Onfi

Drug List

Onfi

Drug Name

Onfi (Clobazam)

Manufactured By

Lundbeck Inc.

Drug Savings

NPC's mission is your health. We recognize your need for help when you are applying for discount programs for your prescription medications. We consist of friendly and experienced advocates that not only know how these free and discount programs work, but are ready to help. We are available to take your call and answer any questions you may have as you search for the right program to fit your needs. We can also explain any supporting material you may need to provide as you apply for these programs. If for any reason you are denied, we also are experienced in the best appeals process with a high success rate.

NPC's mission is your health. We recognize your need for help when you are applying for discount programs for your prescription medications. We consist of friendly and experienced advocates that not only know how these free and discount programs work, but are ready to help. We are available to take your call and answer any questions you may have as you search for the right program to fit your needs. We can also explain any supporting material you may need to provide as you apply for these programs. If for any reason you are denied, we also are experienced in the best appeals process with a high success rate.

Treats Disease/Condition

Uses

ONFI (clobazam) CIV is a prescription medicine used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome in people 2 years of age or older.

How To Use

ONFI Tablet Oral Administration ONFI tablets can be taken with or without food. ONFI tablets can be administered whole, broken in half along the score, or crushed and mixed in applesauce. ONFI Oral Suspension Oral Administration ONFI oral suspension can be taken with or without food [see CLINICAL PHARMACOLOGY]. Shake ONFI Oral Suspension well before every administration. When administering the oral suspension, use only the oral dosing syringe provided with the product. Each carton includes two syringes, but only one syringe should be used for dosing. The second oral syringe is reserved as a replacement in case the first syringe is damaged or lost. Insert the provided adapter firmly into the neck of the bottle before first use and keep the adapter in place for the duration of the usage of the bottle. To withdraw the dose, insert the dosing syringe into the adapter and invert the bottle then slowly pull back the plunger to prescribed dose. After removing the syringe from the bottle adapter, slowly squirt ONFI Oral Suspension into the corner of the patient's mouth. Replace the cap after each use. The cap fits over the adapter when the adapter is properly placed. See ONFI Oral Suspension “Instructions for Use” for complete instruction on how to properly dose and administer the ONFI Oral Suspension. Dosage Adjustments In Geriatric Patients Plasma concentrations at any given dose are generally higher in the elderly: proceed slowly with dose escalation. The starting dose should be 5 mg/day for all elderly patients. Then titrate elderly patients according to weight, but to half the dose presented in Table 1, as tolerated. If necessary and based upon clinical response, an additional titration to the maximum dose (20 mg/day or 40 mg/day, depending on weight) may be started on day 21 [see Use in Specific Populations].

Side Effects

he most common side effects seen in patients taking ONFI include: sleepiness; drooling; constipation; cough; pain with urination; fever; acting aggressive, being angry or violent; difficulty sleeping; slurred speech; tiredness; and problems with breathing

Drug Interactions

ONFI is a weak CYP3A4 inducer. As some hormonal contraceptives are metabolized by CYP3A4, their effectiveness may be diminished when given with ONFI. Additional non-hormonal forms of contraception are recommended when using ONFI [see CLINICAL PHARMACOLOGY, PATIENT INFORMATION]. Drugs Metabolized By CYP2D6 ONFI inhibits CYP2D6. Dose adjustment of drugs metabolized by CYP2D6 may be necessary [see CLINICAL PHARMACOLOGY]. Effect Of Other Drugs On ONFI Strong And Moderate Inhibitors Of CYP2C19 Strong and moderate inhibitors of CYP2C19 may result in increased exposure to Ndesmethylclobazam, the active metabolite of clobazam. This may increase the risk of dose-related adverse reactions. Dosage adjustment of ONFI may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g., omeprazole) [see CLINICAL PHARMACOLOGY]. CNS Depressants And Alcohol Concomitant use of ONFI with other CNS depressants may increase the risk of sedation and somnolence [see WARNINGS AND PRECAUTIONS]. Alcohol, as a CNS depressant, will interact with ONFI in a similar way and also increases clobazam's maximum plasma exposure by approximately 50%. Therefore, caution patients or their caregivers against simultaneous use with other CNS depressant drugs or alcohol, and caution that the effects of other CNS depressant drugs or alcohol may be potentiated [see WARNINGS AND PRECAUTIONS]. Drug Abuse And Dependence Controlled Substance ONFI contains clobazam which is a Schedule IV controlled substance. Abuse ONFI can be abused in a similar manner as other benzodiazepines, such as diazepam. The pharmacological profile of ONFI is similar to that of other benzodiazepines listed in Schedule IV of the Controlled Substance Act, particularly in its potentiation of GABAergic transmission through its action on GABAA receptors, which leads to sedation and somnolence. The World Health Organization epidemiology database contains reports of drug abuse, misuse, and overdoses associated with clobazam. Drug abuse is the intentional non-therapeutic use of a drug, repeatedly or even sporadically, for its rewarding psychological or physiological effects. Dependence Dependence Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood levels of the drug, and/or administration of an antagonist. In clinical trials, cases of dependency were reported following abrupt discontinuation of ONFI. The risk of dependence is present even with use of ONFI at the recommended dose range over periods of only a few weeks. The risk of dependence increases with increasing dose and duration of treatment. The risk of dependence is increased in patients with a history of alcohol or drug abuse. Withdrawal Abrupt discontinuation of ONFI causes withdrawal symptoms. As with other benzodiazepines, ONFI should be withdrawn gradually [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS]. In ONFI clinical pharmacology trials in healthy volunteers, the most common withdrawal symptoms after abrupt discontinuation were headache, tremor, insomnia, anxiety, irritability, drug withdrawal syndrome, palpitations, and diarrhea [see WARNINGS AND PRECAUTIONS]. Other withdrawal reactions to clobazam reported in the literature include restlessness, panic attacks, profuse sweating, difficulty in concentrating, nausea and dry retching, weight loss, blurred vision, photophobia, and muscle pain and stiffness. In general, benzodiazepine withdrawal may cause seizures, psychosis, and hallucinations

In Case of Overdose

Overdose and intoxication with benzodiazepines, including ONFI, may lead to CNS depression, associated with drowsiness, confusion and lethargy, possibly progressing to ataxia, respiratory depression, hypotension, and, rarely, coma or death. The risk of a fatal outcome is increased in cases of combined poisoning with other CNS depressants, including alcohol. Management Of Overdosage The management of ONFI overdose may include gastric lavage and/or administration of activated charcoal, intravenous fluid replenishment, early control of airway and general supportive measures, in addition to monitoring level of consciousness and vital signs. Hypotension can be treated by replenishment with plasma substitutes and, if necessary, with sympathomimetic agents. The efficacy of supplementary administration of physostigmine (a cholinergic agent) or of flumazenil (a benzodiazepine antagonist) in ONFI overdose has not been assessed. The administration of flumazenil in cases of benzodiazepine overdose can lead to withdrawal and adverse reactions. Its use in patients with epilepsy is typically not recommended.

In Case of Missed Dose

Storage

Store tablets and oral suspension at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature.