Risperdal/Risperdal Consta

Risperdal/Risperdal Consta

risperidone

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Risperidone.
Description
Risperdal: Tablets: Each tablet contains 1 mg, 2 mg or 3 mg of risperidone.
Oral Solution: The oral solution contains 1 mg/ml risperidone.
Excipients/Inactive Ingredients: Tablets: Tablet core: Lactose monohydrate, Maize starch, Microcrystalline cellulose, Hypromellose 2910 15 mPa.s, Magnesium stearate, Colloidal anhydrous silica, Sodium lauryl sulfate. Film-coating: Hypromellose 2910 5 mPa.s, Propylene glycol, Titanium dioxide (only in 2 mg and 3 mg tablets), Talc (only in 2 mg and 3 mg tablets), Quinoline yellow (only in 3 mg oral tablets), Orange yellow S aluminum lake (only in 2 mg oral tablets).
Oral Solution: Tartaric acid, Benzoic acid, Sodium hydroxide, Purified water.
Risperdal Consta: Risperdal Consta is an extended-release microspheres formulation of risperidone, composed of risperidone microencapsulated in polylactide-co-glycolide at a concentration of 381 mg risperidone per gram of microspheres.
It also contains the following excipients: Polysorbate 20, carmellose sodium 40 mPa.s, disodium hydrogen phosphate dihydrate, anhydrous citric acid, sodium chloride, sodium hydroxide and water for injection.
Action
Pharmacotherapeutic group: Other antipsychotics. ATC code: N05AX08.
Risperidone is a novel antipsychotic belonging to a new class of antipsychotic agents, the benzisoxazole derivatives.
Pharmacology: Mechanism of action: Risperidone is a selective monoaminergic antagonist with unique properties. It has a high affinity for serotoninergic 5-HT2 and dopaminergic D2-receptors. Risperidone binds also to α1-adrenergic receptors and with lower affinity, to H1-histaminergic and α2-adrenergic receptors. Risperidone has no affinity for cholinergic receptors. Although risperidone is a potent D2-antagonist, which is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical neuroleptics. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.
Risperdal Consta: Clinical Trials: The effectiveness of Risperdal Consta (25 and 50 mg) in the management of manifestations of psychotic disorders (schizophrenia/schizoaffective disorder) was established in one 12-week, placebo-controlled trial in adult psychotic inpatients and outpatients who met the DSM-IV criteria for schizophrenia.
In a 12-week comparative trial in stable patients with schizophrenia, Risperdal Consta was shown to be as effective as the oral tablet formulation. The long-term (50 weeks) safety and efficacy of Risperdal Consta was also evaluated in an open-label trial of stable psychotic inpatients and outpatients who met the DSM-IV criteria for schizophrenia or schizoaffective disorder. Over time efficacy was maintained with Risperdal Consta. (See Toxicology under Actions as follows).
Pharmacokinetics: Risperdal: RISPERDAL oral solution are bio-equivalent to RISPERDAL oral tablets.
Absorption: Risperidone is completely absorbed after oral administration, reaching peak plasma concentrations within 1 to 2 hours. The absorption is not affected by food and thus risperidone can be given with or without meals.
Distribution: Risperidone is rapidly distributed. The volume of distribution is 1 - 2 l/kg. In plasma, risperidone is bound to albumin and alpha1-acid glycoprotein. The plasma protein binding of risperidone is 88%, that of 9-hydroxy-risperidone is 77%.
One week after administration, 70% of the dose is excreted in the urine and 14% in the feces. In urine, risperidone plus 9-hydroxy-risperidone represent 35 - 45% of the dose. The remainder is inactive metabolites.
Metabolism: Risperidone is metabolized by CYP 2D6 to 9-hydroxy-risperidone, which has a similar pharmacological activity as risperidone. Risperidone plus 9-hydroxy-risperidone form the active antipsychotic fraction. Another metabolic pathway of risperidone is N-dealkylation.
Elimination: After oral administration to psychotic patients, risperidone is eliminated with a half-life of about 3 hours. The elimination half-life of 9-hydroxy-risperidone and of the active antipsychotic fraction is 24 hours.
Dose proportionality: Steady-state of risperidone is reached within 1 day in most patients. Steady-state of 9-hydroxy-risperidone is reached within 4 - 5 days of dosing. Risperidone plasma concentrations are dose-proportional within the therapeutic dose-range.
Special populations: Renal and hepatic impairment: A single-dose study showed higher active plasma concentrations and a reduced clearance of the active antipsychotic fraction by 30% in the elderly and 60% in patients with renal insufficiency. Risperidone plasma concentrations were normal in patients with liver insufficiency, but the mean free fraction of risperidone in plasma was increased by about 35%.
Pediatrics: The pharmacokinetics of risperidone, 9-hydroxy-risperidone and the active antipsychotic fraction in children are similar to those in adults.
