR cap Adult Initially 300 mg in 3 equally divided doses daily. Maintenance: 300-400 mg 3-4 times in equally divided dose respectively. An increase of up to 600 mg daily may be made if necessary. Loading dose: 1 g divided into 3 doses (400 mg, 300 mg & 300 mg), administered at 2 hr interval. Institute normal maintenance dose 24 hr after loading dose. Childn Initially 5 mg/kg/day in 2 or 3 equally divided doses. Max: 300 mg daily. Childn >6 yr & adolescents may require the min adult dose (300 mg daily). Inj Max: Adult 50 mg/min IV. Childn & neonate 1-3 mg/kg/min or 50 mg/min whichever is slower. Status epilepticus Adult Loading dose: 10-15 mg/kg slow IV not exceeding 50 mg/min (approx 20 min in a 70 kg patient), followed by a maintenance dose of 100 mg orally or IV every 6-8 hr. Childn & neonate Loading dose: 15-20 mg/kg via slow IV at a rate not exceeding 1-3 mg/kg/min or 50 mg/min whichever is slower. Neurosurgery Prophylaxis: 100-200 mg IM 4 hrly & post-op. Cardiac arrhythmia 3.5-5 mg/kg, repeated once if necessary. Total daily dosage: 700-1,000 mg.
Contraindications
Hypersensitivity to phenytoin or other hydantoins. Co-administration w/ delavirdine. Inj: Sinus bradycardia, SA block, 2nd & 3rd degree AV block, Adam-Stokes syndrome.
Special Precautions
Not effective for absence (petit mal) seizures. Not indicated for seizures due to hypoglycemia or other metabolic causes. Avoid abrupt w/drawal. Alcohol consumption. Hypoalbuminemia. Cardiac effects. Suicidal ideation & behavior. Discontinue therapy if an alternative etiology for the signs & symptoms of hypersensitivity syndrome or drug reaction w/ eosinophilia & systemic symptoms cannot be established; if rash appears. Severe cutaneous AR eg, acute generalized exanthematous pustulosis, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis & DRESS. Risk of serious skin reactions & other hypersensitivity reactions may be higher in Black patients. Immediately discontinue in patients w/ angioedema & acute hepatotoxicity. Hematopoietic complications. Determine serum drug level at the 1st sign of acute toxicity. Exacerbation of porphyria. May raise serum glucose levels in diabetic patients. Renal or hepatic disease. May increase risk for congenital malformations & other adverse development outcomes. May impair ability to drive or operate machinery. Effective contraception during treatment in women of childbearing potential who are not planning a pregnancy. Pregnancy. Not recommended in nursing mothers. Elderly or who are gravely ill. SR cap: Vit D deficiency, risk of osteomalacia, bone fractures, osteoporosis, hypocalcaemia, hypophosphatemia. Inj: IM route is not recommended for the treatment of status epilepticus. Hypotension &/or myocardial insufficiency. Careful cardiac (including respiratory) monitoring when administering IV loading doses. Avoid SC or perivascular inj. Contains propylene glycol which when in prolonged use of >24 hr could result in propylene glycol toxicity.
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, peripheral polyneuropathy; 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; hypersensitivity syndrome/drug reaction w/ eosinophilia & systemic symptoms, systemic lupus erythematosus, periarteritis nodosa, Ig abnormalities, angioedema; abnormal thyroid function test; scarlatiniform or morbilliform rashes, bullous, exfoliative, or purpuric dermatitis, lupus erythematosus, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria; taste perversion. SR cap: Bone fractures, osteomalacia, osteoporosis, hypocalcemia, hypophosphatemia, decreased levels of vit D metabolites. Inj: Asystole/cardiac arrest, bradycardia & hypotension; local irritation, inflammation, tenderness, necrosis, sloughing of skin; edema, discoloration & pain distal at inj site.
Drug Interactions
May increase phenytoin serum levels w/ alcohol (acute intake), azapropazone, phenylbutazone, salicylates, halothane, chloramphenicol, erythromycin, INH, sulfadiazine, sulfamethizole, sulfamethocazole-trimethoprim, sulfaphenazole, sulfisoxazole, sulfonamides, felbamate, oxacarbazepine, Na valproate, succinimides, topiramate, amphotericin B, fluconazole, itraconazole, ketoconazole, miconazole, voriconazole, fluorouracil, capecitabine, chlordiazepoxide, diazepam, disulfiram, methylphenidate, trazodone, viloxazine, amiodarone, dicumarol, diltiazem, nifedipine, ticlodipine, cimetidine, fluvastatin, estrogens, tacrolimus, tolbutamide, omeprazole, fluoxetine, fluvoxamine, sertraline. May decrease phenytoin serum level w/ alcohol (chronic intake), rifampin, ciprofloxacin, vigabatrin, bleomycin, carboplatin, cisplatin, doxorubicin, methotrexate, sucralfate, fosamprenavir, nelfinavir, ritonavir, theophylline, reserpine, folic acid, diazoxide, St. John's wort. Molidone HCl contains Ca ions which interfere w/ absorption of phenytoin. Ingestion time w/ Ca prep including antacid prep should be staggered. May increase or decrease phenytoin serum levels w/ ciprofloxacin, carbamazepine, phenobarb, Na valproate, valproic acid, teniposide, chlordiazepoxide, diazepam, phenothiazines. Phenytoin may alter serum levels &/or effects of doxycycline, rifampin, tetracycline, carbamazepine, lamotrigine, phenobarb, Na valproate, valproic acid, azoles, posaconazole, voriconazole, albendazole, praziquantel, teniposide, delavirdine, efavirenz, fosamprenavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir, theophylline, digitoxin, digoxin, disopyramide, mexiletine, nicardipine, nimodipine, nisoldipine, quinidine, verapamil, corticosteroids, warfarin, 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. May cause decreased serum levels of protein-bound iodine (PBI). May produce lower than normal values for dexamethasone or metyrapone tests. May cause increased serum levels of glucose, alkaline phosphatase & γ-glutamyl transpeptidase (GGT). May affect blood Ca & sugar metabolism tests.
MIMS Class
Anticonvulsants
ATC Classification
N03AB02 - phenytoin ; Belongs to the class of hydantoin derivatives antiepileptics.
Presentation/Packing
Form
Dilantin inj 250 mg/5 mL
Packing/Price
(vial) 10 × 1's (Rp6,174,491/boks)
Form
Dilantin SR cap 100 mg
Packing/Price
100's (Rp720,451/botol)
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