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Diacomit Oral Susp Generic Name & Formulations
Legal Class
Rx
General Description
Stiripentol 250mg, 500mg; per packet; pwd for oral susp; fruit flavor; contains phenylalanine.
Pharmacological Class
Antiepileptic.
See Also
How Supplied
Caps—60; Pkts—60
Manufacturer
Generic Availability
NO
Diacomit Oral Susp Indications
Indications
Treatment of seizures associated with Dravet syndrome in patients taking clobazam.
Diacomit Oral Susp Dosage and Administration
Adults and Children
<6mos or <7kg: not established. Swallow caps whole. Take with water and food. Oral susp: mix in water and drink immediately. ≥6mos–<1yr (≥7kg): 50mg/kg/day in 2 divided doses. ≥1yr (7–<10kg): 50mg/kg/day in 2 divided doses; (≥10kg): 50mg/kg/day in 2–3 divided doses. All: max 3000mg/day.
Diacomit Oral Susp Contraindications
Not Applicable
Diacomit Oral Susp Boxed Warnings
Not Applicable
Diacomit Oral Susp Warnings/Precautions
Warnings/Precautions
Monitor for somnolence; if occurs when concomitant clobazam, consider reducing initial clobazam by 25%; if persists, consider reducing by an additional 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.
Diacomit Oral Susp Pharmacokinetics
See Literature
Diacomit Oral Susp Interactions
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.
Diacomit Oral Susp Adverse Reactions
Adverse Reactions
Somnolence, decreased appetite, agitation, ataxia, weight decreased, hypotonia, nausea, tremor, dysarthria, insomnia.
Diacomit Oral Susp Clinical Trials
See Literature
Diacomit Oral Susp Note
Notes
Enroll pregnant patients in the North American Antiepileptic Drug Pregnancy Registry by calling (888) 233-2334.
Diacomit Oral Susp Patient Counseling
See Literature
