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|Trade names||Risperdal, others |
|Pregnancy category||AU: B3 US: C (Risk not ruled out)|
|Routes of administration||By mouth (tablets and liquid form), IM|
|ATC code||N05AX08 ( WHO )|
|Legal status||AU: S4 (Prescription only) UK: POM (Prescription only) US: ℞-only|
|Bioavailability||70% (oral) |
|Metabolism||Liver (CYP2D6 mediated to 9-hydroxyrisperidone) |
|Elimination half-life||20 hours (Oral), 3–6 days (IM) |
|Excretion||Urinary (70%) feces (14%) |
RISPERDAL CONSTA® (risperidone)
Please inform your healthcare professional of any medications or supplements that you are taking. These medicines are not approved for the treatment of patients with dementia-related psychosis. Layout table for eligibility information Ages Eligible for Study:
This is not a complete list of all possible side effects. Check with your healthcare professional while on treatment.
Layout table for eligibility information Ages Eligible for Study: Clinical monitoring of weight is recommended. R Paliperidone Palmitate mg eq every 4 wks Drug: Visit www.
Metabolic Changes: Elderly female patients appeared to be at increased risk for TD, although it is impossible to predict which patients will develop the syndrome.
Use cautiously in patients at risk for aspiration pneumonia. The dose for those randomized to the conventional dose group will remain the same 50 mg plus placebo.
|Active substance||risperidone, risperidone|
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Call your healthcare professional immediately if you think you are having this problem. Please inform your healthcare professional of any medications or supplements that you are taking. Let your healthcare professional know if these symptoms occur.
If you already have diabetes or have risk factors such as being overweight or a sources history of diabetes, blood sugar testing should be done at the beginning and during the treatment. If administering a strong inducer is necessary, consider managing the patient using paliperidone extended-release tablets.
CAEs e. Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including paliperidone.
For intramuscular injection only. This scale permits a global evaluation of the patient's condition at a given time. You are encouraged to report side effects of prescription drugs to the FDA.
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IMPORTANT SAFETY INFORMATION For RISPERDAL CONSTA®
Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and problems with erection. Drug Interactions:
All rights reserved. TD includes uncontrollable movements of the face, tongue, and other parts of the body. Weight Gain:
The dose for those randomized to the conventional dose group will remain the same 50 mg plus placebo. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents. Elderly women appeared to be at increased risk for TD, although it is impossible to predict which patients will develop the syndrome.
The Prescribing Information included here may not be appropriate for use outside the United States. Care should be taken to avoid inadvertent injection into a blood vessel. Risperidone Consta Active Comparator:
- Layout table for eligibility information Ages Eligible for Study
- John's wort is co-administered
- Avoid the use of drugs that also increase QTc interval and in patients with risk factors for prolonged QTc interval
- Talk with your doctor and family members or friends about deciding to join a study
- Commonly Observed Adverse Reactions
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Those who are randomized to high dose Consta will receive a Consta 50 mg injection plus 25 mg injection total dose 75 mg q 2 weeks as the starting dose. A qualified rater administered the CGI-S.
The metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. Orthostatic Hypotension and Syncope: Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. For general information, Learn About Clinical Studies.
In some cases it has been serious and life-threatening. Tardive Dyskinesia TD: Potential for Cognitive and Motor Impairment: Weight gain has been observed with atypical antipsychotic use.
Patients who develop symptoms of hyperglycemia during treatment should also undergo fasting blood glucose testing. Paliperidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.
Patients who develop symptoms of hyperglycemia during treatment should also undergo fasting blood glucose testing. Patients particularly the elderly taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for define estradiol potential risk of falls.
Discontinue drug if clinically appropriate.
CAEs e. Hyperglycemia and Diabetes Mellitus: Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and close medical monitoring, and treatment of any concomitant serious medical problems.
Esophageal dysmotility and aspiration have been associated with antipsychotic drug use.
Use cautiously in patients at risk for aspiration clotrimazole gentamicin cream. QT Prolongation: All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks.
For general information, Learn About Clinical Studies. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
CAEs eg, stroke, transient ischemia attacksincluding fatalities, were reported in placebo-controlled trials in elderly patients with dementiarelated psychosis taking oral risperidone, aripiprazole, and olanzapine. Esophageal dysmotility and aspiration have been associated with antipsychotic drug use.
Secondary Outcome Measures: All patients treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer's dementia. Increased sensitivity in risperdal consta pi with Parkinson's disease or those with dementia with Lewy bodies has been reported.
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Patients starting treatment with APS who have or are at risk for diabetes mellitus should undergo fasting blood glucose testing at the beginning of and during treatment. The Prescribing Information included here may not be appropriate for use outside the United States.
Clinical monitoring of weight is recommended. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.
Third party trademarks used herein are trademarks of their respective owners. Weight gain has been observed with atypical antipsychotic use. If no improvement from baseline is shown, the randomized dose of Consta will be increased to mg q 2 weeks given as two 50 mg injections for those in the high dose Consta group.
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Risperdal consta pi
Talk with your doctor and family members or friends about deciding to join a study. In some cases it has been serious and life-threatening.
Drug Interactions: NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications.
The complications of diabetes can be serious and even life-threatening. Speak to your healthcare provider if you plan to become pregnant. Some patients require continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and problems with erection.
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