Generic name: clobazam (KLOE ba zam)
Brand name: Onfi
Drug class: Benzodiazepine anticonvulsants
Onfi (clobazam) benzodiazepine (ben-zoe-dye-AZE-eh-peen). It is thought that clobazam works by enhancing the activity of certain neurotransmitters in the brain.
Onfi is used in combination with other medications to treat seizures caused by Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.
Onfi in for use in patients 2 years of age or older. It is not known if this medicine is safe and effective in children less than 2 years old.
Warnings
Do not stop using Onfi suddenly, or you could have increased seizures or unpleasant withdrawal symptoms.
Clobazam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.
MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Before taking this medicine
You should not take Onfi if you are allergic to clobazam.
To make sure Onfi is safe for you, tell your doctor if you have ever had:
- breathing problems or lung disease;
- depression, mood problems, or suicidal thoughts or behavior;
- a drug or alcohol addiction; or
- liver or kidney disease.
Some people have thoughts about suicide while taking clobazam. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
If you use Onfi while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.
Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of clobazam on the baby.
Onfi can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using clobazam, use a back-up barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using birth control for at least 28 days after your last dose of clobazam.
If you are breastfeeding, tell your doctor if you notice drowsiness or feeding problems in the nursing baby.
Onfi should not be given to a child younger than 2 years old.
How should I take Onfi?
Take Onfi exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Never use clobazam in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.
Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
You may take Onfi with or without food.
If you cannot swallow a tablet whole, you may break it in half or crush it and mix the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.
Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
To use the oral film, place it on the top of your tongue. Swallow several times as the film dissolves, without drinking liquid.
Clobazam doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.
Do not stop using Onfi suddenly, even if you feel fine. Stopping suddenly may cause increased seizures or unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.
Tell your doctor if your seizures get worse or you have them more often while taking Onfi.
Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Dosing information
Usual Adult Dose for Lennox-Gastaut Syndrome:
Initial daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight 30 kg or more: 10 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight 30 kg or more: 20 mg orally per day
Day 14 daily dose:
-Body weight 30 kg or less: 20 mg orally per day
-Body weight 30 kg or more: 40 mg orally per day
Use: Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
Usual Geriatric Dose for Lennox-Gastaut Syndrome:
Initial dose: 5 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight 30 kg or more: 10 mg orally per day
Day 14 daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight 30 kg or more: 20 mg orally per day
Maximum dose:
-Body weight 30 kg or less: 20 mg/day
-Body weight 30 kg or more: 40 mg/day
Use: Adjunctive treatment of seizures associated with LGS
Usual Pediatric Dose for Lennox-Gastaut Syndrome:
2 years or older:
Initial daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight 30 kg or more: 10 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight 30 kg or more: 20 mg orally per day
Day 14 daily dose:
-Body weight 30 kg or less: 20 mg orally per day
-Body weight 30 kg or more: 40 mg orally per day
Use: Adjunctive treatment of seizures associated with LGS
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of clobazam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.
Overdose symptoms may include extreme drowsiness or weakness, confusion, slow breathing, or loss of consciousness.
What to avoid
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Onfi side effects
Get emergency medical help if you have signs of an allergic reaction to Onfi (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Clobazam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have weak or shallow breathing, if you are hard to wake up, or if you stop breathing.
Call your doctor at once if you have:
- severe drowsiness, feeling like you might pass out;
- unusual changes in mood or behavior;
- aggression, thoughts of hurting yourself; or
- problems with balance or muscle movement.
The sedative effects of clobazam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking this medicine.
Common Onfi side effects may include:
- constipation;
- drowsiness, lack of energy;
- fever; or
- drooling.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Onfi?
Taking Onfi with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Tell your doctor about all your other medicines, especially:
- cold or cough medicine that contains dextromethorphan;
- antifungal medicine; or
- a stomach acid reducer (such as Nexium or Prilosec).
This list is not complete. Other drugs may interact with clobazam, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.