Thursday, October 6, 2016

Clozapine Orally Disintegrating Tablets



Pronunciation: KLOE-za-peen
Generic Name: Clozapine
Brand Name: FazaClo

Clozapine Orally Disintegrating Tablets may cause serious blood disorders, heart problems, low blood pressure (with or without fainting), breathing problems, and seizures. Blood tests will be required before and during treatment with Clozapine Orally Disintegrating Tablets. You will not be able to have your medicine filled without these blood tests. Discuss these blood tests with your doctor.


The risk of seizures may be greater with higher doses or if you have a history of seizures. Do not perform activities in which a sudden loss of consciousness could cause harm to yourself or others (eg, driving, swimming).


The risk of heart or breathing problems may be greater if you are taking benzodiazepines (eg, lorazepam) or other medicines for mental or mood problems. Tell your doctor about any other medicines that you take.


Clozapine Orally Disintegrating Tablets may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Clozapine Orally Disintegrating Tablets are not approved to treat mental problems caused by dementia.





Clozapine Orally Disintegrating Tablets are used for:

Managing schizophrenia in patients who do not respond to other medicines. It is used to decrease the risk of suicidal behavior in certain patients. It may also be used for other conditions as determined by your doctor.


Clozapine Orally Disintegrating Tablets are an atypical antipsychotic. It may work by affecting certain chemicals in the brain, which has an effect on thinking and behavior.


Do NOT use Clozapine Orally Disintegrating Tablets if:


  • you are allergic to any ingredient in Clozapine Orally Disintegrating Tablets

  • you have bone marrow problems (eg, myeloproliferative disorders) or certain blood problems

  • you have a history of blood or heart problems caused by Clozapine Orally Disintegrating Tablets

  • you have uncontrolled seizures (eg, epilepsy) or bowel blockage (paralytic ileus)

  • you have severe drowsiness

  • you are taking metoclopramide

  • you are taking other medicines that may decrease bone marrow function or cause certain blood problems. Ask your doctor if you are unsure if any of your medicines may cause these problems

Contact your doctor or health care provider right away if any of these apply to you.



Before using Clozapine Orally Disintegrating Tablets:


Some medical conditions may interact with Clozapine Orally Disintegrating Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of blood clots, blood problems, blood vessel problems, heart problems or a heart attack, high blood pressure, a stroke, lung or breathing problems, or high blood cholesterol levels

  • if you or a member of your family have had a certain type of irregular heartbeat (QT prolongation, long QT syndrome)

  • if you have low blood potassium or magnesium levels, or if you are at risk for low blood potassium or magnesium levels

  • if you have a history of blood problems caused by another medicine

  • if you have a history of an enlarged prostate; prolonged, painful erections; liver or kidney problems; seizures (eg, epilepsy); neuroleptic malignant syndrome (NMS); glaucoma; stomach or bowel problems; or dementia

  • if you have diarrhea, poor health, severe loss of weight or muscle caused by another disease (eg, cancer), phenylketonuria, diabetes, or a family member with diabetes, or you are very overweight

  • if you have decreased metabolism of certain medicines

  • if you smoke, are exposed to tobacco smoke, or you regularly consume food and drinks high in caffeine (eg, coffee, tea, soda)

  • if you are scheduled for surgery or to receive anesthesia

Some MEDICINES MAY INTERACT with Clozapine Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Benzodiazepines (eg, lorazepam) or other medicines for mental or mood problems because the risk of heart or breathing problems may be increased

  • Antiarrhythmics (eg, amiodarone, propafenone, flecainide, quinidine), diuretics (eg, furosemide, hydrochlorothiazide), dolasetron, droperidol, iloperidone, macrolide antibiotics (eg, erythromycin), mefloquine, methadone, ondansetron, pentamidine, phenothiazines (eg, chlorpromazine, thioridazine), pimozide, quinolone antibiotics (eg, ciprofloxacin), tacrolimus, ziprasidone or any other medicine that may increase the risk of a certain type irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

  • Cimetidine, lithium, metoclopramide, risperidone, selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine, fluvoxamine), or tramadol because they may increase the risk of Clozapine Orally Disintegrating Tablets's side effects

  • Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), or rifamycins (eg, rifampin) because they may decrease Clozapine Orally Disintegrating Tablets's effectiveness

  • Anticholinergics (eg, benztropine), carbamazepine, debrisoquin, dextromethorphan, medicines for depression or high blood pressure, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Clozapine Orally Disintegrating Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Clozapine Orally Disintegrating Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Clozapine Orally Disintegrating Tablets:


Use Clozapine Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Clozapine Orally Disintegrating Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Continue to take Clozapine Orally Disintegrating Tablets even if you feel well. Do not miss any doses.

  • Taking Clozapine Orally Disintegrating Tablets at the same time each day will help you to remember to take it.

  • Do not remove the blister from the outer pouch until you are ready to take Clozapine Orally Disintegrating Tablets.

  • Make sure that your hands are dry when you open Clozapine Orally Disintegrating Tablets. Do not push the tablet through the foil.

  • Peel back the foil on the blister pack and place the tablet on the tongue. Allow the tablet to dissolve and swallow with saliva. Clozapine Orally Disintegrating Tablets may be taken with or without water.

  • You may chew the tablets if you desire.

  • Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.

