Seizure disorders:
Indications for: SYMPAZAN
Adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome.
Adults and Children:
<2yrs: not established. Allow each film to dissolve completely before administering the next film; do not give with liquids. Individualize. ≥2yrs: Give in divided doses twice daily (except for 5mg dose). ≤30kg: initially 5mg, then increase to 10mg on Day 7, then increase to 20mg on Day 14. >30kg: initially 10mg, then increase to 20mg on Day 7, then increase to 40mg on Day 14. Do not increase dose sooner than weekly. Elderly, CYP2C19 poor metabolizers, mild to moderate hepatic impairment (Child-Pugh score 5–9): initially 5mg/day; titrate according to weight (as shown above) but to half the dose, an additional titration to max dose (20mg/day or 40mg/day, depending on weight) may be started at Day 21.
Boxed Warning:
Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.
SYMPAZAN Warnings/Precautions:
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.
SYMPAZAN Classification:
Benzodiazepine.
SYMPAZAN Interactions:
Increased risk of profound sedation, respiratory depression, coma, and death with opioids; reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. May increase risk of sedation/somnolence with concomitant other CNS depressants, alcohol. May diminish effect of hormonal contraceptives (use non-hormonal forms). May need to adjust dose of drugs metabolized by CYP2D6. May be potentiated by CYP2C19 inhibitors (eg, fluconazole, fluvoxamine, ticlopidine, omeprazole); may need dose adjustment. Concomitant cannabidiol may increase risk of clobazam-related reactions; consider dose reduction of either drug if occur.
Adverse Reactions:
Constipation, somnolence, sedation, pyrexia, lethargy, drooling; withdrawal reactions.
Note:
To register pregnant patients in the North American Antiepileptic Drug (NAAED) Pregnancy Registry, call (888) 233-2334.
Drug Elimination:
Renal (82%), fecal (11%).
Generic Drug Availability:
NO
How Supplied:
Oral films—60
