Sympazan Generic Name & Formulations
Sympazan Dosage and Administration
Adults and Children
Sympazan Boxed Warnings
Increased risk of drug-related mortality from concomitant use with opioids. Monitor for somnolence or sedation. Monitor for signs/symptoms of serious skin reactions (eg, SJS, TEN), esp. during the first 8 weeks of initiation or when re-introducing therapy; discontinue at the first sign of rash unless it's not drug-related. Monitor for the emergence or worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation; taper by decreasing total daily dose by 5–10mg/day on a weekly basis. Drug or alcohol abusers. Severe renal or hepatic impairment or ESRD. Elderly. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: monitor infants.
After single-dose administration, the time to peak concentrations (Tmax) of clobazam oral film under fasted conditions ranged from 0.33 to 4.0 hours.
The volume of distribution at steady state was ~100 L. The in vitro plasma protein binding of clobazam and N-desmethylclobazam is ~80-90% and 70%, respectively.
Renal (82%), fecal (11%).
Sympazan Adverse Reactions
Sympazan Clinical Trials
Sympazan Patient Counseling