Clobazam

CLOBAZAM

Manufacturer: VistaPharm, LLC

Score: 148.0

Quick Summary

Clobazam is a benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. The initial dose should be 5 mg/day for patients ≤30 kg body weight and 10 mg/day for patients >30 kg body weight, with titration as tolerated up to 20 mg/day or 40 mg/day, respectively. Clobazam is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. The most common adverse reactions include somnolence or sedation, pyrexia, lethargy, and drooling.

Key Clinical Findings and Indications

Clobazam is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older
Clobazam is a benzodiazepine that potentiates GABAergic neurotransmission

Important Safety Information

Warning

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death

Contraindications

History of hypersensitivity to the drug or its ingredients

Adverse Reactions

Somnolence or sedation
Pyrexia
Lethargy
Drooling

Dosing Recommendations

General Guidance

Dose adjustments are needed for geriatric patients, patients with mild or moderate hepatic impairment, and patients who are known CYP2C19 poor metabolizers

Lennox-Gastaut syndrome

Adult Dose

5 mg/day for patients ≤30 kg body weight and 10 mg/day for patients >30 kg body weight

Pediatric Dose

5 mg/day for patients ≤30 kg body weight and 10 mg/day for patients >30 kg body weight

Special Population Considerations

Pregnancy

Clobazam should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus
Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal

Nursing Mothers

Administration of clobazam to rats prior to and during mating and early gestation resulted in adverse effects on fertility and early embryonic development

Pediatric Use

Safety and effectiveness in patients less than 2 years of age have not been established
In a study in which clobazam was orally administered to rats during the juvenile period of development, adverse effects on growth and behavior were observed

Geriatric Use

Clinical studies of clobazam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
Elderly subjects appear to eliminate clobazam more slowly than younger subjects