Finished product reference
Valproate Semisodium
Tablet, Delayed Release · Oral · 125 mg
- List code
- 11636
- Pharmacologic class
- Mood stabiliser and antiepileptic (valproate; divalproex sodium)
What it is and how it works
Valproate semisodium is a stable coordination compound of sodium valproate and valproic acid that dissociates to valproate in the gastrointestinal tract. Valproate increases brain GABA levels, blocks voltage-gated sodium channels and T-type calcium currents; these actions underlie its antimanic and anticonvulsant effects.
Indications
Treatment of manic episodes in bipolar disorder and prevention of recurrence in patients who responded to valproate; in some products, epilepsy (generalised and focal seizures).
Dosage and administration (summary)
Orally for mania: initially 750 mg daily in 2–3 divided doses, increased rapidly according to response to the lowest effective dose, usually 1–2 g daily; tablets should be swallowed whole.
Contraindications
Active liver disease or personal/family history of severe hepatic dysfunction (especially drug-related); hepatic porphyria; mitochondrial disorders caused by POLG mutations; urea cycle disorders; pregnancy (for bipolar disorder) and women of childbearing potential unless the conditions of a pregnancy prevention programme are met.
Warnings and precautions
Valproate is highly teratogenic (neural tube defects and other malformations) and causes neurodevelopmental disorders after in utero exposure; it should not be started in girls or women of childbearing potential unless other treatments are ineffective or not tolerated, with strict contraception and regular review. Severe hepatotoxicity and pancreatitis may occur, particularly early in treatment; monitor liver function and advise patients to report symptoms. Hyperammonaemia, thrombocytopenia, weight gain and suicidal ideation can occur; monitor blood counts before surgery.
Pregnancy
Contraindicated in pregnancy for bipolar disorder because of a high risk of congenital malformations and neurodevelopmental disorders.
Storage and supply
Store below 25 °C in the original package, protected from moisture.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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