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Onfi

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Overview

What is Onfi?

Clobazam is a white or almost white, crystalline powder with a slightly bitter taste; is slightly soluble in water, sparingly soluble in ethanol, and freely soluble in methylene chloride. The melting range of clobazam is from 182ºC to 185ºC. The molecular formula is CHONCl and the molecular weight is 300.7.

Each ONFI tablet contains 10 mg or 20 mg of clobazam. Tablets also contain as inactive ingredients: modified corn starch, lactose monohydrate, magnesium stearate, silicon dioxide, and talc.

ONFI is also available for oral administration as an off-white suspension containing clobazam at a concentration of 2.5 mg/mL. Inactive ingredients include magnesium aluminum silicate, xanthan gum, citric acid monohydrate, disodium hydrogen phosphate dihydrate, simethicone emulsion, polysorbate 80, methylparaben, propylparaben, propylene glycol, sucralose, maltitol solution, berry flavor, purified water.



What does Onfi look like?



What are the available doses of Onfi?

Tablets: 10 mg and 20 mg with a functional score for oral administration.Each ONFI tablet is a white to off-white, oval tablet with a functional score on one side and either a "1" and "0" or a "2" and "0" debossed on the other side.

Oral Suspension: 2.5 mg/mL for oral administration. Each bottle contains 120 mL of an off-white suspension.

What should I talk to my health care provider before I take Onfi?

Pregnancy:  Based on animal data, may cause fetal harm ()

How should I use Onfi?

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

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 effectiveness increases with increasing dose . Do not proceed with dose escalation more rapidly than weekly, because serum concentrations of clobazam and its active metabolite require 5 and 9 days, respectively, to reach steady-state.


What interacts with Onfi?

Sorry No Records found


What are the warnings of Onfi?

Sorry No Records found


What are the precautions of Onfi?

Sorry No Records found


What are the side effects of Onfi?

Sorry No records found


What should I look out for while using Onfi?

ONFI is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death .


What might happen if I take too much Onfi?


How should I store and handle Onfi?

Each ONFI tablet contains 10 mg or 20 mg of clobazam and is a white to off-white, oval tablet with a functional score on one side and either a "1" and "0" or a "2" and "0" debossed on the other side.NDC 67386-314-01: 10 mg scored tablet, Bottles of 100 NDC 67386-315-01: 20 mg scored tablet, Bottles of 100ONFI oral suspension is a berry flavored off-white liquid supplied in a bottle with child-resistant closure.  The oral suspension is packaged with a dispenser set which contains two calibrated oral dosing syringes and a bottle adapter.  Store and dispense ONFI oral suspension in its original bottle in an upright position.  Use within 90 days of first opening the bottle, then discard any remainder. NDC 67386-313-21: 2.5 mg/mL supplied in a bottle containing 120 mL of suspension.Store tablets and oral suspension at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature.Each ONFI tablet contains 10 mg or 20 mg of clobazam and is a white to off-white, oval tablet with a functional score on one side and either a "1" and "0" or a "2" and "0" debossed on the other side.NDC 67386-314-01: 10 mg scored tablet, Bottles of 100 NDC 67386-315-01: 20 mg scored tablet, Bottles of 100ONFI oral suspension is a berry flavored off-white liquid supplied in a bottle with child-resistant closure.  The oral suspension is packaged with a dispenser set which contains two calibrated oral dosing syringes and a bottle adapter.  Store and dispense ONFI oral suspension in its original bottle in an upright position.  Use within 90 days of first opening the bottle, then discard any remainder. NDC 67386-313-21: 2.5 mg/mL supplied in a bottle containing 120 mL of suspension.Store tablets and oral suspension at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature.Each ONFI tablet contains 10 mg or 20 mg of clobazam and is a white to off-white, oval tablet with a functional score on one side and either a "1" and "0" or a "2" and "0" debossed on the other side.NDC 67386-314-01: 10 mg scored tablet, Bottles of 100 NDC 67386-315-01: 20 mg scored tablet, Bottles of 100ONFI oral suspension is a berry flavored off-white liquid supplied in a bottle with child-resistant closure.  The oral suspension is packaged with a dispenser set which contains two calibrated oral dosing syringes and a bottle adapter.  Store and dispense ONFI oral suspension in its original bottle in an upright position.  Use within 90 days of first opening the bottle, then discard any remainder. NDC 67386-313-21: 2.5 mg/mL supplied in a bottle containing 120 mL of suspension.Store tablets and oral suspension at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature.Each ONFI tablet contains 10 mg or 20 mg of clobazam and is a white to off-white, oval tablet with a functional score on one side and either a "1" and "0" or a "2" and "0" debossed on the other side.NDC 67386-314-01: 10 mg scored tablet, Bottles of 100 NDC 67386-315-01: 20 mg scored tablet, Bottles of 100ONFI oral suspension is a berry flavored off-white liquid supplied in a bottle with child-resistant closure.  The oral suspension is packaged with a dispenser set which contains two calibrated oral dosing syringes and a bottle adapter.  Store and dispense ONFI oral suspension in its original bottle in an upright position.  Use within 90 days of first opening the bottle, then discard any remainder. NDC 67386-313-21: 2.5 mg/mL supplied in a bottle containing 120 mL of suspension.Store tablets and oral suspension at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature.Each ONFI tablet contains 10 mg or 20 mg of clobazam and is a white to off-white, oval tablet with a functional score on one side and either a "1" and "0" or a "2" and "0" debossed on the other side.NDC 67386-314-01: 10 mg scored tablet, Bottles of 100 NDC 67386-315-01: 20 mg scored tablet, Bottles of 100ONFI oral suspension is a berry flavored off-white liquid supplied in a bottle with child-resistant closure.  The oral suspension is packaged with a dispenser set which contains two calibrated oral dosing syringes and a bottle adapter.  Store and dispense ONFI oral suspension in its original bottle in an upright position.  Use within 90 days of first opening the bottle, then discard any remainder. NDC 67386-313-21: 2.5 mg/mL supplied in a bottle containing 120 mL of suspension.Store tablets and oral suspension at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature.Each ONFI tablet contains 10 mg or 20 mg of clobazam and is a white to off-white, oval tablet with a functional score on one side and either a "1" and "0" or a "2" and "0" debossed on the other side.NDC 67386-314-01: 10 mg scored tablet, Bottles of 100 NDC 67386-315-01: 20 mg scored tablet, Bottles of 100ONFI oral suspension is a berry flavored off-white liquid supplied in a bottle with child-resistant closure.  The oral suspension is packaged with a dispenser set which contains two calibrated oral dosing syringes and a bottle adapter.  Store and dispense ONFI oral suspension in its original bottle in an upright position.  Use within 90 days of first opening the bottle, then discard any remainder. NDC 67386-313-21: 2.5 mg/mL supplied in a bottle containing 120 mL of suspension.Store tablets and oral suspension at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

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 GABA receptor.

Non-Clinical Toxicology
ONFI is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death .

Concomitant use of benzodiazepines, including ONFI, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe ONFI concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when ONFI is used with opioids

Clinically significant adverse reactions that appear in other sections of the labeling include the following:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).