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Fazaclo is a medicine used to treat severely ill people with schizophrenia who do not respond to standard treatment. Fazaclo is also used to reduce the risk of repeated suicidal behavior in people with schizophrenia or schizoaffective disorder who are at risk for experiencing suicidal behavior again.
Fazaclo may only be available through a restricted program called the Clozapine Risk Evaluation Mitigation Strategy (REMS) Program. Only healthcare providers and pharmacies registered with the program are able to prescribe and distribute Fazaclo. In addition, you can only take Fazaclo if you are enrolled in and meet all conditions of the program. Your healthcare provider will explain the Clozapine REMS Program to you.
How does this medication work?
The symptoms of schizophrenia are thought to be caused by chemical imbalances in the brain. Although it is unclear exactly how Fazaclo works, it seems to help balance the chemicals in the brain, thereby helping to improve your symptoms.
What are the beneficial effects of this medication and when should I begin to have results?
Schizophrenia: Fazaclo has been shown to relieve symptoms of schizophrenia as measured by an appropriate symptom rating scale that is commonly used by healthcare providers to evaluate the effectiveness of the medicine in people with this condition.
Reduced Risk of Suicidal Behavior: Studies show that the likelihood of experiencing a major suicide attempt or hospitalization due to suicide risk was lower for people taking Fazaclo compared to people taking another medicine used to treat schizophrenia.
When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's directions. It is important that you take Fazaclo exactly as your healthcare provider has prescribed.
How do I know it is working?
Your healthcare provider may ask you questions from time to time to assess how well your symptoms are controlled.
The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.
Fazaclo can cause severe neutropenia (a decrease in the number of white blood cells that fight infection), which can lead to a serious infection. Tell your healthcare provider right away if you experience any signs or symptoms of an infection (such as a flu-like symptoms, fever, tiredness, weakness or lack of energy, or mouth ulcers) while you are taking Fazaclo.
Fazaclo can cause a sudden fall in blood pressure with symptoms such as dizziness, lightheadedness, or fainting when rising too quickly from a sitting or lying position.
Fazaclo can cause seizures. Tell your healthcare provider if you have a history of seizures.
Fazaclo can cause certain heart problems with symptoms such as chest pain; fast, fluttery, or throbbing heartbeat; shortness of breath; fever; flu-like symptoms; or low blood pressure.
Fazaclo is not approved to treat mental problems caused by dementia (an illness involving confusion, loss of memory, and impaired judgment) in the elderly. It can be life-threatening when used in elderly people with mental problems caused by dementia.
More common side effects may include: drowsiness, dizziness, headache, shaking, fast heartbeat, low blood pressure, fainting, increased saliva production, sweating, dry mouth, changes in your vision, constipation, nausea, fever.
Less common side effects may include:
High blood sugar with symptoms such as excessive thirst, an increase in urination, increased appetite, weakness, confusion, fruity smelling breath, or feeling sick to your stomach.
Increased cholesterol (fats in your blood) and triglycerides (a type of blood fat), and weight gain.
Neuroleptic malignant syndrome (NMS) (a life-threatening brain disorder) with symptoms such as high fever, excessive sweating, muscle rigidity, confusion, changes in your breathing, fast or irregular heartbeat, or changes in your blood pressure.
Pulmonary embolism (a blood clot in the lungs), with symptoms such as sudden shortness of breath, chest pain, or other breathing problems.
Tardive dyskinesia, defined as abnormal muscle movements, including tremor, shuffling, and uncontrolled, involuntary movements.
Do not take Fazaclo if you are allergic to it or to any of its ingredients.
Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Fazaclo. Also, talk to your healthcare provider about your complete medical history, especially if you have heart problems (such as history of heart attack, heart failure, or long QT syndrome) or history of a stroke, seizures, diabetes, high cholesterol levels, narrow-angle glaucoma (high pressure in the eye), an enlarged prostate, a condition called phenylketonuria (an inability to process phenylalanine, a protein in your body), liver or kidney problems, or if you are pregnant, plan to become pregnant, or are breastfeeding.
The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.
Adults: The recommended starting dose is 12.5 milligrams once or twice a day. Your healthcare provider may increase your dose as needed, until the desired effect is achieved.
If you have kidney or liver impairment or are taking certain medications, your healthcare provider may adjust your dose appropriately.
Take Fazaclo exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Fazaclo without first talking to your healthcare provider.
Place the tablet in your mouth as soon as you remove it from the blister pack or bottle. The tablet will dissolve quickly after you put it in your mouth. You can chew the tablet or let it dissolve on its own.
Do not take Fazaclo tablets with water.
The Fazaclo tablets in blister packs should be kept in the original package until you are ready to take the medicine. Once you are ready to take your medicine, peel the foil from the pack and gently remove a tablet. Do not push the tablet through the foil because this could damage the tablet.
Take Fazaclo with or without food.
Do not drive, operate machinery, or engage in other dangerous activities until you know how Fazaclo affects you.
If Fazaclo is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Fazaclo may interact with numerous medications. Therefore, it is very important that you tell your healthcare provider about any other medications you are taking.
The effects of Fazaclo during pregnancy are unknown. Fazaclo can be found in your breast milk if you take it while breastfeeding. Do not breastfeed while you are taking Fazaclo. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.
If you miss a dose of Fazaclo, take it as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular dosing schedule. Do not take two doses at once.
If you miss taking Fazaclo for more than 2 days, contact your healthcare provider for instructions.
Store at room temperature. Protect from moisture.
In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
National Poison Control#: Call 1-800-222-1222
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