The reference site for Clozapine

Clozapine, sold under the brand name Clozaril among others, is an atypical antipsychotic medication. It is mainly used for schizophrenia that does not improve following the use of other antipsychotic medications.

WHAT IS Clozapine?

Clozapine is used to treat severe schizophrenia symptoms in people who have not responded to other medications. It is particularly effective in reducing the risk of suicide in schizophrenic or schizoaffective patients judged to belong to a high risk group with chronic risk for suicidal behavior.

Clozapine works equally well against positive (e.g. delusions, hallucinations) and negative (e.g. emotional and social withdrawal) symptoms of schizophrenia. It has no dyscognitive effect often seen with other psychoactive drugs and is even able to increase the capabilities of the patient to react to this environment and thereby fosters social rehabilitation.

Clozapine is sold as Clozaril®, Leponex® and FazaClo®.

 

Brand Name(s): Clozaril; Leponex; FazaClo
CAS nº: 5786-21-0
(CLAW za peen)

 

Product Info

The sections below will provide you with more specific information and guidelines related to clozapine and its correct use. Please read them carefully.

FDA Information

Clozapine was approved by the United States Food and Drug Administration (FDA) in 1989 and is the only FDA-approved medication indicated for treatment-resistant schizophrenia and for reducing the risk of suicidal behaviour in patients with schizophrenia.

History:

Clozapine was developed by Sandoz in 1961, and introduced in Europe ten years later. In 1975, after reports of agranulocytosis leading to death in some clozapine-treated patients, clozapine was voluntarily withdrawn by the manufacturer. Clozapine fell out of favor for more than a decade. However, when studies demonstrated that clozapine was more effective against treatment-resistant schizophrenia than other antipsychotics, the FDA and health authorities in most other countries approved its use only for treatment-resistant schizophrenia, and required regular (weekly) hematological monitoring to detect granulocytopenia, before agranulocytosis develops. In December of 2002, clozapine was also approved for reducing the risk of suicide in schizophrenic or schizoaffective patients judged to be at chronic risk for suicidal behavior.

Please visit the official site of the FDA for further information.

Why is this medication prescribed?

Clozapine is used to treat severe schizophrenia symptoms in people who have not responded to other medications. It is also administered to reduce the risk of suicide in schizophrenic or schizoaffective patients judged to belong to a high risk group with chronic risk for suicidal behavior.

Clozapine works equally well against positive (e.g. delusions, hallucinations) and negative (e.g. emotional and social withdrawal) symptoms of schizophrenia. It has no dyscognitive effect often seen with other psychoactive drugs and is even able to increase the capabilities of the patient to react to this environment and thereby fosters social rehabilitation.

Other uses for this medicine

This medication has not been approved for any alternative uses other than those mentioned in the product information section.

Dosage and using this medicine

Take clozapine exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor.

Take the regular oral tablet with a full glass of water. Drink plenty of water to keep from getting constipated. Your doctor may also recommend a laxative.

The FazaClo® orally-disintegrating tablet can be taken without water. When you are ready for your dose, remove the tablet from the blister pack by gently peeling the foil back and dropping the tablet into your hand. Do not push the tablet through the foil. Quickly place the tablet in your mouth. It will dissolve rapidly on your tongue and can be swallowed with saliva. No water is needed.

If your doctor has prescribed one-half of an orally-disintegrating tablet, you will need to break the tablet in half. After taking the tablet half, throw the other half away. Do not store it for later use.

Clozapine can be taken with or without food.

While you are taking clozapine, your blood will need to be tested every week for the first 6 months of treatment. It is important that you not miss any scheduled visits to your doctor or you may not be able to continue using clozapine. You may still need to have weekly blood tests for at least 4 weeks after you stop using clozapine.

Additionally, if you have not taken your clozapine for more than 2 days in a row, call your doctor before you start taking it again. You may need to start with a lower dose than you were taking before. Do not stop taking clozapine without first talking to your doctor.

What special precautions should I follow?

Before taking Clozapine:

Clozapine is not for use in older adults with dementia.

