Seizure disorders:

Indications for DIACOMIT ORAL SUSP:

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.

Warnings/Precautions:

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.

See Also:

Pharmacologic Class:

Antiepileptic.

Interactions:

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.

Adverse Reactions:

Somnolence, decreased appetite, agitation, ataxia, weight decreased, hypotonia, nausea, tremor, dysarthria, insomnia.

Note:

Enroll pregnant patients in the North American Antiepileptic Drug Pregnancy Registry by calling (888) 233-2334.

Generic Availability:

NO

How Supplied:

Caps—60; Pkts—60