Generic Name: Clozapine orally disintegrating tablets

  • What is FazaClo?

    FazaClo is an atypical antipsychotic used for the management of treatment-resistant schizophrenia.

    FazaClo is also used for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are at chronic risk for re-experiencing suicidal behavior. People with schizoaffective disorder have symptoms of both schizophrenia and mood disorders, such as mental or physical mania (overactivity).

  • What is the most important information I should know about FazaClo?

    FazaClo is not approved for use in children.

    Elderly patients with who are on FazaClo are at an increased risk of death. These patients should not be taking FazaClo.

    A rare but serious and potentially fatal condition known as neuroleptic malignant syndrome can occur with FazaClo. If you experience a very high fever, rigidity in your muscles, shaking, confusion, sweating, or increased heart rate and blood pressure, contact your doctor immediately.

    Although it is extremely rare, a blood disorder called agranulocytosis (a reduction or depletion of white blood cells that can reduce the body's resistance to infection) has been associated with FazaClo. People who take FazaClo must have their blood tested on a regular basis. If you experience lethargy, weakness, fever, sore throat, malaise, or any other sign of possible infection, contact your doctor immediately as this may be a sign of a more serious problem.

    Phenylketonuric patients should know that FazaClo contains phenylalanine (a component of aspartame). Each 12.5-mg, orally disintegrating tablet contains 0.87 mg phenylalanine. Each 25-mg, orally disintegrating tablet contains 1.74 mg phenylalanine. Each 100-mg, orally disintegrating tablet contains 6.96 mg phenylalanine.) Those patients who have an established diagnosis of diabetes and are started on FazaClo should be regularly monitored for signs and symptoms of elevated sugar levels in the blood (increased thirst, hunger, urination, and weakness).

    FazaClo has been associated with causing seizures, with the size of dose being an important predictor of this side effect. Caution should be used in patients who have a pre-existing seizure disorder or other predisposing factors.

    When you first start FazaClo therapy, do not drive, operate machinery, or participate in any activity where a sudden loss of consciousness could cause serious risk to you or to others (such as swimming or climbing).

    FazaClo has been associated with an increased risk of fatal myocarditis (inflammation of the myocardium or the muscular part of the heart) especially during the first month of therapy (but it could occur at any time). If you are experiencing fatigue, a fast heartbeat, fever, or chest pains, contact your doctor immediately.

    FazaClo may cause a drop in your blood pressure, especially when you first start taking this medication or if the dose is increased. If this happens, try not to stand up too quickly and contact your doctor concerning this problem. Sometimes the decrease in blood pressure may be accompanied with loss of consciousness and in rare cases may lead to respiratory and/or cardiac arrest.

    FazaClo should be used with caution in patients with known cardiovascular and/or pulmonary disease; a gradual increase of your dose and careful monitoring is recommended.

    See "What are possible food and drug interactions associated with this medication?" for drugs that you should not take with FazaClo.

    FazaClo may cause some slowing down or obstruction of your bowel muscles, which may cause constipation or a more serious side effect. On rare occasions, these cases may be fatal.

  • Who should not take FazaClo?

    FazaClo should not be used by patients with previous sensitivity to Clozaril or any other component of this drug.

    Do not take FazaClo if you have bone marrow problems.

    Do not use FazaClo if you have uncontrolled seizures (epilepsy) or loss of bowel muscle movements.

    FazaClo should not be used if you have a history of blood problems caused by FazaClo.

  • What should I tell my doctor before I take the first dose of FazaClo?

    Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with FazaClo. Also, talk to your doctor about your complete medical history, especially if you have a history of liver disease, narrow angle glaucoma, diabetes, prostate enlargement, dementia-related psychosis, known cardiovascular and/or pulmonary disease, a history of loss of bowel muscle movement, history of seizure disorder, prolonged or painful erections, a history of agranulocytosis (inadequate white blood cell production), a history of blood clots or any blood problems, high cholesterol, if you are a phenylketonuric or are allergic to FazaClo. In addition, tell your doctor if you are pregnant, planning to become pregnant, or are breastfeeding.
  • What is the usual dosage?

    The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

    Adults: The recommended beginning dose of FazaClo is one-half of a 25-milligram (mg) tablet (12.5 mg) once or twice daily, followed by a continued daily dosage increments of 25 to 50 mg daily. If well tolerated, the targeted dose of 300 to 450 mg daily can be achieved by the end of 2 weeks. Dosage increments after that should not be made more than once or twice weekly, with increments not to exceed 100 mg. Cautious dosage increases and divided doses are necessary to minimize side effects. Many patients respond adequately to doses between 300 and 600 mg daily, but it may be necessary to raise the dose within the range of 600 and 900 mg daily to obtain acceptable response. The daily dose should not exceed 900 mg. It may take as long as 6 to 8 weeks to determine the correct dose of FazaClo.

    When terminating treatment with FazaClo, a gradual reduction over a 1- to 2-week period is recommended.

  • How should I take FazaClo?

    FazaClo rapidly disintegrating tablets are dispensed in a blister pack which should be left unopened until the time of use. Do not push the tablet through the blister foil. When you are about to take FazaClo, peel the foil from the blister and gently remove the orally disintegrating tablet. Immediately place the tablet in your mouth. Allow it to disintegrate and then swallow with saliva. No water is needed when taking FazaClo.

    FazaClo should be taken exactly as prescribed by your doctor. It may take a few weeks for FazaClo to work; do not stop taking the drug if you do not see results right away. It may take as long as 6 to 8 weeks to determine the correct dose of FazaClo.

    Do not take more or less of the medication without speaking to your doctor. If a dose is missed or forgotten for more than 2 days, do not start taking the drug again without speaking to your doctor.

  • What should I avoid while taking FazaClo?

    Avoid standing up too quickly when beginning treatment with FazaClo as the drug may cause a drop in your blood pressure, especially when you first start taking this medication or if the dose is increased. Call your doctor if this problem continues or increases in intensity.

    You may experience drowsiness when you start this medication. Avoid driving or operating machinery until you know how this medication affects you.

    Avoid alcohol while on FazaClo due to a potential increase in side effects.

  • What are possible food and drug interactions associated with FazaClo?

    If FazaClo is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining FazaClo with the following: alcohol, antiarrhythmics, anticholinergics, barbiturates such as phenobarbital, benzodiazepines, carbamazepine, cimetidine, debrisoquin, dextromethorphan, erythromycin, hydantoins, nicotine, phenothiazines, quinolone antibiotics such as ciprofloxacin, rifampin, risperidone, SSRIs, and tricyclic antidepressants.
  • What are the possible side effects of FazaClo?

    Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

    Side effects may include: drowsiness, sedation, seizures, dizziness, decrease in blood pressure, faster heartbeat, headache, tremor, constipation, abdominal discomfort, nausea, excessive salivation during sleep, fever, constipation

  • Can I receive FazaClo if I am pregnant or breastfeeding?

    The effects of FazaClo during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

    This drug should only be used during pregnancy or nursing if it is clearly needed.

  • What should I do if I miss a dose of FazaClo?

    If you missed a dose of FazaClo, take the dose as soon as possible unless it is almost time for the next dose. If a dose is skipped, you should not double the next dose. If a dose is missed or forgotten for more than two days, do not start taking the drug again without speaking to your doctor.
  • How should I store FazaClo?

    Store at room temperature.