Tell your doctor if you are using any of the following drugs: phenytoin (Dilantin®), carbamazepine (Tegretol®), rifampin (Rifadin®, Rimactane®), cimetidine (Tagamet®), erythromycin (E-Mycin®, E.E.S®, Ery-Tab®), atropine (Donnatal®, and others), belladonna, clidinium (Quarzan®), dicyclomine (Bentyl®), scopolamine (Transderm-Scop®), drugs that weaken your immune system (such as cancer medicine or steroids), or drugs that make you sleepy (such as alcohol, cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety). If you are using any of these drugs, you may not be able to take clozapine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed above that can affect clozapine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without first telling your doctor.

Furthermore, do not take clozapine without first talking to your doctor if you have seizures or epilepsy, paralytic ileus, a history of decreased white blood cells when taking clozapine, heart disease, high blood pressure, a previous heart attack, irregular heartbeats, liver disease, kidney disease, lung disease, diabetes, a history of bone marrow or blood cell disorders, narrow angle glaucoma, or an enlarged prostate or urination problems. If you have any of these conditions, you may not be able to use clozapine or you may need a dosage adjustment or special tests during treatment.

Additionally, clozapine may raise your blood sugar. Symptoms include extreme thirst, increased urination, excessive hunger, or weakness. If you are diabetic and you use medication to control your blood sugar, your dosage may need to be adjusted while you are using clozapine.

You may need to stop using clozapine temporarily if you will be having surgery. Tell the surgeon that you are using this medication.

Clozapine orally-disintegrating tablets contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Avoid driving, operating machinery, or performing other hazardous activities during treatment with clozapine. Clozapine may cause seizures, dizziness, or fainting. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol while taking clozapine.

Also note that this medication falls into the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. However, do not use clozapine without telling your doctor if you are pregnant or plan to become pregnant during treatment.

On the other hand, clozapine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

What should I do if I forget a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time.

Never take extra medicine to make up for the missed dose.

What side effects can this medication cause?

Stop using clozapine and get emergency medical help if you have any of these signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Moreover, stop using clozapine and get emergency medical help if you feel tired or short of breath, or if you have rapid breathing, chest pain, uneven heartbeats, unusual swelling or water retention. These could be signs of swelling in your heart muscle or a blood clot in your lung. Both side effects are life-threatening.

Contact your doctor at once if you feel unusually weak or tired, feel as if you have the flu, or have fever, sore throat, or sores or white patches in your mouth or throat. These could be signs that your white blood cells are low, a serious side effect that could lead to a life-threatening infection.

Call your doctor at once if you have any of these serious side effects:

seizure (black-out or convulsions)
fainting or light-headedness
shallow breathing
weak pulse
high fever with muscle stiffness, confusion, sweating, fast or uneven heartbeats
twitching or uncontrolled muscle movements
nausea
stomach pain
low fever
loss of appetite
dark urine or clay-colored stools
jaundice (yellowing of the skin or eyes)

Other less serious side effects are more likely to occur, such as:

constipation
nausea, vomiting, upset stomach
drowsiness
salivation (drooling)
increased sweating
sleep problems or nightmares

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What storage conditions are needed for this medicine?

Always keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

For FazaClo® tablets, keep them in the unopened blister pack until you are ready to take the medicine.

Please remember to throw away any medication that is outdated or no longer needed. Should you have any questions, talk to your pharmacist about the proper disposal of your medication.

In case of an emergency/overdose

In the case of an overdose, call your local poison control center on 1-800-222-1222. However, if the victim has collapsed or is not breathing, call the local emergency services on 911.

Symptoms of overdose may include:

confusion
fainting
fast heart rate
drowsiness
drooling
difficulty breathing
seizures
coma
death

Product Images

PICTURES OF CLOZAPINE PILLS

Below you will find images and specific information on the principal types of clozapine that exist, including their respective brand name(s), strength, inscription codes, manufacturers and/or distributors.

The information below includes general information and guidelines for patients taking this medication and should never be used to substitute professional medical advice that can be provided by a qualified physician or family doctor.

Name: CLOZARIL®
Strength(s): 25 MG
Imprint: CLOZARIL | 25
Manufacturer: NOVARTIS

 

Name: CLOZAPINE
Strength(s): 100 MG
Imprint: 4360 | 100
Manufacturer: IVAX PHARMACEUTICALS

 

Name: CLOZARIL®
Strength(s): 100 MG
Imprint: CLOZARIL | 100
Manufacturer: NOVARTIS

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