Sanbetoin

Sanbetoin

phenytoin

Manufacturer:

Sanbe

Marketer:

Sanbe
Concise Prescribing Info
Contents
Phenytoin Na
Indications/Uses
Control of status epilepticus of the tonic-clonic (grand mal) type & prevention & treatment of seizures occurring during or following neurosurgery &/or severe head injury. Treatment of migraine, trigeminal neuralgia & certain psychoses; cardiac arrhythmias, digitalis intoxication, & post-event treatment of MI.
Dosage/Direction for Use
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.
Contraindications
Hypersensitivity to phenytoin or other hydantoins. Sinus bradycardia, SA block, 2nd & 3rd degree AV block, Adams-Stoke syndrome. Co-administration w/ delavirdine.
Special Precautions
Not for absence (petit mal) seizures; seizures due to hypoglycemia or other metabolic causes. IM route is not recommended for the treatment of status epilepticus. 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. 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. 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.
Adverse Reactions
Anaphylactoid reaction & anaphylaxis; CV, connective tissue, GI, hematopoietic, dermatology system; CNS; immunologic; inj site reactions; thyroid function test abnormal; taste perversion.
Drug Interactions
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 hypoglycemic agents (tolbutamide), proton pump inhibitors (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.
MIMS Class
Anticonvulsants
ATC Classification
N03AB02 - phenytoin ; Belongs to the class of hydantoin derivatives antiepileptics.
Presentation/Packing
Form
Sanbetoin inj 50 mg/mL
Packing/Price
2 mL x 10 × 1's (Rp750,000/boks)
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