WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [ see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )] . The use of benzodiazepines, including clobazam oral suspension, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing clobazam oral suspension and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see Warnings and Precautions ( 5.2 )]. The continued use of benzodiazepines, including clobazam oral suspension, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of clobazam oral suspension after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clobazam oral suspension or reduce the dosage [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.3 )]. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS ; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete boxed warning. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation ( 5.1 , 7.1 ). The use of benzodiazepines, including clobazam oral suspension, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing clobazam oral suspension and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction ( 5.2 ). Abrupt discontinuation or rapid dosage reduction of clobazam oral suspension after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clobazam oral suspension or reduce the dosage ( 2.2 , 5.3 ).
Adult Dosing
General dosing
For doses above 5 mg/day administer in two divided doses Patients ≤30 kg body weight: Initiate at 5 mg daily and titrate as tolerated up to 20 mg daily Patients greater than 30 kg body weight: Initiate at 10 mg daily and titrate as tolerated up to 40 mg daily Dosage adjustment needed in following groups: o Geriatric patients ( 2.4 , 8.5 ) o Known CYP2C19 poor metabolizers o Mild or moderate hepatic impairment; no information for severe hepatic impairment ( 2.7 , 8.8 ) Measure prescribed amount of oral suspension using provided adapter and dosing syringe Oral suspension: Can be taken with or without food 2.1 Dosing Information A daily dose of clobazam oral suspension greater than 5 mg should be administered in divided doses twice daily; a 5 mg daily dose can be administered as a single dose. Dose patients according to body weight. Individualize dosing within each body weight group, based on clinical efficacy and tolerability. Each dose in Table 1 (e.g., 5 to 20 mg in ≤30 kg weight group) has been shown to be effective, although effectiveness increases with increasing dose .
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