Risperdal Consta: General Characteristics of Risperidone After Administration of Risperdal Consta in Patients: After a single IM injection with Risperdal Consta, the release profile consists of a small initial release of drug (<1% of the dose), followed by a lag time of 3 weeks. The main release of drug starts from week 3 onwards, is maintained from 4-6 weeks and subsides by week 7. Oral antipsychotic supplementation should therefore be given during the first 3 weeks of Risperdal Consta treatment (see Dosage & Administration).
The combination of the release profile and the dosage regimen (IM injection every 2 weeks) results in sustained therapeutic plasma concentrations. Therapeutic plasma concentrations remain until 4-6 weeks after the last Risperdal Consta injection.
The elimination phase is complete in approximately 7-8 weeks after the last injection.
The absorption of risperidone from Risperdal Consta is complete.
Active moiety and risperidone clearances were 5 and 13.7 L/hr in extensive metabolizers, respectively, and 3.2 and 3.3 L/hr in poor metabolizers of CYP2D6, respectively.
After repeated IM injections with 25 or 50 mg Risperdal Consta every 2 weeks, median trough and peak plasma concentrations of active moiety fluctuated between 9.9-19.2 ng/mL and 17.9-45.5 ng/mL, respectively. The pharmacokinetics of risperidone are linear in the dose range of 25-50 mg injected every 2 weeks. No accumulation of risperidone was observed during long-term use (12 months) in patients who were injected with 25-50 mg every 2 weeks.
Pharmacokinetic/Pharmacodynamic Relationship: There was no relationship between the plasma concentrations of the active moiety and the change in total PANSS (Positive and Negative Syndrome Scale) and total ESRS (Extrapyramidal Symptom Rating Scale) scores across the assessment visits in any of the phase III trials where efficacy and safety was examined.
Toxicology: Risperdal: Non-Clinical Information: In (sub)chronic toxicity studies, in which dosing was started in sexually immature rats and dogs, dose-dependent effects were present in male and female genital tract and mammary gland. These effects were related to the increased serum prolactin levels, resulting from the dopamine D2-receptor blocking activity of risperidone. In a toxicity study with juvenile rats, increased pup mortality and a delay in physical development was observed. In a 40-week study with juvenile dogs, sexual maturation was delayed. Long bone growth was not affected at a dose similar to the maximum human dose in adolescents (6 mg/day); effects were observed at a dose 4-fold (on an AUC basis) or 7-fold (on a mg/m2 basis) the maximum human dose in adolescents.
All other safety data relevant to the prescriber have been included in the appropriate section.
Risperdal Consta: Preclinical Safety Data: Similar to the subchronic toxicity studies with oral risperidone in rats and dogs, the major effects of treatment with Risperdal Consta (up to 12 months of IM administration) were prolactin-mediated mammary gland stimulation, male and female genital tract changes, and central nervous system (CNS) effects, related to the pharmacodynamic activity of risperidone.
Risperdal Consta administration to male and female rats for 12 and 24 months produced osteodystrophy at a dose of 40 mg/kg/2 weeks. The effect dose for osteodystrophy in rats was on a mg/m2 basis 8 times the maximum recommended human dose and is associated with a plasma exposure 2 times the maximum anticipated exposure in humans at the maximum recommended dose. No osteodystrophy was observed in dogs treated for 12 months with Risperdal Consta up to 20 mg/kg/2 weeks. This dose yielded plasma exposures up to 14 times the maximum recommended human dose.
There was no evidence of mutagenic potential.
As expected for a potent dopamine D2-antagonist in an IM carcinogenicity study in Wistar (Hannover) rats (doses of 5 and 40 mg/kg every 2 weeks), prolactin-mediated increased incidences of endocrine pancreas, pituitary gland, and adrenal medullary neoplasia were observed at 40 mg/kg, while mammary gland neoplasia were present at 5 and 40 mg/kg.
Hypercalcemia, postulated to contribute to an increased incidence of adrenal medullary tumors, was observed in both dose groups. There is no evidence to suggest that hypercalcemia might cause phaeochromocytomas in humans.
Renal tubular adenomas occurred in male rats at 40 mg/kg/2 weeks. No renal tumors occurred in the low dose, the sodium chloride 0.9% or the microspheres vehicle control group. The mechanism underlying the renal tumors in Risperdal Consta treated male Winstar (Hannover) rats is unknown. A treatment-related increase in renal tumor incidence did not occur in the oral carcinogenicity studies with Wistar (Wiga) or in Swiss mice administered oral risperidone. Studies conducted to explore the substrain differences in the tumor organ profile suggest that the Wistar (Hannover) substrain employed in the carcinogenicity study differs substantially from the Wistar (Wiga) substrain employed in the oral carcinogenicity study with respect to spontaneous age-related non-neoplastic renal changes, serum prolactin increases, and renal changes in response to risperidone. There are no data suggesting kidney-related changes in dogs treated chronically with Risperdal Consta. The relevance of the osteodystrophy, the prolactin-mediated tumors and of the presumed rat substrain-specific renal tumors in terms of human risk is unknown.
Local irritation at the injection site in dogs and rats was observed after administration of high doses of Risperdal Consta. In a 24-month IM carcinogenicity study in rats, no increased incidence of injection site tumors was seen in either the vehicle or the active drug groups.
