Clobazam

DEA Class;  Rx

Common Brand Names; ONFI, Sympazan

History of hypersensitivity to drug or ingredients

Somnolence or sedation; generally occurs within the first month of treatment and may diminish with continued treatment; caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that therapy does not affect them adversely (eg, impair judgment, thinking or motor skills)

Serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported in both children and adults; monitor closely, especially during the first 8 weeks of treatment initiation or when reintroducing therapy; discontinue at the first sign of drug-related rash and do not resume unless rash is clearly not drug related; if signs or symptoms suggest SJS/TEN, do not resume therapy; alternative therapy should be considered

Consider history of substance abuse because of predisposition of such patients to physical and/or psychological dependence; patients with history of substance abuse should be under careful surveillance when receiving drug or other psychotropic agents because of predisposition of such patients to habituation and dependence

Use of drug, particularly in patients at elevated risk of abuse, necessitates counseling about risks and proper use of drug along with monitoring for signs and symptoms of abuse, misuse, and addiction; do not exceed recommended dosing frequency

Avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (eg, opioid analgesics, stimulants); advise patients on proper disposal of unused drug; if a substance use disorder is suspected, evaluate patient and institute (or refer them for) early treatment, as appropriate

For patients using treated more frequently than recommended, to reduce risk of withdrawal reactions, use a gradual taper to discontinue therapy (a patient-specific plan should be used to taper the dose)

There are no adequate and well-controlled studies in pregnant women

Drug is excreted in human milk; postmarketing experience suggests that breastfed infants of mothers taking benzodiazepines, may have effects of lethargy, somnolence and poor sucking; effect of drug on milk production is unknown; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed infant from drug or from underlying maternal condition; if exposing a breastfed infant to drug, observe for any potential adverse effects