Recommended Clobazam Dosing in Pediatric Patients
The recommended dosing of clobazam for pediatric patients should be based on body weight, with children ≤30 kg starting at 5 mg daily and titrating up to 20 mg daily, while children >30 kg should start at 10 mg daily and titrate up to 40 mg daily. 1
Initial Dosing and Titration
For children weighing ≤30 kg:
- Starting dose: 5 mg daily
- Day 7: Increase to 10 mg daily
- Day 14: Increase to 20 mg daily (maximum dose) 1
For children weighing >30 kg:
- Starting dose: 10 mg daily
- Day 7: Increase to 20 mg daily
- Day 14: Increase to 40 mg daily (maximum dose) 1
Daily doses greater than 5 mg should be administered in two divided doses, while a 5 mg daily dose can be given as a single dose 1
Do not increase the dose more rapidly than weekly, as clobazam and its active metabolite require 5 and 9 days, respectively, to reach steady-state 1
Special Populations and Considerations
For CYP2C19 poor metabolizers:
- Start with 5 mg/day for all patients
- Titrate slowly to half the recommended dose in Table 1, as tolerated 1
For elderly patients (although less relevant to pediatrics):
- Use lower starting doses and slower titration due to higher plasma concentrations 1
For children with epileptic encephalopathy:
- Starting doses of 0.2 mg/kg/day (range 0.13-0.33 mg/kg/day) with target doses of 0.48 mg/kg/day (range 0.26-0.80 mg/kg/day) have been used effectively 2
Administration Guidelines
- Clobazam oral suspension can be taken with or without food 1
- Shake the oral suspension well before every administration 1
- Use only the provided oral dosing syringe to ensure accurate dosing 1
- Slowly squirt the medication into the corner of the patient's mouth 1
Efficacy and Safety Profile
- Clobazam has shown good efficacy in pediatric refractory epilepsy, with response rates (≥50% seizure reduction) of 67.7% in some studies 2
- Complete seizure freedom has been reported in 28% of pediatric patients 2
- Common adverse effects include:
Discontinuation Protocol
- To reduce the risk of withdrawal reactions, seizure frequency increases, or status epilepticus, use a gradual taper 1
- Decrease the total daily dose by 5-10 mg/day on a weekly basis until discontinued 1
- If withdrawal reactions occur, consider pausing the taper or returning to the previous dosage level before continuing with a slower taper 1
Monitoring and Precautions
- Monitor for central nervous system depression, especially when used with other CNS depressants 1
- Watch for serious dermatological reactions and discontinue at first sign of rash unless clearly not drug-related 1
- Monitor for suicidal thoughts or behaviors, as with other antiepileptic drugs 1
- Be aware of potential for abuse, misuse, and addiction; assess risk before prescribing and throughout treatment 1
Clobazam has demonstrated effectiveness in various pediatric epilepsy syndromes, with particularly good evidence for Lennox-Gastaut syndrome, for which it is FDA-approved in patients 2 years of age or older 1, 3.