Indications/Uses
Risperdal: RISPERDAL TABLET (1MG, 2MG & 3MG) AND RISPERDAL ORAL SOLUTION 1MG/ML: RISPERDAL is indicated for the treatment of a broad range of patients with schizophrenia, including first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia, and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted affect, emotional and social withdrawal, poverty of speech) are prominent. RISPERDAL alleviates affective symptoms (such as depression, guilt feelings, anxiety) associated with schizophrenia. RISPERDAL is also effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
RISPERDAL TABLETS (1MG) AND RISPERDAL ORAL SOLUTION 1MG/ML: RISPERDAL is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents.
Dosage/Direction for Use
Risperdal: Schizophrenia: Switching from other antipsychotics: When medically appropriate, gradual discontinuation of the previous treatment while RISPERDAL therapy is initiated is recommended. Also, if medically appropriate, when switching patients from depot antipsychotics, initiate RISPERDAL therapy in place of the next scheduled injection. The need for continuing existing anti-Parkinson medications should be re-evaluated periodically.
Adults: RISPERDAL may be given once daily or twice daily.
Patients should start with 2 mg/day RISPERDAL. The dosage may be increased on the second day to 4 mg. From then on the dosage can be maintained unchanged, or further individualized, if needed. Most patients will benefit from daily doses between 4 and 6 mg. In some patients, a slower titration phase and a lower starting and maintenance dose may be appropriate.
Doses above 10 mg/day have not been shown to be superior in efficacy to lower doses and may cause extrapyramidal symptoms. Since the safety of doses above 16 mg/day has not been evaluated, doses above this level should not be used.
A benzodiazepine may be added to RISPERDAL when additional sedation is required.
Elderly (65 years of age and older): A starting dose of 0.5 mg twice daily is recommended. This dosage can be individually adjusted with 0.5 mg twice daily increments to 1 to 2 mg twice daily.
Children: Risperidone is not recommended for use in children below age 18 with schizophrenia due to a lack of data on efficacy.
Conduct disorder: Children and adolescents from 5 to 18 years of age: For subjects ≥ 50 kg, a starting dose of 0.5 mg of oral solution once daily is recommended. This dosage can be individually adjusted by increments of 0.5 mg once daily not more frequently than every other day, if needed. The oral solution is the recommended pharmaceutical form to administer 0.5 mg. The optimum dose is 1 mg once daily for most patients. Some patients, however, may benefit from 0.5 mg once daily while others may require 1.5 mg once daily. For subjects < 50 kg, a starting dose of 0.25 mg of oral solution once daily is recommended. The oral solution is the recommended pharmaceutical form to administer 0.25 mg. This dosage can be individually adjusted by increments of 0.25 mg once daily not more frequently than every other day, if needed. The optimum dose is 0.5 mg once daily for most patients. Some patients, however, may benefit from 0.25 mg once daily while others may require 0.75 mg of oral solution once daily. The oral solution is the recommended pharmaceutical form to administer 0.75 mg.
As with all symptomatic treatments, the continued use of RISPERDAL must be evaluated and justified on an ongoing basis.
RISPERDAL is not recommended in children less than 5 years of age, as there is no experience in children less than 5 years of age with this disorder.
Renal and hepatic impairment: Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than normal adults. Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone.
Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower for patients with renal or hepatic impairment.
RISPERDAL should be used with caution in these groups of patients. Administration: RISPERDAL may be given as oral tablets or oral solution.
Risperdal Consta: Risperdal Consta should be administered every 2 weeks by deep IM gluteal injection using the enclosed safety needle. Injections should alternate between the buttocks. Do not administer IV (see Instructions for Use/Handling as follows).
Adults: Recommended Dose: 25 mg IM every 2 weeks. Some patients may benefit from the higher doses of 37.5 or 50 mg. The maximum dose should not exceed 50 mg every 2 weeks.
Sufficient antipsychotic coverage should be ensured during the 3-week lag period following the 1st Risperdal Consta injection (see Pharmacology: Pharmacokinetics under Actions).
Upward dosage adjustment should not be made more frequently than every 4 weeks. The effect of this dose adjustment should not be anticipated earlier than 3 weeks after the 1st injection with the higher dose.
Elderly: Recommended Dose: 25 mg IM every 2 weeks. Sufficient antipsychotic coverage should be ensured during the 3-week lag period following the 1st Risperdal Consta injection (see Pharmacology: Pharmacokinetics under Actions).
Hepatic and Renal Impairment: Risperdal Consta has not been studied in patients with hepatic and renal impairment. If patients with hepatic or renal impairment would require treatment with Risperdal Consta, a starting dose of 0.5 mg twice daily of oral risperidone is recommended during the 1st week. In the 2nd week, 1 mg twice daily or 2 mg once a day can be given. If an oral dose of at least 2 mg is well tolerated, an injection of 25 mg Risperdal Consta can be administered every 2 weeks.
Administration: Instructions for Use/Handling: Risperdal Consta extended-release microspheres may only be suspended in the diluent supplied in the dose pack and must be administered with the 20G Needle-Pro safety needle supplied in the dose pack.
