Pharmaniaga Phenytoin Na Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Phenytoin Na

Indications/Uses

Control of tonic-clonic (grand mal) status epilepticus. Prevention & treatment of seizures during or following neurosurgery.

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Dosage/Direction for Use

Status epilepticus Adult Loading dose: 10-15 mg/kg slow IV at rate not exceeding 50 mg/min. Maintenance dose: 100 mg IV every 6-8 hr. Childn Loading dose: 15-20 mg/kg slow IV at rate not exceeding 1-3 mg/kg/min. Neurosurgery prophylaxis 100-200 mg IM at approx 4-hr intervals during & post-op.

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Overdosage

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Contraindications

Hypersensitivity to phenytoin or other hydantoins. Sinus bradycardia, SA block, 2nd- & 3rd-degree AV block, Stokes-Adams syndrome. Co-administration w/ delavirdine.

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Special Precautions

Not to be inj IM for status epilepticus. Avoid SC or perivascular inj. Not effective for absence (petit mal) seizures. Not indicated for seizures due to hypoglycemia or other metabolic causes. Discontinue use in patients w/ acute hepatotoxicity. Increased risk of suicidal ideation/thoughts or behaviour. Hypotension & severe myocardial insufficiency; local toxicity eg, Purple Glove syndrome. Hypersensitivity syndrome (HSS)/DRESS; immunosuppressed patients; exfoliative dermatitis, SJS & TEN. Hematopoietic complications; exacerbation of porphyria, hyperglycemia. Black patients. Acute alcohol intake. Avoid abrupt discontinuation. May affect ability to drive & use machines. Hepatic impairment. Women of childbearing potential should use effective contraception. Pregnancy. Not recommended during lactation. Elderly, gravely ill patients.

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Use In Pregnancy & Lactation

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Adverse Reactions

Anaphylactoid reaction & anaphylaxis; hypotension; nystagmus, ataxia, slurred speech, decreased coordination & mental confusion, dizziness, vertigo, insomnia, transient nervousness, motor twitching, headache, paresthesia & somnolence, phenytoin-induced dyskinesia, sensory peripheral polyneuropathy; facial features coarsening, lip enlargement, gingival hyperplasia, hypertrichosis, Peyronie's disease; acute hepatic failure, toxic hepatitis, liver damage, vomiting, nausea, constipation; hematopoietic complications; HSS/DRESS, SLE, periarteritis nodosa, Ig abnormalities; local inj site reactions; scarlatiniform or morbilliform rashes, bullous, exfoliative or purpuric dermatitis, lupus erythematosus, SJS, TEN; taste perversion.

Drug Interactions

Increased serum levels w/ acute alcohol intake, analgesic/anti-inflammatory agents, anesth, antifungals, benzodiazepines/psychotropic agents, Ca-channel blockers/CV agents, H₂-antagonists, HMG-CoA reductase inhibitors, hormones, immunosuppressants, oral hypoglycemic agents, PPIs, SSRIs. Decreased serum levels w/ chronic alcohol intake, antiretrovirals, bronchodilators, CV agents, folic acid, hyperglycemic agents, St. John's wort. Increased or decreased serum levels w/ antibacterials, anticonvulsants, antineoplastics, psychotropic agents. Altered serum levels &/or effects of anthelmintics, corticosteroids, coumarin anticoagulants, cyclosporine, diuretics, hyperglycemic & neuromuscular-blocking agents, opioid analgesics, psychotropic agents/antidepressants, vit D. Decreased serum levels of protein-bound iodine. Increased serum levels of glucose, alkaline phosphatase, γ-glutamyl transpeptidase.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Anticonvulsants

ATC Classification

N03AB02 - phenytoin ; Belongs to the class of hydantoin derivatives antiepileptics.

Regulatory Classification

Presentation/Packing

Form

Pharmaniaga Phenytoin Na inj 250 mg/5 mL

Packing/Price

10 × 1's

Pharmaniaga Phenytoin Na

phenytoin

Manufacturer:

Pharmaniaga LifeScience

Distributor:

Pharmaniaga Logistics