Clozaril

Pronunciation

Generic Name: clozapine (KLOE za peen)
Brand Names: Clozaril, FazaClo, Clopine, CloZAPine Synthon, Denzapine, Zaponex

What is Clozaril?

Clozaril (clozapine) is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Clozaril is used to treat severe schizophrenia, or to reduce the risk of suicidal behavior in people with schizophrenia or similar disorders.

Clozaril may also be used for purposes not listed in this medication guide.

Important information

Serious and sometimes fatal infections may occur during treatment with Clozaril. Call your doctor right away if you have signs of infection such as: sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, and trouble swallowing.

Clozaril is not for use in psychotic conditions related to dementia. Clozaril may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

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You should not take Clozaril if you have untreated or uncontrolled epilepsy, a bone marrow disorder, paralytic ileus or intestinal blockage, a history of infection caused by taking Clozaril, or if you are also using drugs that weaken your immune system (such as cancer medicine or steroids).

Clozaril can lower blood cells that help your body fight infections. This can make it easier for you to develop a serious or life-threatening infection. Your blood will need to be tested often.

Clozaril may impair your thinking or reactions, and may cause seizures (black-out or convulsions). Be careful if you drive or do anything that requires you to be alert.

Before taking this medicine

Clozaril is not for use in psychotic conditions related to dementia. Clozaril may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not take Clozaril if you are allergic to clozapine, or if you have:

  • untreated or uncontrolled epilepsy;

  • a bone marrow disorder;

  • paralytic ileus or intestinal blockage;

  • a history of infection caused by taking clozapine; or

  • if you are also using drugs that weaken your immune system (such as cancer medicine or steroids).

To make sure Clozaril is safe for you, tell your doctor if you have:

  • heart disease or prior heart attack, or a personal or family history of Long QT syndrome;

  • weak immune system (caused by disease or by using certain medicine);

  • epilepsy or other seizure disorder, or a history of head injury or brain tumor;

  • lung disease;

  • diabetes, or risk factors such as being overweight or having a family history of diabetes;

  • liver or kidney disease;

  • high cholesterol or triglycerides;

  • an enlarged prostate or urination problems;

  • glaucoma; or

  • if you smoke.

FDA pregnancy category B. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking Clozaril, do not stop taking it without your doctor's advice.

Clozaril can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking Clozaril.

How should I take Clozaril?

Take Clozaril exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Clozaril can be taken with or without food.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Clozaril.

The orally-disintegrating tablet (FazaClo) can be taken without water. Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet. Use dry hands to remove the tablet and place it in your mouth. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

If your doctor has prescribed one-half of an orally-disintegrating tablet, you will need to break the tablet in half. Throw the other half away. Do not save it for later use.

Clozaril can lower blood cells that help your body fight infections, especially in women and older adults, and in people who are malnourished or have serious medical problems. This can make it easier for you to develop a serious or life-threatening infection. Your blood will need to be tested often. Your future treatments may be delayed based on the results of these tests.

If you need surgery, tell the surgeon ahead of time that you are using Clozaril. You may need to stop using the medicine for a short time.

You should not stop using Clozaril suddenly or you could have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

If you stop taking Clozaril for more than 2 days in a row, call your doctor before you start taking it again.

Clozaril can have long lasting effects on your body. You may need frequent medical tests for a short time after you stop using this medication.

Store Clozaril at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Clozaril may impair your thinking or reactions, and may cause seizures (black-out or convulsions). Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase some of the side effects of Clozaril.

Clozaril side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Clozaril: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with Clozaril. Call your doctor right away if you have signs of infection such as:

  • sudden weakness or ill feeling;

  • fever, chills, sore throat; or

  • mouth sores, red or swollen gums, and trouble swallowing.

Stop using Clozaril and call your doctor at once if you have:

  • skin rash, easy bruising or bleeding, severe tingling, numbness, pain, muscle weakness;

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

  • sudden cough, wheezing, rapid breathing, coughing up blood;

  • seizure (black-out or convulsions);

  • a light-headed feeling, like you might pass out;

  • feeling short of breath (even while lying down or with mild exertion), swelling in your hands or feet;

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors;

  • tight feeling in your neck or jaw, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

  • little or no urinating;

  • high blood sugar (increased thirst, increased urination, hunger, fruity breath odor, dry skin, weight loss);

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • slow heart rate, weak pulse, slow breathing (breathing may stop).

Common Clozaril side effects may include:

  • weight gain;

  • constipation;

  • dry mouth, blurred vision;

  • drooling, especially at night; or

  • drowsiness, dizziness, spinning sensation.

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.

See also: Side effects (in more detail)

Clozaril Dosing Information

Usual Adult Dose of Clozaril for Schizophrenia:

Treatment resistant schizophrenia:
Initial dose: 12.5 mg orally once or twice a day.
Maintenance dose: If the first dose is well- tolerated, dosages may then be titrated in daily increments of 25 mg to 50 mg for approximately two weeks until a daily dose of 300 to 450 mg is achieved. If, after the initial titration, a larger dose is necessary a slower increase in dose, not to exceed a 100 mg increment once or twice a week, may be initiated. Cautious titration and a divided dosage schedule may minimize the risks of hypotension, seizure, and sedation in the patient. However, sedation following daytime doses may necessitate administration of most or all of the daily dose at bedtime.
Maximum dose: 900 mg per day.

Reduction of the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder:
Initial dose: 12.5 mg orally once or twice a day.
Maintenance dose: If the first dose is well- tolerated, dosages may then be titrated in daily increments of 25 mg to 50 mg for approximately two weeks until a daily dose of 300 to 450 mg is achieved. If, after the initial titration, a larger dose is necessary a slower increase in dose, not to exceed a 100 mg increment once or twice a week, may be initiated. Cautious titration and a divided dosage schedule may minimize the risks of hypotension, seizure, and sedation in the patient. However, sedation following daytime doses may necessitate administration of most or all of the daily dose at bedtime.
Maximum dose: 900 mg per day.

What other drugs will affect Clozaril?

Taking Clozaril with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking Clozaril with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with clozapine. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Clozaril, especially:

  • methadone;

  • any other medicines to treat a psychiatric disorder, especially chlorpromazine, haloperidol, iloperidone, mesoridazine, pimozide, thioridazine, or ziprasidone;

  • arsenic trioxide, vandetanib, vemurafenib;

  • an antibiotic--azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine;

  • an antidepressant--amitriptyline, citalopram, clomipramine, desipramine;

  • anti-malaria medication--artemether and lumefantrine, chloroquine, halofantrine, mefloquine;

  • heart rhythm medicine--amiodarone, dofetilide, disopyramide, dronedarone, flecainide, ibutilide, procainamide, propafenone, quinidine, sotalol;

  • medicine to prevent or treat nausea and vomiting--dolasetron, droperidol, ondansetron;

  • migraine headache medicine--sumatriptan, zolmitriptan; or

  • Valium or similar sedatives.

This list is not complete and many other drugs can interact with clozapine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Clozaril.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Clozaril only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2014 Cerner Multum, Inc. Version: 14.01. Revision Date: 2013-05-08, 11:41:29 AM.

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