Eperon

Risperidone

Broad range of patients w/ schizophrenia, including 1st episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia & other psychotic conditions, in which +ve symptoms (eg, hallucination, delusions, thought disturbances, hostility, suspiciousness) &/or -ve symptoms (eg, blunted affect, emotional & social w/drawal, poverty of speech) are prominent. Short-term treatment of persistent aggression in patients w/ moderate to severe Alzheimer's type dementia unresponsive to non-pharmacological approaches & when there is a risk of harm to self or others. Behavioural disorders associated w/ autism (eg, irritability, social w/drawal, stereotypic behaviour, hyperactivity & inappropriate speech) in childn & adolescents; bipolar mania. Adjunctive therapy to mood stabilizers in the treatment of manic episodes associated w/ bipolar 1 disorders. Monotherapy in the treatment of acute manic episodes associated w/ bipolar disorder. Conduct & other disruptive behaviour disorders in childn (>5 yr), adolescents & adults w/ subaverage intellectual functioning or mental retardation in whom destructive behaviours are prominent.

Schizophrenia Adult Initially 2 mg once daily, may be increased to 4 mg on the 2nd day. Recommended dose: 4-6 mg. Max: 16 mg/day. Manic episodes in bipolar disorder Adult Initially 2-3 mg once daily, dosage adjustments should occur at intervals of not less than 24 hr, 1 mg/day dosage increments. Dose range: 2-6 mg/day. Behavioral disturbances in patient w/ dementia Initially 0.25 mg bd, may be individually adjusted by 0.25-mg bd increment not more frequently than every other day. Optimum dose: 0.5 mg bd. Conduct disorder Childn & adolescent (5-18 yr), patient ≥50 kg Initially 0.5 mg once daily, may be individually adjusted by 0.5-mg once daily increments not more frequently than every other day. Optimum dose: 1 mg once daily. Patient <50 kg Initially 0.25 mg once daily, may be individually adjusted by 0.25-mg once daily increments not more frequently than every other day. Optimum dose: 0.5 mg once daily. Elderly Schizophrenia & manic episodes in bipolar disorder Initially 0.5 mg bd, may be individually adjusted w/ 0.5-mg bd increments to 1-2 mg bd. Autism Ped (5-17 yr) Individualized dosage. Initially 0.5 mg/day for patients ≥20 kg & 0.25 mg/day for patients <20 kg. Day 4: Increased dose by 0.5 mg for patients ≥20 kg & 0.25 mg for patients <20 kg. Dose increase may proceed at ≥2-wk intervals in increments of 0.5 mg for patients ≥20 kg & 0.25 mg for patients <20 kg. Max: 3.5 mg in patients >45 kg, 2.5 mg in patients ≥20 kg & 1.5 mg in patients <20 kg.

May be taken with or without food.

Hypersensitivity.

Risk of venous thromboembolism. Patients w/ risk factors for stroke. Orthostatic hypotension. Increased the risk of eye complications during & after operation w/ intraoperative floppy iris syndrome. Concomitant use w/ furosemide. Patients w/ known CV disease (eg, heart failure, MI, conduction abnormalities, dehydration, hypovolemia or cerebrovascular disease). Monitor patients w/ history of clinically significant low WBC count or drug-induced leucopenia/neutropenia during the 1st few mth of therapy & discontinuation of therapy at the 1st sign of clinically significant decline in WBC in the absence of other causative factors. Parkinson's disease or dementia w/ lewy bodies; history of seizures or other conditions that potentially lower seizure threshold. Discontinue use if tardive dyskinesia/extrapyramidal symptoms & neuroleptic malignant syndrome occur. Monitor for symptoms of DM & hyperglycaemia including polydipsia, polyuria, polyphagia & weakness; wt gain; body temp regulation. Priapism may occur. Patients w/ history of cardiac arrhythmias; congenital long QT syndrome & concomitant use w/ drugs known to prolong QT interval. May mask the signs & symptoms of overdosage w/ certain drugs or of conditions eg, intestinal obstruction, Reye's syndrome & brain tumor. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Hepatic & renal impairment. May affect the ability to drive or operate machinery. Do not use during pregnancy & lactation. Not recommended in childn <18 yr w/ schizophrenia & bipolar mania. Elderly w/ dementia.

Nasopharyngitis, upper resp tract infection, sinusitis, UTI, pneumonia, cellulitis, rhinitis, influenza; increased/decreased appetite; anemia; hypersensitivity; insomnia, anxiety, nervousness, confusional state, middle insomnia, listless; parkinsonism, akathisia, somnolence, dizziness, sedation, tremor, dystonia, lethargy, postural dizziness, dyskinesia, syncope, transient ischaemic attack, depressed level of consciousness, drooling, CVA, headache, dysarthria, attention disturbance, balance disorder, hypersomnia; blurred vision, conjunctivitis; ear pain; tachycardia, palpitations; orthostatic hypotension, hypotension; nasal congestion, dyspnea, epistaxis, sinus/pulmonary congestion, cough, rhinorrhoea, pharyngolaryngeal pain; nausea, constipation, dyspepsia, vomiting, diarrhea, salivary hypersecretion, dry mouth, abdominal discomfort, abdominal pain, stomach discomfort, upper abdominal pain, dysphagia, fecaloma; rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, erythema, pruritus, acne; back pain, arthralgia, pain in extremity, abnormal posture, joint swelling, myalgia, neck pain; urinary incontinence, enuresis, pollakiuria; galactorrhea; ejaculation failure, fatigue, asthenia, pyrexia, chest pain, peripheral edema, pyrexia, gait disturbance, pitting edema, abnormal feeling, sluggishness; increased blood creatine phosphokinase, heart rate, body temp, blood prolactin & wt.

Caution in combination w/ other centrally-acting drugs or alcohol & drugs known to prolong the QT interval. May antagonize the effect of levodopa & other dopamine agonists. Significant hypotension w/ antihypertensive treatment. Increased plasma conc w/ strong CYP2D6 inhibitors. May elevate plasma conc w/ strong CYP3A4 &/or P-gp inhibitor (eg, itraconazole, ketoconazole & verapamil). Decreased plasma conc w/ CYP3A4 &/or P-gp inducers (eg, carbamazepine). Increased bioavailability w/ cimetidine & ranitidine.

Antipsychotics

N05AX08 - risperidone ; Belongs to the class of other antipsychotics.

POM