Although dose response for effectiveness has not been established for RISPERDAL CONSTAThe recommended dose for monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder is 25 mg IM every 2 weeks. 0.5-1 mg/day PO; may be increased or decreased in increments of 0.5 mg q12hr at intervals >3 days; not to exceed 6 mg/dayFor patient who have never taken risperidone, establish tolerability with PO risperidone before initiating the IM or SC dosage forms>13 years: 0.5 mg/day PO in morning or evening initially; may be increased in increments of 0.5-1 mg/day at intervals ≥24 hr to recommended dosage of 3 mg/day; dosage range: 1-6 mg/day (dosages >3 mg/day have not been proved more effective and are associated with increased incidence of adverse effects)If persistent somnolence occurs, daily dose may be divided q12hr >10 years: 0.5 mg/day PO in morning or evening initially; may be increased in increments of 0.5-1 mg/day at intervals ≥24 hr to recommended dosage of 2.5 mg/day; dosage range: 0.5-6 mg/day (dosages >2.5 mg/day have not been proved more effective and are associated with increased incidence of adverse effects)If persistent somnolence occurs, daily dose may be divided q12hrIrritability associated with autistic disorder in children aged 5-16 years5-16 years (<20 kg): 0.25 mg/day PO initially; may be increased after ≥4 days to recommended dosage of 0.5 mg/day5-16 years (≥20 kg): 0.5 mg/day PO initially; may be increased after ≥4 days to recommended dosage of 1 mg/dayNot approved for dementia-related psychosis, because of increased risk of cardiovascular or infectious related deaths (see Black Box Warnings)Risk of orthostatic hypotension higher in elderly; monitoring of renal function and orthostatic blood pressure may be necessary; for titrating to target dose, twice-daily regimen should be used and dosage maintained for 2-3 days before change is made to once-daily dose regimenPO: 0.5 mg q12hr; may be increased in increments ≤0.5 mg q12hr; increases to dosages >1.5 mg q12hr should occur at intervals ≥1 weekIM: 12.5-25 mg injected into deltoid or gluteal muscle every 2 weeks; dosage should not be adjusted more frequently than every 4 weeksRecommended to establish tolerability of PO risperidone before initiating treatment with IM risperidone0.25-1 mg/day PO initially; may be increased gradually as tolerated; not to exceed 1.5-2 mg/dayBlood and lymphatic system disorders: Anemia, granulocytopeniaCardiac disorders: Tachycardia, sinus bradycardia, sinus tachycardia, atrioventricular block first degree, bundle branch block left, bundle branch block right, atrioventricular blockEye Disorders: Vision blurred, oculogyration, ocular hyperemia, eye discharge, conjunctivitis, eye rolling, eyelid edema, eye swelling, eyelid margin crusting, dry eye, lacrimation increased, photophobia, glaucoma, visual acuity reducedGastrointestinal disorders: Dysphagia, fecaloma, fecal incontinence, gastritis, lip swelling, cheilitis, aptyalismGeneral disorders: Thirst, gait disturbance, chest pain, influenza-like illness, pitting edema, edema, chills, sluggishness, malaise, face edema, discomfort, generalized edema, drug withdrawal syndrome, peripheral coldness, feeling abnormalInfections and infestations: Nasopharyngitis, upper respiratory tract infection, sinusitis, urinary tract infection, pneumonia, influenza, ear infection, viral infection, pharyngitis, tonsillitis, bronchitis, eye infection, localized infection, cystitis, cellulitis, otitis media, onychomycosis, acarodermatitis, bronchopneumonia, respiratory tract infection, tracheobronchitis, otitis media chronicInvestigations: Body temperature increased, alanine aminotransferase increased, heart rate increased, eosinophil count increased, white blood cell count decreased, hemoglobin decreased, blood creatine phosphokinase increased, hematocrit decreased, body temperature decreased, blood pressure decreased, transaminases increasedMetabolism and nutrition disorders: Polydipsia, anorexiaMusculoskeletal, connective tissue, and bone disorders: Joint swelling, musculoskeletal chest pain, posture abnormal, myalgia, neck pain, muscular weakness, muscle rigidity, muscle contracture, rhabdomyolysisNervous system disorders: Dizziness postural, disturbance in attention, unresponsive to stimuli, depressed level of consciousness, movement disorder, hypokinesia, bradykinesia, transient ischemic attack, coordination abnormal, cerebrovascular accident, masked facies, speech disorder, syncope, loss of consciousness, muscle contractions involuntary, Parkinson disease, tongue paralysis, akinesia, cerebral ischemia, cerebrovascular disorder, neuroleptic malignant syndrome, diabetic coma, head titubationPsychiatric disorders: Agitation, blunted affect, confusional state, middle insomnia, nervousness, sleep disorder, listlessnessRenal and urinary disorders: Enuresis, dysuria, pollakiuria, urinary incontinence Reproductive system and breast disorders: Vaginal discharge, menstrual disorder, retrograde ejaculation, sexual dysfunctionAlopecia, anaphylactic reaction, angioedema, atrial fibrillation, cardiopulmonary arrest, diabetic ketoacidosis in patients with impaired glucose metabolism, dysgeusia, hypoglycemia, hypothermia, ileus, inappropriate antidiuretic hormone secretion, intestinal obstruction, jaundice, mania, pancreatitis, pituitary adenoma, precocious puberty, pulmonary embolism, QT prolongation, sleep apnea syndrome, sudden death, thrombocytopenia, thrombotic thrombocytopenic purpura, urinary retention, Stevens-Johnson syndrome, toxic epidermal necrolysis (SJS/TEN), and water intoxicationIncreased incidence of cerebrovascular disease reported; may alter cardiac conduction; life threatening arrhythmias reported with therapeutic doses of antipsychoticsMay cause anticholinergic effects including blurred vision, urinary retention, agitation, confusion, blurred vision, and xerostomiaUse with caution in patients with history of seizures, Parkinson disease, Lewy body dementia, cardiovascular disease, hypovolemia, dehydrationLeukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropeniaIf patient has history of clinically significant low WBC count or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of clinically significant WBC decline <1000/μL in absence of other causative factors, and continue monitoring WBC count until recoveryMay cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; perform complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapyUse caution in patients at risk of pneumonia; esophageal dysmotility and aspiration reported with antipsychotic useMay cause extrapyramidal symptoms including acute dystonic reactions, akathisia, pseudoparkinsonism, and tardive dyskinesiaIntraoperative floppy iris syndrome reported in patients receiving risperidone therapyMonitor for fever, mental status changes, muscle rigidity and or autonomic instability; neuroleptic malignant syndrome associated with risperidone useProlactin elevations occur and persist during chronic administration; risperidone is associated with higher levels of prolactin elevation than other antipsychotic agentsFDA warning regarding off-label use for dementia in elderlySeizures observed during premarketing studies of risperidone in adult patients with schizophreniaEsophageal dysmotility and aspiration have been associated with antipsychotic useDisruption of body temperature regulation has been attributed to antipsychotic agentsThere is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including risperidone, during pregnancyHealthcare professionals are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research programs/ pregnancyregistry/Limited data from published literature reports the presence of risperidone and its metabolite, 9- hydroxyrisperidone, in human breast milk at relative infant dose ranging between 2.3 and 4.7% of the maternal weight-adjusted dosageReports of sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) in breastfed infants exposed to risperidoneConsider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal conditionA: Generally acceptable.

Woche: 0,5 mg zweimal täglich