Clobazam

Special Alert:

The U.S. Food and Drug Administration (FDA) is warning that the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). It may start as a rash but can quickly progress, resulting in injury to internal organs, the need for hospitalization, and even death. As a result, FDA is requiring warnings about this risk to be added to the prescribing information and patient Medication Guides for these medicines. This hypersensitivity reaction to these medicines is serious but rare. DRESS can include fever, rash, swollen lymph nodes, or injury to organs including the liver, kidneys, lungs, heart, or pancreas.

Talk to your doctor about any concerns you have regarding your treatment.

Clobazam may increase the risk of serious or life-threatening breathing problems, sedation, or coma if used along with certain medications. Tell your doctor if you are taking or plan to take: antidepressants; medications for anxiety, mental illness, and seizures; sedatives; sleeping pills; opioids such as codeine, fentanyl (Duragesic, Subsys), morphine (Astramorph, Kadian), or oxycodone (in Percocet, in Roxicet, others); or tranquilizers. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take clobazam with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care immediately: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Clobazam may be habit forming. Do not take a larger dose, take it more often, or for a longer time than your doctor tells you to. Tell your doctor if you have ever drunk large amounts of alcohol, if you use or have ever used street drugs, or have overused prescription medications. Do not drink alcohol or use street drugs during your treatment. Drinking alcohol or using street drugs during your treatment with clobazam also increases the risk that you will experience these serious, life-threatening side effects. Also tell your doctor if you have or have ever had depression or another mental illness.

Clobazam may cause a physical dependence (a condition in which unpleasant physical symptoms occur if a medication is suddenly stopped or taken in smaller doses), especially if you take it for several days to several weeks. Do not stop taking this medication or take fewer doses without talking to your doctor. Stopping clobazam suddenly can worsen your condition and cause withdrawal symptoms that may last for several weeks to more than 12 months. Your doctor probably will decrease your clobazam dose gradually. Call your doctor or get emergency medical treatment if you experience any of the following symptoms: unusual movements; ringing in your ears; anxiety; memory problems; difficulty concentrating; sleep problems; seizures; shaking; muscle twitching; changes in mental health; depression; burning or prickling feeling in hands, arms, legs or feet; seeing or hearing things that others do not see or hear; thoughts of harming or killing yourself or others; overexcitement; or losing touch with reality.

Clobazam is used with other medication(s) to control seizures in adults and children 2 years of age and older who have Lennox-Gastaut syndrome (a disorder that causes seizures and often causes developmental delays). Clobazam is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain.

Clobazam comes as a tablet and a suspension (liquid) to take by mouth, and as a film to apply on the tongue. It is usually taken once or twice a day, with or without food. Take clobazam at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

If you are unable to swallow the tablets whole, you may break them in half on the score mark or crush and mix them with a small amount of applesauce.

The liquid comes an adapter and two oral dosing syringes. Use only one of the two oral dosing syringes to measure your dose and save the second syringe. If the first oral syringe is damaged or lost, the second provided syringe may be used as a replacement.

To take the liquid, follow these steps:

1. Before the first use, uncap the bottle and firmly insert the adapter into the neck of the bottle until the adapter top is even with the bottle top. Do not remove the adapter during the period of time you are using this bottle.
2. Shake the liquid well before each use to mix the medication evenly.
3. To measure your dose, push the plunger of the syringe all the way down and insert the syringe into the adapter of the upright bottle. Then turn the bottle upside down and slowly pull the plunger back until the black ring is in line with your prescribed dose.
4. Remove the syringe from the bottle adapter and slowly squirt the liquid from the syringe into the corner of your mouth.
5. Place the bottle cap over the adapter after each use.
6. Wash the oral syringe after each use. To wash the syringe, remove the plunger completely, wash the barrel and plunger with soap and water, rinse, and allow to dry. Do not place the syringe parts in the dishwasher.

To take the film, follow these steps:

1. Open the foil pouch and remove the film. Be sure that your hands are dry and clean.
2. Place the film on the top of your tongue.
3. Close your mouth and swallow your saliva normally. Do not chew, spit, or talk while the film dissolves. Do not take with liquids.
4. Wash your hands.

If your doctor has told you to take more than one film per dose, wait until the first film has completely dissolved before applying the second film.

Your doctor will probably start you on a low dose of clobazam and gradually increase your dose, not more than once every week.

Some people may respond differently to clobazam based on their heredity or genetic makeup. Your doctor may order a blood test to help find the dose of clobazam that is best for you.

Clobazam may help control your condition but will not cure it. Continue to take clobazam even if you feel well. Do not stop taking clobazam without talking to your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with clobazam and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking clobazam,

• tell your doctor and pharmacist if you are allergic to clobazam, any other medications, or any of the ingredients in clobazam tablets, suspension, or film. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: antihistamines; dextromethorphan (Delsym, in Nuedexta, in Robitussin DM); fluconazole (Diflucan); fluvoxamine (Luvox); omeprazole (Prilosec, in Zegerid); or ticlopidine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with clobazam, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have or have ever had thoughts about harming or killing yourself, or planning or trying to do so or lung, kidney, or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you take clobazam regularly during the last few months of your pregnancy, your baby may experience withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, or diarrhea. If you become pregnant while taking clobazam, call your doctor.
• if you are using hormonal contraceptives (birth control pills, patches, rings, implants, injections, or intrauterine devices), you should know that this type of birth control may not work well when used with clobazam. Hormonal contraceptives should not be used as your only method of birth control while you are taking clobazam and for 28 days after your final dose. Talk to your doctor about nonhormonal birth control methods that will work for you.
• tell your doctor if you are breastfeeding. If you are breastfeeding while taking clobazam, tell your doctor if your baby is not feeding well or is extremely drowsy.
• talk to your doctor about the risks and benefits of taking this medication if you are 65 years of age or older. Older adults should receive low doses of clobazam because higher doses may not work better and may cause serious side effects.
• you should know that clobazam may make you drowsy and affect your thinking, ability to make decisions, and coordination. Do not drive a car, operate machinery, or do other dangerous activities until you know how this medication affects you.
• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking clobazam. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants, such as clobazam, to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); thinking about harming or killing yourself, or planning or trying to do so; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Clobazam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• problems with coordination
• difficulty speaking or swallowing
• drooling
• change in appetite
• vomiting
• constipation
• cough
• joint pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS or IMPORTANT WARNING sections, call your doctor immediately or get emergency medical treatment:

• difficult, painful, or frequent urination
• cough, difficulty breathing, fever
• sores in your mouth, rash, hives, peeling or blistering skin
• fever

Clobazam may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not open the foil pouch for the film until right before you are ready to use it. Store clobazam in a safe place so that no one else can take it accidentally or on purpose. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Store clobazam suspension (liquid) in an upright position. Do not use any remaining liquid more than 90 days after first opening the bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• drowsiness
• confusion
• lack of energy
• problems with coordination
• slow, shallow breathing
• decreased urge to breathe
• fainting
• blurred vision

Keep all appointments with your doctor.

Do not let anyone else take your medication. Clobazam is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Onfi^®
• Sympazan^®