Clozaril; FazaClo; Versacloz
AA-Clozapine; Clozaril; Gen-Clozapine
- This drug may lower the ability of the bone marrow to make white blood cells. This can lead to very bad and sometimes deadly infections. Your child will need to have his/her blood work checked before care, during care, and for at least 4 weeks after this drug is stopped. Do what the doctor tells you about blood tests while your child is taking this drug.
- This drug may cause seizures in some people. The chance of seizures may be higher with higher doses or if your child has ever had seizures. Have your child use care when doing tasks or actions (like climbing and swimming) that may not be safe for your child or others if your child were to pass out.
- This drug may raise the chance of a very bad and sometimes deadly heart problem (myocarditis). Most of the time, these heart problems have happened within the first 2 months of care but may happen at anytime. Call the doctor right away if your child has a big weight gain, a heartbeat that does not feel normal, chest pain or pressure, a fast heartbeat, fever, flu-like signs, shortness of breath, swelling in the arms or legs, or very bad dizziness or passing out.
- Low blood pressure, passing out, slow heartbeat, and heart attacks have happened with this drug. These problems can be deadly. The chance of these problems is highest when this drug is first started. Do not give your child more than you were told or raise your child’s dose faster than you were told. Tell the doctor if your child has heart problems (like if your child has ever had a heart attack, blood vessel problems, heart failure, or a heartbeat that is not normal) or brain problems. Tell the doctor if your child has fluid loss (dehydrated) or if your child takes drugs for high blood pressure.
- There is a higher chance of death in older adults who take this drug for mental problems caused by dementia. Most of the deaths were linked to heart disease or infection. This drug is not approved to treat mental problems caused by dementia.
- Your child may only get this drug through a special program. Talk with the doctor.
- It is used to treat problems with how one acts.
- It is used to treat schizophrenia.
- It may be given to your child for other reasons. Talk with the doctor.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child has any of these health problems: Low potassium levels, low magnesium levels, or low white blood cell count.
- If your child has bone marrow disease, talk with the doctor.
- If your child has ever had a low white blood cell count when taking a drug before.
- If your child is taking any drugs that stop the bone marrow from making some of the cells that the body needs. There are many drugs that can do this. Ask the doctor or pharmacist if you are not sure.
- If your child is not able to get blood tests as you have been told by your child’s doctor.
If your child is breast-feeding a baby:
- Be sure your child does not breast-feed a baby while taking this drug.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
- High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These changes may raise the chance of heart and brain blood vessel disease. Talk with the doctor.
- If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- Talk with the doctor before giving your child other drugs and natural products that may slow your child’s actions.
- If your child smokes or will be stopping smoking, talk with the doctor. How much drug your child takes may need to be changed.
- Blood clots have happened with this drug. Tell the doctor if your child has ever had a blood clot.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- An unsafe heartbeat that is not normal (long QT on ECG) has happened with this drug. Chest pain, heart attack, and sudden deaths have also rarely happened in people taking this drug. Talk with the doctor.
- Have your child get a heart function test as you have been told by the doctor. Talk with the doctor.
- Tell the doctor if your child uses caffeine products like tea, coffee, cola, and chocolate. How much drug your child takes may need to be changed.
- Have your child be careful in hot weather or while your child is being active. Have your child drink lots of fluids to stop fluid loss.
- This drug can cause very bad and sometimes deadly stomach or bowel problems like very hard stools (constipation) or bowel block. To help avoid these problems, have your child drink lots of noncaffeine liquids unless told to drink less liquid by the doctor. Laxatives may also help. Talk with your child’s doctor.
- This drug may cause weight gain. Your child’s weight may need to be checked often.
- Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of signs of withdrawal. If your child needs to stop this drug, you will want to slowly stop it as ordered by the doctor.
- Dizziness, sleepiness, and feeling less stable may happen with this drug. These may lead to falling. Broken bones or other health problems can happen from falling. Talk with the doctor.
If your child is pregnant:
- Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
- Taking this drug in the third trimester of pregnancy may lead to muscle movements that cannot be controlled and withdrawal in the newborn. Talk with the doctor.
- If your child has phenylketonuria (PKU), talk with your child’s doctor. Some products have phenylalanine.
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
- Shakiness, trouble moving around, or stiffness.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Swelling, warmth, numbness, change of color, or pain in a leg or arm.
- Coughing up blood.
- Blue or very pale skin in the arms or legs.
- Very bad headache.
- Feeling very tired or weak.
- Feeling confused.
- Slow heartbeat.
- Very hard stools (constipation).
- Change in eyesight.
- A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your child’s doctor right away if your child has any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or is sweating a lot.
- Some people who take this drug may get a very bad muscle problem called tardive dyskinesia. This muscle problem may not go away even if this drug is stopped. Sometimes, signs may lessen or go away over time after this drug is stopped. The risk of tardive dyskinesia may be greater in people with diabetes and in older adults, especially older women. The risk is also greater the longer your child takes this drug or with higher doses. Muscle problems may also occur after short-term use with low doses. Call your child’s doctor right away if your child has trouble controlling body movements or if your child has muscle problems with his/her tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.
- Very bad and sometimes deadly liver problems have happened with this drug. Call your child’s doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
- Feeling sleepy.
- Hard stools (constipation).
- Dry mouth.
- Upset stomach or throwing up.
- Weight gain.
- Not able to sleep.
- Sweating a lot.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.
Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
- Give this drug with or without food.
- To gain the most benefit, do not miss giving your child doses.
- Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
- Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your child’s tongue and let it melt. Water is not needed. Do not let your child swallow it whole. Your child may chew the tablet.
- Shake well before use.
- Measure liquid doses carefully. Use the measuring device that comes with this drug.
- Give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses or extra doses.
- If you miss giving your child this drug for 2 or more days, call your child’s doctor to find out how to restart.
- Store at room temperature. Do not refrigerate or freeze.
- Store in a dry place. Do not store in a bathroom.
- Protect from light.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- Store in pouch until ready for use.
- Give oral-disintegrating tablet right after opening. Throw away any part of opened pouch that is not used.
- Throw away any part not used 100 days after opening the first time.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
© 2018 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.