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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 patients 2 years and older. It also has anxiolytic properties.
## Primary Indications
Adjunctive treatment of seizures in Lennox-Gastaut syndrome (LGS).
## Adult Dosing
* **LGS:** The usual starting dose is 5 mg twice daily.
* **Titration:** The dose may be increased by 5 mg to 10 mg every week.
* **Maintenance:** The usual maintenance dose is 10 mg to 20 mg twice daily.
* **Maximum Dose:** The maximum recommended dose is 20 mg twice daily (40 mg/day).
## Pediatric Dosing (2 years and older)
* **LGS:** The usual starting dose is 0.5 mg/kg/day, divided into two doses.
* **Titration:** The dose may be increased by 0.5 mg/kg to 1 mg/kg every week.
* **Maintenance:** The usual maintenance dose is 1 mg/kg/day, divided into two doses.
* **Maximum Dose:** The maximum recommended dose is 1 mg/kg/day, divided into two doses, not to exceed 20 mg twice daily (40 mg/day).
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. No specific dose adjustments are established, but consider starting with a lower dose and titrating slowly.
* **Renal Impairment:** Use with caution. No specific dose adjustments are established, but consider starting with a lower dose and titrating slowly.
* **Concomitant Medications:** Dose may need to be adjusted when co-administered with strong CYP3A4 inhibitors or inducers.
## Contraindications
* Hypersensitivity to clobazam or other benzodiazepines.
* Severe respiratory impairment.
* Severe hepatic impairment.
* Myasthenia gravis.
* Acute narrow-angle glaucoma.
## Adverse Effects
Common: Somnolence, decreased appetite, constipation, aggression, irritability, pyrexia, ataxia, vomiting, upper respiratory tract infection.
Serious: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), somnolence, withdrawal symptoms, dependence, suicidal behavior or ideation.
## Key Drug Interactions
* **CNS Depressants (alcohol, opioids, other benzodiazepines):** Increased risk of sedation, respiratory depression, and coma.
* **CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir):** May increase clobazam concentrations and risk of adverse effects. Consider dose reduction of clobazam.
* **CYP3A4 Inducers (e.g., rifampin, carbamazepine):** May decrease clobazam concentrations and efficacy. Consider dose increase of clobazam.
* **Levetiracetam:** Clobazam can increase levetiracetam concentrations. Monitor for levetiracetam toxicity.
* **Valproic Acid:** Clobazam can increase valproic acid concentrations. Monitor for valproic acid toxicity.
## Monitoring
* Monitor for seizure frequency and control.
* Assess for signs of somnolence, ataxia, and CNS depression.
* Monitor for signs and symptoms of SCARs and discontinue at the first sign of rash.
* Monitor for behavioral changes, including suicidal behavior or ideation.
* Monitor for withdrawal symptoms upon discontinuation.
* Consider monitoring clobazam and its active metabolite (N-desmethylclobazam) levels, especially in cases of suspected toxicity or lack of efficacy.
## Clinical Pearls
* Clobazam is typically used as adjunctive therapy for LGS and should not be used as monotherapy for epilepsy.
* Due to the risk of SCARs, patients should be advised to seek immediate medical attention if a rash develops.
* Withdrawal symptoms can occur upon abrupt discontinuation. Tapering the dose gradually is recommended.
* Clobazam can be taken with or without food.
* The active metabolite, N-desmethylclobazam, has a long half-life and contributes to the overall therapeutic effect and potential for accumulation.
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**Disclaimer:** This information is intended for clinical use and does not replace professional judgment. Always refer to the most current prescribing information and consult with a qualified healthcare professional for specific patient care decisions.
