Risperidex Special Precautions



Dexcel Pharma/AmediusTec


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Special Precautions
Elderly Patients with Dementia: Overall Mortality: Elderly patients with dementia treated with atypical antipsychotic drugs have an increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical antipsychotic drugs, including risperidone. In placebo-controlled trials with risperidone in  this population, the incidence of mortality was 4.0% for risperidone–treated patients compared to 3.1% for placebo-treated patients. The mean age (range) of patients who died was 86 years (range 67-100).
Concomitant use with Furosemide: In the risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%); mean age 89 years, range 75-97) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96) or furosemide alone (4.1%; mean age 80 years, range 67-90). The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials.
No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. Nevertheless, caution should be exercised and the risks and benefits of this combination should be considered prior to the decision to use.
There was no increased incidence of mortality among patients taking other diuretics as concomitant medication with risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.
Cerebrovascular Adverse Events (CAE): For specific dosage recommendations for elderly patients, patients with renal and liver disease and patients with dementia, see Dosage & Administration.
Cerebrovascular adverse events (eg stroke, transient ischemic attack), including fatalities, were reported in patients (mean age 85 years range; range 73-97) in trials of risperidone in elderly patients with dementia-related psychosis.
In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo.
Risperidone Tablets are not approved for the treatment of patients with dementia-related psychosis.
In placebo-controlled trials in elderly patients with dementia there was a significantly higher incidence (approximately 3-fold increased) of CAEs, such as stroke (including fatalities) and transient ischaemic attack in patients treated with Risperidex Tablets compared with patients treated with placebo (mean age 85 years; range 73 to 97). The pooled data from six placebo controlled studies in mainly elderly patients (>65 years of age) with dementia showed that CAEs (serious and non-serious, combined) occurred in 3.3% (33/1009) of patients treated with risperidone and 1.2% (8/712) of patients treated with placebo. The odds ratio (95% exact confidence interval) was 2.96 (1.34, 7.50). The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. Risperidex should be used with caution in patients with risk factors for stroke.
The risk of CVAEs was higher in patients on risperidone with mixed or vascular type of dementia when compared to Alzheimer's dementia.
Physicians are advised to assess the risks and benefits of the use of risperidone in elderly patients with dementia, taking into account risk predictors for stroke in the individual patient.
Patients/caregivers should be cautioned to immediately report signs and symptoms of potential CVAEs such as sudden weakness or numbness in the face, arms or legs, and speech or vision problems. All treatment options should be considered without delay, including discontinuation of risperidone.
Patients should be re-assessed regularly, and the need for continued treatment.
Orthostatic Hypotension: Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur, especially during the initial dose-titration period. Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment. Risperidone Tablets should be used with caution in patients with known cardiovascular disease (e.g. heart failure, myocardial infarction, conduction and abnormalities, dehydration, hypovolemia, or cerebrovascular disease), and the dosage should be gradually titrated as recommended (see Dosage & Administration). A dose reduction should be considered if hypotension occurs.
Leukopenia, Neutropenia, and Agranulocytosis: Events of leucopenia, neutropenia, and agranulocytosis have been reported with antipsychotic agents, including Risperidone Tablets. Agranulocytosis has been reported very rarely (<1/10,000 patients) during post-marketing surveillance.
Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leukopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of risperidone should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count < 1 x 109/L) should discontinue Risperidone Tablets and have their WBC followed until recovery.
Venous Thromboembolism: Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Risperidone Tablets and preventive measures undertaken.
Tardive Dyskinesia/Extrapyramidal Symptoms (TD/EPS): Drugs with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterized by rhythmical involuntary movements, predominantly of the tongue and/or face. It has been reported that the occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. Because Risperidone Tablets have lower potential to induce extrapyramidal symptoms than classical neuroleptics, it should have a reduced risk of inducing tardive dyskinesia as compared to classical neuroleptics. If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotic drugs should be considered.
Neuroleptic Malignant Syndrome (NMS): Neuroleptic Malignant Syndrome, characterized by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotics. Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. In this event, all antipsychotic drugs, including Risperidone Tablets, should be discontinued.
Parkinson's Disease and Dementia with Lewy Bodies: Physicians should weigh the risks versus the benefits when prescribing antipsychotics, including Risperidone Tablets, to patients with Parkinson’s Disease or Dementia with Lewy Bodies (DLB) since both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotic medications. Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Hyperglycemia and Diabetes Mellitus: Hyperglycemia, diabetes mellitus and exacerbation of pre-existing diabetes have been reported in patients treated with atypical antipsychotics, including risperidone. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. Any patient treated with atypical antipsychotics, including Risperidex Tablets should be monitored for symptoms of hyperglycemia and diabetes mellitus (see Adverse Reactions). However, epidemiological studies suggest an increased risk of diabetes and hyperglycaemia with atypical antipsychotics.
Patients with an established diagnosis of diabetes mellitus, risk factors for diabetes (eg obesity, family history of diabetes), or those who develop symptoms of hyperglycaemia during treatment with a typical antipsychotics should be monitored for symptoms of hyperglycaemia including polydipsia, polyuria, polyphagia and weakness.
Weight Gain: Significant weight gain has been reported. Monitoring weight gain is advisable when Risperidex Tablets are being used.
QT Interval: As with other antipsychotics, caution should be exercised when Risperidone Tablets are prescribed in patients with a history of cardiac arrhythmias, in patients with congenital long QT syndrome and in concomitant use with drugs known to prolong the QT interval.
Priapism: Drugs with alpha-adrenergic blocking effects have been reported to induce priapism. Priapism has been reported with Risperidone Tablets during postmarketing surveillance (see Adverse Reactions).
Body Temperature Regulation: Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing Risperidone Tablets to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g. exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration.
Antiemetic Effect: An antiemetic effect was observed in preclinical studies with risperidone. This effect, if it occurs in humans, may mask the signs and symptoms of overdosage with certain drugs or of conditions such as intestinal obstruction, Reye’s syndrome, and brain tumor.
Seizures: As with other antipsychotic drugs, Risperidex Tablets should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Intraoperative Floppy Iris Syndrome: Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in patients treated with medicines with alpha1a-adrenergic antagonist effect, including risperidone (see Adverse Reactions).
IFIS may increase the risk of eye complications during and after the operation. Current or past use of medicines with alpha1a-adrenergic antagonist effect should be made known to the ophthalmic surgeon in advance of surgery. The potential benefit of stopping alpha1 blocking therapy prior to cataract surgery has not been established and must be weighed against the risk of stopping the antipsychotic therapy.
Other: See Dosage & Administration for specific dosage recommendations for elderly patients, for elderly patients with dementia, for patients with bipolar mania, for pediatric patients with conduct and other disruptive behavior disorders, and for patients with renal or hepatic impairment. For conduct disorder effects on sexual maturation and gonadal function in children and adolescents have not been evaluated beyond 12 months in relation to long-term treatment. Safety data beyond 12 months is lacking in relation to the effect of long-term treatment.
Effects on Ability to Drive and Use Machines: Risperidex Tablets may interfere with activities requiring mental alertness. Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.
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