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
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(KLOE za peen)

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.

Call your doctor if you have shortness of breath, swelling in your hands or feet, fever, weakness, sore throat, sudden numbness or weakness, sudden vision or speech problems, chest pain, cough, wheezing, pain or swelling in one or both legs, mouth sores, seizure, or jaundice (yellowing of your skin or eyes).

There are many other medicines that can interact with clozapine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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.

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:

Clozapine may raise your blood sugar, causing symptoms such as increased thirst, loss of appetite, increased urination, drowsiness, nausea, or fruity breath odor. Call your doctor right away if you have any of these symptoms.

FDA pregnancy category B: This medication is not expected to be harmful to an unborn baby. Do not use clozapine without telling your doctor if you are pregnant or plan to become pregnant during treatment. Clozapine can pass into breast milk and may harm a nursing baby. You should not use this medication if you are breast-feeding a baby.

Clozapine orally-disintegrating tablets contain phenylalanine. Talk to your doctor before using this form of clozapine if you have phenylketonuria (PKU).

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