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Valproate sodium manufacturers

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valproate sodium

Powder for solution for infusion 400 mg - 4 ml, 20 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Comments
Vial - 20 ml, ampoule - 4 ml
Manufacturer #15084

Manufacturer usually replies in 18 days

Sodium valproate

Sodium Valproate is valproic acid. Sodium valproate and valproate semisodium treat epilepsy and bipolar disorder and used to prevent migraine headaches. It is useful in the prevention of seizures in those with absence, partial, and generalized seizures. While it is not known how it works exactly, it is proposed that it affects GABA levels. This blocks voltage-gated sodium channels and inhibits histone deacetylases. Valproic acid is made from valeric acid and is a branched short-chain fatty acid. Sodium Valproate is sold under the brand names Epilim, Episenta, Epival among others. Meunier and Carraz first discovered it in 1967 and later Glaxo Wellcome Inc, filed for the first patent in 1991. Due to its worldwide use and safety record, it features on the WHO's List of Essential Medicines and is now sold as a generic medication. With 5 million prescriptions is was one of the most used medicines in the USA in 2017.

Dosage Forms & Strengths and Administration

Sodium valproate can be administered intravenously or by mouth, and the tablet forms are sold in long- and short-acting formulations. Sodium valproate is sold as a capsule in 250mg strength, the capsule and tablet for delayed-release come in varying strengths of 125mg, 250mg, and 500mg. It is sold as a extended-release tablet in 250mg and 500mg strengths and as a capsule delayed release sprinkle in 125mg strength. It is also sold as syrup in 250mg/5mL and as an injectable solution in 100mg/mL strength. In the treatment of Complex Partial Seizures, either as monotherapy and adjunctive therapy the dose of 10-15 mg per kilo per day, given through an IV, every 12 hours, infused over 1 hr. The maximum daily dose is 60 mg per kg per day. In the treatment of Simple & Complex Absence Seizures, the dose is 10-15 mg per kilo per day, given through an IV, every 12hours, infused over 1 hr. in the treatment of Migraine, the dose is 250 mg, taken orally every 12 hours and the dose adjusted as per the response. In the treatment of Bipolar Mania, the dose is 750 mg per day, taken orally in divided doses.

The price of Sodium Valproate

In the USA, the consumers have to pay between $26.80 – $154.71 for a supply of 50 (10 x 5 milliliters) of the injection. In India, the price of 10, 200 mg tablets is USD 0.75.

How does Sodium Valproate?

Valproate sodium gets converted into its active form valproate ion, in blood after ingestion. Although the mechanism of not fully known, it is understood that valproate sodium increases concentrations of gamma-aminobutyric acid (GABA) in the brain. It does this by inhibiting enzymes responsible for the catabolism of GABA. Its effects are exerted by acting on GABA levels in the CNS and by blocking voltage-gated ion channels. It also inhibits histone deacetylase.

Finding Sodium Valporate Manufacturers and Suppliers

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