Clobazam

FDA label

Read the full label on DailyMed ↗

Titration Do not escalate more rapidly than weekly (steady state of clobazam/active metabolite takes 5-9 days).

Renal No adjustment needed for mild-to-moderate renal impairment (severe impairment/ESRD not studied)

Hepatic Mild-to-moderate (Child-Pugh 5-9): start 5 mg/day, titrate to half the usual weight-based dose; severe impairment not established

Instructions

• Doses above 5 mg/day given in two divided doses
• Tablets: give whole, broken along the score, or crushed and mixed in applesauce; with or without food
• Taper to discontinue: decrease total daily dose by 5-10 mg/day on a weekly basis
• Geriatric patients and CYP2C19 poor metabolizers: start 5 mg/day and titrate to half the usual dose

Cautions

• Somnolence and sedation; potentiated by other CNS depressants and alcohol
• Serious dermatological reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• DRESS/multiorgan hypersensitivity
• Suicidal behavior and ideation
• Neonatal sedation and withdrawal syndrome with late-pregnancy use
• Physical dependence and withdrawal (including seizures/status epilepticus with abrupt discontinuation)
• Abuse, misuse, and addiction

Adverse reactions

• Constipation
• Somnolence/sedation
• Pyrexia
• Lethargy
• Drooling
• Ataxia
• Aggression
• Upper respiratory tract infection

Pregnancy Late-pregnancy use can cause neonatal sedation and/or withdrawal; animal studies show developmental toxicity (fetal malformations, mortality) below therapeutic exposures.

Lactation Excreted in human milk; reports of sedation, poor feeding, and poor weight gain in exposed infants — monitor.