Please check your internet connection and try again.
# Clobazam (oral formulation)
## Overview
Clobazam is a 1,5-benzodiazepine with anticonvulsant properties. It is used as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older.
## Primary Indications
Adjunctive therapy for seizures in Lennox-Gastaut syndrome (LGS) in patients $\geq$ 2 years of age.
## Adult Dosing
* **LGS:** Initial dose: 5 mg twice daily.
* **Titration:** Increase dose weekly by 5 mg to 10 mg per day, divided into two doses, until an effective dose is reached.
* **Maintenance:** Typically 10 mg to 20 mg twice daily.
* **Maximum Dose:** 20 mg twice daily (40 mg/day).
## Pediatric Dosing (2 to <10 years of age)
* **LGS:** Initial dose: 2.5 mg twice daily.
* **Titration:** Increase dose weekly by 2.5 mg to 5 mg per day, divided into two doses, until an effective dose is reached.
* **Maintenance:** Typically 5 mg twice daily.
* **Maximum Dose:** 10 mg twice daily (20 mg/day).
*Note: Dosing for pediatric patients 10 years of age and older with a weight of $\ge$ 30 kg is the same as adults.*
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. No specific dose adjustment guidelines are established, but lower doses may be warranted.
* **Renal Impairment:** Use with caution. No specific dose adjustment guidelines are established, but lower doses may be warranted.
## Contraindications
* Known hypersensitivity to clobazam or other benzodiazepines.
* Severe hepatic impairment.
## Adverse Effects
* **Common:** Somnolence, fatigue, decreased appetite, constipation, increased salivation, aggression, irritability, vomiting, diarrhea, weight loss.
* **Serious:** Respiratory depression, severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), withdrawal symptoms, suicidal behavior or ideation, cognitive and psychomotor impairment.
## Key Drug Interactions
* **CYP3A4 Inhibitors/Inducers:** Clobazam is a substrate of CYP3A4. Concomitant use with strong CYP3A4 inhibitors may increase clobazam levels. Concomitant use with strong CYP3A4 inducers may decrease clobazam levels.
* **CNS Depressants:** Additive effects with alcohol, opioids, and other sedating medications, potentially leading to increased sedation, respiratory depression, and coma.
* **Other Anticonvulsants:** Clobazam can affect levels of other AEDs (e.g., stiripentol, eslicarbazepine acetate, valproic acid). Monitor for toxicity or loss of efficacy.
## Monitoring
* **Efficacy:** Monitor for seizure frequency and severity.
* **Safety:** Monitor for somnolence, behavioral changes, signs of withdrawal, and suicidal ideation.
* **Drug Interactions:** Monitor for signs of toxicity or reduced efficacy of concomitant medications, especially other AEDs.
* **Withdrawal Symptoms:** Taper dose slowly when discontinuing to minimize withdrawal symptoms.
## Clinical Pearls
* Clobazam can cause significant somnolence, especially at the start of therapy or with dose increases. Advise patients to avoid activities requiring mental alertness until the effects are known.
* Clobazam has a long half-life, and accumulation can occur, particularly with chronic use or in patients with hepatic/renal impairment.
* Sudden discontinuation may lead to withdrawal symptoms, including seizures, insomnia, anxiety, and tremors. Tapering is essential.
* Serious skin reactions are a risk; counsel patients to seek immediate medical attention for any rash.
***
*Disclaimer: This information is intended for clinical decision-making and should be used in conjunction with current prescribing information and professional judgment. Always verify current dosing, indications, contraindications, and drug interactions with official product labeling or reliable drug information resources.*
