Alert

clozapine

Pronunciation: KLOE za peen

Brand: Clozaril, FazaClo, Versacloz

CloZAPine

slide 1 of 24, CloZAPine,

100 mg, round, yellow, imprinted with A08

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CloZAPine

slide 2 of 24, CloZAPine,

25 mg, round, yellow, imprinted with LOGO 4359, 25

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CloZAPine

slide 3 of 24, CloZAPine,

50 mg, round, yellow, imprinted with Logo 4404, 50

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CloZAPine

slide 4 of 24, CloZAPine,

200 mg, oval, yellow, imprinted with Logo 4405, 200

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CloZAPine

slide 5 of 24, CloZAPine,

100 mg, round, yellow, imprinted with Logo 7772, 100

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CloZAPine

slide 6 of 24, CloZAPine,

25 mg, round, peach, imprinted with C 7, M

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CloZAPine

slide 7 of 24, CloZAPine,

100 mg, round, green, imprinted with C11, M

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CloZAPine

slide 8 of 24, CloZAPine,

100 mg, round, yellow, imprinted with 100, Logo 4360

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CloZAPine

slide 9 of 24, CloZAPine,

100 mg, round, green, imprinted with C11, M

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CloZAPine

slide 10 of 24, CloZAPine,

100 mg, round, yellow, imprinted with Logo 4360

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CloZAPine

slide 11 of 24, CloZAPine,

25 mg, round, yellow, imprinted with 345

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CloZAPine

slide 12 of 24, CloZAPine,

25 mg, round, yellow, imprinted with Hourglass Logo 4359, 25

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CloZAPine

slide 13 of 24, CloZAPine,

100 mg, round, peach, imprinted with C 100

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CloZAPine

slide 14 of 24, CloZAPine,

150 mg, round, yellow, imprinted with A09

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FazaClo

slide 15 of 24, FazaClo,

150 mg, round, yellow, imprinted with A09

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CloZAPine

slide 16 of 24, CloZAPine,

200 mg, round, yellow, imprinted with A10

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FazaClo

slide 17 of 24, FazaClo,

200 mg, round, yellow, imprinted with A10

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CloZAPine

slide 18 of 24, CloZAPine,

25 mg, round, yellow, imprinted with I7

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CloZAPine

slide 19 of 24, CloZAPine,

25 mg, round, peach, imprinted with C 25

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CloZAPine

slide 20 of 24, CloZAPine,

25 mg, round, peach, imprinted with C 25

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Clozaril

slide 21 of 24, Clozaril,

100 mg, round, yellow, imprinted with CLOZARIL, 100

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Clozaril

slide 22 of 24, Clozaril,

200 mg, capsule, yellow, imprinted with CLOZARIL, 200 mg

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Clozaril

slide 23 of 24, Clozaril,

25 mg, round, yellow, imprinted with CLOZARIL, 25

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Clozaril

slide 24 of 24, Clozaril,

50 mg, round, yellow, imprinted with CLOZARIL, 50 mg

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What is the most important information I should know about clozapine?

Clozapine can lower certain blood cells, and you may get infections more easily, even serious or fatal infections. Clozapine can also cause a serious heart problem.

Call your doctor right away if you have: chest pain, trouble breathing, fast or pounding heartbeats, fluttering in your chest, sudden dizziness, or signs of infection (weakness, fever, flu symptoms, cough, mouth sores, skin sores).

Clozapine is not approved for use in older adults with dementia-related psychosis.

What is clozapine?

Clozapine is an antipsychotic medicine that is used to treat schizophrenia after other treatments have failed. Clozapine is available only from a certified pharmacy under a special program.

Clozapine is also used to reduce the risk of suicidal behavior in people with schizophrenia or similar disorders.

Clozapine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking clozapine?

Clozapine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

You should not take clozapine if you are allergic to it.

Tell your doctor if you have ever had:

  • heart problems, high blood pressure,
  • a heart attack or stroke (including "mini-stroke");
  • long QT syndrome (in you or a family member);
  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
  • a seizure, head injury, or brain tumor;
  • diabetes, or risk factors such as being overweight or having a family history of diabetes;
  • high cholesterol or triglycerides;
  • a bowel obstruction called paralytic ileus;
  • liver or kidney disease;
  • an enlarged prostate or urination problems;
  • glaucoma;
  • malnourishment or dehydration; or
  • if you smoke.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you get pregnant, tell your doctor right away. Do not stop taking clozapine without your doctor's advice.

You should not breastfeed while using clozapine.

Clozapine is not approved for use by anyone younger than 18 years old.

How should I take clozapine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take clozapine with or without food.

Shake the oral suspension (liquid) for 10 seconds before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

Clozapine can lower certain blood cells, and you may get infections more easily, even serious or fatal infections. Clozapine can also have long lasting effects on your body. You may need frequent medical tests while using this medicine and for a short time after your last dose.

You should not stop using clozapine suddenly. Follow your doctor's instructions about tapering your dose.

If you start taking clozapine again after 2 or more days off the medicine, you may need to use a lower dose than when you stopped. Follow your doctor's dosing instructions very carefully.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

If you miss taking clozapine for more than 2 days in a row, call your doctor before you start taking it again.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, confusion, fast heartbeats, feeling light-headed, weak or shallow breathing, drooling, choking, or seizure.

What should I avoid while taking clozapine?

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid beverages that contain caffeine, such as coffee, tea, cola, or energy drinks.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

What are the possible side effects of clozapine?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

  • fever, flu-like symptoms, extreme weakness;
  • mouth sores, skin sores;
  • new or worsening cough, trouble breathing;
  • pain or burning when you urinate; or
  • vaginal itching or discharge.

Further doses may be delayed until your infection clears up.

High doses or long-term use of clozapine can cause a serious movement disorder that may not be reversible. The longer you use clozapine, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Call your doctor at once if you have:

  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
  • a seizure (blackout-out or convulsions);
  • chest pain, fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • slow heartbeats;
  • severe constipation;
  • dry or hard bowel movements, or painful gas;
  • nausea, vomiting, stomach pain or bloating;
  • liver problems --loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • severe nervous system reaction --very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
  • signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood.

Untreated constipation may lead to serious bowel complications, hospitalization, or death. Tell your doctor right away if you are not having bowel movements at least 3 times per week.

Common side effects may include:

  • weight gain;
  • dizziness, tremor, feeling light-headed, or fainting;
  • fast heart rate;
  • headache, drowsiness;
  • nausea, constipation;
  • dry mouth, or increased salivation;
  • vision problems; or
  • fever, increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect clozapine?

When you start or stop taking clozapine, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Clozapine can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using clozapine with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, cold or allergy medicine, or medicine for anxiety or seizures.

Tell your doctor about all your current medicines. Many drugs can affect clozapine, especially:

  • St. John's wort;
  • an antibiotic, antifungal, or antiviral medicine;
  • medicine to treat mood disorders;
  • medicine to treat Parkinson's disease;
  • medicine to treat overactive bladder; or
  • medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;

This list is not complete and many other drugs may affect clozapine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about clozapine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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