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# 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).
## Adult Dosing
* **Initiation:** 5 mg orally twice daily.
* **Titration:** Increase dose by 5 mg to 10 mg every week based on clinical response and tolerability.
* **Maintenance:** Typical maintenance dose is 10 mg to 20 mg orally twice daily.
* **Maximum Dose:** 20 mg orally twice daily.
## Pediatric Dosing
* **Age 2 to <10 years or weight <30 kg:**
* **Initiation:** 5 mg orally once daily.
* **Titration:** Increase dose by 2.5 mg to 5 mg every week based on clinical response and tolerability.
* **Maintenance:** Typical maintenance dose is 5 mg to 10 mg orally twice daily.
* **Maximum Dose:** 10 mg orally twice daily.
* **Age ≥10 years or weight ≥30 kg:**
* **Initiation:** 5 mg orally twice daily.
* **Titration:** Increase dose by 5 mg to 10 mg every week based on clinical response and tolerability.
* **Maintenance:** Typical maintenance dose is 10 mg to 20 mg orally twice daily.
* **Maximum Dose:** 20 mg orally twice daily.
## Dose Adjustments
* **Hepatic Impairment:** No specific dosage adjustments are recommended, but caution is advised.
* **Renal Impairment:** No specific dosage adjustments are recommended, but caution is advised.
## Contraindications
* Known hypersensitivity to clobazam or other benzodiazepines.
* Severe respiratory insufficiency.
* Severe hepatic insufficiency.
* Sleep apnea syndrome.
## Adverse Effects
* **Common:** Somnolence, fatigue, drooling, constipation, anorexia, aggression, irritability, respiratory depression.
* **Serious:** Suicidal behavior and ideation, severe drowsiness, withdrawal symptoms, dependence, cognitive impairment, paradoxical reactions.
## Key Drug Interactions
* **CYP3A4 Inhibitors/Inducers:** Clobazam is a substrate of CYP3A4. Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase clobazam levels. Concomitant use with strong CYP3A4 inducers (e.g., rifampin, carbamazepine) may decrease clobazam levels.
* **CNS Depressants:** Additive CNS depression may occur with alcohol, opioids, other benzodiazepines, sedating antihistamines, and antipsychotics.
* **Anticonvulsants:** Clobazam can affect the metabolism of other anticonvulsants (e.g., brivaracetam, eslicarbazepine, phenytoin, phenobarbital, rufinamide, stiripentol, valproic acid), potentially altering their plasma concentrations. Monitor for changes in efficacy or toxicity.
## Monitoring
* **Seizure frequency and type:** Monitor for efficacy.
* **Signs of CNS depression:** Somnolence, sedation, confusion.
* **Behavioral changes:** Especially in children, monitor for aggression, irritability, and suicidal ideation.
* **Withdrawal symptoms:** If discontinuation is planned, taper dose gradually.
* **Concomitant anticonvulsant levels:** If applicable, monitor for significant changes.
## Clinical Pearls
* Clobazam should be used as adjunctive therapy for LGS seizures.
* Due to the risk of somnolence, patients should be cautioned about operating heavy machinery or driving until they know how clobazam affects them.
* Sudden discontinuation can lead to withdrawal symptoms, including seizures, anxiety, insomnia, and confusion. Tapering is recommended.
* Monitor closely for increased seizure frequency or severity, especially when adding or discontinuing other anticonvulsants.
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**Disclaimer:** This information is intended for healthcare professionals and is not a substitute for professional medical advice. Always consult the most current prescribing information and your healthcare provider for any questions regarding medication use.
