At your WHO-GMP facility in Mumbai, you likely manufacture this in 25 mg, 50 mg, 100 mg, and 200 mg strengths, including Dispersible/Chewable tablets which are often preferred for better absorption and patient compliance.

Gastrointestinal Side Effects

Diarrhea occurs in approximately 5% to 7% of patients taking Lamotrigine. It is usually mild and often resolves as the body adjusts to the medication.

• Common GI Symptoms: Nausea and vomiting are more frequent than diarrhea, occurring in up to 15% of patients.

• Abdominal Pain: Some patients report generalized stomach discomfort or dyspepsia.

• Dose-Dependency: GI side effects are sometimes associated with rapid dose escalation; this is why a “slow titration” schedule is clinically mandatory.

Mechanism: Why GI Issues Occur

Direct Mucosal Irritation: Like many oral medications, the chemical properties of the tablet can cause local irritation to the gastric and intestinal lining.

Serotonin Modulation: While Lamotrigine primarily blocks voltage-gated sodium channels to stabilize neuronal membranes, it also has secondary effects on neurotransmitters like serotonin, which play a major role in gut motility.

Microbiome Alteration: In some cases, AEDs can slightly shift the gut flora, leading to temporary changes in bowel habits.

The Pharmacist’s “Technical Warning”

As you build your firm’s digital authority, you must distinguish between minor GI issues and serious reactions:

• The “Lamotrigine Rash”: If diarrhea is accompanied by a fever, swollen lymph nodes, or any skin rash, it may be a sign of Stevens-Johnson Syndrome (SJS) or DRESS syndrome. This is a medical emergency.

• Aseptic Meningitis: Rarely, Lamotrigine can cause inflammation of the brain lining; symptoms include fever, nausea, and a stiff neck.

• Slow Titration: To minimize both GI side effects and the risk of a serious rash, the dose must be increased very slowly over a period of 6 to 8 weeks.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

• The “Dispersible” USP: On your marketplace, highlight your Dispersible/Chewable tablets. These are highly sought after in international markets because they can be dissolved in water, reducing the direct contact time of a solid bolus with the stomach lining, potentially lowering GI upset.

• Stability & Packaging: Lamotrigine is sensitive to moisture. Utilizing Alu-Alu blister packaging is essential for maintaining a 36-month shelf life during export to Zone IVb regions.

• FDC Potential: While Lamotrigine is usually monotherapy, B2B buyers often look for suppliers who also carry Valproate or Carbamazepine, though these require strict “Interaction Warnings” in your product dossiers.

• Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international neurology tenders.