Remove the dose pack of Risperdal Consta from the refrigerator and allow it to come to room temperature prior to reconstitution. Flip off the plastic coloured cap from the vial of Risperdal Consta. Open the syringe by breaking the seal of the white cap and remove the white cap together with the rubber tip cap inside.
Attach one of the Hypoint needle with an easy clockwise twisting motion to the luer connection of the syringe. Pull the sheath away from the Hypoint needle. Do not twist.
Inject the entire contents (diluent) of the syringe with diluent into the vial.
Withdraw the syringe with the Hypoint needle from the vial.
Unscrew the Hypoint needle from the syringe and discard the needle appropriately.
Before shaking the vial, attach the 2nd Hypoint needle with an easy clockwise twisting motion to the luer connection of the syringe. Do not remove the sheath from the needle at this stage. Shake the vial vigorously for at least 10 sec. Mixing is complete when the suspension appears uniform, thick and milky in colour, and all the powder is fully dispersed.
Do not store the vial after reconstitution or the suspension may settle.
Take the syringe and pull sheath away from the Hypoint needle. Do not twist.
Insert the Hypoint needle into the upright vial. Slowly withdraw the suspension from the vial in an upright, but slightly angled, position to ensure that the entire contents are drawn up into the syringe.
Withdraw the syringe with the Hypoint needle from the vial.
Unscrew the Hypoint needle from the syringe and discard the needle appropriately. For identification purposes, tear section of the vial label at the perforation and apply detached section to the syringe. Peel the blister pouch of the Needle-Pro device open half way. Grasp sheath using the plastic peel pouch.
Attach the luer connection of the Needle-Pro device with an easy clockwise twisting motion to the syringe. Seat the needle firmly on the Needle-Pro device with a push and clockwise twist.
Prepare the patient for injection. Resuspension of Risperdal Consta will be necessary prior to administration as settling will occur over time once product is reconstituted. Shake vigorously for as long as it takes to resuspend the microspheres.
Pull sheath away from the needle. Do not twist sheath as needle may be loosened from Needle-Pro device.
Tap the syringe gently to make any air bubbles rise to the top. Remove air bubbles from the syringe barrel by moving the plunger rod forward with the needle in an upright position. Inject the entire content of the syringe IM into the buttock of the patient.
Warning: To avoid a needle stick injury with a contaminated needle, do not intentionally disengage the Needle-Pro device; or attempt to straighten the needle or engage Needle-Pro device if the needle is bent or damaged; or mishandle the needle protection device that could lead to protrusion of the needle from the needle protector sheath.
After procedure is completed, press the needle into the sheath using a one-handed technique. Perform a one-handed technique by gently pressing the sheath against a flat surface. As the sheath is pressed, the needle is firmly engaged into the sheath.
Visually confirm that the needle is fully engaged into the needle protection sheath. Immediately discard appropriately.
Overdosage
Risperdal: Symptoms and signs: In general, reported signs and symptoms have been those resulting from an exaggeration of the drug's known pharmacological effects. These include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms. In overdose, QT-prolongation and convulsions have been reported. Torsade de pointes has been reported in association with combined overdose of oral RISPERDAL and paroxetine.
In case of acute overdosage, the possibility of multiple drug involvement should be considered.
Treatment: Establish and maintain a clear airway and ensure adequate oxygenation and ventilation. Administration of activated charcoal together with a laxative should be considered. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
There is no specific antidote to RISPERDAL. Therefore, appropriate supportive measures should be instituted. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents. In case of severe extrapyramidal symptoms, anticholinergic medication should be administered. Close medical supervision and monitoring should continue until the patient recovers.
Risperdal Consta: Overdosage is less likely to occur with parenteral than with oral medication, information pertaining to oral risperidone is presented.
Symptoms: In general, reported signs and symptoms have been those resulting from an exaggeration of Risperdal's known pharmacological effects. These include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms.
Overdosages of up to 360 mg have been reported. The available evidence suggests a wide safety margin. In overdose, rare cases of QT prolongation have been reported.
In case of acute overdosage, the possibility of multiple drug involvement should be considered.
Treatment: Establish and maintain a clear airway, and ensure adequate oxygenation and ventilation. Gastric lavage (after intubation, if the patient is unconscious) and administration of activated charcoal together with a laxative should be considered. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
There is no specific antidote to Risperdal/Risperdal Consta. Therefore, appropriate supportive measures should be instituted. Hypotension and circulatory collapse should be treated with appropriate measures eg, IV fluids and/or sympathomimetic agents. In case of severe extrapyramidal symptoms, anticholinergic medication should be administered. Close medical supervision and monitoring should continue until the patient recovers.
Contraindications
Risperdal: RISPERDAL is contraindicated in patients with a known hypersensitivity to the product.
Risperdal Consta: Patients with a known hypersensitivity to the components of Risperdal Consta.
It is also contraindicated in coma caused by CNS depressants, bone marrow depression and avoided in phaeochromocytoma.
