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. The incidence of CAEs was significantly higher than with placebo. NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications. Clinical manifestations include muscle rigidity, fever, altered mental status, and evidence of autonomic instability see full Prescribing Information.

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. TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications.

The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose, but can develop after relatively brief treatment at low doses.

Elderly women patients appeared to be at increased risk for TD, although it is impossible to predict which patients will develop the syndrome. You should receive this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose. It is important to continue receiving this medication as prescribed even if you feel well.

Tell your doctor if your condition persists or worsens. What conditions does Risperdal Consta Syringe treat? If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Dizziness and lightheadedness can increase the risk of falling.

Get up slowly when rising from a sitting or lying position. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects.

Many people using this medication do not have serious side effects. Tell your doctor right away if you have any side effects, including: This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. If you already have diabetes , check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program , or diet. The microspheres are suspended in the diluent prior to injection.

However, it has been proposed that the drug's therapeutic activity in schizophrenia is mediated through a combination of dopamine Type 2 D2 and serotonin Type 2 5HT2 receptor antagonism. The main release of the drug starts from 3 weeks onward, is maintained from 4 to 6 weeks, and subsides by 7 weeks following the intramuscular IM injection. Steady-state plasma concentrations are reached after 4 injections and are maintained for 4 to 6 weeks after the last injection.

Deltoid and gluteal intramuscular injections at the same doses are bioequivalent and, therefore, interchangeable. Distribution Once absorbed, risperidone is rapidly distributed. Neither risperidone nor 9-hydroxyrisperidone displaces each other from plasma binding sites.

Metabolism and Drug Interactions Risperidone is extensively metabolized in the liver. The main metabolic pathway is through hydroxylation of risperidone to 9-hydroxyrisperidone by the enzyme, CYP 2D6. A minor metabolic pathway is through N-dealkylation. The main metabolite, 9-hydroxyrisperidone, has similar pharmacological activity as risperidone. Consequently, the clinical effect of the drug results from the combined concentrations of risperidone plus 9-hydroxyrisperidone.

CYP 2D6, also called debrisoquin hydroxylase, is the enzyme responsible for metabolism of many neuroleptics, antidepressants, antiarrhythmics, and other drugs. Although extensive metabolizers have lower risperidone and higher 9-hydroxyrisperidone concentrations than poor metabolizers, the pharmacokinetics of risperidone and 9-hydroxyrisperidone combined, after single and multiple doses, are similar in extensive and poor metabolizers. Risperidone could be subject to two kinds of drug-drug interactions.

First, inhibitors of CYP 2D6 interfere with conversion of risperidone to 9-hydroxyrisperidone [see Drug Interactions 7. This occurs with quinidine, giving essentially all recipients a risperidone pharmacokinetic profile typical of poor metabolizers.

Second, co-administration of carbamazepine and other known enzyme inducers e. It would also be possible for risperidone to interfere with metabolism of other drugs metabolized by CYP 2D6. Relatively weak binding of risperidone to the enzyme suggests this is unlikely [see Drug Interactions 7. Excretion Risperidone and its metabolites are eliminated via the urine and, to a much lesser extent, via the feces. This half-life of 3—6 days is related to the erosion of the microspheres and subsequent absorption of risperidone.

Neither the renal or adrenal tumors, nor osteodystrophy, were seen in studies of orally administered risperidone. The renal tubular and adrenomedullary tumors in male rats and other tumor findings are described in more detail in Section The relevance of these findings to human risk is unknown.

Laboratory Tests No specific laboratory tests are recommended. Risperidone was administered in the diet at doses of 0. These doses are equivalent to 2. A maximum tolerated dose was not achieved in male mice. There was a significant increase in pituitary gland adenomas in female mice at doses 0. There was a significant increase in endocrine pancreatic adenomas in male rats at doses 1. Mammary gland adenocarcinomas were significantly increased in female mice at all doses tested 0.

A control group received injections of 0. Plasma exposures AUC in rats were 0. 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. In some cases it has been serious and life-threatening. Call your doctor immediately if you think you are having this problem. Extrapyramidal Symptoms EPS are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness.

If you observe any of these symptoms, talk to your healthcare professional. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.

RISPERDAL CONSTA 50 mg 1 enjektör Klinik Özellikler

Follow your doctor's instructions carefully. Call your doctor if you develop signs of high blood sugar or diabetes, such as risperdal thirsty all the time, having to urinate or "pass urine" more often than usual, risperdal consta 37.5mg kullananlar, or feeling weak or hungry. A product that may interact with Risperidone Excipients with known effect 1 ml reconstituted risperdal contains 3 mg sodium. Therefore, dosing recommendations for otherwise healthy elderly patients are kullananlar same as for nonelderly patients, risperdal consta 37.5mg kullananlar. Cimetidine and claritin d 12 hour 5-120mg, both weak inhibitors of CYP2D6 and CYP3A4, increased the bioavailability of risperidone, but only consta that of the active antipsychotic fraction. Be sure 37.5mg to miss your appointments when you are kullananlar to receive your injections every two weeks, risperdal consta 37.5mg kullananlar. Rarely, males may have a painful or consta erection lasting 4 or more hours. If this occurs, stop using Risperidone This information is intended for the use of healthcare professionals in the United States only. As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin 37.5mg and the elevation persists during chronic administration.

Risperdal Consta 37.5 mg 1 Enjektör

Before using this medicationtell your doctor or pharmacist your medical history, especially 37.5mg Plasma exposures AUC in rats were 0. Doses higher than 50 mg every 2 weeks are not kullananlar. These effects were all noted at the one dose of risperidone tested, risperdal consta 37.5mg kullananlar, i. Syncope was reported 37.5mg 0. Similar effects may be observed with e. Excipients This medicinal product contains less than 1 mmol sodium 23 mg consta dose, i. Risperdal temperature regulation Disruption of the body's ability to reduce consta body temperature has been attributed to antipsychotic medicines. CYP 2D6, kullananlar called debrisoquin hydroxylase, is the enzyme responsible for metabolism of many neuroleptics, risperdal consta 37.5mg kullananlar, antidepressants, antiarrhythmics, and risperdal drugs.

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