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Epanutin

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Indications:

Control of grand mal and psychomotor seizures; prevention and treatment of seizures occurring during or after neurosurgery; control of grand mal type of status epilepticus (parenteral administration).

Contraindications:

Hypersensitivity to phenytoin or other hydantoins; sinoatrial block; sinus bradycardia; second- and third-degree atrioventricular block; Adams-Stokes syndrome.

Adverse reactions:

Cardiovascular CV collapse, hypotension, atrial and ventricular conduction depression, ventricular fibrillation (IV use). CNS Nystagmus; ataxia; dysarthria; slurred speech; mental confusion; dizziness; insomnia; transient nervousness; motor twitching; diplopia; fatigue; irritability; drowsiness; depression; numbness; tremor; headache; choreoathetosis (IV use). Dermatologic Rashes, sometimes accompanied by fever; bullous, exfoliative or purpuric dermatitis; lupus erythematosus; Stevens-Johnson syndrome; toxic epidermal necrolysis; hirsutism; alopecia. EENT Conjunctivitis. GI Nausea; vomiting; diarrhea; constipation. Hematologic Thrombocytopenia; leukopenia; granulocytopenia; agranulocytosis; pancytopenia; macrocytosis; megaloblastic anemia; eosinophilia; monocytosis; leukocytosis; simple anemia; hemolytic anemia; aplastic anemia. Hepatic Toxic hepatitis and liver damage; hepatocellular degeneration and necrosis; hepatitis; jaundice; nephrosis. Miscellaneous Gingival hyperplasia; coarsening of facial features; lip enlargement; Peyronie’s disease; polyarthropathy; hyperglycemia; weight gain; chest pain; IgA depression; fever; photophobia; gynecomastia; periarteritis nodosa; pulmonary fibrosis; tissue injury at injection site; lymph node hyperplasia; hypothyroidism.

Interactions:

Acetaminophen May increase hepatotoxicity potential with chronic phenytoin use. Amiodarone, chloramphenicol, disulfiram, estrogens, felbamate, fluconazole, isoniazid, cimetidine, trimethoprim, phenylbutazone, oxyphenbutazone, phenacemide, sulfonamides May increase phenytoin serum levels. Carbamazepine, sucralfate, antineoplastic agents, rifampin, rifabutin May decrease phenytoin serum levels. Corticosteroids, coumarin anticoagulants, doxycycline, estrogens, levodopa, felodipine, methadone, loop diuretics, oral contraceptives, quinidine, rifampin, rifabutin May impair effects of these agents. Cyclosporine May reduce cyclosporine levels. Disopyramide May cause decreased disopyramide levels and bioavailability and may enhance anticholinergic actions. Enteral nutritional therapy May reduce phenytoin concentrations. Folic acid May cause folic acid deficiency. Metyrapone Phenytoin may cause subnormal response to metyrapone. Mexiletine May decrease mexiletine levels and effects. Nondepolarizing muscle relaxants May cause these agents to have shorter duration or decreased effects. Phenobarbital, sodium valproate, valproic acid May increase or decrease phenytoin levels. Phenytoin may increase phenobarbital and decrease valproic acid levels. Primidone May increase concentrations of primidone and metabolites. Sympathomimetics (eg, dopamine) May cause profound hypotension and possibly cardiac arrest. Theophyllines Effects of either agent may be decreased. Incompatibility Do not mix with other drugs in syringe. Laboratory Test Interactions Phenytoin may interfere with metapyrone and dexamethasone tests, causing inaccurate results because of increased metabolism of these agents. Drug may cause decreases in serum levels of protein-bound iodine. It may cause increased levels of glucose, alkaline phosphatase and gamma glutamyl transpeptidase.

Warnings:

Pregnancy Pregnancy category undetermined. Consult health care provider. Possible risk of birth defects must be considered along with risk of seizures to fetus in untreated epileptic mothers. Lactation Excreted in breast milk. Hypersensitivity Rapid substitution of alternate therapy may be necessary. Special Risk Patients Use drug with caution with hepatic function impairment, acute intermittent porphyria, alcohol abuse, hypotension, and severe myocardial insufficiency. Bioavailability Because products vary in bioavailability; brand interchange is not recommended. Seizures Drug should not be given to treat seizures due to hypoglycemia or other metabolic causes or petit mal (absence) epilepsy. Withdrawal Abrupt withdrawal may precipitate status epilepticus. Dosage must be reduced or other anticonvulsant medicine substituted gradually.

Form:

SOLUTION FOR INJECTION

Dosage and Administration

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