Sabril Tablets 500 mg FC tablets

Sabril Tablets 500 mg FC tablets

S3
PDF Leaflet Revision Date: 16 March 2023

API: Vigabatrin | Company: Sanofi-Aventis

Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of resistant partial epilepsy.

Dosage (summary)

Starting dose: 1 g/day (2 tablets), max 3 g/day.

Special Populations

  • Elderly
  • Renal impairment

Pregnancy & Breastfeeding

Contraindicated in pregnancy and lactation due to teratogenicity.

Key Drug Interactions

  • Clonazepam may exacerbate sedation.

Contraindications

  • Hypersensitivity to vigabatrin
  • Pregnancy
  • Lactation
  • Renal impairment (creatinine clearance < 60 mL/min)

Common side effects

  • Visual field defects
  • Sedation
  • Fatigue
  • Dizziness

Counselling Points

  • Regular ophthalmological exams required
  • Report any visual changes immediately
  • Gradual withdrawal recommended to avoid rebound seizures

Serious warnings

  • Risk of irreversible visual field defects
  • Monitor for psychiatric symptoms
Important Disclaimer

The Sabril Tablets 500 mg FC tablets professional information leaflet below is the property of Sanofi-Aventis and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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