Valproic acid


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Migraine prophylaxis Initial: 250 mg bid. Max: 1 g/day; extended-release 500 mg once daily for 7 days, increased to 1 g once daily. Usual dose: 500-1000 mg/day. Acute manic episodes of bipolar disorder As valproate semisodium: Initial: 750 mg/day in divided doses, increase as needed based on response. Max: 60 mg/kg/day. Complex partial seizures As valproic acid or valproate semisodium: ≥10 yr Initial: 10-15 mg/kg/day in 2-4 divided doses, increase if needed. Max: 60 mg/kg/day. As Na valproate: 600 mg/day in 2 divided doses, increase if needed. Usual: 1-2 g/day. Max: 2.5 g/day. Simple and complex absence seizures As monotherapy, conversion to monotherapy or adjunctive therapy. As valproic acid or valproate semisodium: ≥10 yr Initial: 15 mg/kg/day in 2-4 divided doses, increase if needed. Max: 60 mg/kg/day. Bipolar disorder As valpromide: 0.6-1.8 g/day in 2 divided doses. Usual: 1.2 g/day. May increase slowly to reach optimal dose w/ simultaneous and progressive dose reduction of concurrent psychotropic drugs. IV Complex partial seizures; Simple and complex absence seizures As monotherapy, conversion to monotherapy or adjunctive therapy. As Na valproate: Initial: 10-15 mg/kg/day, increase slowly until control is achieved. Usual: 20-30 mg/kg/day. Daily doses to be given in 2-4 divided doses. Max: 60 mg/kg/day.
Contraindications
Pre-existing or family history of hepatic dysfunction, porphyria, urea cycle disorders, known mitochondrial disorders caused by POLG mutation and in children (<2 years) who are suspected of having a mitochondrial disorder. Hepatic impairment. Pregnancy (prophylaxis of migraine).
Special Precautions
Patients with HIV, cytomegalovirus (CMV) infection, SLE. Renal impairment. Children (<2 years on anticonvulsant polytherapy, with congenital metabolic disorders, severe seizure disorders, mental retardation, organic brain disease). Use in children ≥2 years of age who are suspected of having POLG-related disorder only after other anticonvulsants have failed. Lactation. Patient Counselling Seek medical advice during first signs of pancreatitis (e.g. abdominal pain, nausea, vomiting and anorexia), blood and liver toxicity. Monitoring Parameters Monitor LFT before and during the 1st 6 mth of therapy. Monitor blood cell count (including platelet count), bleeding time and coagulation tests before the start of therapy or before surgery, and in cases of spontaneous bruising or bleeding. Monitor for atypical behaviour (e.g. suicidal ideation and behaviour) during and after therapy.
Adverse Reactions
Headache, nausea, vomiting, diarrhoea, anorexia, increased appetite, wt gain, nystagmus, somnolence, dizziness, fatigue, hyperammonaemic encephalopathy, hypothermia, hallucinations. Thrombocytopenia (dose related), tremors, LFT elevation. Chronic use may lead to carnitine deficiency.
Potentially Fatal: Fatal hepatotoxicity esp in childn <2 yr, multi-organ and dermatologic hypersensitivty reactions (e.g. Stevens-Johnson syndrome, erythema multiforme), pancreatitis, blood dyscrasias.
ROUTE(S) : IV / PO / Parenteral: D
ROUTE(S) : IV: X
ROUTE(S) : PO / Parenteral: X when used for migraine prophylaxis
Drug Interactions
Increased risk of toxicity w/ bupropion. Increased risk of convulsions w/ mefloquine. Increased risk of carnitine deficiency w/ pivmecillinam and pivampicillin. Increased risk of hepatotoxicity and carbamazepine toxicity w/ a decrease in valproic acid levels w/ concurrent carbamazepine. Decreased valproic acid and increased ethosuximide serum levels w/ ethosuximide. Decreased valproic acid levels w/ carbapenems, rifampicin, phenytoin, phenobarbital (or primidone) and antineoplastic drug regimens. Increased valproic acid levels w/ felbamate and aspirin. Increased risk of hepatotoxicity w/ olanzepine. Concurrent use increased phenobarbital, nimodipine, nifedipine, lamotrigine, zidovudine, amitriptyline, nortriptyline and benzodiazepines levels. Concurrent use decreased tigabine and clozapine levels. Increased risk of absence status w/ clonazepam. Increased risk of hyperammonaemia w/ topiramate. Increased free valproic acid concentrations w/ highly protein bound drugs.
ATC Classification
N03AG01 - valproic acid ; Belongs to the class of fatty acid derivatives antiepileptic.
Disclaimer: This information is independently developed by CIMS based on valproic acid from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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