Clobazam Tablets

Description

Clobazam Tablets (5mg / 10mg / 20mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Clobazam Tablets in India. Clobazam is a 1,5-benzodiazepine with anticonvulsant and anxiolytic properties. It is used as adjunctive therapy for selected seizure disorders, including Lennox-Gastaut syndrome in jurisdictions where approved. Because Clobazam is a benzodiazepine and may be a controlled medicine, manufacturing, distribution and export are subject to applicable regulatory requirements.

2. Product Specifications

3. Manufacturing Technology

• Low-Dose Uniformity: Validated dispensing, blending and in-process controls support consistent active-ingredient distribution.
• Scored Presentations: Where registered as scored and suitable for splitting, score-line performance is evaluated according to applicable specifications.
• Dissolution: Formulation and compression parameters are controlled to achieve registered dissolution requirements.
• Controlled Supply: Manufacture, storage, distribution and export follow applicable controlled-medicine licenses and permits.

4. Quality Assurance

• Dissolution: Tested against applicable registered or pharmacopoeial requirements.
• Assay & Content Uniformity: Potency and dosage-unit uniformity are verified against approved specifications.
• Related Substances: Specified impurities and degradation products are monitored during release and stability testing.

5. Clobazam Pharmacology and Uses

Clobazam binds to benzodiazepine sites on GABA-A receptors and enhances inhibitory GABAergic neurotransmission, contributing to anticonvulsant effects. Sedation can still occur and individual response varies.

• Lennox-Gastaut Syndrome: Used as adjunctive therapy for seizures associated with LGS in approved markets.
• Other Epilepsies: May be used as add-on treatment for selected seizure disorders according to local indications and specialist assessment.
• Anxiety: In some jurisdictions Clobazam has an approved role in short-term management of severe anxiety; indications differ by country.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Controlled-Medicine Documentation: Export and import authorizations are handled only where legally required and appropriately licensed.
• Logistics: International shipment according to applicable controlled-drug requirements.

7. Frequently Asked Questions

Q: Who manufactures Clobazam Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Clobazam tablet formulations in India, subject to applicable regulatory permissions.

Q: Is Clobazam sold under different brand names?
A: Yes. Generic equivalence and interchangeability depend on the registered formulation and local regulatory requirements.

Q: Can Clobazam cause dependence?
A: Yes. Benzodiazepines can cause physical dependence. Abrupt discontinuation can cause serious withdrawal symptoms, including seizures, so dose reduction should be medically supervised.

Q: Can I drive while taking Clobazam?
A: It can cause sleepiness, slowed reaction time or impaired coordination. Do not drive or operate machinery until you know how it affects you.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Dose: Initiation, titration and maintenance depend on age, weight, indication, concomitant medicines and approved prescribing information.
• Pediatric Use: Must follow age/weight recommendations and restrictions in registered product information.
• Discontinuation: Do not stop abruptly after continued use; a clinician-directed gradual taper may be required.
• Administration: Follow the specific product instructions regarding food, splitting or crushing.

9. Side Effects and Precautions

• CNS: Somnolence, sedation, dizziness, ataxia and impaired coordination can occur.
• Dependence & Withdrawal: Physical dependence can develop; rapid reduction or abrupt discontinuation can cause serious withdrawal reactions.
• Respiratory Depression: Combining benzodiazepines with opioids, alcohol or other CNS depressants can cause profound sedation and dangerous respiratory depression.
• Serious Skin Reactions: Rare SJS/TEN have been reported. Significant rash or mucosal lesions require urgent medical assessment.
• Interactions: Cannabidiol can increase exposure to Clobazam's active metabolite and may require monitoring or dose adjustment.

10. Storage Instructions

• Store below 25°C in a dry place.
• Protect from excessive heat and moisture.
• Keep in the original packaging.
• Keep strictly out of reach of children.