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Therapeutic Category
- ANTIEPILEPTICS&ANTICONVULSANTS
- Pharmaceutical Form : S.R. Coated Tablet
- Composition : sodium valproate 200 mg/ enteric coated tablet
- Active Substance : sodium valproate 200 mg
INDICATIONS:
Epilepsy: Primary generalized epilepsy (petit mall absences, various forms of myoclonic and tonic clonic grand mall seizures) Partial (focal) epilepsy either alone or as adjuvant therapy
Mania: For the treatment of Mania where other therapy has proved inadequate or is inappropriate
WARNINGS AND PRECAUTIONS:
Female children/Female adolescents/Women of childbearing potential/Pregnancy:
Valproate should not be used in female children, in female adolescents, in women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated because of its high teratogenic potential and risk of developmental disorders in infants exposed in utero to valproate. The benefit and risk should be carefully reconsidered at regular treatment reviews, at puberty and urgently when a woman of childbearing potential treated with valproate plans a pregnancy or if she becomes pregnant.
Women of childbearing potential must use effective contraception during treatment and be informed of the risks associated with the use of valproate during pregnancy.
In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible.
Valproate therapy should only be continued after a reassessment of the benefits and risks of the treatment with valproate for the patient by a physician experienced in the management of epilepsy.
DOSAGE AND ADMINISTRATION:
Sodium valproate E.C.tablets may be given twice daily.
Sodium valproate should preferably be taken with or after food: the enteric-coated tablet must be swallowed whole, if necessary with a little water.
Sodium valproate 500 mg E.C.tablets is recommended for patients requiring high doses. Sodium valproate may take several days to show an initial effect and in some cases may take from 2 to 6 weeks to exhibit its maximum effect.
Epilepsy
Monotherapy:
Adults: Dosage should start with 600 mg daily increasing by 200mg/day at three-day intervals until control is achieved. This is generally within the range 1000 to 2000 mg/day.(i.e. 20 to 30 mg/kg/day) where adequate control is not achieved within this range the dose may be further increased to 2500 mg/day.
Children >20 Kg: The starting dose is 400 mg/day (regardless of weight) and increased at time intervals until control is achieved. This is generally within the range 20-30 mg/kg/day.
Children <20Kg: 20 mg/kg/day, and in severe cases this may be increased but only in patients in whom plasma Valproic acid levels can be monitored. Above 40 mg/kg/day, clinical chemistry and hematological parameters should be monitored.
General considerations: Optimum dosage is mainly determined by seizure control and routine measurement of plasma levels is unnecessary.
Combined therapy:
In certain cases it may be necessary to raise the dose by 5 to 10 mg/kg/day when used in combination with anticonvulsants which induce liver enzyme activity, e.g. phenytoin, phenobarbitone and carbamazepine.
Mania
Initially dosage should start with 600 mg daily increasing by 200 mg/day at three-day intervals until control is achieved. This is generally within the range 1,000 to 2,000 mg/day, (i.e. 20 to 30 mg/kg/day). Where adequate control is not achieved within this range the dose may be further increased to 2,500 mg/day.
Impaired renal function: Lower doses may be required since free drug levels may be high owing to lowered serum albumin and poor urinary excretion of free drug metabolites.
PRESENTATION:
Valpromed enteric coated tablets: box of 30 E.C.tablets
STORAGE CONDITIONS: store at temperature not exceeding 30˚c.