Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Clozaril
  2. FazaClo
  3. Versacloz

Descriptions


Clozapine is used to treat schizophrenia (mental disorder) in patients who have used other medicines that did not work well. It is also used to prevent suicidal behavior in patients with schizophrenia or schizoaffective disorder. Clozapine changes some of the chemicals in the brain that are thought to cause schizophrenia.

This medicine is only available through a restricted program. You might be asked to read and sign papers that explain how the medicine works and some of the unwanted effects.

This product is available in the following dosage forms:

  • Tablet
  • Tablet, Disintegrating
  • Suspension

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of clozapine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clozapine in the elderly. However, elderly patients are more likely to have constipation, trouble passing urine, uncontrolled movements, or age-related liver, kidney, or heart problems, which may require caution in patients receiving clozapine. This medicine should not be used for behavioral problems in older adults with dementia.

Pregnancy

Information about this clozapine-oral-route
Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Cisapride
  • Dronedarone
  • Droperidol
  • Fluconazole
  • Mesoridazine
  • Metoclopramide
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone Acetate
  • Alfuzosin
  • Amiodarone
  • Amoxapine
  • Amprenavir
  • Apomorphine
  • Aprepitant
  • Armodafinil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Balofloxacin
  • Bedaquiline
  • Bepridil
  • Besifloxacin
  • Boceprevir
  • Bosentan
  • Bupropion
  • Buspirone
  • Caffeine
  • Carbamazepine
  • Chloroquine
  • Chlorpromazine
  • Cimetidine
  • Cinacalcet
  • Cinoxacin
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clobazam
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Darunavir
  • Dasatinib
  • Deferasirox
  • Dexamethasone
  • Diltiazem
  • Disopyramide
  • Disulfiram
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Efavirenz
  • Enoxacin
  • Enzalutamide
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Ethinyl Estradiol
  • Etravirine
  • Famotidine
  • Fingolimod
  • Flecainide
  • Flumequine
  • Fluoxetine
  • Fluvoxamine
  • Fosamprenavir
  • Fosphenytoin
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Hydromorphone
  • Hydroquinidine
  • Ibutilide
  • Iloperidone
  • Imatinib
  • Indinavir
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Levofloxacin
  • Lithium
  • Lomefloxacin
  • Lomitapide
  • Lopinavir
  • Lumefantrine
  • Mate
  • Mefloquine
  • Methadone
  • Methoxsalen
  • Mexiletine
  • Mibefradil
  • Miconazole
  • Mifepristone
  • Milnacipran
  • Mizolastine
  • Modafinil
  • Montelukast
  • Moricizine
  • Moxifloxacin
  • Nadifloxacin
  • Nafcillin
  • Nalidixic Acid
  • Nefazodone
  • Nelfinavir
  • Nevirapine
  • Nilotinib
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Omeprazole
  • Oxcarbazepine
  • Oxolinic Acid
  • Paliperidone
  • Pasireotide
  • Pazopanib
  • Pazufloxacin
  • Pefloxacin
  • Pentamidine
  • Perflutren Lipid Microsphere
  • Perphenazine
  • Phenobarbital
  • Phenylpropanolamine
  • Phenytoin
  • Pipemidic Acid
  • Pixantrone
  • Prednisone
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propranolol
  • Protriptyline
  • Prulifloxacin
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Regorafenib
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Rosoxacin
  • Rufinamide
  • Rufloxacin
  • Salmeterol
  • Sertindole
  • Sertraline
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • St John's Wort
  • Sunitinib
  • Tacrolimus
  • Tegafur
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Terbinafine
  • Teriflunomide
  • Tetrabenazine
  • Thiabendazole
  • Ticagrelor
  • Ticlopidine
  • Tipranavir
  • Topiramate
  • Toremifene
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Verapamil
  • Vinflunine
  • Voriconazole
  • Zileuton
  • Zotepine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice
  • Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, history of or
  • Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
  • Blood vessel problems (poor circulation) or
  • Head injury, history of or
  • Heart attack, recent or history of or
  • Heart disease or
  • Heart failure or
  • Heart rhythm problems (eg, arrhythmia, long QT syndrome, slow heart rate), or history of or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood) or
  • Hypotension (low blood pressure) or
  • Lung problems or
  • Stroke, history of—May cause side effects to become worse.
  • Blood diseases (eg, agranulocytosis, granulocytopenia), history of or
  • Bone marrow disorder or
  • Intestinal blockage (eg, paralytic ileus) or
  • Seizures (epilepsy), poorly controlled—Should not be used in patients with these conditions.
  • Bowel problems (eg, constipation) or
  • Diabetes or
  • Difficult urination or
  • Dyslipidemia (high fat in the blood) or
  • Enlarged prostate or
  • Glaucoma, narrow angle or
  • Hyperglycemia (high blood sugar) or
  • Liver disease (eg, hepatitis) or
  • Neuroleptic malignant syndrome, history of or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.