  • If you split the tablets, discard the half of the tablet not taken out of the reach of children and pets. Do not save for future use. Talk to your pharmacist about proper disposal for Clozapine Orally Disintegrating Tablets.

  • Do not suddenly stop taking Clozapine Orally Disintegrating Tablets. You may have an increased risk of side effects. If you need to stop Clozapine Orally Disintegrating Tablets or add a new medicine, your doctor will gradually lower your dose.

  • If you miss a dose of Clozapine Orally Disintegrating Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss taking a dose of Clozapine Orally Disintegrating Tablets for more than 2 days, do not start taking it again. Contact your doctor right away for instructions.

Ask your health care provider any questions you may have about how to use Clozapine Orally Disintegrating Tablets.



Important safety information:


  • Clozapine Orally Disintegrating Tablets may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Clozapine Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks while you take Clozapine Orally Disintegrating Tablets.

  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Clozapine Orally Disintegrating Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Clozapine Orally Disintegrating Tablets may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Do not take more than the recommended dose without checking with your doctor.

  • Clozapine Orally Disintegrating Tablets may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor right away if you notice any signs of infection like fever, sore throat, rash, chills, mouth or nose sores, or unusual tiredness or weakness.

  • Women and patients of Jewish background may be at greater risk of developing blood problems with Clozapine Orally Disintegrating Tablets.

  • Seizures may occur in patients who take Clozapine Orally Disintegrating Tablets, which may cause you to suddenly lose consciousness. Avoid activities where loss of consciousness could be dangerous to you or others (eg, driving, swimming, climbing, operating machinery).

  • Serious, and possibly fatal, heart problems have rarely occurred in patients who take Clozapine Orally Disintegrating Tablets. Symptoms may include chest pain; fast or irregular heartbeat; fever; rapid or difficult breathing; swelling of the hands, feet, or ankles; or unusual tiredness. Seek immediate medical attention if you experience any of these symptoms.

  • Clozapine Orally Disintegrating Tablets contains phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.

  • Clozapine Orally Disintegrating Tablets may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

  • Avoid food and drink high in caffeine, like coffee, tea, cocoa, cola, and chocolate.

  • Tell your doctor or dentist that you take Clozapine Orally Disintegrating Tablets before you receive any medical or dental care, emergency care, or surgery.

  • NMS is a possibly fatal syndrome that can be caused by Clozapine Orally Disintegrating Tablets. Symptoms may include fever, stiff muscles, confusion, abnormal thinking, fast or irregular heartbeat, and sweating. Contact your doctor at once if you have any of these symptoms.

  • Some patients who take Clozapine Orally Disintegrating Tablets may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Clozapine Orally Disintegrating Tablets in high doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your tongue, face, mouth, jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements), arms, or legs while taking Clozapine Orally Disintegrating Tablets.

  • Lab tests, including complete blood cell counts and heart function, may be performed while you use Clozapine Orally Disintegrating Tablets and for at least 4 weeks after you stop taking it. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Clozapine Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially blood problems, dizziness (especially when standing), constipation, fast heartbeat, and urinary problems.

  • Clozapine Orally Disintegrating Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • Use of Clozapine Orally Disintegrating Tablets are not recommended in INFANTS.

  • PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Clozapine Orally Disintegrating Tablets while you are pregnant. Using Clozapine Orally Disintegrating Tablets during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if Clozapine Orally Disintegrating Tablets are found in breast milk. Do not breast-feed while taking Clozapine Orally Disintegrating Tablets.


Possible side effects of Clozapine Orally Disintegrating Tablets:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; dizziness; drowsiness; dry mouth; headache; heartburn; increased sweating or saliva production; lightheadedness when you stand up; nausea; strange dreams; trouble sleeping; weight gain.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; burning, numbness, or tingling; calf or leg pain or tenderness; chest pain; confusion; dark urine; decreased coordination; delirium; fainting; fast or difficult breathing; fast or irregular heartbeat; fever, chills, or sore throat; increased hunger, thirst, or urination; involuntary movements of the tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements); loss of appetite; new or worsening mental or mood changes; numbness of an arm or leg; obsessive-compulsive symptoms (eg, washing hands or checking doors continuously); persistent cough; restlessness; seizures; severe headache, dizziness, or vomiting; severe or persistent nausea or constipation; severe stomach pain; shortness of breath; sluggishness; stiff muscles; swelling of the hands, ankles, or feet; symptoms of a stroke (eg, one-sided weakness, slurred speech); tremor; trouble swallowing; trouble urinating; uncontrolled muscle movements; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; vomiting; yellowing of the skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Clozapine side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; delirium; excessive salivation; fainting; fast or irregular heartbeat; seizures; severe or persistent dizziness or drowsiness; slow or shallow breathing.


Proper storage of Clozapine Orally Disintegrating Tablets:

Store Clozapine Orally Disintegrating Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Clozapine Orally Disintegrating Tablets in the original packaging; do not remove the tablet from the blister until ready to use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Clozapine Orally Disintegrating Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Clozapine Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Clozapine Orally Disintegrating Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Clozapine Orally Disintegrating Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Clozapine resources


  • Clozapine Side Effects (in more detail)
  • Clozapine Use in Pregnancy & Breastfeeding
  • Drug Images
  • Clozapine Drug Interactions
  • Clozapine Support Group
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