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# Clobazam (Oral Formulation)
## Overview
Clobazam is a benzodiazepine derivative used as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) in pediatric and adult patients. It possesses anticonvulsant and anxiolytic properties.
## Primary Indications
Adjunctive therapy for seizures in Lennox-Gastaut syndrome (LGS).
## Adult Dosing
* **Initiation:** Typically 5 mg twice daily.
* **Titration:** May be increased by 5-10 mg every week as needed, up to a maximum of 20 mg twice daily (40 mg/day).
* **Maintenance:** Common maintenance doses range from 5-20 mg twice daily.
## Pediatric Dosing
* **2 to <10 years:**
* **Initiation:** 5 mg once daily.
* **Titration:** May be increased by 5 mg every week as needed, up to a maximum of 10 mg twice daily (20 mg/day).
* **10 years and older (or weighing ≥30 kg):**
* **Initiation:** 10 mg once daily.
* **Titration:** May be increased by 10 mg every week as needed, up to a maximum of 20 mg twice daily (40 mg/day).
*Note: Dosing for children under 2 years of age is not well established and should be individualized based on response and tolerability.*
## Dose Adjustments
* **Hepatic Impairment:** Use with caution; no specific dosage adjustments are recommended, but lower doses may be appropriate.
* **Renal Impairment:** Use with caution; no specific dosage adjustments are recommended, but lower doses may be appropriate.
## Contraindications
* Known hypersensitivity to clobazam or other benzodiazepines.
* Severe hepatic insufficiency.
## Adverse Effects
* **Common:** Somnolence, constipation, decreased appetite, aggression, irritability, ataxia, fatigue, vomiting, upper respiratory tract infection.
* **Serious:** Suicidal ideation and behavior, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), respiratory depression, dependence and withdrawal.
## Key Drug Interactions
* **CYP2C19 Inhibitors/Inducers:** Clobazam is a substrate of CYP2C19. Potent inhibitors (e.g., fluconazole) may increase clobazam levels, while potent inducers (e.g., rifampin) may decrease them.
* **CNS Depressants:** Additive CNS depression may occur with other sedating medications (e.g., alcohol, opioids, other benzodiazepines, anticonvulsants).
* **Anticonvulsants:** Clobazam can affect levels of other anticonvulsants (e.g., valproic acid, stiripentol). Stiripentol in combination with clobazam and valproate has been associated with increased clobazam exposure.
## Monitoring
* **Seizure frequency and severity:** Assess efficacy.
* **Signs of CNS depression:** Somnolence, sedation, dizziness.
* **Behavioral changes:** Monitor for aggression, irritability, or suicidal ideation.
* **Signs of withdrawal:** If discontinuing therapy, monitor for symptoms such as anxiety, insomnia, and seizures.
* **Liver function tests:** Consider periodically, especially with long-term use.
## Clinical Pearls
* Clobazam is a Schedule IV controlled substance.
* Tapering of clobazam is recommended upon discontinuation to avoid withdrawal symptoms.
* The risk of suicidal behavior or ideation occurs with antiepileptic drugs. Patients should be monitored for clinical worsening, emergence of suicidal thoughts/behaviors, and unusual changes in behavior.
* Clobazam can cause significant somnolence, which may impair the ability to drive or operate machinery.
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*This information is for educational purposes only and does not substitute for professional medical advice. Always consult with a qualified healthcare provider for any questions regarding a medical condition or treatment. Prescribing information should be reviewed for complete details.*