Special Precautions
Risperdal: 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 RISPERDAL. In placebo-controlled trials with RISPERDAL in this population, the incidence of mortality was 4.0% for RISPERDAL-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 RISPERDAL 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): In placebo-controlled trials in elderly patients with dementia, there was a higher incidence of cerebrovascular adverse events, (cerebrovascular accidents and transient ischemic attacks), including fatalities, in patients treated with RISPERDAL compared to patients receiving placebo (mean age 85 years; range 73 - 97).
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. RISPERDAL should be used with caution in patients with known cardiovascular disease (e.g. heart failure, myocardial infarction, conduction 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.
Leucopenia, neutropenia, and agranulocytosis: Events of leucopenia, neutropenia and agranulocytosis have been reported with antipsychotic agents, including RISPERDAL. Agranulocytosis has been reported very rarely (< 1/10000 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 RISPERDAL 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 RISPERDAL 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 RISPERDAL 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 RISPERDAL has a 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.
Extrapyramidal symptoms and psychostimulants: Caution is warranted in patients receiving both psychostimulants (e.g. methylphenidate) and risperidone concomitantly, as extrapyramidal symptoms could emerge when adjusting one or both medications. Gradual withdrawal of one or both treatments should be considered (see Interactions).
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 RISPERDAL, should be discontinued.
Parkinson's Disease and Dementia with Lewy Bodies: Physicians should weigh the risks versus the benefits when prescribing antipsychotics, including RISPERDAL, 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 in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. 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. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related events in patients treated with the atypical antipsychotics, Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g. obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
Weight gain: Significant weight gain has been reported. Monitoring weight gain is advisable when RISPERDAL is being used.
QT Interval: As with other antipsychotics, caution should be exercised when RISPERDAL is 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 RISPERDAL 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 RISPERDAL 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, RISPERDAL 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 RISPERDAL (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 Schizophrenia: Elderly for specific posology recommendations for elderly patients under Dosage & Administration, Conduct and other disruptive behavior disorders for pediatric patients with conduct and other disruptive behavior disorders under Dosage & Administration, and Renal and Hepatic Impairment for patients with renal or hepatic impairment under Dosage & Administration.
Effects on Ability to Drive and Use Machines: RISPERDAL may interfere with activities requiring mental alertness. Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.
Risperdal Consta: For risperidone-naive patients, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with Risperdal Consta.
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 Risperdal. In placebo-controlled trials with oral Risperdal in this population, the incidence of mortality was 4% for Risperdal-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 oral Risperdal placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; 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 2 of the 4 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): In placebo-controlled trials in elderly patients with dementia, there was a higher incidence of cerebrovascular adverse events (cerebrovascular accidents and transient ischemic attacks,), including fatalities in patients (mean age 85 years; range 73-97) treated with oral Risperdal compared to patients receiving placebo.
Alpha-Blocking Activity: Due to the α-blocking activity of risperidone, orthostatic hypotension can occur, especially during initiation of treatment. Risperidone should be used with caution in patients with known cardiovascular disease (eg, heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolemia, or cerebrovascular disease). The risk/benefit of further treatment with Risperdal Consta should be assessed if clinically relevant hypotension persists.
Tardive Dyskinesia/Extrapyramidal Symptoms (TD/EPS): Drugs with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterized by rhythmic 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 has a 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): Characterized by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatinine phosphokinase levels has been reported to occur in association with antipsychotics. Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. In this event, all antipsychotic drugs, including risperidone, should be discontinued. After the last administration of Risperdal Consta, the plasma levels of risperidone are present for up to a minimum of 6 weeks.
Physicians should weigh the risks versus the benefits when prescribing antipsychotics, including Risperdal Consta, to patients with Parkinson's disease or dementia with Lewy bodies (DLB) since both groups may be at increased risk of neuroleptic malignant as well as having an increased sensitivity to antipsychotic medications. Manifestations of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Hyperglycemia: Hyperglycemia or exacerbation of preexisting diabetes has been reported in very rare cases during treatment with Risperdal. Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Classical neuroleptics are known to lower the seizure threshold. Caution is recommended when treating patients with epilepsy.
Effects on the Ability to Drive or Operate Machinery: Risperidone may interfere with the activities requiring mental alertness. Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.
Use in pregnancy: The safety of risperidone for use during human pregnancy has not been established. Although, in experimental animals, risperidone did not show direct reproductive toxicity, some indirect prolactin- and CNS-mediated effects were observed. No teratogenic effect of risperidone was noted in any study. Therefore, Risperdal/Risperdal Consta should only be used during pregnancy if the benefits outweigh the risks.
Use in lactation: In animal studies, risperidone and 9-hydroxy-risperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast milk. Therefore, women receiving Risperdal/Risperdal Consta should not breastfeed.
Use in children: Risperidone has not been studied in children <18 years.
Use In Pregnancy & Lactation
Risperdal: Pregnancy: The safety of risperidone for use during human pregnancy has not been established.
