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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.
* Off-label uses include other seizure disorders and anxiety.
## Adult Dosing
* **LGS:** Initial dose is typically 5 mg twice daily. Increase by 5 mg to 10 mg every week as needed.
* **Maximum daily dose:** 20 mg twice daily (40 mg/day).
* **Other indications (off-label):** Dosing varies widely.
## Pediatric Dosing
* **LGS (2 to less than 10 years of age):** Initial dose is typically 5 mg once daily. Increase by 5 mg every week as needed.
* **Maximum daily dose:** 10 mg twice daily (20 mg/day).
* **LGS (10 years of age and older, or weighing 30 kg or more):** Initial dose is typically 5 mg twice daily. Increase by 5 mg to 10 mg every week as needed.
* **Maximum daily dose:** 20 mg twice daily (40 mg/day).
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. Initiate at lower doses and titrate slowly.
* **Renal Impairment:** No specific dose adjustments are established, but use with caution.
## Contraindications
* Known hypersensitivity to clobazam or other benzodiazepines.
* Severe hepatic impairment.
## Adverse Effects
* **Common:** Somnolence, decreased appetite, constipation, fatigue, aggression, irritability, upper respiratory tract infection, vomiting, diarrhea, drooling.
* **Serious:** Suicidal behavior and ideation, severe drowsiness/sedation, withdrawal symptoms (taper slowly), respiratory depression (especially when used with other CNS depressants), hypersensitivity reactions.
## Key Drug Interactions
* **CNS Depressants (e.g., alcohol, opioids, other benzodiazepines, barbiturates):** Additive CNS depression, potentially leading to severe sedation, respiratory depression, and death.
* **CYP3A4 Inhibitors (e.g., ketoconazole, fluconazole):** May increase clobazam concentrations.
* **CYP3A4 Inducers (e.g., rifampin, carbamazepine):** May decrease clobazam concentrations.
* **CYP2C19 Inhibitors (e.g., omeprazole):** May increase clobazam concentrations.
* **Sodium Oxybate:** Contraindicated due to risk of severe respiratory depression, profound sedation, coma, and death.
## Monitoring
* Monitor for somnolence, sedation, and cognitive impairment.
* Assess for signs of withdrawal if discontinuing therapy.
* Monitor for suicidal behavior and ideation.
* Monitor for potential drug interactions.
## Clinical Pearls
* Clobazam is a Schedule IV controlled substance; ensure appropriate prescribing and dispensing practices.
* Discontinuation should be gradual to avoid withdrawal symptoms.
* The risk of serious adverse reactions, including somnolence and suicidal behavior, may be increased in pediatric patients.
* Clobazam is metabolized to N-desmethylclobazam (norclobazam), which is also pharmacologically active and has a longer half-life.
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**Disclaimer:** This information is intended for clinical use and does not substitute for professional medical advice. Always verify current prescribing information with the manufacturer's official product information or other reliable sources.
