Topalex Tablets Range 25 mg; 50 mg; 100 mg Tablets
PDF Leaflet Revision Date: 03 May 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Indicated for epilepsy as monotherapy or adjunctive therapy.
Dosage (summary)
Adults: Start at 25 mg nightly, titrate to 100-500 mg/day. Children: Start at 0.5-1 mg/kg nightly, titrate to 100-400 mg/day.
Special Populations
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Teratogenic in animals; potential fetal harm in humans. Use only if benefits outweigh risks.
Key Drug Interactions
- Phenytoin may increase plasma concentrations
- Carbamazepine decreases plasma concentrations
- Valproic acid may cause hyperammonemia
Contraindications
- Hypersensitivity to any component
- Children under 2 years
Common side effects
- Anorexia
- Dizziness
- Somnolence
- Depression
- Weight decreased
Counselling Points
- Monitor for mood changes
- Ensure adequate hydration
- Avoid abrupt withdrawal
Serious warnings
- Risk of metabolic acidosis
- Risk of nephrolithiasis
- Risk of serious skin reactions
Important Disclaimer
The Topalex Tablets Range 25 mg; 50 mg; 100 mg Tablets professional information leaflet below is the property of Janssen Pharmaceutica 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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