Drug Notebook

FDA Alerts

    Agranulocytosis
  • Substantial risk of potentially life-threatening agranulocytosis; reserve for use in the following indications: 1) for treatment of severely ill schizophrenic patients who fail to show an acceptable response to adequate courses of standard antipsychotic therapy, either because of insufficient efficacy or an inability to achieve an effective dosage due to intolerable adverse effects. 2) for reducing risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at risk of reexperiencing suicidal behavior.
  • Measure baseline WBC count and ANC before initiation of therapy and measure WBC count and ANC at regular intervals during treatment and for at least 4 weeks after discontinuance. (See Agranulocytosis under Cautions.)
  • Available only through distribution systems that ensure periodic monitoring of WBC count and ANC prior to provision of patient's next supply of drug. (See Restricted Distribution under Dosage and Administration.)

    Seizures
  • Risk of seizures, particularly at higher dosages. Use with caution in patients with a history of seizures or other predisposing factors. Avoid activity where sudden loss of consciousness could cause serious risk to patient or others. (See Seizures under Cautions.)

    Myocarditis
  • Increased risk of fatal myocarditis, particularly during, but not limited to, first month of therapy. Promptly discontinue if myocarditis is suspected. (See Myocarditis under Cautions.)

    Increased Mortality in Geriatric Patients
  • Substantially higher mortality rate (4.5%) in geriatric patients with dementia-related psychosis† receiving atypical antipsychotic agents (e.g., aripiprazole, olanzapine, quetiapine, risperidone) compared with those receiving placebo (2.6%).
  • Most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).
  • Atypical antipsychotics are not approved for the treatment of dementia-related psychosis. (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)

    Other Cardiovascular and Respiratory Effects
  • Risk of orthostatic hypotension, with or without syncope, particularly during initial titration in association with rapid dosage escalation. Profound collapse may occur rarely, possibly accompanied by respiratory and/or cardiac arrest.
  • In patients who have had even a brief interruption of therapy (i.e., ≥2 days since last dose), reinitiate therapy at dosage of 12.5 mg once or twice daily. (See Reinitiation of Therapy under Dosage and Administration.)
  • Caution advised when initiating clozapine in patients receiving benzodiazepines or other psychotropic agents since collapse, respiratory arrest, and cardiac arrest reported during initial treatment in such patients. See Specific Drugs under Interactions.

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clozapine
(KLOE za peen)

What is clozapine?
Clozapine is an antipsychotic medication. It works by changing the actions of chemicals in the brain. Clozapine is used to treat severe schizophrenia symptoms in people who have not responded to other medications. Clozapine is also used to help reduce the risk of suicidal behavior in people with schizophrenia or similar disorders. Clozapine may also be used for other purposes not listed in this medication guide.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Clozapine 100MG Tablets IVAX PHARMACEUTICALS, INC.60/$101.98 or 180/$301.97
Clozapine 25MG Tablets IVAX PHARMACEUTICALS, INC.60/$42.99 or 180/$122.98

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What are the possible side effects of clozapine?

Stop using clozapine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling short of breath, even at night or with mild exertion;

  • swelling in your hands or feet;

  • fever, weakness, sore throat, stiff muscles, confusion, sweating, fast or uneven heartbeats;

  • sudden numbness or weakness, especially on one side of the body;

  • sudden headache, confusion, problems with vision, speech, or balance;

  • chest pain, sudden cough, wheezing, rapid breathing, fast heart rate, pain or swelling in one or both legs;

  • white patches or sores inside your mouth or on your lips;

  • nausea, vomiting, loss of appetite, and jaundice (yellowing of your skin or eyes); or

  • seizure (black-out or convulsions).

Less serious side effects may include:

  • constipation;

  • drooling, especially at night;

  • increased sweating;

  • drowsiness, dizziness, spinning sensation;

  • sleep problems or nightmares; or

  • weight gain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take clozapine?
Take clozapine exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label. Clozapine can be taken with or without food. Take the regular oral tablet (Clozaril) with a full glass of water. The orally-disintegrating tablet (FazaClo) can be taken without water. Gently peel back the foil from the blister pack and drop the tablet onto your dry hand. Do not push tablet through the foil. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.

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What is the most important information I should know about clozapine?
Clozapine is not for use in psychotic conditions related to dementia. You should not take clozapine if you have uncontrolled epilepsy, paralytic ileus or intestinal blockage, an infection caused by clozapine, or if you are also using drugs that weaken your immune system (such as cancer medicine or steroids). While you are taking clozapine, your blood may need to be tested every week for the first 6 months of treatment. Do not miss any scheduled blood tests. Do not stop taking clozapine or change your dose without first talking to your doctor.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect clozapine?
Before taking clozapine, tell your doctor if you are using any of the following drugs: cimetidine (Tagamet); citalopram (Celexa); lithium (Eskalith, Lithobid); rifampin (Rifadin, Rimactane); blood pressure medications; heart rhythm medications such as propafenone (Rythmol) or flecaininde (Tambocor); seizure medicine such as phenytoin (Dilantin) or carbamazepine (Tegretol); antibiotics such as ciprofloxacin (Cipro) or erythromycin (E-Mycin, E.E.S, Ery-Tab); atropine (Donnatal, and others), belladonna, clidinium (Quarzan), dicyclomine (Bentyl), scopolamine (Transderm-Scop); or

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Clozapine has been assigned to pregnancy category B by the FDA. High dose animal studies have failed to reveal evidence of specific teratogenic effects. There are no controlled data in human pregnancy. Clozapine is only recommended for use during pregnancy when need is clearly established and when benefit outweighs risk.

As of December, 1990, at least 14 women were known to have been exposed to clozapine during pregnancy. No adverse effects have been reported in the offspring of those pregnancies.

Clozapine is excreted into human milk. The effects in the nursing infant are unknown. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

A single case report has suggested that clozapine is excreted into human breast milk and achieves milk levels which are two to three times maternal plasma levels. The clinical implications in breast-fed infants is unknown. The authors of the case report however, suggest that breast-feeding be avoided if possible in women taking clozapine.

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Who should NOT use this medication?

  • Myeloproliferative disorders.
  • Uncontrolled seizure disorder.
  • Paralytic ileus.
  • History of clozapine-induced agranulocytosis or severe granulocytopenia.
  • Severe CNS depression or comatose states from any cause.
  • Concomitant use of other agents with well-known potential to cause agranulocytosis or suppress bone marrow function.
  • Known hypersensitivity to clozapine or any ingredient in the formulation.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include confusion, fast heart rate, drowsiness, drooling, weak or shallow breathing, feeling like you might pass out, and seizure (convulsions).

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What should I discuss with my healthcare provider before taking clozapine?
Clozapine is not for use in psychotic conditions related to dementia. Clozapine has caused fatal heart attack and stroke in older adults with dementia-related conditions. You should not take this medication if you are allergic to clozapine, or if you have: untreated or uncontrolled epilepsy; paralytic ileus or intestinal blockage; a history of infection while taking clozapine; or if you are also using drugs that weaken your immune system (such as cancer medicine or steroids). Before taking clozapine, tell your doctor if you are allergic to any drugs, or if you have:

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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