A retrospective observational cohort study based on a US claims database compared the risk of congenital malformations for live births among women with and without antipsychotic use during the first trimester of pregnancy. The risk of congenital malformations with risperidone, after adjusting for confounder variables available in the database, was elevated compared to no antipsychotic exposure (relative risk=1.26, 95% CI: 1.02-1.56). No biological mechanism has been identified to explain these findings and teratogenic effects have not been observed in non-clinical studies. Based on the findings of this single observational study, a causal relationship between in utero exposure to risperidone and congenital malformations has not been established.
Although, in experimental animals, risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed.
Neonates exposed to antipsychotic drugs (including RISPERDAL) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in these neonates. These complications have varied in severity; while is some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.
RISPERDAL should only be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Breast-feeding: In animal studies, risperidone and 9-hydroxy-risperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast milk. Therefore, women receiving RISPERDAL should not breast feed.
Risperdal Consta: Use in pregnancy: The safety of risperidone for use during human pregnancy has not been established. Although, in experimental animals, risperidone did not show direct reproductive toxicity, some indirect prolactin- and CNS-mediated effects were observed. No teratogenic effect of risperidone was noted in any study. Therefore, Risperdal Consta should only be used during pregnancy if the benefits outweigh the risks.
Use in lactation: In animal studies, risperidone and 9-hydroxy-risperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast milk. Therefore, women receiving Risperdal Consta should not breastfeed.
Adverse Reactions
Risperdal: Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of risperidone based on the comprehensive assessment of the available adverse event information. A causal relationship with risperidone cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical trial data: The safety of RISPERDAL was evaluated from a clinical trial database consisting of 9803 patients exposed to one or more doses of RISPERDAL for the treatment of various psychiatric disorders in adults, elderly patients with dementia, and pediatrics. Of these 9803 patients, 2687 were patients who received RISPERDAL while participating in double-blind, placebo-controlled trials. The conditions and duration of treatment with RISPERDAL varied greatly and included (in overlapping categories) double-blind, fixed- and flexible-dose, placebo- or active-controlled studies and open-label phases of studies, inpatients and outpatients, and short-term (up to 12 weeks) and longer-term (up to 3 years) exposures.
The majority of all adverse reactions were mild to moderate in severity.
Double-blind, placebo-controlled data - Adult patients: Adverse reactions reported by ≥ 1% of RISPERDAL-treated adult patients in nine 3- to 8-week double-blind, placebo-controlled trials are shown in Table 1. (See Table 1.)

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Double-blind, Placebo-controlled data - Elderly patients with dementia: Adverse reactions reported by ≥ 1% of RISPERDAL-treated elderly patients with dementia in six 4- to 12-week double-blind, placebo-controlled trials are shown in Table 2. Table 2 includes only those adverse reactions that are either not listed in Table 1 or those adverse reactions that occurred at ≥ 2 times the frequency of the adverse reactions listed in Table 1. (See Table 2.)

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Double-blind, placebo-controlled data - Pediatric patients: Adverse reactions reported by ≥ 1% of RISPERDAL-treated pediatric patients in eight 3- to 8-week double-blind, placebo-controlled trials are shown in Table 3. Table 3 includes only those adverse reactions that are either not listed in Table 1 or those adverse reactions that occurred at ≥ 2 times the frequency of the adverse reactions listed in Table 1. (See Table 3.)

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Other clinical trial data: Paliperidone is the active metabolite of risperidone, therefore the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another. This subsection includes additional adverse reactions reported with risperidone and/or paliperidone in clinical trials. Adverse reactions reported with risperidone and/or paliperidone by ≥ 1% of RISPERDAL-treated subjects in a pooled dataset of 23 double-blind, placebo-controlled pivotal studies (9 in adults, 6 in elderly patients with dementia, and 8 in pediatric patients) are shown in Table 4. (See Table 4.)

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Adverse reactions reported with risperidone and/or paliperidone by < 1% of RISPERDAL-treated subjects in a pooled dataset of 23 double-blind, placebo-controlled pivotal studies (9 in adults, 6 in elderly patients with dementia, and 8 in paediatric patients) are shown in Table 5. (See Table 5.)

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Adverse reactions reported with risperidone and/or paliperidone in other clinical trials but not reported by RISPERDAL-treated subjects in a pooled dataset of 23 double-blind, placebo-controlled pivotal studies are shown in Table 6. (See Table 6.)

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Postmarketing data: Adverse events first identified as adverse reactions during postmarketing experience with risperidone and/or paliperidone are included in Table 7. In the table, the frequencies are provided according to the following convention: Very common: ≥ 1/10; Common: ≥ 1/100 to < 1/10; Uncommon: ≥ 1/1,000 to < 1/100; Rare: ≥ 1/10,000 to < 1/1,000; Very rare: < 1/10,000, including isolated reports; Unknown: Cannot be estimated from the available data.
In Table 7, adverse reactions are presented by frequency category based on incidence in clinical trials, when known. (See Table 7.)

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Risperdal Consta: In clinical trials, the following side effects associated with Risperdal Consta at doses within the therapeutic range have been reported.
Common (>1/100): Weight gain (≥2.7 kg over 1 year), depression, fatigue and extrapyramidal symptoms. The incidence of extrapyramidal symptoms in patients administered with Risperdal Consta at doses up to 50 mg was comparable to that in the placebo group.
