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ONFITM (clobazam)

Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back    |    New drug index   ]
DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED < Anticonvulsant sectionled
PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  
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(DESCRIPTION) top of page

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

Description
Proprietary Name: ONFITM
Established Name: Clobazam
Dosage Form: Tablet
Route of Administration: Oral
Pharmacologic Class of Drug: Antiepileptic drug of the benzodiazepine class
Chemical Name: 7-Chloro-1-methyl-5-phenyl-1H-1,5 benzodiazepine-2,4(3H,5H)-dione

Drug UPDATES
ONFI® (clobazam) tablets, for oral use, CIV;  ONFI® (clobazam) oral suspension, CIV

[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)
ABBREVIATED MONOGRAPH - SEE PACKAGE INSERT.




CLINICAL PHARMACOLOGY: top of page

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
GABAA receptor.

INDICATIONS AND USAGE  top of page

ONFI is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older

CONTRAINDICATIONS top of page

None

PRECAUTIONS top of page

•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 top of page

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  top of page

DOSAGE AND ADMINISTRATION
•Patients leq30 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:
•Geriatric patients
•Known CYP2C19 poor metabolizers
•Mild or moderate hepatic impairment; no information for severe hepatic impairment

HOW SUPPLIED top of page

Tablet: 10 mg and 20 mg with a functional score
Oral Suspension: 2.5 mg/mL in 120 mL bottles


REFERENCE

Package Insert data: 

Manufactured by: Catalent Pharma Solutions, LLC Winchester, KY 40391, U.S.A. For: Lundbeck Inc. Deerfield, IL 60015, U.S.A.
™ Trademark of Lundbeck Inc.
October 2011
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