"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.
Antipsychotic drugs are used to "...
AGRANULOCYTOSIS; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
CLOZARIL treatment has caused agranulocytosis, defined as an absolute neutrophil count (ANC) less than 500/mm³. Agranulocytosis can lead to serious infection and death. Prior to initiating treatment with CLOZARIL, obtain a baseline white blood cell count (WBC) and ANC. The ANC must be greater than or equal to 2000/mm³and the WBC must be greater than or equal to 3500/mm³for a patient to begin treatment with CLOZARIL. During treatment, patients must have regular monitoring of ANC and WBC. Discontinue CLOZARIL and do not rechallenge if the ANC is less than 1000/mm³or the WBC is less than 2000/mm³. Advise patients to immediately report symptoms consistent with agranulocytosis or infection (e.g., fever, weakness, lethargy, or sore throat) [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
Because of the risk of agranulocytosis, CLOZARIL is available only through a restricted program called the Clozaril National Registry. Under the Clozaril National Registry, prescribers, patients, and pharmacies must enroll in the program [see WARNINGS AND PRECAUTIONS].
Orthostatic Hypotension, Bradycardia, Syncope
Orthostatic hypotension, bradycardia, syncope, and cardiac arrest have occurred with CLOZARIL treatment. The risk is highest during the initial titration period, particularly with rapid dose escalation. These reactions can occur with the first dose, with doses as low as 12.5 mg per day. Initiate treatment at 12.5 mg once or twice daily; titrate slowly; and use divided dosages. Use CLOZARIL cautiously in patients with cardiovascular or cerebrovascular disease or conditions predisposing to hypotension (e.g., dehydration, use of antihypertensive medications) [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
Seizures have occurred with CLOZARIL treatment. The risk is dose-related. Initiate treatment at 12.5 mg, titrate gradually, and use divided dosing. Use caution when administering CLOZARIL to patients with a history of seizures or other predisposing risk factors for seizure (CNS pathology, medications that lower the seizure threshold, alcohol abuse). Caution patients about engaging in any activity where sudden loss of consciousness could cause serious risk to themselves or others [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
Myocarditis and Cardiomyopathy
Fatal myocarditis and cardiomyopathy have occurred with CLOZARIL treatment. Discontinue CLOZARIL and obtain a cardiac evaluation upon suspicion of these reactions. Generally, patients with clozaril-related myocarditis or cardiomyopathy should not be rechallenged with CLOZARIL. Consider the possibility of myocarditis or cardiomyopathy if chest pain, tachycardia, palpitations, dyspnea, fever, flu-like symptoms, hypotension, or
ECG changes occur [see WARNINGS AND PRECAUTIONS].
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CLOZARIL is not approved for use in patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS].
CLOZARIL is available in pale yellow tablets of 25 mg and 100 mg for oral administration.
Active Ingredient: clozapine
Inactive Ingredients are colloidal silicon dioxide, lactose, magnesium stearate, povidone, starch (corn), and talc.
What are the possible side effects of clozapine (Clozaril, FazaClo)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with clozapine. Call your doctor right away if you have signs of infection such as:
- fever, chills, body aches, flu symptoms;
- mouth and throat ulcers;
- cough, sore throat;
- rapid heart rate; or
- rapid and shallow breathing.
Stop using clozapine and call your doctor at once if you have any of...
What are the precautions when taking clozapine (Clozaril)?
See also Warning and Side Effects sections.
Before taking clozapine, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood disorders (e.g., leukemia, low white blood cell count), history of blood disorders caused by clozapine, serious bowel problems (e.g., paralytic ileus), seizures not controlled by medication.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bowel problems...
Last reviewed on RxList: 8/2/2013
This monograph has been modified to include the generic and brand name in many instances.
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