Proper Use

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Do not miss any doses.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take the oral liquid or tablet with or without food.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or chew it as desired.

Shake the bottle of the oral liquid for 10 seconds before each use. Measure the dose with the dosing syringe that comes with the package. Wash the oral syringe with warm water after using it.

Drink plenty of fluids with this medicine to help prevent constipation.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (disintegrating tablets, suspension, or tablets):
    • For schizophrenia or prevention of suicidal behavior:
      • Adults—At first, 12.5 milligrams (mg) per day as a single dose or 2 times per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 900 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss 2 or more days of clozapine doses, talk to your doctor before you start taking it again. You might have to restart the medicine at a lower dose than you were taking before.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not refrigerate or freeze the oral liquid. Throw away any unused medicine 100 days after opening the bottle for the first time.

Precautions

Clozapine can cause some very serious blood problems that you will not be able to feel. Your doctor will check your blood at regular visits and it is important that you have your blood tests done when they are scheduled. The pharmacy will give you this medicine only if your blood tests show that it is safe for you to take it. Your doctor will make sure the medicine is working properly and change the dosage if needed.

If you have been using this medicine regularly, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to help prevent the illness from suddenly returning and to decrease the chance of having symptoms such as headache, nausea, vomiting or diarrhea.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants, which are medicines that slow down the nervous system and possibly cause drowsiness. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Clozapine can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. Let your doctor know right away if you think you have the flu or an infection. Possible signs and symptoms include fever, feeling tired, sore throat, or weakness. Certain precautions you can take when your blood count is low to reduce the risk of infection include:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

Contact your doctor as soon as possible if you have chest pain or discomfort, a fast heartbeat, trouble breathing, or fever and chills. These can be symptoms of a very serious problem with your heart.

Clozapine may cause drowsiness, blurred vision or convulsions (seizures). Do not drive, operate machines, or do anything else that could be dangerous while you are taking this medicine.

This medicine can cause changes in your heart rhythm, such as a condition called QT prolongation. It may cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or urination. Diabetic patients should check their blood and urine sugar levels more often than normal while taking this medicine.

In some patients, clozapine may cause increased watering of the mouth. Other patients, however, may get dryness of the mouth. For temporary relief of mouth dryness, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Check with your doctor right away if you are having convulsions (seizures), difficulty with breathing, fast heartbeat, high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder) among the elderly, especially elderly women. Stop using this medicine and check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Blurred vision
  2. confusion
  3. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  4. fainting
  5. fast, pounding, or irregular heartbeat or pulse
  6. fever
  7. shakiness in the legs, arms, hands, or feet
  8. sleepiness or unusual drowsiness
  9. sweating
  10. trembling or shaking of the hands or feet
  11. unusual tiredness or weakness

