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Generic Name: clobazam (KLOE-ba-zam)
Brand Name: Onfi

Onfi is used for:

Treating a certain type of seizure disorder (Lennox-Gastaut syndrome [LGS]). It is used along with other medicines. It may also be used for other conditions as determined by your doctor.

Onfi is a benzodiazepine. Exactly how it works is not understood, but it is thought to involve the action of a certain chemical (gamma-aminobutyric acid [GABA]) in the brain and nervous system.

Do NOT use Onfi if:

  • you are allergic to any ingredient in Onfi
  • you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Onfi:

Some medical conditions may interact with Onfi. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have glaucoma or increased pressure in the eye, liver or kidney problems, myasthenia gravis, or the blood disorder porphyria
  • if you have a history of lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD]), mood or mental problems (eg, depression), or suicidal thoughts or actions
  • if you have a history of alcohol or other substance abuse or dependence

Some MEDICINES MAY INTERACT with Onfi. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Clozapine, methadone, opioid pain medicines (eg, codeine), other benzodiazepines (eg, alprazolam), perampanel, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects, such as increased drowsiness, slow or shallow breathing, and confusion, may occur
  • Fluconazole, fluvoxamine, omeprazole, or ticlopidine because they may increase the risk of Onfi's side effects
  • Hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Onfi
  • Carbamazepine, hormonal birth control (eg, birth control pills), or tamoxifen because their effectiveness may be decreased by Onfi

This may not be a complete list of all interactions that may occur. Ask your health care provider if Onfi may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Onfi:

Use Onfi as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Onfi comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Onfi refilled.
  • Take Onfi by mouth with or without food.
  • Swallow Onfi whole. If you cannot swallow the tablet whole, you may crush it and mix it in applesauce. Swallow the mixture right away after mixing with the applesauce, followed by a glass of water. Do not store the mixture for future use.
  • If you miss a dose of Onfi, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Onfi.

Important safety information:

  • Onfi may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Onfi with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Onfi; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT change your dose or use more often than prescribed without checking with your doctor.
  • Do not suddenly stop taking Onfi without first talking with your doctor, especially if you have been taking Onfi regularly over a long period of time. You may have an increased risk of seizures or side effects (eg, mood changes, trouble sleeping). If you need to stop Onfi, your doctor may need to gradually lower your dose.
  • Carry an ID card at all times that says you have a seizure disorder and you take Onfi.
  • Patients who take Onfi may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Onfi closely. Contact your doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact your doctor right away if any signs of suicidal thoughts or actions occur.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Onfi and for 28 days after you stop taking it. To prevent pregnancy, use an extra nonhormonal form of birth control (eg, condoms). Talk with your doctor or pharmacist about effective birth control.
  • Tell your doctor or dentist that you take Onfi before you receive any medical or dental care, emergency care, or surgery.
  • Use Onfi with caution in the ELDERLY; they may be more sensitive to its effects.
  • Onfi should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Onfi may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Onfi while you are pregnant. Using Onfi late in pregnancy may increase the risk of breathing or feeding problems, very low body temperature, or withdrawal symptoms in the newborn. Onfi is found in breast milk. Do not breast-feed while using Onfi.

Some people who use Onfi for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Onfi suddenly, you may have WITHDRAWAL symptoms. These may include diarrhea, dry heaving, hallucinations, headache, irregular heartbeat, mental or mood problems (eg, anxiety, irritability, nervousness, panic attacks, restlessness), muscle pain and stiffness, nausea, seizures, stomach and muscle cramps, sweating, trouble concentrating or sleeping, tremor, weight loss, or vision changes (eg, blurred vision, sensitivity to light). Do not suddenly stop taking Onfi without first checking with your doctor.

Possible side effects of Onfi:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; drooling; drowsiness; sluggishness; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); appetite changes; confusion; decreased coordination; difficult or painful urination; difficulty breathing; fever, chills, or persistent cough or sore throat; hallucinations; new or worsening mental or mood changes (eg, agitation, aggressiveness, behavior changes, depression, irritability, rage, restlessness); red, swollen, blistered, or peeling skin; shortness of breath; speech problems; suicidal thoughts or actions; trouble sleeping; trouble swallowing; unusual bruising or bleeding; unusual tiredness or weakness; vision changes (eg, blurred vision, double vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; confusion; decreased coordination; fainting; severe drowsiness, dizziness, or light-headedness; slow or shallow breathing; sluggishness.

Proper storage of Onfi:

Store Onfi at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Onfi out of the reach of children and away from pets.

General information:

  • If you have any questions about Onfi, please talk with your doctor, pharmacist, or other health care provider.
  • Onfi is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Onfi or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Onfi. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Onfi. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Onfi.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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