Drugs A - Z

Clozapine Oral tablet

It is used to treat schizophrenia

Generic Name: clozapine

Brand Names: Clozaril, FazaClo

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for clozapine to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of clozapine and consists of the following: elements to assure safe use and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

CLOZAPINE (KLOE za peen) is used to treat schizophrenia. This medicine is only used when others have not worked. It has a risk of serious side effects and is only available through a monitoring and dispensing system that includes special doctors, pharmacists, and laboratories. For the first few months of treatment, you will be required to have routine blood testing before your prescription can be refilled.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • being treated for cancer
  • blood disease or disorder, like leukemia
  • constipation, fecal impaction, or a history of an obstruction of the intestine
  • dementia
  • diabetes
  • heart disease
  • history of irregular heartbeat
  • kidney disease
  • liver disease
  • low blood counts, like low white cell, platelet, or red cell counts
  • low levels of potassium or magnesium in the blood
  • lung or breathing disease, like asthma
  • Parkinson's disease
  • seizures
  • an unusual or allergic reaction to clozapine, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. This medicine may be taken with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not suddenly stop taking this medicine. You may need to gradually reduce the dose. Only stop taking this medicine on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you miss your medicine for more than 2 days, you should not restart your medicine at the same dose. Contact your doctor for instructions.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • cisapride
  • dofetilide
  • dronedarone
  • fluconazole
  • medicines for treating cancer
  • medicines that lower your chance of fighting infection
  • mesoridazine
  • metoclopramide
  • pimozide
  • posaconazole
  • quinidine
  • thioridazine
  • ziprasidone

This medicine may also interact with the following medications:

  • alcohol
  • antihistamines for allergy, cough and cold
  • atropine
  • birth control pills
  • caffeine
  • certain antibiotics like ciprofloxacin, erythromycin, mefloquine, moxifloxacin
  • certain medicines for bladder problems like oxybutynin, tolterodine
  • certain medicines for depression, anxiety, or psychotic disturbances
  • certain medicines for irregular heart beat like amiodarone, encainide, flecainide, propafenone, sotalol
  • certain medicines for Parkinson's disease like benztropine, trihexyphenidyl
  • certain medicines for sleep
  • certain medicines for stomach problems like dicyclomine, hyoscyamine
  • certain medicines for travel sickness like scopolamine
  • cimetidine
  • dolasetron
  • enoxacin
  • ipratropium
  • lithium
  • medicines for blood pressure
  • medicines for seizures
  • methadone
  • nicotine
  • pentamidine
  • rifampin or rifabutin
  • skeletal muscle relaxants
  • St. John's Wort
  • tacrolimus
  • terbinafine


Last Updated: May 07, 2013
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