Less common

  1. Anxiety
  2. black, tarry stools
  3. chest pain
  4. chills
  5. convulsions
  6. cough or hoarseness
  7. decrease in the frequency of urination
  8. decrease in urine volume
  9. difficult or labored breathing
  10. difficulty in passing urine (dribbling)
  11. discouragement
  12. dry mouth
  13. feeling sad or empty
  14. fever with or without chills
  15. frequent strong or increased urge to urinate
  16. general feeling of tiredness or weakness
  17. headache
  18. hyperventilation
  19. irritability
  20. lack of appetite
  21. loss of bladder control
  22. loss of interest or pleasure
  23. lower back or side pain
  24. muscle spasm or jerking of all extremities
  25. painful or difficult urination
  26. pounding in the ears
  27. restlessness or need to keep moving
  28. severe or continuing headache
  29. shakiness and unsteady walk
  30. slurred speech
  31. sore throat
  32. sores, ulcers, or white spots on the lips or in the mouth
  33. sudden jerky movements of the body
  34. sudden loss of consciousness
  35. swollen glands
  36. throat discomfort
  37. tightness in the chest
  38. trouble concentrating
  39. trouble sleeping
  40. unsteadiness, trembling, or other problems with muscle control or coordination

Rare

  1. Absence of or decrease in movement
  2. change in appetite
  3. dark urine
  4. decreased sexual ability
  5. difficult or fast breathing or sudden shortness of breath
  6. increased sweating
  7. increased thirst
  8. increased urination
  9. lip smacking or puckering
  10. muscle stiffness (severe)
  11. nausea
  12. puffing of the cheeks
  13. rapid or worm-like movements of the tongue
  14. swelling or pain in the leg
  15. uncontrolled chewing movements
  16. uncontrolled movements of the arms and legs
  17. unusual bleeding or bruising
  18. unusually pale skin
  19. vomiting
  20. weakness
  21. yellow eyes or skin

Incidence not known

  1. Abdominal or stomach pain
  2. bloating
  3. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  4. clay-colored stools
  5. confusion as to time, place, or person
  6. constipation
  7. diarrhea
  8. epileptic seizure that will not stop
  9. feeling that others are watching you or controlling your behavior
  10. feeling that others can hear your thoughts
  11. feeling, seeing, or hearing things that are not there
  12. holding false beliefs that cannot be changed by fact
  13. inability to move the eyes
  14. increased blinking or spasms of the eyelid
  15. indigestion
  16. itching
  17. joint pain
  18. light-colored stools
  19. muscle twitching
  20. pains in the stomach, side, or abdomen, possibly radiating to the back
  21. rhythmic movement of the muscles
  22. severe mood or mental changes
  23. skin rash
  24. sticking out of the tongue
  25. swelling around the eyes
  26. swelling of the body or feet and ankles
  27. trouble with speaking
  28. unpleasant breath odor
  29. unusual behavior
  30. unusual excitement, nervousness, or restlessness
  31. unusual facial expressions
  32. unusual weight gain
  33. upper right abdominal or stomach pain
  34. vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Acid or sour stomach
  2. belching
  3. feeling of constant movement of self or surroundings
  4. heartburn
  5. relaxed and calm sensation of spinning
  6. sleepiness

Less common

  1. Blurred or loss of vision
  2. change or problem with discharge of semen
  3. disturbed color perception
  4. double vision
  5. halos around lights
  6. inability to sit still
  7. increase in body movements
  8. muscle pain or ache
  9. muscle weakness
  10. night blindness
  11. nightmares
  12. overbright appearance of lights
  13. pain in the back, neck, or legs
  14. pain in the chest below the breastbone
  15. severe muscle stiffness
  16. sore tongue
  17. stuffy nose
  18. tunnel vision
  19. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence not known

  1. Blistering, peeling, or loosening of the skin
  2. hives
  3. increased sensitivity of the skin to sunlight
  4. painful or prolonged erection of the penis
  5. red skin lesions, often with a purple center
  6. red, irritated eyes
  7. reddening of the skin, especially around the ears
  8. severe stomach pain
  9. severe sunburn
  10. sores, welting, or blisters
  11. swelling of the eyes, face, or inside of the nose
  12. swelling of the salivary glands

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.