Clozapine

Conditions Treated

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 who have not been helped by other medications or who have tried to kill themselves and are likely to try to kill or harm themselves again. Clozapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Possible Side Effects

What Side Effects Can This 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
• confusion
• changes in behavior
• sore throat
• unusual bleeding or bruising
• loss of appetite
• upset stomach
• yellowing 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/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication 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. Do not try to push the orally disintegrating tablet through the foil packaging. Instead, use dry hands to peel back the foil. 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. Clozapine controls 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. Your doctor will probably want to decrease your dose gradually.

What Dietary Instructions Should I Follow

Talk to your doctor about drinking caffeinated beverages while taking this medicine.

Are There Any Special Instructions

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: antihistamines; benztropine (Cogentin); cimetidine (Tagamet); ciprofloxacin (Cipro); dicyclomine (Bentyl); epinephrine; erythromycin (E.E.S., E-Mycin, others); medications for high blood pressure, mental illness, or nausea; medications for irregular heartbeat such as encainide, flecainide (Tambocor), propafenone (Rythmol), and quinidine (Quinidex);medications for seizures such as carbamazepine (Tegretol) or phenytoin (Dilantin); rifampin (Rifadin, Rimactane); sedatives; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft);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 problems with your urinary system or prostate (a male reproductive gland); paralytic ileus (condition in which food cannot 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. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking clozapine. you should know 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 experience hyperglycemia (increases in your blood sugar) 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 a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness. 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 aspartame that forms phenylalanine.