
Proval200 mg
General Pharmaceuticals Ltd.
Sodium Valproate is an anticonvulsant and mood-stabilising medicine used in the following conditions: Established / Approved Uses Epilepsy: Monotherapy or adjunctive (add-on) therapy for complex…
Sodium Valproate is an anticonvulsant and mood-stabilising medicine used in the following conditions:
Use of Sodium Valproate for indications outside of epilepsy, bipolar mania and migraine prophylaxis should be guided by a specialist physician.
Dosage of Sodium Valproate must be individualised based on indication, response, and, where relevant, plasma valproate concentration (a typical therapeutic reference range is approximately 50-100 micrograms/mL, though clinical response guides dosing more than levels alone).
| Indication | Typical Adult Dosing |
|---|---|
| Epilepsy (monotherapy or adjunct) | Start around 10-15 mg/kg/day in divided doses; increase gradually (e.g. by 5-10 mg/kg/week) to effect. Usual maintenance 20-30 mg/kg/day (commonly 1-2 g/day); maximum generally 60 mg/kg/day. |
| Acute mania (bipolar disorder) | Initial dose commonly 750 mg/day in divided doses (or a loading regimen under specialist supervision), titrated to clinical response; maximum 60 mg/kg/day. |
| Migraine prophylaxis | Typically 400-600 mg/day in divided doses, increased as needed up to about 1000-1500 mg/day; not for treating an acute migraine attack. |
Dosing in children is weight-based, generally 15-30 mg/kg/day in divided doses depending on age and indication, increased gradually under specialist supervision. See Use in Special Populations and Pediatric Uses for important age-related cautions.
Sodium Valproate is contraindicated in patients with hepatic disease or significant hepatic dysfunction — see Contraindications.
Dose adjustment is not usually required based on renal function alone, but the free (unbound) fraction of the drug is increased, so lower total doses with closer monitoring may be prudent in significant renal impairment.
Doses of Sodium Valproate should be taken as regularly scheduled. In patients being treated for epilepsy, Sodium Valproate must never be stopped abruptly, as this can precipitate withdrawal seizures or status epilepticus; discontinuation should always be tapered gradually under medical supervision.
Side effects of Sodium Valproate range from common and mild to rare but serious.
Patients should seek prompt medical attention for unusual bruising/bleeding, yellowing of skin or eyes, severe abdominal pain, unusual drowsiness/confusion, or any new mood or behaviour changes while taking Sodium Valproate.
Sodium Valproate is contraindicated in:
For epilepsy or bipolar disorder, use in pregnancy or in women of childbearing potential is not an absolute contraindication but requires specialist risk-benefit assessment — see Pregnancy and Lactation.
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