Please check your internet connection and try again.
# Clobazam (oral formulation)
## Overview
Clobazam is a benzodiazepine derivative with anticonvulsant properties. It is thought to act by enhancing the activity of the inhibitory neurotransmitter GABA.
## Primary Indications
* Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older.
* Off-label uses may include other seizure types and anxiety disorders.
## Adult Dosing
* **Adjunctive therapy for LGS:** Initial dose 5 mg twice daily. Increase dose gradually by 5-10 mg every week as needed, not to exceed a maximum daily dose of 20 mg twice daily.
## Pediatric Dosing
* **Adjunctive therapy for LGS (2 to <10 years):** Initial dose 2.5 mg twice daily. Increase dose gradually by 2.5-5 mg every week as needed, not to exceed a maximum daily dose of 10 mg twice daily.
* **Adjunctive therapy for LGS (10 to <30 kg):** Initial dose 5 mg twice daily. Increase dose gradually by 5 mg every week as needed, not to exceed a maximum daily dose of 10 mg twice daily.
* **Adjunctive therapy for LGS (≥30 kg):** Initial dose 5 mg twice daily. Increase dose gradually by 5-10 mg every week as needed, not to exceed a maximum daily dose of 20 mg twice daily.
* Dosing in children younger than 2 years is not established.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. Consider lower doses and slow titration.
* **Renal Impairment:** Use with caution. Data is limited, but dose reduction may be considered based on clinical response and renal function.
## Contraindications
* Known hypersensitivity to clobazam or other benzodiazepines.
* Severe hepatic impairment.
## Adverse Effects
* **Common:** Somnolence, decreased appetite, constipation, drooling, fatigue, aggression, irritability, vomiting.
* **Serious:** Serious skin reactions (e.g., Stevens-Johnson syndrome), respiratory depression, withdrawal symptoms, increased seizure frequency, suicidal behavior/ideation, dependence.
## Key Drug Interactions
* **CNS Depressants (e.g., alcohol, opioids, other sedatives):** Increased risk of profound sedation, respiratory depression, and potentially fatal outcomes.
* **CYP3A4 Inhibitors/Inducers:** Clobazam is a CYP3A4 substrate. Concomitant use with potent CYP3A4 inhibitors may increase clobazam levels, and inducers may decrease them.
* **Other Antiepileptic Drugs (AEDs):** Potential for complex interactions, requiring careful monitoring of seizure control and for adverse effects.
## Monitoring
* Monitor for seizure frequency and control.
* Monitor for signs of somnolence, sedation, and cognitive impairment.
* Monitor for signs of withdrawal symptoms upon discontinuation.
* Monitor for suicidal behavior/ideation.
* Monitor for dermatological reactions.
## Clinical Pearls
* Clobazam is a Schedule IV controlled substance.
* Taper dose gradually when discontinuing to avoid withdrawal symptoms.
* Patients and caregivers should be advised about the risk of somnolence and to avoid driving or operating heavy machinery until they know how clobazam affects them.
* Warn about the risk of serious skin reactions and advise patients to seek immediate medical attention if a rash develops.
* Regularly reassess the need for clobazam, especially if seizure control is achieved.
**Disclaimer:** This information is intended for clinical use and does not replace a thorough review of the full prescribing information or local protocols. Always verify current dosing and safety information with the most up-to-date product labeling and institutional guidelines.
