Description

Clonazepam Tablets (0.25mg / 0.5mg / 1mg / 2mg)

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 Clonazepam Tablets in India. Clonazepam is a potent, long-acting Benzodiazepine widely prescribed for the control of Epilepsy (specifically Lennox-Gastaut syndrome, akinetic, and myoclonic seizures) and the treatment of Panic Disorder. It is distinguished by its strong anticonvulsant and anxiolytic properties with a prolonged duration of action.

We offer Contract Manufacturing (Third Party) services for this controlled psychotropic medication. Clonazepam is effective at very low doses (micrograms to low milligrams). Our WHO-GMP certified facility in Mumbai utilizes high-precision Geometric Blending and automated weight control systems to ensure absolute content uniformity. We also manufacture Mouth Dissolving Tablets (MDT), which are crucial for administering medication to patients during a seizure or to children who cannot swallow whole tablets. Healthy Inc manages the secure export logistics, holding the necessary licenses to supply regulated markets across the Americas, Europe, and Asia.

2. Product Specifications

3. Manufacturing Technology

Precision dosing for critical care.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Mouth Dissolving Technology (MDT): We utilize a specialized super-disintegrant matrix that allows the tablet to dissolve on the tongue within 30 seconds without water. This is a lifesaving feature for epileptic patients who may be unable to swallow during a seizure event or post-ictal state.

  • Micronization: Clonazepam has poor water solubility. We use Micronized API to increase the surface area, ensuring rapid and consistent absorption in the bloodstream.

  • Content Uniformity: Since a 0.5mg dose is tiny compared to the tablet weight, we use validated mixing protocols to ensure the active drug is evenly distributed, preventing dangerous dose variations.

• The Exporter: Healthy Inc

  • Controlled Logistics: As a psychotropic substance, Clonazepam requires specific export permits. We handle all Narcotics Commissioner clearances and secure freight requirements for our partners.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes (or <1 min for MDT).

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for degradation impurities (Aminoclonazepam) to ensure safety.

5. Why Use Clonazepam?

Stabilizing the electrical storm in the brain.

• Mechanism: Clonazepam binds to the Benzodiazepine Site on the GABA-A receptor. This binding increases the frequency of chloride channel opening, enhancing the effect of GABA (the brain’s primary inhibitory neurotransmitter). This hyperpolarizes neurons, making them resistant to the rapid, repetitive firing that characterizes a seizure or panic attack.

• Key Indications:

  • Epilepsy: Lennox-Gastaut Syndrome, Absence Seizures (Petit Mal), and Myoclonic Seizures.

  • Panic Disorder: Treatment of panic attacks with or without agoraphobia.

  • Movement Disorders: Akathisia and Restless Legs Syndrome (Off-label).

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF) with Psychotropic Export Licenses.

7. Frequently Asked Questions

• Q: Who manufactures Clonazepam Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Klonopin or Rivotril?

  A: Klonopin (Roche/Genentech) and Rivotril (Roche) are brand names. We manufacture the Generic Equivalent (Clonazepam).

• Q: Is it addictive?

  A: Yes. It is a controlled substance with a risk of abuse and dependence. It should be used for the shortest duration possible and tapered off slowly.

• Q: Can I drink alcohol with it?

  A: NEVER. Combining Clonazepam with alcohol can cause extreme sedation, respiratory depression, coma, or death.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Seizure Disorders: Adults start 1.5mg daily (divided doses). Increase by 0.5mg every 3 days. Max 20mg/day.

• Panic Disorder: Start 0.25mg twice daily. Target dose 1mg/day.

• Pediatrics: Weight-based dosing (Initial 0.01-0.03 mg/kg/day).

• Administration: Swallow whole or dissolve MDT on tongue.

9. Side Effects and Precautions

• CNS: Drowsiness, dizziness, coordination problems (ataxia), memory impairment.

• Respiratory: Caution in patients with COPD or sleep apnea (can depress breathing).

• Paradoxical Reaction: Rarely causes aggression or excitability (especially in children/elderly).

• Withdrawal: Warning: Abrupt discontinuation can cause status epilepticus (non-stop seizures). Must be tapered.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep strictly out of reach of children.