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Precautions and Warnings With Clozapine Oral Suspension

Specific Clozapine Oral Suspension Precautions and Warnings

Some warnings and precautions to be aware of prior to taking clozapine oral suspension include the following:
 
  • Clozapine oral suspension can cause agranulocytosis, which is when your body doesn't make enough granulocytes, a type of white blood cell. When you don't have enough white blood cells, you have a higher risk for infections.

    Because agranulocytosis is life-threatening, you are required to get frequent blood tests to check your white blood cell count in order to continue taking clozapine oral suspension. For the first six months of treatment, you will need weekly blood tests. If you don't develop problems, you can start having blood tests every other week for six months and then every four weeks.

    Contact your healthcare provider right away if you experience signs of agranulocytosis, such as:
    • An infection of any kind
    • Extreme tiredness or weakness
    • Fever
    • Sores or ulcers in your mouth or on your skin.
 
  • You should know that this medication increases your risk for having a seizure, even if you have never had a seizure before. This effect is dose related, which means the higher the dose, the greater the risk. 
 
  • Clozapine oral suspension can cause a dangerous drop in blood pressure and heart rate when you get up from a seated or lying-down position (known medically as orthostatic hypotension). This could cause you to become dizzy, lightheaded, or faint. The risk for orthostatic hypotension is greatest when your body is first getting used to the medication. For this reason, you will be started on clozapine oral suspension slowly. It is important to follow your healthcare provider's dosing instructions for starting this medicine.
 
  • This medication can cause you to feel drowsy and dizzy and may affect your thinking, judgment, and motor skills. Do not perform any activities that require mental alertness, such as driving or making important decisions, until you know how this medication affects you.
 
  • Clozapine oral suspension can increase your risk for developing inflammation of the heart muscle (known medically as myocarditis) and weakening of the heart muscle (cardiomyopathy). Although these problems can occur at any time, myocarditis is more likely to occur within the first two months of treatment, while cardiomyopathy usually happens after eight weeks of treatment. Let your healthcare provider know if you have signs of these life-threatening conditions, such as:
    • Chest pain
    • Shortness of breath
    • A fast heartbeat
    • Dizziness
    • Fever
    • Tiredness
    • Swelling of the ankles, legs, or feet.
 
  • Like other antipsychotic medications, clozapine oral suspension may increase the risk of death and strokes when used to treat people with dementia. The potential benefits of using antipsychotics in people with dementia must be carefully weighed against the risks. No antipsychotic, including clozapine oral suspension, is approved to treat psychosis or behavioral symptoms that can occur in people with dementia.
 
  • Although generally rare, clozapine oral suspension can cause a condition known as eosinophilia, which is when your body has a higher-than-normal level of a type of white blood cell known as eosinophils. There are many possible causes of eosinophilia, but if you develop it while taking clozapine oral suspension, it could be a sign that you are having a life-threatening reaction to the drug. If this is the case, you will need to stop taking it. 
 
  • Like other antipsychotic medications, clozapine oral suspension may cause a rare but life-threatening problem known as neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop signs of NMS, which may include:
    • A high fever or sweating
    • Confusion
    • Muscle stiffness
    • A fast or irregular heartbeat (pulse).
 
  • This medication may cause a change in the electrical activity of your heart known as QT prolongation, which could lead to life-threatening heart rhythm problems. Certain people may have an increased risk for QT prolongation, including those with long QT syndrome, heart rhythm problems, low blood levels of potassium or magnesium, or people who take other medicines that may cause QT prolongation (see Drug Interactions With Clozapine Oral Suspension).

    Let your healthcare provider know if you get dizzy or lightheaded, or feel like your heart is pounding or beating abnormally during treatment.
 
  • Antipsychotic medications, including clozapine oral suspension, can cause an irreversible movement disorder known as tardive dyskinesia. Tardive dyskinesia involves uncontrollable facial, tongue, or body movements. The risk for the condition increases with longer clozapine oral suspension use and higher doses; however, it can happen at any time and at any dose. There is no treatment for tardive dyskinesia, and it may not be reversible, even if the medication is stopped. Tell your healthcare provider if you experience any abnormal movements during treatment.
 
  • Clozapine oral suspension may cause high blood glucose (blood sugar) levels, which increases your risk for developing diabetes (see Clozapine and Diabetes). It can also cause weight gain and high cholesterol. All of these problems put you at higher risk for heart disease and strokes. Your healthcare provider will monitor your blood sugar levels, cholesterol, and weight during treatment. You may need to take other medicines to help control these problems if they occur.
 
  • Some people who take this medication may develop a fever, especially within the first three weeks of treatment. Usually the fever is harmless and goes away on its own. However, because a fever may be a sign of an infection or other serious problem, your healthcare provider will want to evaluate you closely if you develop a fever during treatment.
 
  • There have been reports of people developing blood clots in their lungs or veins of the legs while taking clozapine oral suspension. Seek immediate medical attention if you have signs of blood clots, which may include:
    • Shortness of breath
    • Chest pain
    • Warmth, pain, or swelling in a leg.
 
  • You could develop a condition known as anticholinergic toxicity while taking this medication. Let your healthcare provider know if you develop any symptoms of this condition, such as:
    • Dry mouth
    • Increased sweating
    • Constipation
    • A fast heart rate.
 
  • Clozapine oral suspension can cause severe constipation. You can help prevent constipation by drinking plenty of fluids and remaining well hydrated. You may also need to take medicines to keep your bowel movements regular. Talk to your healthcare provider about the best ways to prevent or treat constipation during treatment.
 
  • You could develop serious symptoms if you suddenly stop taking clozapine oral suspension. These symptoms include:

    • Excessive sweating
    • Headaches
    • Nausea
    • Vomiting
    • Diarrhea
    • A recurrence of your disease symptoms (such as hallucinations or delusions).
 
If you need to stop taking clozapine oral suspension, your healthcare provider will try to stop it slowly. If you need to quickly stop taking the medication, which could be the case if you develop potentially dangerous side effects, your healthcare provider will need to closely monitor you.
 
 
  • This medication passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Versacloz and Breastfeeding).
 
  • Clozapine oral suspension is a pregnancy Category B medication. This means it is probably safe for use during pregnancy, although the full risks are currently unknown (see Versacloz and Pregnancy).
 
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