| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ONFI safely and effectively. See full prescribing information for ONFI.
ONFI (clobazam) tablets, for oral use, CIV Initial U.S. Approval: 2011
| Mechanism of Action
The exact mechanism of action for clobazam, a 1,5-benzodiazepine, is not fully
understood but is thought to involve potentiation of GABAergic
neurotransmission resulting from binding at the benzodiazepine site of the
|ONFI is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older|
| •Somnolence or Sedation: Monitor for central nervous system (CNS) depression. Risk may be increased with concomitant use of other CNS depressants.
•Withdrawal: Symptoms may occur with rapid dose reduction or discontinuation. Discontinue ONFI gradually.
•Physical and psychological dependence: Patients with a history of substance abuse should be monitored for signs of habituation and dependence.
•Suicidal behavior and ideation: Monitor for suicidal thoughts or behaviors.
| Adverse reactions that occurred in at least 5% of ONFI-treated patients and more frequently than placebo included somnolence or sedation, drooling, constipation, cough, urinary tract infection, aggression, insomnia, dysarthria, and fatigue.
To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck Inc. at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
| DOSAGE AND ADMINISTRATION
•Patients ≤30 kg body weight: initiate therapy at 5 mg daily and titrate as tolerated up to 20 mg daily.
•Patients >30 kg body weight: initiate therapy at 10 mg daily and titrate as tolerated up to 40 mg daily.
•Doses above 5 mg/day should be administered in two divided doses.
•ONFI tablets can be administered whole, or crushed and mixed in applesauce.
•Reduce dose, or discontinue drug, gradually.
Dosage adjustment needed in the following groups:
| Tablet: 10 mg and 20 mg with a functional score
Oral Suspension: 2.5 mg/mL in 120 mL bottles
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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