Select therapeutic use:
Indications for ONFI:
Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS).
Adults and Children:
<2yrs: not established. Tabs may be swallowed whole, scored, or crushed and mixed in applesauce. ≥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. 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.
Severe renal or hepatic impairment or ESRD. Monitor for the emergence or worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior. 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. Avoid abrupt cessation; taper by decreasing total daily dose by 5–10mg/day on a weekly basis. Drug abusers. Elderly. Pregnancy (Cat.C). Nursing mothers.
Increased somnolence, sedation with concomitant CNS depressants, alcohol. May be potentiated by CYP2C19 inhibitors (eg, fluconazole, fluvoxamine, ticlopidine, omeprazole), alcohol. May diminish effect of hormonal contraceptives (use non-hormonal forms). May need to adjust dose of drugs metabolized by CYP2D6.
Somnolence, sedation, drooling, constipation, pyrexia, lethargy, cough, UTI, aggression, insomnia, dysarthria, fatigue; hypersensitivity reactions.
Tabs—100; Susp—120mL (w. 2 dosing syringes)