Uncommon (>0.1/100): Decreased weight, nervousness, sleep disorder, apathy, impaired concentration, tardive dyskinesia, seizures, neuroleptic malignant syndrome, abnormal vision, hypotension, syncope, rash, pruritus, peripheral edema, injection site reaction.
Symptoms of hyperprolactinemia eg, nonpuerperal lactation, amenorrhea, abnormal sexual function, ejaculation failure, decreased libido and impotence.
Hematological variations eg, increased and decreased white blood cell or thrombocyte count have been found, likewise in some patients, increases in hepatic enzyme have been reported.
In addition, the following side effects have been reported with oral risperidone: Insomnia, agitation, anxiety, headache, constipation, abdominal pain, rhinitis, urinary incontinence, priapism, somnolence, dizziness, dyspepsia, nausea/vomiting, body temperature deregulation, water intoxication due to either polydipsia or the syndrome of inappropriate secretion of antidiuretic hormone (SIADH). Cerebrovascular adverse events, including cerebrovascular accidents and transient ischemic attacks, have been observed during treatment with oral Risperdal (see Precautions). Hyperglycemia and exacerbation of preexisting diabetes have been reported in very rare cases during risperidone treatment.
Drug Interactions
Risperdal: Pharmacodynamic-related interactions: Centrally-acting drugs and alcohol: Given the primary CNS effects of RISPERDAL, it should be used with caution in combination with other centrally acting drugs or alcohol.
Levodopa and dopamine agonists: RISPERDAL may antagonize the effect of levodopa and other dopamine agonists.
Psychostimulants: The combined use of psychostimulants (e.g. methylphenidate) with risperidone can lead to the emergence of extrapyramidal symptoms upon change of either or both treatments (see Precautions).
Drugs with hypotensive effects: Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment.
Drugs known to prolong the QT interval: Caution is advised when prescribing RISPERDAL with drugs known to prolong the QT interval.
Pharmacokinetic-related interactions: Food does not affect the absorption of RISPERDAL.
Risperidone is mainly metabolized through CYP2D6, and to a lesser extent through CYP3A4. Both risperidone and its active metabolite 9-hydroxy-risperidone are substrates of P-glycoprotein (P-gp). Substances that modify CYP2D6 activity, or substances strongly inhibiting or inducing CYP3A4 and/or P-gp activity, may influence the pharmacokinetics of the risperidone active antipsychotic fraction.
Strong CYP2D6 inhibitors: Co-administration of RISPERDAL with a strong CYP2D6 inhibitor may increase the plasma concentrations of risperidone, but less so of the active antipsychotic fraction. Higher doses of a strong CYP2D6 inhibitor may elevate concentrations of the risperidone active antipsychotic fraction (e.g., paroxetine, see as follows). When concomitant paroxetine or another strong CYP2D6 inhibitor, especially at higher doses, is initiated or discontinued, the physician should re-evaluate the dosing of RISPERDAL.
CYP3A4 and/or P-gp inhibitors: Coadministration of RISPERDAL with a strong CYP3A4 and/or P-gp inhibitor may substantially elevate plasma concentrations of the risperidone active antipsychotic fraction. When concomitant itraconazole or another strong CYP3A4 and/or P-gp inhibitor is initiated or discontinued, the physician should re-evaluate the dosing of RISPERDAL.
CYP3A4 and/or P-gp inducers: Co-administration of RISPERDAL with a strong CYP3A4 and/or P-gp inducer may decrease the plasma concentrations of the risperidone active antipsychotic fraction. When concomitant carbamazepine or another strong CYP3A4 and/or P-gp inducer is initiated or discontinued, the physician should re-evaluate the dosing of RISPERDAL.
Highly protein-bound drugs: When RISPERDAL is taken together with highly protein-bound drugs, there is no clinically relevant displacement of either drug from the plasma proteins.
When using concomitant medication, the corresponding label should be consulted for information on the route of metabolism and the possible need to adjust dosages.
Pediatric population: Interaction studies have only been performed in adults. The relevance of the results from these studies in pediatric patients is unknown.
Examples: Examples of drugs that may potentially interact or that were shown not to interact with risperidone are listed below: Antibacterials: Erythromycin, a moderate CYP3A4 inhibitor, does not change the pharmacokinetics of risperidone and the active antipsychotic fraction.
Rifampicin, a strong CYP3A4 inducer and a P-gp inducer, decreased the plasma concentrations of the active antipsychotic fraction.
Anticholinesterases: Donepezil and galantamine, both CYP2D6 and CYP3A4 substrates, do not show a clinically relevant effect on the pharmacokinetics of risperidone and the active antipsychotic fraction.
Antiepileptics: Carbamazepine, a strong CYP3A4 inducer and a P-gp inducer, has been shown to decrease the plasma levels of the active antipsychotic fraction of risperidone.
Topiramate modestly reduced the bioavailability of risperidone, but not that of the active antipsychotic fraction. Therefore, this interaction is unlikely to be of clinical significance.
