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Lamotrigine Tablets product image

Lamotrigine Tablets IP

Composition: Each uncoated tablet contains Lamotrigine IP 25 mg.

Usage: Prevention and control of certain seizures, as prescribed.

Category: Antiepileptic drugs

Therapeutic category: Anticonvulsant / Antiepileptic

SKU: Lamotrigine Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Lamotrigine Tablets IP is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Lamotrigine Tablets (25 mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (company-supplied)

Exported by: Healthy Inc (company-supplied)

1. Product Introduction

Lamotrigine Tablets IP 25 mg contain lamotrigine, an anticonvulsant used to treat certain seizure disorders. Lamotrigine is also approved in some markets for maintenance treatment of bipolar I disorder. Its use requires individual dose titration and monitoring for serious skin reactions.

Healthy Life Pharma Pvt. Ltd. is identified as manufacturer and Healthy Inc as exporter in the supplied company description. Contract manufacturing, regulatory status and product availability should be confirmed with the company.

2. Product Specifications

Product nameLamotrigine Tablets IP
CompositionEach uncoated tablet contains Lamotrigine IP 25 mg
Other strengths mentioned50 mg, 100 mg, 200 mg — availability and approved compositions require confirmation
CAS number84057-84-1
Dosage formUncoated oral tablet (confirmed); dispersible/chewable options not confirmed
Therapeutic classAntiepileptic / anticonvulsant; mood stabilizer in approved indications
StandardIP for supplied 25 mg composition
Shelf life / packagingAs per approved stability data and packaging specification

3. Manufacturing Technology

Lamotrigine tablet manufacturing requires careful controls for ingredient identification, blend uniformity, tablet weight, compression, disintegration and dissolution. Packaging and moisture protection should be validated for the intended market. Details such as direct compression, proprietary disintegrants, flavors and starter packs are formulation-specific and require confirmation.

Tablet splitting should only be done where the approved product label permits it; content uniformity of a whole tablet does not establish dose uniformity of split fragments.

4. Quality Assurance

Quality testing may include identity, assay, content uniformity, dissolution, related substances and stability. Acceptance criteria must follow the applicable registered specification and pharmacopoeial monograph. Exact dissolution thresholds, shelf life and manufacturing certifications should be supported by current documentation.

5. Pharmacology and Clinical Use

Lamotrigine affects voltage-sensitive sodium channels and reduces release of excitatory neurotransmitters. Depending on age, seizure type and local approval, it may be used for focal seizures, primary generalized tonic-clonic seizures and seizures associated with Lennox–Gastaut syndrome. It may also be used for maintenance treatment of bipolar I disorder in certain jurisdictions; it is not established as an acute treatment for mania.

Choice of therapy and regimen depend on diagnosis, concomitant medicines and patient-specific factors.

6. Export and Regulatory Support

For B2B inquiries, ask for the current product specification, Certificate of Analysis, stability data, approved artwork and relevant registration documents. CTD/ACTD dossiers, COPP, FSC, WHO-GMP certification, bioequivalence data and export authorization must be confirmed for the product and destination market before being represented as available.

7. Frequently Asked Questions

Q: What is the confirmed strength?
A: The supplied composition confirms Lamotrigine IP 25 mg per uncoated tablet.

Q: Is Lamotrigine used for epilepsy?
A: Yes, for selected seizure disorders under medical supervision.

Q: Why is the dose increased slowly?
A: Excessive starting doses or rapid escalation can increase the risk of serious rash. The schedule depends strongly on interacting medicines.

Q: Can I stop it suddenly?
A: Do not stop or restart treatment without medical guidance; abrupt withdrawal may increase seizure risk, and restarting after an interruption may require re-titration.

Q: Are 50 mg, 100 mg and 200 mg available?
A: These strengths are mentioned in the supplied description but have not been verified as marketed variants.

8. Dosage and Administration

Individualized titration is essential. Starting dose and escalation differ substantially when taking valproate, enzyme-inducing antiseizure medicines or estrogen-containing hormonal contraceptives. Do not follow a universal 25 mg starter schedule without a clinician’s instructions. Use only the approved tablet form as directed; an uncoated standard tablet should not be assumed to be chewable or dispersible.

Missed doses, interruptions and any plan to discontinue require advice from the prescribing clinician.

9. Side Effects and Precautions

Serious skin reactions: Lamotrigine can cause Stevens–Johnson syndrome and toxic epidermal necrolysis, especially during early treatment or with inappropriate titration. Seek urgent medical assessment for a new rash, particularly with fever, mouth sores, facial swelling or systemic symptoms; do not restart unless a clinician explicitly advises it.

Other possible effects include dizziness, headache, nausea, blurred or double vision and problems with coordination. Rare but serious risks include aseptic meningitis, blood disorders, hypersensitivity reactions, suicidal thoughts and certain cardiac conduction concerns in susceptible patients. Discuss pregnancy, breastfeeding, interacting medicines and contraception with a healthcare professional.

10. Storage Instructions

Keep in the original packaging, protected from excess moisture, heat and light, following the storage conditions on the approved label. Keep out of reach of children.