MEDICATION GUIDE
Clozapine (kloe′ za peen) Tablets, USP
for oral use
What is the most important information I should know about clozapine tablets?
Clozapine tablets can cause serious side effects including:
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Severe neutropenia (low white blood cell (WBC) counts) that can lead to serious infections and death. Your healthcare provider will do WBC blood tests before starting treatment with clozapine tablets and weekly for the first 6 months. After your first 6 months of treatment, your healthcare provider will determine how frequent you will have blood tests. If you have symptoms of severe neutropenia or an infection, your healthcare provider will do more frequent WBC blood test(s) to check if clozapine tablets are causing your symptoms and may send you to see a blood specialist (hematologist). Tell your health care provider right away if you have any of the following symptoms or signs of neutropenia or infection:
- ofeel like you have the flu
- owounds that take a long time to heal
- ofever or chills
- oskin, throat, vaginal, urinary tract, or lung infection
- ofeel extremely tired or weak
- opain or burning while peeing
- osores or ulcers inside your mouth, gums, or on your skin
- ounusual vaginal discharge or itching
- osores or pain in or around your rectal area
- oabdominal pain or bloating
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Orthostatic hypotension (decreased blood pressure), bradycardia (slow heart rate), or syncope (fainting) that can lead to death. You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Tell your healthcare provider right away if you feel dizzy or pass out.
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Seizures. See “What should I avoid while taking clozapine tablets?”
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Myocarditis (heart muscle inflammation), pericarditis (inflammation of outer layer of the heart) and cardiomyopathy (heart muscle weakness) that can lead to death. Symptoms of myocarditis, pericarditis, and cardiomyopathy include:
- ochest pain
- oflu-like symptoms
- ofast heartbeat or palpitations
- ofeel tired or faint
- oshortness of breath
- oswollen legs, ankles, or feet
- ofever
- • Increased risk of death in elderly people with dementia-related psychosis. Medicines like clozapine tablets can increase the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and dementia. Clozapine tablets are not for treatment of elderly people with dementia-related psychosis.
What are clozapine tablets?
Clozapine tablets are a prescription antipsychotic medicine used to treat people:
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•Who are severely ill with schizophrenia not helped by other schizophrenia medicines
- •With schizophrenia or schizoaffective disorder who have been suicidal and may be at risk of suicidal behavior again
It is not known if clozapine tablets are safe and effective in children.
Who should not take clozapine tablets? Do not take clozapine tablets if you:
- •are allergic to clozapine or any of the ingredients in clozapine tablets. See the end of this Medication Guide for a complete list of ingredients in clozapine tablets.
Before taking clozapine tablets, tell your healthcare provider about all your medical conditions, including if you:
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•have or have had heart problems or a family history of heart problems including heart attack, heart failure, abnormal heart rhythm or long QT syndrome, or stroke
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•have or have had low or high blood pressure
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•have or have had kidney or liver problems
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•have or have had seizures (convulsions)
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•have or have had stomach or intestinal problems including constipation, slow emptying of your stomach, or diarrhea
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•have or have had low levels of potassium or magnesium in your blood
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•have or have had diabetes or high blood sugar in you or your family
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•have or have had high levels of total cholesterol, “bad” cholesterol (LDL-C), or triglycerides, or low levels of “good” cholesterol (HDL-C)
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•have increased pressure in your eyes (glaucoma), an enlarged prostate, or problems passing urine
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•have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
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•smoke tobacco
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•plan to stop smoking tobacco while taking clozapine tablets
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•use products containing caffeine
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•are pregnant or plan to become pregnant. Talk to your healthcare provider if you become pregnant while taking clozapine tablets.
- oIf you become pregnant while receiving clozapine tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
- •are breast feeding or plan to breast feed. Clozapine can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take clozapine tablets.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
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•Clozapine tablets and other medicines may affect each other causing side effects.
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•Your healthcare provider can tell you if it is safe to take clozapine tablets with your other medicines. Do not start or stop any medicines while taking clozapine tablets without talking to your healthcare provider first.
- •Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take clozapine tablets?
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•Take clozapine tablets exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking clozapine tablets unless your healthcare provider tells you to. Talk to your healthcare provider or pharmacist if you are not sure how to take clozapine tablets.
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•Take clozapine tablets with or without food.
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•If you miss taking clozapine tablets for 1 day or more, call your healthcare provider right away. Do not take 2 doses at the same time unless your healthcare provider tells you to.
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•If you take too much (overdose) clozapine, call your healthcare provider or the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Symptoms of clozapine tablets overdose can include:
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•feeling sleepy
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•fast or irregular heartbeat
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•having a lot of saliva in your mouth
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•confusion
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•low blood pressure
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•seizures
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•coma
- •shallow or difficult breathing
What should I avoid while taking clozapine tablets?
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•You should not drink alcohol while taking clozapine tablets because it can increase your chances of getting serious side effects.
