Onfi 20 mg/1
clobazam · TABLET · Lundbeck Pharmaceuticals LLC
Onfi is a tablet containing clobazam at 20 mg/1, taken oral. Manufactured by Lundbeck Pharmaceuticals LLC.
Key Facts
- Brand Name
- Onfi
- Generic Name
- clobazam
- NDC Code (Product)
67386-315- Manufacturer
- Lundbeck Pharmaceuticals LLC
- Strength
- 20 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- NDA202067
- Drug Class
- Benzodiazepine [EPC]
- Marketing Start
- 12/10/2013
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ONFI ® (clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. ONFI is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For doses above 5 mg/day administer in two divided doses ( 2.1 ) Patients ≤30 kg body weight: Initiate at 5 mg daily and titrate as tolerated up to 20 mg daily ( 2.1 ) Patients >30 kg body weight: Initiate at 10 mg daily and titrate as tolerated up to 40 mg daily ( 2.1 ) Dosage adjustment needed in following groups: Geriatric patients ( 2.4 , 8.5 ) Known CYP2C19 poor metabolizers ( 2.5 ) Mild or moderate hepatic impairment; no information for severe hepatic impairment ( 2.7 , 8.8 ) Tablets: Administer whole, broken in half along the score, or crush and mix in applesauce ( 2.3 ) Measure prescribed amount of oral suspension using provided adapter and dosing syringe ( 2.3 ) Tablets and Oral suspension: Can be taken with or without food ( 2.3 ) 2.1 Dosing Information A daily dose of ONFI greater than 5 mg should be administered in divided doses twice daily; a 5 mg daily dose can be administered as a single dose. Dose patients according to body weight. Individualize dosing within each body weight group, based on clinical efficacy and tolerability. Each dose in Table 1 (e.g., 5 to 20 mg in ≤30 kg weight group) has been shown to be effective, although effective…
Contraindications
4 CONTRAINDICATIONS ONFI is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions [see Warnings and Precautions ( 5.6 , 5.7 )] . History of hypersensitivity to the drug or its ingredients ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Alcohol: Increases blood levels of clobazam by about 50% ( 7.2 ) Drugs metabolized by CYP2D6: Lower doses of these drugs may be required when used concomitantly with ONFI ( 7.3 ) Strong or Moderate CYP2C19 Inhibitors: Dosage adjustment of ONFI may be necessary ( 7.4 ) 7.1 Opioids The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites, and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation [see Warnings and Precautions ( 5.1 )] . 7.2 CNS Depressants and Alcohol Concomitant use of ONFI with other CNS depressants may increase the risk of sedation and somnolence [see Warnings and Precautions ( 5.4 )] . Alcohol, as a CNS depressant, will interact with ONFI in a similar way and also increases clobazam's maximum plasma exp…
Adverse Reactions
6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other sections of the labeling include the following: Risks from Concomitant Use with Opioids [see Warnings and Precautions ( 5.1 )] Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.2 )] Dependence and Withdrawal Reactions [see Warnings and Precautions ( 5.3 )] Potentiation of Sedation from Concomitant Use with Central Nervous System Depressants [see Warnings and Precautions ( 5.4 )] Somnolence or Sedation [see Warnings and Precautions ( 5.5 )] Serious Dermatological Reactions [see Contraindications ( 4 ), Warnings and Precautions ( 5.6 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.7 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.8) ] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions ( 5.9) ] Adverse reactions that occurred at least 10% more frequently than placebo in any ONFI dose included constipation, somnolence or sedation, pyrexia, lethargy, and drooling ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.…
Frequently Asked Questions
What is Onfi used for?
Onfi contains clobazam. It is a tablet taken oral. Consult your doctor for specific uses.
Is Onfi a controlled substance?
Yes, Onfi is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Onfi?
The generic name for Onfi is clobazam. There are 11 other brand versions of clobazam.
What is the NDC code for Onfi 20 mg/1?
The NDC (National Drug Code) for Onfi 20 mg/1 is 67386-315, listed by Lundbeck Pharmaceuticals LLC.