Indications for DIACOMIT:
Treatment of seizures associated with Dravet syndrome in patients taking clobazam.
Adults and Children:
<2yrs: not established. Swallow caps whole. Take with water and food. Oral susp: mix in water and drink immediately. ≥2yrs: 50mg/kg/day in 2–3 divided doses; max 3000mg/day.
Monitor for somnolence; if occurs when concomitant clobazam, consider reducing initial clobazam by 25%. Increased risk of suicidal thoughts or behavior; monitor for new or worsening depression, suicidal thoughts/behavior, and/or any unusual changes. Neutropenia. Thrombocytopenia. Obtain hematologic testing prior to initiation, then every 6 months. Monitor patient's weight during therapy; and the growth rate of pediatric patients. Phenylketonuria (oral susp). Moderate or severe renal/hepatic impairment: not recommended. Withdraw gradually. Avoid abrupt cessation. Elderly. Pregnancy. Nursing mothers.
May affect CYP1A2, CYP2B6, and CYP3A4 substrates (eg, theophylline, caffeine, sertraline, thiotepa, midazolam, triazolam, quinidine); consider dose adjustment. May potentiate CYP2C8, CYP2C19, P-gp, or BCRP substrates (eg, diazepam, clopidogrel, carbamazepine, methotrexate, prazosin, glyburide) and clobazam; consider dose reduction of these drugs. May be antagonized by strong CYP1A2, CY3A4 or CYP2C19 inducers (eg, rifampin, phenytoin, phenobarbital, carbamazepine); avoid or adjust dose. May increase risk of sedation and somnolence with concomitant other CNS depressants, alcohol.
Somnolence, decreased appetite, agitation, ataxia, weight decreased, hypotonia, nausea, tremor, dysarthria, insomnia.
Enroll pregnant patients in the North American Antiepileptic Drug Pregnancy Registry by calling (888) 233-2334.