fazaclo

FazaClo (clozapine) is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

FazaClo orally disintegrating tablets are used to treat severe schizophrenia, or to reduce the risk of suicidal behavior in people with schizophrenia or similar disorders.

Clozapine is available only from a certified pharmacy under a special program. You must be registered in the program and agree to undergo frequent blood tests.

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

Important information

You should not take FazaClo if you have ever developed a severe infection while taking clozapine. Serious and sometimes fatal infections may occur during treatment. You will need frequent blood tests while taking FazaClo.

Call your doctor right away if you have signs of infection (sudden weakness or ill feeling, fever, sore throat).

FazaClo can cause severe dizziness, slow heartbeats, fainting, or seizures. Do not take more of this medicine than recommended.

Call your doctor at once if you have chest pain, trouble breathing, fluttering in your chest, or if you feel like you might pass out.

FazaClo is not approved for use in psychotic conditions related to dementia. FazaClo may increase the risk of death in older adults with dementia-related conditions.

Before taking this medicine

You should not take FazaClo if you are allergic to clozapine, or if you have ever developed a severe infection while taking FazaClo.

FazaClo is not approved for use in psychotic conditions related to dementia. Clozapine may increase the risk of death in older adults with dementia-related conditions.

To make sure FazaClo is safe for you, tell your doctor if you have:

• heart disease or high blood pressure;

• a personal or family history of long QT syndrome;

• a history of heart attack or stroke (including "mini-stroke");

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• a history of seizures, head injury, or brain tumor;

• diabetes, or risk factors such as being overweight or having a family history of diabetes;

• high cholesterol or triglycerides;

• a bowel obstruction called paralytic ileus;

• liver or kidney disease;

• an enlarged prostate or urination problems;

• glaucoma;

• if you are malnourished or dehydrated; or

• if you smoke.

FDA pregnancy category B. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking FazaClo, do not stop taking it without your doctor"s advice.

Clozapine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking this medicine.

How should I take FazaClo?

Take FazaClo orally disintegrating tablets exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

FazaClo can be taken with or without food.

FazaClo orally disintegrating tablets can be taken without water. Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet. Use dry hands to remove the tablet and place it in your mouth. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

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

FazaClo can lower blood cells that help your body fight infections, especially in women and older adults, and in people who are malnourished or have serious medical problems. This can make it easier for you to develop a serious or life-threatening infection. Your blood will need to be tested often. Your future treatments may be delayed based on the results of these tests.

If you need surgery, tell the surgeon ahead of time that you are using FazaClo. You may need to stop using the medicine for a short time.

You should not stop using FazaClo suddenly or you could have unpleasant withdrawal symptoms. Follow your doctor"s instructions about tapering your dose. If you stop taking FazaClo for more than 2 days in a row, call your doctor before you start taking it again.

FazaClo can have long lasting effects on your body. You may need frequent medical tests for a short time after you stop using this medicine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking FazaClo?

FazaClo can cause severe dizziness, slow heartbeats, fainting, or seizures. Do not take more of this medicine than recommended. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase some of the side effects of FazaClo.

FazaClo side effects

Get emergency medical help if you have any of these signs of an allergic reaction to FazaClo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with FazaClo. Call your doctor right away if you have signs of infection such as:

• sudden weakness or ill feeling;

• fever, swollen glands, body aches, flu symptoms; or

• mouth sores, red or swollen gums, and trouble swallowing.

High doses or long-term use of clozapine can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take Fazaclo , the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.

Also call your doctor at once if you have:

• headache with chest pain and severe dizziness, pounding heartbeats or fluttering in your chest;

• a light-headed feeling, like you might pass out;

• sudden cough, rapid breathing, coughing up blood;

• tight feeling in your neck or jaw, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

• seizure (black-out or convulsions);

• swelling, rapid weight gain, little or no urinating;

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

• signs of inflammation in your body - easy bruising or bleeding, severe tingling or numbness, muscle weakness, upper stomach pain, jaundice (yellowing of the skin or eyes), chest pain, new or worsening cough, trouble breathing.

Common FazaClo side effects may include:

• weight gain;

• tremor, dizziness, spinning sensation;

• headache, drowsiness;

• fast heart rate;

• nausea, constipation;

• dry mouth, or increased salivation;

• blurred vision; or

• 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.

See also: Side effects (in more detail)

FazaClo dosing information

Usual Adult Dose of FazaClo for Schizophrenia:

Treatment resistant schizophrenia:
Initial dose: 12.5 mg orally once or twice a day.
Maintenance dose: If the first dose is well- tolerated, dosages may then be titrated in daily increments of 25 mg to 50 mg for approximately two weeks until a daily dose of 300 to 450 mg is achieved. If, after the initial titration, a larger dose is necessary a slower increase in dose, not to exceed a 100 mg increment once or twice a week, may be initiated. Cautious titration and a divided dosage schedule may minimize the risks of hypotension, seizure, and sedation in the patient. However, sedation following daytime doses may necessitate administration of most or all of the daily dose at bedtime.
Maximum dose: 900 mg per day.

Reduction of the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder:
Initial dose: 12.5 mg orally once or twice a day.
Maintenance dose: If the first dose is well- tolerated, dosages may then be titrated in daily increments of 25 mg to 50 mg for approximately two weeks until a daily dose of 300 to 450 mg is achieved. If, after the initial titration, a larger dose is necessary a slower increase in dose, not to exceed a 100 mg increment once or twice a week, may be initiated. Cautious titration and a divided dosage schedule may minimize the risks of hypotension, seizure, and sedation in the patient. However, sedation following daytime doses may necessitate administration of most or all of the daily dose at bedtime.
Maximum dose: 900 mg per day.

What other drugs will affect FazaClo?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking FazaClo with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with clozapine. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with FazaClo, especially:

• carbamazepine;

• droperidol;

• methadone;

• an antibiotic - erythromycin, moxifloxacin, pentamidine;

• an antidepressant - citalopram, escitalopram;

• anti-malaria medication - mefloquine, halofantrine;

• heart rhythm medicine - amiodarone, disopyramide, flecainide, procainamide, quinidine, sotalol; or

• medicine to treat a psychiatric disorder - chlorpromazine, droperidol, haloperidol, iloperidone, pimozide, thioridazine, ziprasidone.

This list is not complete and many other drugs can interact with clozapine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.