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.

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. Avoid abrupt cessation; taper by decreasing total daily dose by 5–10mg/day on a weekly basis. Drug abusers. Severe renal or hepatic impairment or ESRD. Elderly. Neonates/infants: monitor for symptoms of withdrawal. Pregnancy. Labor & delivery, nursing mothers: monitor.

Pharmacologic Class:

Benzodiazepine.

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 be potentiated by CYP2C19 inhibitors (eg, fluconazole, fluvoxamine, ticlopidine, omeprazole); may need dose adjustment. May diminish effect of hormonal contraceptives (use non-hormonal forms). May need to adjust dose of drugs metabolized by CYP2D6.

Adverse Reactions:

Constipation, somnolence, sedation, pyrexia, lethargy, drooling; withdrawal symptoms, physical/psychological dependence.

Note:

To register pregnant patients in the North American Antiepileptic Drug (NAAED) Pregnancy Registry, call (888) 233-2334.

Generic Availability:

NO

How Supplied:

Oral films—60

Pricing for SYMPAZAN

5mg film (Qty: 60)
Appx. price $781
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