(kloe’ za peen)
IMPORTANT WARNING:
| Clozapine can cause a serious blood condition. Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before starting treatment, once a week for the first 6 months, and at least once every other week thereafter to check your response to clozapine.Clozapine 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, because if you suddenly lose consciousness you could harm yourself or others.Clozapine may cause swelling of the heart muscle (myocarditis), a condition that can 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 may cause low blood pressure and/or dizziness when you stand up, especially when you first start taking it. Tell your doctor if you are taking medications for anxiety such as diazepam (Valium), sleeping pills, or other medications for schizophrenia. Follow your doctor’s directions about starting to take a low dose of clozapine and gradually increasing the dose. If you stop taking clozapine for 2 days or longer, talk to your doctor about restarting clozapine on a low dose.Studies have shown that older adults with dementia (significant loss of intellectual abilities, such as memory, severe enough to affect social or occupational functioning) who take antipsychotic medications such as clozapine to treat behavioral problems have an increased chance of death. Clozapine is not approved by the FDA for use in the treatment of behavioral disorders in older adults with dementia. Talk to the doctor who prescribed clozapine, if you, a family member, or someone you take care of is taking this medication to treat behavioral problems associated with dementia. For more information visit the FDA website: http://www.fda.gov/cder |
Why is this medication prescribed?
Clozapine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in patients for whom other medicine has not worked or who are at risk of attempting suicide. Clozapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
How should this medicine be used?
Clozapine comes as a tablet and an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth. It is usually taken one to three times a day. Take clozapine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take clozapine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
The amount of clozapine you take may need to be adjusted, especially during the first few weeks. You will have weekly blood tests for the first 6 months while taking clozapine and for 4 weeks after stopping it. You may have blood tests less often after the first 6 months. At the beginning, you will receive only a 1-week supply of this medication at a time, but this may be increased after 6 months, depending on how often you have blood tests. You may also receive up to 1 week of additional medication for emergencies such as bad weather or holidays.
Clozapine helps treat schizophrenia but does not cure it. It may take several weeks or longer before you feel the full benefit of clozapine. Continue to take clozapine even if you feel well. Do not stop taking clozapine without talking to your doctor, especially if you have taken large doses for a long time. Your doctor probably will want to decrease your dose gradually.
To take the orally disintegrating tablet, use dry hands to peel back the foil packaging. Immediately take out the tablet and place it on your tongue. The tablet will quickly dissolve and can be swallowed with saliva. No water is needed to swallow disintegrating tablets.Do not open the foil packaging or remove the orally disintegrating tablet until just before you are ready to take it.
Other uses for this medicine
This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking clozapine,
- tell your doctor and pharmacist if you are allergic to clozapine or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention those listed in the IMPORTANT WARNING section and any of the following: antiarrhythmics such as encainide, flecanide (Tambocor), propafenone (Rythmol), quinidine (Quinidex); antidepressants (’mood elevators’) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); antihistamines; benztropine (Cogentin); cimetidine (Tagamet); ciprofloxacin (Cipro); dicyclomine (Bentyl); epinephrine; erythromcyin (E.E.S., E-Mycin, others); medications for high blood pressure, mental illness, or nausea; medication for seizures such as carbamazepine (Tegretol) or phenytoin (Dilantin); rifampin (Rifadin, Rimactane); sedatives; sleeping pills; tranquilizers; and trihexyphenidyl (Artane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- in addition to the condition listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had blood disorders; seizures; Alzheimer’s disease; problems with your urinary system or prostate; paralytic ileus (food is unable to move through the intestine); glaucoma; irregular heartbeat; high or low blood pressure; or heart, kidney, lung, or liver disease; or if you or anyone in your family has or has ever had diabetes. Also tell your doctor if you have ever had to stop taking a medication for mental illness because of severe side effects.
- tell your doctor if you are pregnant, plan to become pregnant. If you become pregnant while taking clozapine, call your doctor. Do not breastfeed while you are taking this medication.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking clozapine.
- you should know that this medication may make you drowsy or cause seizures. Do not drive a car or operate machinery until you know how this medication affects you.
- remember that alcohol can add to the drowsiness caused by this medication.
- tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.
- you should know that you may have increases in your blood sugar (hyperglycemia) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking clozapine or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking clozapine: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause more serious symptoms, such as dry mouth, upset stomach and vomiting, shortness of breath, breath that smells fruity, or decreased consciousness, and may become life-threatening if it is not treated at an early stage.
- if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the orally disintegrating tablets contain phenylalanine.
What special dietary instructions should I follow?
Talk to your doctor about drinking caffeinated beverages while taking this medicine.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
If you miss taking clozapine for more than 2 days, you should call your doctor before taking any more medication. Your doctor may want to restart your medication at a lower dose.
What side effects can this medication cause?
Clozapine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- drowsiness
- dizziness
- increased salivation
- constipation
- dry mouth
- restlessness
- headache
Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNINGS or SPECIAL PRECAUTIONS sections, call your doctor immediately:
- shaking hands that you cannot control
- seizures
- fainting
- difficulty urinating or loss of bladder control
- confusion
- changes in vision
- shakiness
- fever
- severe muscle stiffness
- sweating
- changes in behavior
- sore throat
- unusual bleeding or bruising
- loss of appetite
- upset stomach
- yellowness of the skin or eyes
- pain in the upper right part of the stomach
- flu-like symptoms
- lack of energy
Clozapine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed and any orally disintegrating tablets that you removed from the blister pack but did not use immediately. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- dizziness
- fainting
- slow breathing
- change in heartbeat
- loss of consciousness
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to clozapine.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
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Last Revised - 04/01/2006