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lamotrigine

LAMOTRIGINE CHEWABLE DISPERSIBLE

Manufacturer: Alembic Pharmaceuticals Limited

Score: 148.0

Quick Summary

Lamotrigine is an antiepileptic drug used for the treatment of partial-onset seizures, generalized seizures of Lennox-Gastaut syndrome, and primary generalized tonic-clonic seizures in patients with epilepsy. It is also used as a maintenance treatment for bipolar I disorder to delay the occurrence of mood episodes. The drug has a risk of serious skin rashes, including Stevens-Johnson syndrome, and patients should be closely monitored for signs of rash. The recommended initial dose and subsequent dose escalations should not be exceeded, and the drug should be discontinued at the first sign of rash unless it is clearly not drug-related.

Key Clinical Findings and Indications

  • Treatment of partial-onset seizures, generalized seizures of Lennox-Gastaut syndrome, and primary generalized tonic-clonic seizures in patients with epilepsy
  • Maintenance treatment for bipolar I disorder to delay the occurrence of mood episodes

Important Safety Information

Warning

Risk of serious skin rashes, including Stevens-Johnson syndrome

Contraindications

  • Hypersensitivity to the drug or its ingredients

Adverse Reactions

  • Dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, pharyngitis, and rash

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on concomitant medications, renal or hepatic impairment, and pregnancy status

Epilepsy

Adult Dose

25 mg every other day, increasing to 50 mg/day over 4 weeks

Pediatric Dose

0.15 mg/kg/day, increasing to 0.3 mg/kg/day over 4 weeks

Bipolar disorder

Adult Dose

25 mg every other day, increasing to 100 mg/day over 4 weeks

Pediatric Dose

Not recommended

Special Population Considerations

Pregnancy

  • Category C: risk of fetal harm cannot be ruled out
  • Dose adjustments may be necessary during pregnancy

Nursing Mothers

  • Lamotrigine is present in breast milk, and caution should be exercised when administering to nursing mothers

Pediatric Use

  • Approved for use in patients aged 2 years and older with epilepsy
  • Not recommended for use in pediatric patients with bipolar disorder

Geriatric Use

  • Dose selection should be cautious, starting at the low end of the dosing range

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