- •Do not drive, operate machinery, swim, climb, or do dangerous activities until you know how clozapine tablets affect you.
What are the possible side effects of clozapine tablets?
Clozapine tablets can cause serious side effects, including:
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•See "What is the most important information I should know about clozapine tablets?"
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falls. Clozapine tablets may make you sleepy, dizzy, may cause a decrease in your blood pressure when changing positions, and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
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slow emptying of your stomach and intestines (decreased gastric motility). Severe constipation and bowel problems can happen and can lead to hospitalization, surgery, and death. You may not feel or be aware of constipation symptoms. Your healthcare provider will examine you for possible bowel problems. Tell your healthcare provider if you get any signs and symptoms of decreased gastrointestinal motility during treatment with clozapine tablets, including:
Staying well hydrated, increasing physical activity, and taking fiber during treatment with clozapine tablets can help prevent constipation and other bowel problems. Your healthcare provider may prescribe medicines to prevent severe problems.
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high count of a certain white blood cell (eosinophilia). Clozapine tablets can cause a high count of eosinophils in some people and can be serious. This is a different risk than the risk of clozapine tablets causing an abnormally low white blood cell count (neutropenia). Your health care provider may send you to see an internal medicine specialist (internist) or blood specialist (hematologist). Tell your healthcare provider right away if you have any of these symptoms:
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serious heart rhythm problems (QTc Interval Prolongation) that can cause death. Your healthcare provider will do a physical exam and may obtain blood tests and an electrocardiogram before starting you on treatment with clozapine tablets. Tell your healthcare provider right away if you have any of these symptoms:
- opassing out or feeling like you will pass out
- odizziness
- ofeeling as if your heart is pounding or missing beats
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problems with your metabolism such as:
- o high blood sugar (hyperglycemia) or diabetes. Increases in blood sugar can happen in some people who take clozapine tablets. Extremely high blood sugar can lead to coma and death. If you have diabetes or risk factors for diabetes (such as being overweight), your health care provider should check your blood sugar before you start clozapine tablets and during treatment. Tell your healthcare provider if you have any of these symptoms of high blood sugar while taking clozapine tablets:
- ofeel very thirsty
- ofeel very hungry
- ofeel sick to your stomach
- oneed to urinate more than usual
- ofeel weak or tired
- ofeel confused, or your breath smells fruity
- o increased fat levels (cholesterol and triglycerides) in your blood (dyslipidemia). Your healthcare provider should check the fat levels in your blood before you start and during treatment with clozapine tablets.
- o weight gain. You and your healthcare provider should check your weight regularly.
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neuroleptic malignant syndrome (NMS). NMS is a rare but serious condition that can lead to death and must be treated in a hospital. Tell your healthcare provider right away if you become severely ill and have any of these symptoms:
- ohigh fever
- oconfusion
- oincreased sweating
- ostiff muscles
- ochanges in breathing, heartbeat, and blood pressure
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liver problems. Clozapine tablets can cause serious life-threatening liver problems that can lead to death. Tell your healthcare provider right away if you have any of these symptoms:
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fever. Some people may have a fever while they take clozapine tablets. If you have a fever, your healthcare provider will do blood tests to check for neutropenia or an infection. Your healthcare provider may also send you to see a blood specialist (hematologist). Tell your healthcare provider if you have a fever.
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blood clot in your lung (pulmonary embolism) or in the veins of your legs (deep vein thrombosis). Get emergency help right away if you have symptoms of a blood clot including:
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a problem that includes dry mouth, increased sweating, increased pulse rate, constipation, and urinary retention (anticholinergic toxicity).
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problems thinking clearly and moving your body. See “What should I avoid while taking clozapine tablets?”
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uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia). Tardive dyskinesia may not go away, even if you stop clozapine tablets. Tardive dyskinesia may also start after you stop taking clozapine tablets.
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stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.
The most common side effects of clozapine tablets include:
- osleepiness or drowsiness
- oheadache
- odizziness
- oshaking movements (tremors)
- oheart and blood vessel problems
- olow blood pressure
- ofast heartbeat
- ohaving a lot of saliva in your mouth
- opassing out (syncope)
- odry mouth
- oincreased sweating
- oconstipation and nausea
- ovision problems
- ofever
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•These are not all the possible side effects of clozapine tablets.
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•Your healthcare provider may lower your dose or temporarily or permanently stop treatment with clozapine tablets if you have certain symptoms or if your WBC count is low.
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•Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
- •You may report side effects to FDA at 1-800-FDA-1088.
How should I store clozapine tablets?
- •Store clozapine tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Keep clozapine tablets and all medicines out of the reach of children.
General information about the safe and effective use of clozapine tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use clozapine tablets for a condition for which it was not prescribed. Do not give clozapine tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider (including pharmacist) for information about clozapine tablets that is written for health professionals.
What are the ingredients in clozapine tablets?
Active ingredients: clozapine
Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone, and talc.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India
Packaged and Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268 USA
Refer to package label for Distributor's NDC Number