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FazaClo
(clozapine)

Important
FazaClo FDA Boxed Warning

Please note that it is important not to accept anyone's attempt to downplay this warning.  The FDA does not lightly issue a "boxed warning", the highest level caution given by that organization.  Read this carefully so you can decide for yourself if the the benefits of taking this drug or allowing it to be given to your child are worth these risks. 

Clozapine (FazaClo) can cause a serious blood condition. Your doctor will order certain lab tests before you start your treatment, during your treatment, and for at least 4 weeks after your treatment. Your doctor will order the lab tests once a week at first and may order the tests less often as your treatment continues. If you experience any of the following symptoms, call your doctor immediately: extreme tiredness; weakness; fever, sore throat, chills, or other signs of flu or infection; or sores in your mouth or throat.
 
A program has been set up by the manufacturers of clozapine (FazaClo) to be sure that people do not take clozapine (FazaClo) without the necessary monitoring. You, your doctor, and your pharmacist must be registered with the program, and your pharmacist will not dispense your medication unless he or she has received the results of your blood tests. Ask your doctor for more information about this program and how you will receive your medication.
 
Clozapine (FazaClo) may cause seizures. Tell your doctor if you have or have ever had seizures. Do not drive a car, operate machinery, swim, or climb while taking clozapine (FazaClo), because if you suddenly lose consciousness, you could harm yourself or others.
 
Clozapine (FazaClo) may cause myocarditis (swelling of the heart muscle that may be dangerous). If you experience any of the following symptoms, call your doctor immediately: extreme tiredness; difficulty breathing or fast breathing; fever; chest pain; or fast, irregular, or pounding heartbeat.
 
Clozapine (FazaClo)  may cause dizziness, lightheadedness, or fainting when you stand up, especially when you first start taking it or when your dose is increased. Tell your doctor if you are taking medications for anxiety such as diazepam (Valium), sleeping pills, or other medications for schizophrenia. Your doctor will probably start you on a low dose of clozapine  and gradually increase your dose to give your body time to adjust to the medication and decrease the chance that you will experience this side effect. Talk to your doctor if you do not take clozapine (FazaClo)  for 2 days or longer. Your doctor will probably tell you to restart your treatment with a low dose of clozapine (FazaClo).
 
Use in Older Adults:
Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as clozapine (FazaClo) have an increased chance of death during treatment. If you experience any of the following symptoms, call your doctor immediately: slow or difficult speech, sudden dizziness or faintness, or weakness or numbness of an arm or leg.
 
Clozapine (FazaClo) is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed clozapine if you, a family member, or someone you care for has dementia and is taking this medication. For more information visit the FDA website: http://www.fda.gov/Drugs

 

 

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