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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
* **Lennox-Gastaut Syndrome (LGS):** Initial dose: 5 mg twice daily. Increase by 5-10 mg every week as tolerated to a target maintenance dose of 0.5-1 mg/kg/day, divided into two doses. The maximum dose is 20 mg twice daily.
## Pediatric Dosing
* **Lennox-Gastaut Syndrome (LGS):**
* **2 to <10 years:** Initial dose: 0.25 mg/kg twice daily. Increase by 0.25-0.5 mg/kg every week as tolerated to a target maintenance dose of 0.5-1 mg/kg/day, divided into two doses. Maximum dose: 10 mg twice daily.
* **10 years and older (or weighing 30 kg or more):** Dosing is the same as adults. Initial dose: 5 mg twice daily. Increase by 5-10 mg every week as tolerated to a target maintenance dose of 0.5-1 mg/kg/day, divided into two doses. Maximum dose: 20 mg twice daily.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. Dose reduction may be necessary.
* **Renal Impairment:** Use with caution. Dose reduction may be necessary.
* **Concomitant Medications:**
* **Strong CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole):** May increase clobazam levels. Consider reducing clobazam dose.
* **Strong CYP2C19 Inhibitors (e.g., fluconazole):** May increase clobazam levels. Consider reducing clobazam dose.
* **Phenytoin, Phenobarbital, Primidone:** May increase clobazam levels. Monitor for adverse effects and consider dose reduction.
* **CNS Depressants:** Additive effects. Use concurrently with caution and consider dose reduction.
## Contraindications
* Known hypersensitivity to clobazam or other benzodiazepines.
* Severe hepatic impairment.
## Adverse Effects
* **Common:** Somnolence, constipation, decreased appetite, fatigue, aggression, irritability, insomnia, ataxia, drooling, vomiting.
* **Serious:** Suicidal behavior and ideation, severe drowsiness, respiratory depression, dependence and withdrawal symptoms, hypersensitivity reactions.
## Key Drug Interactions
* **CNS Depressants (e.g., alcohol, opioids, other sedatives):** Additive CNS depression.
* **CYP3A4 and CYP2C19 Inhibitors/Inducers:** May alter clobazam pharmacokinetics.
* **Antiepileptic Drugs (AEDs):** Potential for altered efficacy or increased adverse effects.
## Monitoring
* Monitor for efficacy and adverse effects, particularly somnolence, dizziness, and behavioral changes.
* Monitor for signs of suicidal behavior and ideation.
* Monitor for signs of withdrawal if discontinuing therapy.
* Consider therapeutic drug monitoring if efficacy is suboptimal or toxicity is suspected, especially with interacting medications.
## Clinical Pearls
* Clobazam should be tapered gradually when discontinuing to avoid withdrawal symptoms.
* Patients and caregivers should be advised about the risk of somnolence and the importance of not operating heavy machinery or driving until the effects of the drug are known.
* The N-desmethylclobazam (norclobazam) metabolite is pharmacologically active and contributes to the overall effect and duration of action.
**Disclaimer:** This information is intended for healthcare professionals. Always consult the most current prescribing information and institutional guidelines before administering any medication.
