"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 "...
- Clinician Information:
Fazaclo Patient Information including How Should I Take
In this Article
- What is clozapine (Fazaclo)?
- What are the possible side effects of clozapine (Fazaclo)?
- What is the most important information I should know about clozapine (Fazaclo)?
- What should I discuss with my healthcare provider before taking clozapine (Fazaclo)?
- How should I take clozapine (Fazaclo)?
- What happens if I miss a dose (Fazaclo)?
- What happens if I overdose (Fazaclo)?
- What should I avoid while taking clozapine (Fazaclo)?
- What other drugs will affect clozapine (Fazaclo)?
- Where can I get more information?
What should I discuss with my healthcare provider before taking clozapine (Fazaclo)?
Clozapine is not for use in psychotic conditions related to dementia. Clozapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.
You should not take clozapine if you are allergic to it, or if you have:
- untreated or uncontrolled epilepsy;
- a bone marrow disorder;
- paralytic ileus or intestinal blockage;
- a history of infection caused by taking clozapine; or
- if you are also using drugs that weaken your immune system (such as cancer medicine or steroids).
To make sure you can safely take clozapine, tell your doctor if you have any of these other conditions:
- heart disease, heart rhythm disorder, high blood pressure;
- history of heart attack or stroke;
- epilepsy or other seizure disorder;
- lung disease;
- liver or kidney disease;
- a history of bone marrow or blood cell disorders;
- an enlarged prostate or urination problems;
- glaucoma; or
- if you smoke.
FDA pregnancy category B. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking clozapine, do not stop taking it without your doctor's advice.
Clozapine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking clozapine.
Clozapine orally-disintegrating tablets contain phenylalanine. Talk to your doctor before using this form of clozapine if you have phenylketonuria (PKU).
How should I take clozapine (Fazaclo)?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. 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. Keep the tablet in its blister pack until you are ready to take it. Gently peel back the foil from the blister pack and drop the tablet onto your dry hand. Place the tablet in your mouth. It will begin to dissolve right away. 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.
If your doctor has prescribed one-half of an orally-disintegrating tablet, you will need to break the tablet in half. Throw the other half away. Do not save it for later use.
Clozapine can lower blood cells that help your body fight infections. This can make it easier for you to develop a serious or life-threatening infection. This risk is higher in women and older adults, and in people who are malnourished or have serious medical problems.
While you are taking clozapine, your blood will need to be tested every week for the first 6 months of treatment, and then every 2 to 4 weeks. Your doctor may also want to check your blood for several weeks after you stop using clozapine. Do not miss any follow-up visits to your doctor.
If you stop taking clozapine for more than 2 days in a row, call your doctor before you start taking it again.
If you need surgery, tell the surgeon ahead of time that you are using clozapine.
Store at room temperature away from moisture and heat.
Additional Fazaclo Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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