Generic Name: Clozapine Orally Disintegrating Tablets (KLOE za peen)
Brand Name: FazaClo
- This medicine may lower the ability of your bone marrow to make white blood cells. This can lead to very bad and sometimes deadly infections. Use FazaClo (clozapine orally disintegrating tablets) only if your health problem has not been helped by other drugs or if you have planned to harm yourself in the past and have a chance of doing it again. You will need to have your blood work checked before, during, and after treatment is stopped. Do what the doctor tells you about blood tests while taking this medicine.
- This medicine may cause seizures in some people. The chance of seizures may be higher with higher doses or if you have ever had seizures. Use care when driving and doing other tasks or actions (like climbing and swimming) that may not be safe for you or others if you pass out.
- This medicine may raise the chance of a very bad and sometimes deadly heart problem (myocarditis). Call your doctor right away if you have a big weight gain, a heartbeat that does not feel normal, chest pain or pressure, 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 FazaClo. These problems can be deadly. Do not take more than you were told or raise your dose faster than you were told. Tell your doctor if you have heart problems or brain problems. Tell your doctor if you have lots of fluid loss or if you take drugs for high blood pressure.
- There is a higher chance of death in older adults who take this medicine for mental problems caused by dementia. Most of the deaths were linked to heart disease or infection. This medicine is not approved to treat mental problems caused by dementia.
- You may only get FazaClo through a special program. Talk with your doctor.
Uses of FazaClo:
- It is used to treat schizophrenia.
- It is used to treat problems with how one acts.
- It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take FazaClo?
- If you have an allergy to clozapine or any other part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have a low white blood cell count.
- If you have bone marrow disease.
- If you have any of these health problems: Low potassium or magnesium levels.
- If you have ever had a low white blood cell count when taking a drug before.
- If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
- If you are not able to get blood tests as you have been told by your doctor.
- If you are breast-feeding. Do not breast-feed while you take FazaClo.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take FazaClo with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take FazaClo?
- Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how FazaClo affects you.
- To lower the chance of feeling dizzy or passing out, rise slowly over a few minutes when sitting or lying down. Be careful climbing 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 you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Tell your doctor if you get 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.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- An unsafe heartbeat that is not normal (long QT on ECG) has happened with this medicine. Chest pain, heart attack, and sudden deaths have also rarely happened in people taking FazaClo. Talk with the doctor.
- You will need to have heart function tests while taking this medicine. Talk with the doctor.
- Blood clots have happened with FazaClo (clozapine orally disintegrating tablets). Tell your doctor if you have ever had a blood clot. Talk with your doctor.
- Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
- Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
- Dizziness, sleepiness, and feeling less stable may happen with this medicine. These may lead to falling. Broken bones or other health problems can happen from falling. Talk with the doctor.
- Very bad and sometimes deadly liver problems have happened with FazaClo. Call your doctor right away if you have 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.
- Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these strokes have been deadly. This drug is not approved to treat mental problems caused by dementia. Talk with your doctor.
- If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
- If you are 60 or older, use this medicine with care. You could have more side effects.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using FazaClo while you are pregnant.
- Taking this medicine in the third trimester of pregnancy may lead to muscle movements that cannot be controlled and withdrawal in the newborn. Talk with the doctor.
How is this medicine (FazaClo) best taken?
Use FazaClo as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take with or without food.
- To gain the most benefit, do not miss doses.
- Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
- Do not stop taking FazaClo all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this medicine, you will want to slowly stop it as ordered by your doctor.
- If you start or stop smoking, talk with your doctor. How much drug you take may need to be changed.
- Tell your doctor if you use caffeine products (for example, tea, coffee, cola) and chocolate. How much of FazaClo you take may need to be changed.
- This medicine can cause very bad and sometimes deadly stomach or bowel problems like very hard stools (constipation) or bowel block. To help avoid these problems, drink lots of noncaffeine liquids unless told to drink less liquid by your doctor. Laxatives may also help. Talk with your doctor.
- Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your tongue and let it melt. Water is not needed. Do not swallow it whole. You may chew the tablet.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
- If you miss 2 or more days of this medicine, call your doctor to find out how to restart.
See also: Dosage Information (in more detail)
What are some side effects that I need to call my doctor about right away?
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 doctor or get medical help right away if you have 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 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.
- 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.
- Feeling very tired or weak.
- Change in eyesight.
- A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
- Some people who take FazaClo may get a very bad muscle problem called tardive dyskinesia. The risk may be greater in older adults, mainly women. The chance that this will happen or that it will never go away is greater in people who take this medicine in higher doses or for a long time. Muscle problems may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or if you have muscle problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.
What are some other side effects of FazaClo?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Feeling sleepy.
- Hard stools (constipation).
- Dry mouth.
- Upset stomach or throwing up.
- Weight gain.
- Not able to sleep.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
See also: Side effects (in more detail)
If OVERDOSE is suspected:
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.
How do I store and/or throw out FazaClo?
- Store at room temperature. Do not refrigerate or freeze.
- Store in a dry place. Do not store in a bathroom.
- Protect from light.
- Store in pouch until ready for use.
- Use oral-disintegrating tablet right after opening. Throw away any part of opened pouch that is not used.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about FazaClo (clozapine orally disintegrating tablets), please talk with your 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 FazaClo. 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 FazaClo.
Review Date: September 6, 2017
More about FazaClo (clozapine)
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- Drug class: atypical antipsychotics