Description
Clobazam Tablets
Healthy Inc is a specialized global supplier and exporter of advanced anti-epileptic drugs (AEDs). We provide high-purity Clobazam Tablets, sourced from WHO–GMP certified solid dosage facilities. This “1,5-Benzodiazepine” is a top export to neurology centers, epilepsy clinics, and pediatric hospitals in Africa, LATAM, and Southeast Asia, recognized as the preferred adjunctive therapy for refractory epilepsy, particularly Lennox-Gastaut Syndrome (LGS).
Product Overview
This formulation contains Clobazam, a unique benzodiazepine derivative.
The “Less Sedating” Specialist:
- Structural Advantage (1,5 vs 1,4): Unlike classic benzodiazepines (like Diazepam or Lorazepam) which have a 1,4-nitrogen arrangement, Clobazam has a 1,5-benzodiazepine structure. This structural difference makes it more selective for the specific GABA receptors involved in seizure control, while having significantly less affinity for the receptors that cause sedation and cognitive impairment.
- Mechanism: It acts as a positive allosteric modulator of the GABA-A receptor. By binding to the benzodiazepine site, it enhances the influx of chloride ions, hyperpolarizing the neuron and raising the seizure threshold.
- Add-On Therapy: It is the “Gold Standard” add-on drug for patients whose seizures are not controlled by standard AEDs (like Valproate or Carbamazepine), especially in complex pediatric syndromes.
- Tolerance Profile: While tolerance can develop, clinical data suggests Clobazam maintains its anti-seizure efficacy longer than standard benzodiazepines.
Product Composition & Strength
We supply this product as Uncoated Tablets (Scored). The score line is critical for precise titration, especially in pediatric patients.
| Active Ingredient | Strength (Standard) | Primary Role |
|---|---|---|
| Clobazam USP/BP | 5 mg | Pediatric Initiation / Titration |
| Clobazam USP/BP | 10 mg | Standard Maintenance |
| Clobazam USP/BP | 20 mg | High Dose / Adult Refractory |
| Excipients | Q.S. | Lactose / Maize Starch / Talc |
*Pack Sizes: Blister packs of 10s (Box of 10×10), 30s, or Bulk HDPE Jars of 1000s (Hospital Packs).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Psychotropic Substances – Check Local Regs) |
| Dosage Form | Tablet (Oral) |
| Packaging | PVC-Alu Blister or Alu-Alu Blister |
| Storage | Store below 25°C. Keep out of reach of children. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate (Psychotropic Permit may be required). |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Dissolution Consistency: Clobazam is often used in rescue situations or strict maintenance. We ensure rapid dissolution (>85% in 30 mins) to guarantee consistent bioavailability.
- Scoring Precision: The tablets are engineered with a functional score line (snap-tab) to allow for easy breaking into equal halves (e.g., 2.5mg from a 5mg tablet) for pediatric dosing accuracy.
Therapeutic Indications (Human Use)
Indicated for the management of severe anxiety and epilepsy:
- Epilepsy (Adjunctive Therapy): Treatment of partial seizures and generalized tonic-clonic seizures.
- Lennox-Gastaut Syndrome (LGS): Highly effective adjunctive treatment for seizures associated with LGS in patients 2 years of age or older.
- Anxiety (Acute): Short-term relief of severe, disabling anxiety (limited to 2-4 weeks to prevent dependence).
Dosage & Administration
Recommended Dosage (Strictly as per Neurologist):
- Route: Oral.
- Epilepsy (Adults): Start with 5-15 mg/day. Increase gradually to a maximum of 60 mg/day (rarely 80 mg).
- Epilepsy (Pediatrics > 2 years): Dose is based on body weight (mg/kg). Usually started at 5 mg daily and titrated up.
- Anxiety: 20-30 mg daily in divided doses.
- Withdrawal: NEVER stop abruptly. Must be tapered off over weeks or months to avoid rebound seizures (Status Epilepticus).
Safety Warnings:
- Skin Reactions (SJS/TEN): FDA Warning: Rare but serious skin reactions (Stevens-Johnson Syndrome) can occur. Discontinue immediately if rash appears.
- Sedation: Although less than Diazepam, it can still cause drowsiness. Caution with driving.
- Concomitant Use with Opioids: Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
- Dependence: Risk of physical and psychological dependence with long-term use.
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.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in











