Clozapine

Generic name: Clozapine
Drug class: Atypical antipsychotics

Usage of Clozapine

Clozapine is an antipsychotic medicine. It works by changing the actions of chemicals in the brain.

Clozapine is used to treat schizophrenia in adults after other treatments have failed.

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

Clozapine is available only from a certified pharmacy under a special program.

Clozapine side effects

Get emergency medical help if you have signs of an allergic reaction to clozapine (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.

    Clozapine can increase your risk of seizure, especially at high doses. Avoid any activity that could be dangerous if you have a seizure or lose consciousness.

    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 or convulsions);
  • severe constipation;
  • dry or hard bowel movements, or painful gas;
  • nausea, vomiting, stomach pain or bloating;
  • heart problems - chest pain, fast or pounding heartbeats, fluttering in your chest, slow heartbeats, shortness of breath, and sudden dizziness (like you might pass out);
  • 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; or
  • 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 clozapine side effects may include:

  • weight gain;
  • dizziness, tremor;
  • 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.

    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.

    To make sure this medicine is safe for you, 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;
  • constipation or problems with your bowel movements;
  • 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 this medicine.

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

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    How to use Clozapine

    Usual Adult Dose for Schizophrenia:

    Initial dose: 12.5 mg orally once or twice a day Titration and Maintenance dose: May increase total daily dose in increments of 25 mg to 50 mg per day to a target dose of 300 mg to 450 mg per day (administered in divided doses) by the end of week 2. Subsequent dose increases can be in increments of up to 100 mg once or twice weekly. Maximum dose: 900 mg per day Comments: -The absolute neutrophil count (ANC) must be 1500/microL or greater for the general population and at least 1000/microL for patients with documented Benign Ethnic Neutropenia (BEN) prior to initiating treatment; to continue therapy, the ANC must be monitored regularly. -A low starting dose, gradual titration, and divided doses are necessary to minimize the risk of orthostatic hypotension, bradycardia, and syncope. -When therapy is interrupted for 2 or more days, re-initiate with 12.5 mg once or twice a day; based on tolerability, a dose that is restarted may be increased to a previously therapeutic dose more quickly than it was for initial treatment. Uses: -For the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment -To reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder, who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state

    Warnings

    Clozapine affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, sore throat, weakness, or lack of energy.

    Clozapine can increase your risk of seizure, especially at high doses. Avoid any activity that could be dangerous if you have a seizure or lose consciousness.

    Clozapine can cause serious heart problems. Call your doctor right away if you have chest pain, trouble breathing, fast or pounding heartbeats or sudden dizziness.

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

    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.

    Many drugs can affect clozapine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

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