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# Clobazam (Oral Formulation)
## Overview
Clobazam is a benzodiazepine derivative with anticonvulsant properties. It is a Schedule IV controlled substance.
## Primary Indications
Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older.
## Adult Dosing
* **LGS:** The recommended starting dose is 5 mg twice daily. The dose can be increased by 5-10 mg/day every week to a maximum of 20 mg twice daily.
## Pediatric Dosing
* **LGS (2 to <10 years of age OR <30 kg):** The recommended starting dose is 5 mg once daily. The dose can be increased by 2.5-5 mg/day every week to a maximum of 10 mg twice daily.
* **LGS (≥10 years of age AND ≥30 kg):** Same as adult dosing.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. No specific dosage adjustments are available, but lower doses may be appropriate.
* **Renal Impairment:** Use with caution. No specific dosage adjustments are available, but lower doses may be appropriate.
## Contraindications
* Hypersensitivity to clobazam or other benzodiazepines.
* Severe hepatic impairment.
## Adverse Effects
Common adverse effects include somnolence, decreased appetite, constipation, decreased muscle tone, fatigue, gait disturbance, lethargy, nausea, vomiting, drooling, and behavioral problems (e.g., aggression, irritability, impulsivity). Serious adverse effects include severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), respiratory depression, and potential for abuse and dependence.
## Key Drug Interactions
* **CNS Depressants (e.g., alcohol, opioids, other sedatives):** Increased risk of sedation, respiratory depression, and potentially fatal outcomes.
* **CYP3A4 Inhibitors/Inducers:** May alter clobazam concentrations.
* **Strong CYP2C19 Inhibitors (e.g., fluconazole):** May increase clobazam concentrations.
* **Sodium Oxybate:** Contraindicated due to increased risk of profound sedation, respiratory depression, and death.
## Monitoring
* Monitor for signs of sedation, respiratory depression, and behavioral changes.
* Monitor for signs of severe skin reactions.
* Assess for effectiveness in seizure control.
* Monitor for signs of withdrawal if abruptly discontinued.
## Clinical Pearls
* Clobazam can cause significant sedation, especially at the initiation of therapy or with dose increases. Advise patients to avoid activities requiring mental alertness until they know how the medication affects them.
* Abrupt discontinuation may lead to withdrawal symptoms. Taper the dose gradually when discontinuing.
* The active metabolite of clobazam, N-desmethylclobazam, has a long half-life, contributing to its prolonged effects and potential for accumulation.
* Due to the risk of serious skin reactions, patients should be advised to discontinue clobazam and seek immediate medical attention if they develop a rash.
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*Disclaimer: This information is intended for healthcare professionals and does not substitute for professional medical advice. Always consult the most current prescribing information and relevant guidelines before making any treatment decisions.*
