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# Clobazam (oral formulation)
## Overview
Clobazam is a benzodiazepine derivative with anticonvulsant properties. It is primarily used as adjunctive therapy.
## 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.
* After 1 week, the dose may be increased to 10 mg twice daily.
* Further dose increases of 5 mg to 10 mg per day every week, as tolerated, are recommended based on clinical response.
* The maximum recommended maintenance dose is 20 mg twice daily (40 mg per day).
## Pediatric Dosing (2 years and older)
* **LGS:** The recommended starting dose is 5 mg twice daily.
* After 1 week, the dose may be increased to 10 mg twice daily.
* Further dose increases of 5 mg to 10 mg per day every week, as tolerated, are recommended based on clinical response.
* The maximum recommended maintenance dose is 20 mg twice daily (40 mg per day).
## Dose Adjustments
* **Hepatic Impairment:** Caution is advised. No specific dosing recommendations are established, but lower doses may be considered.
* **Renal Impairment:** Caution is advised. No specific dosing recommendations are established, but lower doses may be considered.
## Contraindications
* Known hypersensitivity to clobazam or other benzodiazepines.
* Severe hepatic impairment.
## Adverse Effects
* **Common:** Somnolence, decreased appetite, constipation, irritability, aggression, respiratory tract infections, pneumonia, pyrexia, gait disturbance, lethargy, vomiting.
* **Serious:** Serious skin reactions (e.g., Stevens-Johnson syndrome), drug reaction with eosinophilia and systemic symptoms (DRESS), suicidal behavior and ideation, anterograde amnesia, dependence and withdrawal symptoms, respiratory depression.
## Key Drug Interactions
* **CNS Depressants (e.g., alcohol, opioids, other benzodiazepines):** Increased risk of sedation, respiratory depression, and cognitive impairment.
* **CYP1A2 Inducers (e.g., rifampicin, carbamazepine, phenytoin):** May decrease clobazam levels.
* **CYP2C19 Inhibitors (e.g., fluconazole):** May increase clobazam levels.
* **CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, protease inhibitors):** May increase clobazam levels.
* **CYP3A4 Inducers (e.g., St. John's Wort, carbamazepine, phenytoin):** May decrease clobazam levels.
## Monitoring
* Monitor for efficacy (seizure frequency).
* Monitor for adverse effects, particularly somnolence, changes in behavior, and signs of serious skin reactions or DRESS.
* Monitor for signs and symptoms of withdrawal upon discontinuation.
* Consider therapeutic drug monitoring if co-administered with potent CYP enzyme inducers or inhibitors, although specific target levels are not well-established.
## Clinical Pearls
* Clobazam is intended for adjunctive therapy, not monotherapy.
* It should be withdrawn gradually to avoid withdrawal symptoms.
* Due to the risk of serious skin reactions and DRESS, patients should be advised to seek immediate medical attention if they develop a rash, blistering, or peeling skin.
* Clobazam carries a risk of suicidal thoughts and behavior. Patients should be monitored for any changes in mood or behavior.
* The oral suspension formulation contains sorbitol and may not be suitable for patients with hereditary fructose intolerance.
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*Please verify current prescribing information and institutional protocols for the most up-to-date and specific guidance.*