Description
Lamotrigine Tablets / Dispersible Tablets (25 mg / 50 mg / 100 mg / 200 mg)
Healthy Inc is a specialized global supplier and exporter of advanced neurology, psychiatry, and high-precision neuro-stabilizing therapeutics. We provide ultra-high-purity, kinetically precise Lamotrigine Film-Coated / Dispersible Tablets (25 mg / 50 mg / 100 mg / 200 mg), manufactured in WHO–GMP certified, highly regulated oral solid dosage facilities. This “Voltage-Gated Sodium Channel Antagonist” is a massive-volume, critically mandated export to neurology centers, psychiatric hospitals, pediatric epilepsy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the gold-standard intervention for both refractory Epilepsy syndromes and the maintenance of Bipolar I Disorder.
Product Overview
This highly advanced formulation operates as an electrochemical “surge protector” for the human brain. By stabilizing hyperactive nerve membranes, it simultaneously stops the violent electrical storms that cause seizures and corrects the chemical imbalances that drive severe bipolar depression.
The “Glutamate Blocker & Bipolar Anchor” Specialist:
- Mechanism 1 (The Sodium Channel Blockade): In epileptic patients, neurons fire too rapidly, creating a runaway electrical loop. Lamotrigine aggressively binds to voltage-gated sodium channels in their inactive state. This significantly delays the time it takes for the neuron to “reset” and fire again, physically breaking the seizure loop without causing massive central nervous system sedation.
- Mechanism 2 (Glutamate Inhibition): By blocking the sodium channels, Lamotrigine directly inhibits the presynaptic release of glutamate, the brain’s primary excitatory neurotransmitter. Floods of glutamate are deeply implicated not just in seizures, but in the severe mood dysregulation seen in bipolar patients.
- Mechanism 3 (The Bipolar Depression Lifeline): While manic episodes are dangerous, the depressive crashes of Bipolar I Disorder are frequently lethal (suicide). Most traditional antidepressants (SSRIs) are banned for bipolar patients because they trigger violent manic flips. Lamotrigine is unique: it specifically delays the onset of depressive episodes and lifts the patient out of the crash, acting as the ultimate, safe maintenance therapy for bipolar depression.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Neurology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Neurology/Antiepileptics) |
| CAS Number | 84057-84-1 (Lamotrigine) |
| Dosage Form | Film-Coated Tablet / Dispersible Tablet (DT) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Protects the delicate superdisintegrant matrix from environmental humidity across Zone IVb tropical climates. (Titration starter packs strongly recommended for regulatory approval). |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Titration Compliance & Dispersible Engineering (CRITICAL COMPLIANCE): The commercial viability of Lamotrigine hinges entirely on safe dose initiation. If a patient is given a 100mg tablet on Day 1, they face a high risk of catastrophic skin failure. Our facilities utilize advanced packaging technology to offer color-coded, day-by-day Titration Kits (e.g., 25mg every other day, then 25mg daily, etc.). Furthermore, our Dispersible Tablets (DT) utilize premium taste-masking to ensure high compliance in pediatric epilepsy wards, giving your distributors a massive edge in institutional tenders.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of severe neurological and psychiatric disorders:
- Epilepsy (Adjunctive or Monotherapy): Treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and the severe, difficult-to-treat seizures of Lennox-Gastaut Syndrome in patients aged 2 and older.
- Bipolar I Disorder: Maintenance treatment to delay the time to occurrence of mood episodes (specifically depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy.
Dosage & Administration
Recommended Dosage (Strictly as per Neurologist / Psychiatrist Guidelines):
- The Titration Mandate (FATAL WARNING): Dosing MUST start extremely low (e.g., 25 mg daily or every other day) and increase slowly over 4 to 6 weeks to the maintenance dose (100 mg to 400 mg daily).
- The Valproate Interaction (CRITICAL): If a patient is concurrently taking Valproate (Depakote), the Valproate violently inhibits the liver’s ability to clear Lamotrigine. The Lamotrigine dose must be drastically cut in half, starting at just 25 mg every other day.
- The Carbamazepine Interaction: If a patient is taking enzyme-inducing drugs (like Carbamazepine or Phenytoin), they chew through Lamotrigine rapidly. The Lamotrigine dose must frequently be doubled to achieve clinical effect.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Serious Skin Rashes – SJS/TEN): Lamotrigine can cause severe, life-threatening rashes, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which cause the skin to blister and peel off. The risk is massively elevated by rapid dose escalation, concurrent Valproate use, or pediatric administration. Any patient developing a rash must stop the drug and seek immediate emergency care.
- BLACK BOX WARNING (Hemophagocytic Lymphohistiocytosis – HLH): A rare but highly fatal immune system overactivation syndrome. Symptoms include persistent high fever, enlarged liver/spleen, and massive inflammation.
- Aseptic Meningitis: Rare but severe risk of brain inflammation (meningitis) causing severe headache, fever, and stiff neck.
- Suicidal Behavior: Like all antiepileptic drugs (AEDs), it increases the risk of suicidal thoughts or behavior. Psychiatric monitoring is required.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Neuro-Psychiatry Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Anticonvulsants, Mood Stabilizers, and Dispersible Pediatric Formulations. Whether you are looking for a reliable Government Tender Supplier for epilepsy clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.








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