Oxcarbazepine Tablets (150 mg / 300 mg / 600 mg)
Healthy Inc is a premier global supplier of high-precision neurological therapies. We provide premium Oxcarbazepine Tablets, manufactured in WHO–GMP certified specialized neuro-psychiatric production units. As a first-line monotherapy and adjunctive treatment for partial seizures, this product is a vital export for neurology institutes, psychiatric hospitals, and Ministry of Health (MOH) tenders in Southeast Asia, Africa, and the CIS region.
Product Overview
Oxcarbazepine is an anticonvulsant and mood-stabilizing agent. It is structurally a keto-derivative of carbamazepine but with a distinct metabolic pathway that bypasses the formation of toxic epoxide metabolites, offering an improved tolerability profile for long-term seizure management.
The “Voltage-Gated” Neuro Specialist:
- Mechanism of Action: Oxcarbazepine acts primarily by blocking voltage-gated sodium channels. This stabilizes hyperexcited neuronal membranes, inhibits repetitive neuronal firing, and reduces the propagation of synaptic impulses, effectively preventing seizure activity.
- Rapid Pro-Drug Conversion: Upon ingestion, Oxcarbazepine is rapidly reduced by cytosolic enzymes in the liver to its active metabolite, MHD (10-monohydroxy derivative). It is this metabolite that exerts the primary anticonvulsant effect.
- Dual Indication: While primarily used for epilepsy, it is also widely utilized off-label for the management of Bipolar Disorder and trigeminal neuralgia due to its potent nerve-stabilizing properties.
Technical & Manufacturing Specifications
Formulated for absolute content uniformity and predictable pharmacokinetic release.
| Technical Metric | Specification Standard |
|---|---|
| Active Ingredient | Oxcarbazepine BP / USP / IP |
| Dosage Form | Film-Coated Tablets |
| Available Strengths | 150 mg, 300 mg, 600 mg |
| HS Code | 3004.90.99 (Medicaments) / 2933.99.00 |
| Packaging | Alu-Alu Blister (Optimized for moisture protection) |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from ISO 9001:2015 certified units.
- Micronization Technology: Oxcarbazepine has low aqueous solubility. We utilize advanced micronization of the API to ensure rapid and consistent dissolution, which is critical for maintaining steady-state plasma concentrations in epileptic patients.
- Epoxide-Free Profile: Our manufacturing process ensures high purity levels, specifically monitoring for impurities to ensure the superior side-effect profile that distinguishes Oxcarbazepine from older anticonvulsants.
- Stability Validation: Validated for Zone IVb (40°C / 75% RH). Our specialized film-coating prevents tablet brittle-breakage and chemical degradation in hot and humid export markets.
Therapeutic Indications & Clinical Symptoms
- Partial Seizures: Treatment of focal seizures with or without secondary generalization in adults and children.
- Epilepsy Monotherapy: Used as a standalone treatment for newly diagnosed patients.
- Bipolar Disorder: Mood stabilization in patients resistant to lithium or valproate.
- Neuropathic Pain: Management of chronic nerve pain and trigeminal neuralgia.
Dosage & Administration
- Adults: Initial dose of 300 mg twice daily, titrated upwards based on clinical response.
- Pediatrics: Dosing is weight-based (typically 8–10 mg/kg/day).
- Safety Note: Monitor for Hyponatremia (low sodium levels), especially in elderly patients. Do not discontinue abruptly due to the risk of status epilepticus.
Global Export & Contract Manufacturing Services
Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to Psychiatric Hospitals and National Health Ministries. We offer Third Party Manufacturing for Oxcarbazepine with full CTD Dossier and COPP support. Our logistics network ensures secure transit to Vietnam, Nigeria, Uzbekistan, and the Philippines, providing WHO-GMP quality at competitive B2B prices.