The second week 1 mg twice daily or 2 mg once daily can be given. No data are available. For deltoid administration, use the 1-inch needle alternating injections between the two arms.
For gluteal administration, use the 2-inch needle alternating injections between the two buttocks. Do not administer intravenously see sections 4. For instructions on reconstitution of the medicinal product before administration, see section 6. Increased mortality in elderly with dementia In a meta-analysis of 17 controlled trials of atypical antipsychotics, including oral RISPERDAL, elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo.
The mean age range of patients who died was 86 years range Data from two large observational studies showed that elderly people with dementia who are treated with conventional antipsychotics are also at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.
The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic s of the patients is not clear. Concomitant use with furosemide In the oral RISPERDAL placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone 7.
The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials. Concomitant use of risperidone with other diuretics mainly thiazide diuretics used in low dose was not associated with similar findings. 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 or co-treatment with other potent diuretics should be considered prior to the decision to use.
There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment 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 CVAE An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations.
Orthostatic hypotension Due to the alpha-blocking activity of risperidone, orthostatic hypotension can occur, especially during initiation of treatment. Clinically significant hypotension has been observed post-marketing with concomitant use of risperidone and antihypertensive treatment. Risperidone should be used with caution in patients with known cardiovascular disease e. 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.
The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia. If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics should be considered. Neuroleptic malignant syndrome NMS Neuroleptic Malignant Syndrome, characterised 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.
Parkinson's Disease may worsen with risperidone. Both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotic medicinal products; these patients were excluded from clinical trials. Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Hypersensitivity reactions Although tolerability with oral risperidone should be established prior to initiating treatment with RISPERDAL CONSTA, rarely anaphylactic reactions have been reported during post-marketing experience in patients who have previously tolerated oral risperidone see sections 4.
In some cases, a prior increase in body weight has been reported which may be a predisposing factor. Association with ketoacidosis has been reported very rarely and rarely with diabetic coma. Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Patients treated with any atypical antipsychotic, including RISPERDAL CONSTA, should be monitored for symptoms of hyperglycaemia such as polydipsia, polyuria, polyphagia and weakness and patients with diabetes mellitus should be monitored regularly for worsening of glucose control. Weight should be monitored regularly. Evaluation of the prolactin plasma level is recommended in patients with evidence of possible prolactin-related side effects e. Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history.
QT prolongation QT prolongation has very rarely been reported post-marketing. As with other antipsychotics, caution should be exercised when risperidone is prescribed in patients with known cardiovascular disease, family history of QT prolongation, bradycardia, or electrolyte disturbances hypokalaemia, hypomagnesaemia , as it may increase the risk of arrhythmogenic effects, and in concomitant use with medicines known to prolong the QT interval.
Body temperature regulation Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicines. Venous thromboembolism Cases of venous thromboembolism VTE have been reported with antipsychotic drugs. 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. 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 medicines or of conditions such as intestinal obstruction, Reye's syndrome, and brain tumour.
Excipients This medicinal product contains less than 1 mmol sodium 23 mg per dose, i. Pharmacodynamic-related interactions Drugs known to prolong the QT interval As with other antipsychotics, caution is advised when prescribing risperidone with medicinal products known to prolong the QT interval, such as antiarrhythmics e.
This list is indicative and not exhaustive. Centrally-acting drugs and alcohol Risperidone should be used with caution in combination with other centrally-acting substances notably including alcohol, opiates, antihistamines and benzodiazepines due to the increased risk of sedation.
If you have any of the following: If you are due to have cataract eye surgery. If you have ever had yellowing of your skin or the whites of your eyes jaundice or a blood disorder. If you have porphyria, a rare inherited blood disorder. If you have a tumour on your adrenal gland, a condition called phaeochromocytoma. If you have had an allergic reaction to a medicine. If you are taking or using any other medicines.
This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines. How to take risperidone Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about risperidone and it will also provide you with a full list of the side-effects which you may experience from taking it.
Your dose will depend upon the reason you have been prescribed it, so take risperidone exactly as your doctor tells you to. You may be started on a small dose which will then be gradually increased. You will be prescribed one or two doses to take a day.
Try to get into the habit of taking your doses at the same times each day, as this will help you to avoid missing any. Risperidone is not affected by food in your stomach so you can take your doses either before or after meals. Most people find it helps to swallow the tablet with a drink of water. If you have any difficulties swallowing, let your doctor know so that you can be prescribed tablets that dissolve in your mouth called orodispersible tablets or liquid medicine instead.
If you have been given orodispersible tablets, these are made to dissolve in your mouth. Gently peel open the packaging, remove the tablet and place it on your tongue.
Allow the tablet to dissolve on your tongue before you swallow. If you have been given liquid medicine, make sure you understand how to use the dose syringe pipette to measure out your doses. If you are unsure about this, you can ask your local pharmacist to show you what to do. If you would like to take the medicine added to a little liquid, you can mix it with any non-alcoholic drink except tea. If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose, in which case leave out the missed dose.
Do not take two doses together to make up for a missed dose. Getting the most from your treatment Remember to keep your regular doctor's appointments so that your progress can be checked.
If you are taking risperidone long-term, you may need to have some tests from time to time. If you drink alcohol, ask your doctor for advice about drinking while you are on risperidone. Alcohol will increase the chance that you experience side-effects and is unlikely to be recommended for you.
If you are having an operation, tell the person carrying out the treatment which medicines you are taking. This is important because risperidone may interfere with any anaesthetic you receive. If you are having cataract surgery, it is particularly important that you tell your surgeon you are on risperidone. This is because an eye problem known as 'floppy iris syndrome' has developed in some people and your doctor will want to advise you about the risk of this.
If you buy or take any 'over-the-counter' medicines, check with a pharmacist that they are suitable to take with risperidone. If you have diabetes you may need to check your blood glucose more frequently as risperidone can affect the levels of sugar in your blood. Your doctor will advise you about this.
SSRIs and tricyclic antidepressants: If you suspect that you or someone else might have taken risperidone overdose of this medicine, go to the accident and emergency department of your local hospital. Cerebrovascular adverse events CVAE An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics. Vial with powder White to off-white free flowing powder, risperidone price uk. Most people find it helps to swallow the tablet price a drink of water. This is because an eye problem known as 'floppy iris syndrome' has developed in some people and your doctor will want to advise you about the risk of this. If you experience any other risperidone which you think may be due to the medicine, speak with your doctor or pharmacist for further advice. If you have been taking it regularly for a year or so, your doctor risperidone probably want you to reduce your dose gradually if risperidone becomes necessary, risperidone price uk. Schizophrenia and other psychoses; to ease aggressive or other disruptive behaviours Also called Available as Tablet, risperidone price uk, orodispersible melt-in-the-mouth tablet, risperidone price uk, and price liquid medicine Risperidone belongs to a group of medicines called antipsychotics. Neuroleptic malignant syndrome NMS Neuroleptic Malignant Syndrome, characterised by price, muscle rigidity, risperidone price uk, autonomic instability, altered consciousness and elevated serum creatine price levels has been reported to occur with antipsychotics. Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history. If you have a tumour on your adrenal gland, a price called phaeochromocytoma, risperidone price uk. The potential benefit of stopping alpha1-blocking therapy prior to cataract surgery has not been established and must be weighed against risperidone risk of stopping the antipsychotic therapy.
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