An atypical antipsychotic - It is used to treat schizophrenia
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.
CLOZAPINE (KLOE za peen) is used to treat schizophrenia. This medicine is only used when others have not worked. It has a risk of serious side effects and is only available through a monitoring and dispensing system that includes special doctors, pharmacists, and laboratories. For the first few months of treatment, you will be required to have routine blood testing before your prescription can be refilled.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. This medicine may be taken with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not suddenly stop taking this medicine. You may need to gradually reduce the dose. Only stop taking this medicine on the advice of your doctor or health care professional.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you miss your medicine for more than 2 days, you should not restart your medicine at the same dose. Contact your doctor for instructions.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
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