Clobazam Dosing for Pediatric Seizures
The recommended dosage of clobazam for pediatric patients with seizures is 5 mg/day for patients ≤30 kg and 10 mg/day for patients >30 kg initially, titrating up to 20 mg/day and 40 mg/day respectively, administered in two divided doses for doses above 5 mg/day. 1
Dosing Guidelines Based on Weight
For children ≤30 kg:
- Initial dose: 5 mg/day
- Titration: Gradually increase as tolerated
- Maximum dose: 20 mg/day
- For doses >5 mg/day: Administer in two divided doses
For children >30 kg:
- Initial dose: 10 mg/day
- Titration: Gradually increase as tolerated
- Maximum dose: 40 mg/day
- For doses >5 mg/day: Administer in two divided doses
Alternative Weight-Based Dosing Approach
Research studies have demonstrated effective dosing based on mg/kg:
- Starting dose: 0.2-0.3 mg/kg/day 2
- Target dose: 0.5-0.8 mg/kg/day 2
- Maximum reported dose in clinical practice: Up to 2 mg/kg/day 3
- Mean effective dose in clinical studies: 0.7 mg/kg/day 4
Special Populations and Considerations
Age-Specific Considerations
- Clobazam is FDA-approved for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients 2 years of age or older 1
- Safety and efficacy in children under 2 years have not been well established
Dosage Adjustments
- Geriatric patients: Lower doses may be required 1
- Known CYP2C19 poor metabolizers: Dosage adjustment needed 1
- Hepatic impairment:
- Mild/moderate impairment: Dosage adjustment needed
- Severe impairment: No information available 1
Administration Guidelines
- Clobazam can be taken with or without food 1
- For oral suspension, measure the prescribed amount using an oral dosing syringe 1
- For doses above 5 mg/day, administer in two divided doses 1
Efficacy and Response Rates
- Clinical studies show 67.7% of pediatric patients with refractory epilepsy respond to clobazam treatment (≥50% reduction in seizure frequency) 2
- Complete seizure freedom has been reported in 28% of pediatric patients 2
- Efficacy has been demonstrated across various seizure types and epilepsy syndromes 5
Safety Profile and Adverse Effects
- Most common adverse reactions include:
- Most adverse effects are mild and transitory, with discontinuation due to adverse effects required in only 5-15% of patients 2, 4
- Monitor for signs of respiratory depression, especially when combined with opioids 1
Important Warnings and Precautions
- Concomitant use with opioids may result in profound sedation, respiratory depression, coma, and death 1
- Risk of abuse, misuse, and addiction exists with benzodiazepines including clobazam 1
- Abrupt discontinuation or rapid dosage reduction may precipitate acute withdrawal reactions 1
- Use a gradual taper to discontinue clobazam or reduce the dosage 1
- Monitor for central nervous system depression 1
- Watch for serious dermatological reactions (including Stevens-Johnson syndrome) 1
- Monitor for suicidal thoughts or behaviors 1
Long-term Considerations
- Tolerance may develop in approximately 9% of patients 5
- Long-term efficacy has been demonstrated, with benefits maintained for over one year in 85% of responders 6
- About 40-50% of patients continue clobazam treatment for 4 years or longer 5
Clobazam is a valuable adjunctive treatment for pediatric seizures with a favorable efficacy and safety profile. Following the weight-based dosing guidelines and monitoring for adverse effects will optimize outcomes in pediatric patients with seizures.