Fazaclo

DRUG DESCRIPTION

FazaClo® (clozapine, USP), an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine.

The structural formula is:

FazaClo® (clozapine, USP) Structural Formula Illustration

C18H19ClN4        Mol. Wt. 326.83

FazaClo® (clozapine, USP) is available as yellow, orally disintegrating tablets of 12.5, 25, 100, 150, and 200 mg for oral administration without water. FazaClo® tablets may be chewed.

Each orally disintegrating tablet contains clozapine equivalent to 12.5, 25, 100, 150, or 200 mg.

12.5, 25, 10-, 150, and 200 mg Orally Disintegrating Tablets

Active Ingredient

Clozapine is a yellow, crystalline powder, very slightly soluble in water.

Inactive Ingredients

Aminoalkyl methacrylate copolymer E, mannitol, aspartame, microcrystalline cellulose*, silicified microcrystalline cellulose**, crospovidone, natural and artificial mint flavor, sodium bicarbonate, citric acid, ferric oxide (yellow), and magnesium stearate

What are the possible side effects of clozapine (Clozaril, FazaClo)?

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.

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

  • feeling short of breath, even at night or with mild exertion;
  • swelling in your hands or feet;
  • fever, weakness, sore throat, stiff muscles, confusion, sweating, fast or uneven heartbeats;
  • sudden numbness or weakness, especially on...

Read All Potential Side Effects and See Pictures of Fazaclo »

What are the precautions when taking clozapine (Fazaclo)?

See also Warning section.

Before taking clozapine, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood disorders (e.g., leukemia, low white blood cell count), history of blood disorders caused by clozapine, serious bowel problems (e.g., paralytic ileus), seizures not controlled by medication.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bowel problems (e.g., irritable...

Read All Potential Precautions of Fazaclo »

THIS PRODUCT CONTAINS ASPARTAME AND IS NOT INTENDED FOR USE BY INFANTS. PHENYLKETONURICS: CONTAINS PHENYLALANINE. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.6 mg aspartame, thus, 0.87 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 3.1 mg aspartame, thus, 1.74 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 12.4 mg aspartame, thus, 6.96 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 18.6 mg aspartame, thus, 10.44 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 24.8 mg aspartame, thus, 13.92 mg phenylalanine. The allowable daily intake of aspartame is 50 mg per kilogram of body weight per day. (See PRECAUTIONS, Phenylketonurics.)

What are the possible side effects of clozapine (Clozaril, FazaClo)?

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.

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

  • feeling short of breath, even at night or with mild exertion;
  • swelling in your hands or feet;
  • fever, weakness, sore throat, stiff muscles, confusion, sweating, fast or uneven heartbeats;
  • sudden numbness or weakness, especially on...

Read All Potential Side Effects and See Pictures of Fazaclo »

What are the precautions when taking clozapine (Fazaclo)?

See also Warning section.

Before taking clozapine, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood disorders (e.g., leukemia, low white blood cell count), history of blood disorders caused by clozapine, serious bowel problems (e.g., paralytic ileus), seizures not controlled by medication.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bowel problems (e.g., irritable...

Read All Potential Precautions of Fazaclo »


Fazaclo Consumer (continued)

SIDE EFFECTS: Drooling, drowsiness, dizziness, headache, shaking (tremor), vision problems (e.g., blurred vision) and constipation may occur. Many of these effects (especially drowsiness) lessen as your body gets used to the medication. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: facial/muscle twitching, signs of infection (e.g., severe tiredness, fever, persistent sore throat), seizures, uncontrollable movements, change in the amount of urine.

Seek immediate medical attention if any of these rare but very serious side effects occur: high fever, fast/irregular heartbeat, muscle stiffness, mental/mood changes, difficulty breathing with exercise, swollen legs/feet, sudden weakness, pain/redness/swelling of the arms/legs, chest pain, dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing of eyes/skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking clozapine, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood disorders (e.g., leukemia, low white blood cell count), history of blood disorders caused by clozapine, serious bowel problems (e.g., paralytic ileus), seizures not controlled by medication.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bowel problems (e.g., irritable bowel syndrome), breathing problems, diabetes/family history of diabetes, glaucoma, heart problems, kidney problems, liver problems, obesity/family history of obesity, seizures, difficulty urinating (e.g., prostate problems).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Tell your doctor if you are a descendent of Ashkenazi Jews because you may be at a higher risk for a drop in your white blood cells.

Before having surgery, tell your doctor or dentist that you are using this medication.

The rapidly dissolving form of this drug may contain aspartame or phenylalanine. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about the safe use of this medicine.

This drug may infrequently make your blood sugar level rise, causing or worsening diabetes. This high blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst or urination. If you already have diabetes, be sure to check your blood sugar regularly.

This drug may also cause significant weight gain. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor.

The elderly may be more sensitive to the effects of this drug, especially side effects such as constipation and low blood pressure.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

This medication may pass into breast milk and have undesirable effects on a nursing infant. Breast feeding is not recommended while taking clozapine. Consult your doctor before breast-feeding.


Fazaclo Patient Information Including Side Effects

Brand Names: Clozaril, FazaClo

Generic Name: clozapine (Pronunciation: KLOE za peen)

  • What is clozapine (Fazaclo)?
  • What are the possible side effects of clozapine (Fazaclo)?
  • What is the most important information I should know about clozapine (Fazaclo)?
  • What should I discuss with my healthcare provider before taking clozapine (Fazaclo)?
  • How should I take clozapine (Fazaclo)?
  • What happens if I miss a dose (Fazaclo)?
  • What happens if I overdose (Fazaclo)?
  • What should I avoid while taking clozapine (Fazaclo)?
  • What other drugs will affect clozapine (Fazaclo)?
  • Where can I get more information?

What is clozapine (Fazaclo)?

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

Clozapine is used to treat severe schizophrenia symptoms in people who have not responded to other medications. Clozapine is also used to help reduce the risk of suicidal behavior in people with schizophrenia or similar disorders.

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

What are the possible side effects of clozapine (Fazaclo)?

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.

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

  • feeling short of breath, even at night or with mild exertion;
  • swelling in your hands or feet;
  • fever, weakness, sore throat, stiff muscles, confusion, sweating, fast or uneven heartbeats;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • chest pain, sudden cough, wheezing, rapid breathing, fast heart rate, pain or swelling in one or both legs;
  • white patches or sores inside your mouth or on your lips;
  • nausea, vomiting, loss of appetite, and jaundice (yellowing of your skin or eyes); or
  • seizure (black-out or convulsions).

Less serious side effects may include:

  • constipation;
  • drooling, especially at night;
  • increased sweating;
  • drowsiness, dizziness, spinning sensation;
  • sleep problems or nightmares; or
  • weight gain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

Clozapine is not for use in psychotic conditions related to dementia. Clozapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not take clozapine if you have uncontrolled epilepsy, paralytic ileus or intestinal blockage, an infection caused by clozapine, or if you are also using drugs that weaken your immune system (such as cancer medicine or steroids).

While you are taking clozapine, your blood may need to be tested every week for the first 6 months of treatment. Do not miss any scheduled blood tests.

Do not stop taking clozapine or change your dose without first talking to your doctor.

Call your doctor if you have shortness of breath, swelling in your hands or feet, fever, sore throat, sudden numbness or weakness, sudden vision or speech problems, chest pain, cough, wheezing, pain or swelling in one or both legs, seizure, or jaundice (yellowing of your skin or eyes).

There are many other medicines that can interact with 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 telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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