Description

Lamotrigine Tablets (25mg / 50mg / 100mg / 200mg)

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 Lamotrigine Tablets in India. Lamotrigine is a broad-spectrum Anticonvulsant and Mood Stabilizer. It is a first-line therapy for treating various types of Epilepsy (focal and generalized seizures) and is FDA-approved for the maintenance treatment of Bipolar I Disorder to delay the occurrence of mood episodes (depression, mania).

We offer Contract Manufacturing (Third Party) services for this critical CNS drug. Lamotrigine requires a very specific “slow titration” dosing schedule to prevent serious skin rashes. To support this, we manufacture a full range of strengths (25mg to 200mg) and can produce Dispersible / Chewable Tablets that are easy to administer, especially for children or elderly patients. Our WHO-GMP certified facility in Mumbai ensures strict adherence to quality standards, as consistency is vital for seizure control. Healthy Inc manages the export logistics, supplying neurology centers and psychiatric facilities across the USA, Europe, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Precision dosing for safe titration.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Dispersible Technology: Many patients (especially children) struggle to swallow tablets. We utilize Super-Disintegrants and masking agents (like blackcurrant or berry flavor) to create tablets that can either be chewed, swallowed whole, or dispersed in a spoon of water for easy administration.

  • Content Uniformity: Since patients often split tablets or take low doses (25mg) during the titration phase, we ensure rigorous blend uniformity so that every fragment contains the correct amount of drug.

  • Dissolution: We optimize the release profile to ensure consistent absorption, which is critical for maintaining steady blood levels and preventing breakthrough seizures.

• The Exporter: Healthy Inc

  • Starter Packs: We can support the packaging of “Starter Kits” (e.g., specific blister layouts) that guide the patient through the complex dosing schedule (25mg for 2 weeks, then 50mg, etc.), improving compliance and safety.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

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

• Impurity Profiling: We strictly monitor for related substances to ensure safety over the 3-year shelf life.

5. Why Use Lamotrigine?

It stabilizes the brain’s electrical activity.

• Mechanism: Lamotrigine works by blocking voltage-gated sodium channels. This stabilizes the neuronal membrane and inhibits the release of excitatory neurotransmitters (like glutamate), preventing the repetitive firing of neurons that causes seizures.

• Key Indications:

  • Epilepsy: Partial seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome.

  • Bipolar Disorder: Maintenance treatment to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes).

• Advantage: Unlike some older antiepileptics (like Valproate), Lamotrigine typically does not cause weight gain or sedation.

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).

7. Frequently Asked Questions

• Q: Who manufactures Lamotrigine Tablets?

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

• Q: Is it Lamictal?

  A: Lamictal is the brand name (GSK). We manufacture the Generic Equivalent (Lamotrigine), which is bioequivalent.

• Q: Why must I start with a low dose?

  A: To prevent a serious, life-threatening skin rash (Stevens-Johnson Syndrome). You must start low (usually 25mg) and increase slowly over weeks. Never start at a high dose.

• Q: Can I stop taking it suddenly?

  A: NO. Stopping suddenly can cause “rebound seizures.” You must taper off slowly under a doctor’s supervision.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Titration Schedule (Monotherapy):

  • Weeks 1-2: 25mg once daily.

  • Weeks 3-4: 50mg once daily.

  • Maintenance: 100mg to 200mg daily.

• (Note: Dosage is different if taking Valproate or Carbamazepine interaction).

• Administration: Swallow whole, chew, or disperse in water (if using the DT formulation).

9. Side Effects and Precautions

• Serious Rash: Black Box Warning: Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Stop immediately at the first sign of a rash.

• CNS: Dizziness, double vision (diplopia), ataxia (unsteadiness), and headache.

• Aseptic Meningitis: Rare risk of inflammation of the protective membranes of the brain.

• Suicidality: Monitor for worsening depression or suicidal thoughts (standard warning for all antiepileptics).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.