Risperidone does not show a clinically relevant effect on the pharmacokinetics of valproate or topiramate.
Antifungals: Itraconazole, a strong CYP3A4 inhibitor and a P-gp inhibitor, at a dosage of 200 mg/day increased the plasma concentrations of the active antipsychotic fraction by about 70%, at risperidone doses of 2 to 8 mg/day.
Ketoconazole, a strong CYP3A4 inhibitor and a P-gp inhibitor, at a dosage of 200 mg/day increased the plasma concentrations of risperidone and decreased the plasma concentrations of 9-hydroxy-risperidone.
Antipsychotics: Phenothiazines, may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction.
Aripiprazole, a CYP2D6 and CYP3A4 substrate: Risperidone tablets or injections did not affect the pharmacokinetics of the sum of aripiprazole and its active metabolite, dehydroaripiprazole.
Antivirals: Protease inhibitors: No formal study data are available; however, since ritonavir is a strong CYP3A4 inhibitor and a weak CYP2D6 inhibitor, ritonavir and ritonavir-boosted protease inhibitors potentially raise concentrations of the risperidone active antipsychotic fraction.
Beta-Blockers: Some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction.
Calcium Channel Blockers: Verapamil, a moderate inhibitor of CYP3A4 and an inhibitor of P-gp, increases the plasma concentration of risperidone and the active antipsychotic fraction.
Digitalis Glycosides: Risperidone does not show a clinically relevant effect on the pharmacokinetics of digoxin.
Diuretics: Furosemide: See Precautions regarding increased mortality in elderly patients with dementia concomitantly receiving furosemide.
Gastrointestinal Drugs: H2-receptor antagonists: Cimetidine and ranitidine, both weak inhibitors of CYP2D6 and CYP3A4, increased the bioavailability of risperidone, but only marginally that of the active antipsychotic fraction.
Lithium: Risperidone does not show a clinically relevant effect on the pharmacokinetics of lithium.
SSRIs and Tricyclic Antidepressants: Fluoxetine, a strong CYP2D6 inhibitor, increases the plasma concentration of risperidone, but less so of the active antipsychotic fraction.
Paroxetine, a strong CYP2D6 inhibitor, increases the plasma concentrations of risperidone, but, at dosages up to 20 mg/day, less so of the active antipsychotic fraction. However, higher doses of paroxetine may elevate concentrations of the risperidone active antipsychotic fraction.
Tricyclic antidepressants may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction. Amitriptyline does not affect the pharmacokinetics of risperidone or the active antipsychotic fraction.
Sertraline, a weak inhibitor of CYP2D6, and fluvoxamine, a weak inhibitor of CYP3A4, at dosages up to 100 mg/day are not associated with clinically significant changes in concentrations of the risperidone active antipsychotic fraction. However, doses higher than 100 mg/day of sertraline or fluvoxamine may elevate concentrations of the risperidone active antipsychotic fraction.
Caution For Usage
Risperdal: Incompatibilities: RISPERDAL tablets: none.
RISPERDAL oral solution: incompatible with tea.
Instructions For Use/Handling: Oral Solution: 1: The bottle comes with a child-resistant cap, and should be opened as follows: Push the plastic screw cap down while turning it counter clockwise.
Remove the unscrewed cap.
2: Insert the pipette into the bottle.
3: While holding the bottom ring, pull the top ring up to the mark that corresponds to the number of milliliters or milligrams you need to give.
4: Holding the bottom ring, remove the entire pipette from the bottle. Empty the pipette into any non-alcoholic drink, except for tea, by sliding the upper ring down. Close the bottle. Rinse the pipette with some water.
Risperdal Consta: After Reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hrs at 25°C. From a microbiological point of view, Risperdal Consta should be used immediately. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hrs at 25°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Incompatibilities: Risperdal Consta cannot be mixed or diluted with drugs or fluids other than the supplied diluent for administration.
Storage
Risperdal: RISPERDAL oral tablets should be stored below 30°C.
RISPERDAL oral solution should be stored below 30°C and should be protected from freezing.
Shelf Life: RISPERDAL oral tablets: 3 years.
RISPERDAL oral solution: 3 years when protected from freezing.
Opened container: 3 months when protected from freezing.
Risperdal Consta: Store in the refrigerator (2-8°C). Protect from light. Do not expose in temperatures above 25°C.
If refrigeration is unavailable, Risperdal Consta can be stored at temperatures not exceeding 25°C for not more than 7 days prior to administration. Do not expose unrefrigerated products to temperatures above 25°C.
MIMS Class
ATC Classification
N05AX08 - risperidone ; Belongs to the class of other antipsychotics.
Presentation/Packing
Risperdal tab 1 mg (white half-scored oblong biconvex) x 60's. 2 mg (orange half-scored oblong biconvex) x 60's. 3 mg (yellow half-scored oblong biconvex) x 60's. Risperdal oral soln 1 mg/mL x 30 mL.
Risperdal Consta powd for inj (vial) 25 mg x 1's. 37.5 mg x 1's. 50 mg x 1's.
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