RISPERDAL ( Risperidone )
About RISPERDALApproved for the effective treatment of bipolar maniaRISPERDAL® (risperidone) is a prescription medication that has been approved by the Food and Drug Administration (FDA) for the treatment of bipolar I disorder or to treat acute to manic or mixed episodes associated with bipolar mania. It has been proven effective for use as therapy alone or in combination with drugs called mood stabilizers, (lithium or valproate).
IMPORTANT SAFETY INFORMATION
Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.Schizophrenia: The most common side effects that occurred with RISPERDAL were: anxiety, sleepiness, restlessness, tremors, and muscle stiffness; dizziness, constipation, nausea, indigestion, runny nose, rash, and rapid heartbeat.Bipolar Mania: The most common side effects that occurred in clinical trials, in the treatment of bipolar mania either alone or in combination with a mood stabilizer (lithium or valproate) were: sleepiness, muscle stiffness, restlessness, tremor, indigestion, nausea, abnormal vision, muscle aches, dizziness, runny nose, diarrhea, increased saliva, stomach pain, and urinary incontinence.Autistic Disorder: The most common side effects that occurred with RISPERDAL were: sleepiness, increased appetite, fatigue, upper respiratory tract infection, increased saliva, constipation, dry mouth, tremor, muscle stiffness, dizziness, repetitive behavior, involuntary movement, rapid heartbeat, confusion and weight increase.Studies suggest an increased risk of elevated blood sugar-related side effects, and sometimes potentially fatal, in patients treated with this class of medications, including RISPERDAL. Some people may need regular blood sugar testing.You may have heard the term “tardive dyskinesia.” These are usually persistent, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type. If you have these symptoms, talk to your health care professional.A rare but serious side effect that has been reported with this kind of medicine, including RISPERDAL, is known as NMS or neuroleptic malignant syndrome. NMS is characterized by muscle rigidity, fever and can be serious.Some people taking RISPERDAL may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your health care professional’s dosing instructions, this side effect may be reduced or it may go away over time.You may have heard the term “extrapyramidal symptoms” (EPS). These are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. Some people taking RISPERDAL have these side effects. If you have these symptoms, talk to your health care professional.
Some medications interact with RISPERDAL. Please inform your health care professional of any medications or supplements that you are taking. Avoid alcohol while on RISPERDAL.
Inform your healthcare professional if you are already pregnant or if you are planning to get pregnant while taking RISPERDAL. Do not breast-feed if you are taking RISPERDAL.
RISPERDAL may affect alertness or driving ability, therefore, do not drive or operate machines before talking to your health care professional. Keep out of reach of children.How RISPERDAL Can Help YouRISPERDAL
Effectively improved manic symptomsRISPERDAL has been proven to improve manic symptoms. In a clinical trial, RISPERDAL combined with a mood stabilizer (depakote or lithium) was highly effective in improving manic symptoms compared to placebo (sugar pill) and a mood stabilizer. Your results may vary.In addition to the effective control of your mania symptoms, RISPERDAL provides a convenient solution to people who dislike swallowing pills. RISPERDAL is available in a variety of formulations and strengths, including rapidly disintegrating tablets (called RISPERDAL M-TAB) and oral liquid. Phenylketonurics: RISPERDAL M-TAB contains phenylalanine.Remember, RISPERDAL may not be right for all people with bipolar mania. Be sure to talk with your health care professional. How to Take RISPERDALHow long do I need to take RISPERDAL?Only your health care professional can decide how long you will need to take RISPERDAL. Your health care professional has prescribed RISPERDAL to treat the symptoms of bipolar mania. Remember that in order to get the full benefit of your treatment you need to take RISPERDAL exactly as prescribed by your health care professional.What if I am taking other medications?People who have been prescribed RISPERDAL may also be taking other medications. Please advise your health care professional of any other medications, supplements or vitamins you are taking. It is important that you visit your health care professional regularly because changes in medications or doses may be necessary, and treatment plans may change during different stages of your illness.How Can I Remember to Take RISPERDAL?Remembering to take your medication as prescribed can sometimes be difficult. To review a list of simple, but effective reminders Side EffectsRISPERDAL® (risperidone) has some possible side effects that you should know about.With any medication, some people have side effects and some don’t. If you have any side effects with RISPERDAL, or feel you’re not getting better, please talk to your healthcare professional. Your healthcare professional may adjust the dose to help reduce or minimize your side effects. To assist you in tracking your side effects, a handy chart is available on this web site.Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL® (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.The most common side effects that may occur with RISPERDAL in the treatment of bipolar mania either alone or in combination with a mood stabilizer (Depakote or lithium) are: sleepiness, muscle stiffness, restlessness, tremor, indigestion, nausea, abnormal vision, muscle aches, dizziness, runny nose, diarrhea, increased saliva, stomach pain, and urinary incontinence.The newer atypical antipsychotic medications, including RISPERDAL, can sometimes cause an increased risk of serious elevated blood sugar-related side effects. For this reason, some people may need regular blood sugar testing.Some people taking RISPERDAL may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional’s dosing instructions, this side effect may be reduced or it may go away over time.You may have heard the term “extrapyramidal symptoms (EPS).” These are usually reversible movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. Some people taking RISPERDAL have these side effects. If you have these symptoms, talk to your healthcare professional.
You may have heard the term “tardive dyskinesia.” These are potentially irreversible, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type (antipsychotics). If you have these symptoms, talk to your healthcare professional. Only your healthcare professional should adjust your dose or stop your medication.Getting the Most Out of TreatmentBipolar I Disorder is a treatable mental illness. With medication, psychosocial counseling and support patients can live full, productive lives. You can help create your own success story by being informed!To get the most from your treatment plan, here are a few things to keep in mind:
- Learn about your illness and treatment. If you have questions ask your health care professional
- Make sure you take your medication exactly as prescribed by your health care professional.
- Be patient – your medication takes time to work. Don’t give up if your symptoms haven’t improved as much as you expected – stick with it.
- Develop a stable sleep pattern. Go to bed and wake up around the same time everyday.
- Don’t drink alcohol or use illicit drugs. These can affect your medication, trigger mood episodes and slow down your recovery.
- Learn techniques and identify ways to reduce stress both at home and at work.
- Create a support network of friends and family. Their support and encouragement can help you with your recovery.
- Join a support group. Talking to others who are experiencing the same things as you, helps you realize you are not alone. You can gain valuable insights into how they cope with different situations that they experience on a day-to-day basis. You can also develop valuable friendships.
- Attend counseling programs regularly. These programs will help you learn about your illness, treatments and how to recognize the early warning signs of an impending episode so that you can seek treatment before a full blown episode occurs.
- Learn to recognize the early warning signs of an episode so that you can seek medical treatment promptly.
- Develop a healthy lifestyle – one that includes a healthy diet and regular exercise. Talk to your health care professional before starting a new exercise program.
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