Description
Sodium Valproate Tablets
Healthy Inc is a specialized global supplier and exporter of broad-spectrum antiepileptics and mood stabilizers. We provide high-stability Sodium Valproate Tablets (Enteric Coated & CR), sourced from WHO–GMP certified solid dosage facilities. This “Seizure Controller” is a top export to neurology institutes, psychiatric wards, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the first-line therapy for generalized epilepsy and Bipolar Disorder.
Product Overview
This formulation contains Sodium Valproate, often combined with Valproic Acid in controlled-release formats.
The “Broad-Spectrum” Specialist:
- Mechanism (GABA Booster): Valproate works primarily by inhibiting the enzyme GABA transaminase, which breaks down GABA (gamma-aminobutyric acid). By stopping this breakdown, it increases the concentration of GABA, the brain’s main inhibitory neurotransmitter.
- Mechanism (Ion Channels): It also blocks voltage-gated sodium channels and T-type calcium channels. This multi-modal action suppresses high-frequency repetitive neuronal firing.
- The “Universal” Antiepileptic: Unlike Carbamazepine or Phenytoin (which can worsen absence seizures), Valproate is effective against all seizure types: Absence, Tonic-Clonic, Myoclonic, and Atonic seizures.
- Mood Stabilization: It is highly effective in controlling acute mania in Bipolar Disorder by dampening the “kindling” effect in the limbic system.
Product Composition & Strength
We supply this product as Gastro-Resistant (Enteric Coated) Tablets or Controlled Release (CR/Chrono) Tablets. The coating is critical to prevent gastric irritation and ensure sustained drug levels.
| Active Ingredient | Strength (Standard) | Therapeutic Role | |
|---|---|---|---|
| Sodium Valproate USP/BP | 200 mg (EC) | Pediatric / Initiation | |
| Sodium Valproate USP/BP | 300 mg (CR) | Maintenance / Bipolar | |
| Sodium Valproate + Valproic Acid | 500 mg (CR/Chrono) | High Dose / Once Daily | |
| Excipients | Q.S. | Methacrylic Acid Copolymer / Talc | Enteric Coating Polymer |
*Pack Sizes: Blister packs of 10s (Box of 10×10), 30s, 50s, or Bulk HDPE Jars of 500s.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Tablet (Enteric Coated / Controlled Release) |
| Packaging | Alu-Alu Blister (Highly Hygroscopic) |
| Storage | Store below 25°C. Protect strictly from Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Hygroscopicity Management: Sodium Valproate is extremely deliquescent (turns to liquid by absorbing moisture from air). Our manufacturing suites operate at < 20% Relative Humidity, and we use high-barrier Cold Form Alu-Alu packaging to prevent the tablets from becoming soft or sticky.
- Release Profile: Our CR (Chrono) technology ensures a steady release over 24 hours, flattening the peak-trough fluctuations. This reduces side effects (tremors) and allows for once-daily dosing, improving compliance.
Therapeutic Indications (Human Use)
Indicated for the treatment of generalized and partial epilepsies and mood disorders:
- Epilepsy: Primary generalized epilepsy (absence, myoclonic, tonic-clonic, atonic), partial epilepsy, and Lennox-Gastaut syndrome.
- Bipolar Disorder: Treatment of acute manic or mixed episodes associated with Bipolar I Disorder.
- Migraine Prophylaxis: Prevention of migraine headaches in adults (off-label in some regions, approved in others).
Dosage & Administration
Recommended Dosage (Strictly as per Neurologist):
- Route: Oral.
- Epilepsy (Adults): Start with 600 mg daily in divided doses. Increase by 200 mg every 3 days until control is achieved (maintenance 1000 mg – 2000 mg/day).
- Bipolar Mania: Start with 750 mg daily in divided doses. Max 60 mg/kg/day.
- Administration: Swallow whole. DO NOT CRUSH OR CHEW. Crushing destroys the enteric/matrix coating, leading to severe gastric pain and immediate release of the drug. Take with food to reduce nausea.
Safety Warnings:
- Hepatotoxicity (BLACK BOX WARNING): Fatal liver failure has occurred, usually in the first 6 months. High risk in children < 2 years on polytherapy. Monitor LFTs regularly.
- Teratogenicity (BLACK BOX WARNING): MAJOR CONGENITAL MALFORMATIONS. Causes Neural Tube Defects (Spina Bifida) and cognitive impairment in the fetus (IQ drop). Contraindicated in pregnancy unless no other option exists. Women of childbearing age must use effective contraception (Valproate Pregnancy Prevention Program).
- Pancreatitis: Life-threatening hemorrhagic pancreatitis can occur. Stop immediately if severe abdominal pain and vomiting develop.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for OSD (Oral Solid Dosage) forms, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
