Dilantin Steri-Vial

Dilantin Steri-Vial

phenytoin

Manufacturer:

Viatris

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Phenytoin Na
Indications/Uses
Control of tonic-clonic (grand mal) status epilepticus. Prevention & treatment of seizures occurring during or following neurosurgery.
Dosage/Direction for Use
Status epilepticus Adult Loading dose: 10-15 mg/kg slow IV at rate not to exceed 50 mg/min. Maintenance: 100 mg PO or IV every 6-8 hr. Childn & neonate Loading dose: 15-20 mg/kg slow IV at rate not to exceed 1-3 mg/kg/min or 50 mg/min. Neurosurgery Prophylactic dose: 100-200 mg (2-4 mL) IM at approx 4-hr interval during surgery & post-op period.
Contraindications
Hypersensitivity to phenytoin or other hydantoins. Sinus bradycardia; SA block, 2nd- & 3rd-degree AV block, Adams-Stokes syndrome. Co-administration w/ delavirdine or other NNRTIs.
Special Precautions
Hypersensitivity syndrome (HSS)/drug reaction w/ eosinophilia & systemic symptoms. Discontinue use if exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis or rash are observed. Not to be inj IM for treatment of status epilepticus. Not effective for absence (petit mal) seizures, seizures due to hypoglycemia or other metabolic causes. Increased risk of suicidal ideation/thoughts or behaviour. Risk of local toxicity eg, Purple Glove syndrome. Hypotension, severe myocardial insufficiency; severe cardiotoxic reactions & fatalities w/ bradycardia, atrial & ventricular depression/fibrillation; porphyria; hyperglycemia, diabetes. Monitor for hematopoietic effects & propylene glycol toxicity. May produce confusional states. Acute alcohol intake. Avoid abrupt w/drawal. May affect ability to drive & use machines. Renal impairment. Hepatic impairment or hepatotoxicity. Women of childbearing potential should use effective contraception. Pregnancy. Not recommended during lactation. Elderly, gravely ill patients.
Adverse Reactions
Anaphylactoid reaction, anaphylaxis; asystole/cardiac arrest, bradycardia, hypotension; nystagmus, ataxia, slurred speech, decreased coordination, mental confusion, cerebellar atrophy; dizziness, vertigo, insomnia, transient nervousness, motor twitching, headache, paresthesia, somnolence; phenytoin-induced dyskinesia; sensory peripheral polyneuropathy (long-term therapy); facial features coarsening, lips enlargement, gingival hyperplasia, hypertrichosis, Peyronie's disease; acute hepatic failure, toxic hepatitis, liver damage; nausea, vomiting, constipation; hematopoietic complications; HSS/DRESS, SLE, periarteritis nodosa, Ig abnormalities; inj site reactions; abnormal thyroid function test; dermatological manifestations; taste perversion.
Drug Interactions
Increased serum levels w/ acute alcohol intake, analgesic/anti-inflammatory agents, anesth, antifungals, benzodiapines/psychotropic agents, Ca-channel blockers/CV agents, H2-antagonists, HMG-CoA reductase inhibitors, hormones, immunosuppressants, oral hypoglycemics, proton-pump inhibitors, SSRIs. Decreased serum levels w/ chronic alcohol intake, antiretrovirals, bronchodilators, CV & hyperglycemic agents, folic acid, St. John's wort. Increased or decreased serum levels w/ antibacterials, anticonvulsants, antineoplastics, psychotropic agents. Altered serum levels &/or effects of antibacterials, anticonvulsants, antifungals, antihelmintics, antineoplastics, antiretrovirals, bronchodilators, Ca-channel blockers/CV agents, corticosteroids, coumarin anticoagulants, cyclosporine, diuretics, HMG-CoA reductase inhibitors, hormones, hyperglycemic & neuromuscular blocking agents, opioid analgesics, oral hypoglycemics, psychotropic agents/antidepressants, vit D, folic acid. Decreased serum levels of protein-bound iodine. Increased serum levels of glucose, alkaline phosphatase & γ-glutamyl transpeptidase.
MIMS Class
Anticonvulsants
ATC Classification
N03AB02 - phenytoin ; Belongs to the class of hydantoin derivatives antiepileptics.
Presentation/Packing
Form
Dilantin Steri-Vial soln for inj 250 mg/5 mL
Packing/Price
1's
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