What is the most important information I should know about clobazam?
Clobazam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol.
MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.
Some people have thoughts about suicide while taking seizure medicine. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.
Get emergency medical help if you have a severe skin reaction (skin pain, skin rash with blistering).
Do not stop using clobazam without asking your doctor. You may have increased seizures or life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use. Some withdrawal symptoms may last up to 12 months or longer.
Get medical help right away if you stop using clobazam and have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, or thoughts about suicide.
What is clobazam?
Clobazam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) that is used with other medications to treat seizures caused by Lennox-Gastaut syndrome, in people who are at least 2 years old.
Clobazam may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking clobazam?
You should not take clobazam if you are allergic to it.
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 seizure medicine. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.
If you use clobazam during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.
Do not start or stop seizure medication during pregnancy without your doctor's advice. Clobazam may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Preventing seizures may outweigh these risks. Tell your doctor right away if you become pregnant.
There may be other seizure medications that are safer to use during pregnancy.
Clobazam can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use a back-up barrier birth control to prevent pregnancy: 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.
Not approved for use by anyone younger than 2 years old.
How should I take clobazam?
Follow the directions on your prescription label and read all medication guides or instruction sheets. 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 addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.
You may take clobazam with or without food.
If you cannot swallow a tablet whole, 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). Measure a dose with the supplied measuring device (not a kitchen spoon).
Place the oral film on top of your tongue and allow it to dissolve.
Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.
Seizures may increase if you stop using clobazam suddenly. Do not stop using clobazam without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use.
Store at room temperature away from moisture and heat. Keep your medicine in a place where no one can use it improperly.
Throw away any unused oral suspension 90 days after you first opened the bottle.
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 should I avoid while taking clobazam?
Avoid drinking 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.
What are the possible side effects of clobazam?
Get emergency medical help if you have signs of an allergic reaction (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).
Clobazam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
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.
Call your doctor at once if you have:
- weak or shallow breathing;
- severe drowsiness, feeling like you might pass out; or
- problems with balance or muscle movement.
Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.
Common side effects may include:
- drowsiness, tiredness, trouble sleeping;
- slurred speech;
- anger, aggression;
- painful urination;
- fever, cough, breathing problems; or
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 clobazam?
Taking clobazam 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.
Other drugs may affect clobazam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Where can I get more information?
Your pharmacist can provide more information about clobazam.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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