Dexcel Pharma/AmediusTec


Apex Pharma Marketing
Concise Prescribing Info
Schizophrenia, including 1st episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia, & other psychotic conditions, in which +ve symptoms (eg, hallucinations, delusions, thought disturbances, hostility, suspiciousness) &/or -ve symptoms (eg, blunted affect, emotional & social w/drawal, poverty of speech) are prominent. Alleviate affective symptoms (eg, depression, guilt feelings, anxiety) associated w/ schizophrenia. Short-term treatment of persistent aggression in patients w/ moderate to severe dementia of the Alzheimer's type unresponsive to nonpharmacological 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 disorders. Episodes are characterized by symptoms eg, elevated, expansive or irritable mood, inflated self-esteem, decreased need for sleep, pressured speech, racing thoughts, distractibility, or poor judgment, including disruptive or aggressive behaviours. Monotherapy: Acute manic episodes associated w/ bipolar 1 disorder. Conduct & other disruptive behaviour disorders in childn (>5 yr), adolescents & adults w/ sub-average intellectual functioning or mental retardation in whom destructive behaviours (eg, aggression, impulsitivity & self-injurious behaviours) are prominent.
Dosage/Direction for Use
Schizophrenia Adult Initially 2 mg/day, may be increased to 4 mg on the 2nd day. Doses may be given once daily or bd. Elderly, renal & liver disease Initially 0.5 mg bd, may be individually adjusted w/ 0.5 mg bd increments to 1-2 mg bd. Aggression in patient w/ dementia of the Alzheimer type Initially 0.25 mg bd, may be individually adjusted by increments of 0.25 mg bd not more frequently than every other day. Optimum dose: 0.5 mg bd. Bipolar mania Adult Initially 2-3 mg once daily, may be adjusted at intervals of not <24 hr & in dosage increments of 1 mg/day. Recommended dose: 2-6 mg/day. Conduct & other disruptive behaviour disorders (5-18 yr) Patient ≥50 kg Starting dose of 0.5 mg once daily is recommended. Dosage can be individually adjusted by increments of 0.5 mg once daily not more frequently than every other day, if needed. Optimum dose: 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. Patient <50 kg Starting dose of 0.25 mg once daily is recommended. Dosage can be individually adjusted by increments of 0.25 mg once daily not more frequently than every other day, if needed. Optimum dose: 0.5 mg once daily for most patient. Some patients, however, may benefit from 0.25 mg once daily while others may require 0.75 mg once daily. Autism Ped (5-17 yr) Individualized dosing. Patient ≥20 kg 0.5 mg/day, may increase dose by 0.5 mg on Day 4. <20 kg 0.25 mg/day, may increase dose by 0.25 mg on Day 4. Assess response on Day 14. Dose increased may proceed at ≥2 wk intervals in increments of 0.25 mg for patient <20 kg or 0.5 mg for patient ≥20 kg. Max: Do not exceed total daily dose of 2.5 mg in patient ≥20 kg, 1.5 mg in patient <20 kg or 3.5 mg in patient >45 kg.
May be taken with or without food.
Special Precautions
Elderly w/ dementia or dementia-related psychosis. Renal & hepatic impairment. Known CV disease (eg, heart failure, MI, conduction & abnormalities, dehydration, hypovolaemia or CVA), dosage should be gradually titrated as recommended, a dose reduction should be considered if hypotension occurs. Concomitant use w/ furosemide. Discontinue use at the 1st sign of a clinically significant decline in WBC & in patients w/ severe neutropenia. Monitor patients w/ clinically significant neutropenia for fever or other symptoms or signs of infection. Monitor all possible risk factors for VTE before & during treatment. Discontinue use if signs & symptoms of tardive dyskinesia appear. Neuroleptic malignant syndrome, wt gain, priapism. Monitor for symptoms of hyperglycemia. History of cardiac arrhythmia, congenital long QT syndrome & concomitant use of drugs known to prolong QT interval. Intraoperative floppy iris syndrome may be observed during cataract surgery. Patients w/ epilepsy. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn & adolescent.
Adverse Reactions
Nasopharyngitis, upper resp tract infection, sinusitis, UTI; anemia; hypersensitivity; insomnia, anxiety, nervousness; parkinsonism, akathisia, somnolence, dizziness, sedation, tremor, dystonia, lethargy, postural dizziness, dyskinesia, syncope; blurred vision; eye pain; tachycardia; orthostatic hypotension, hypotension; nasal congestion, dyspnea, epistaxis, sinus congestion; nausea, constipation, dyspepsia, vomiting, diarrhea, salivary hypersecretion, dry mouth, abdominal discomfort, abdominal pain, stomach discomfort, upper abdominal pain; rash, dry skin, dandruff, seborrhoeic dermatitis, hyperkeratosis; back pain, arthralgia, pain in extremity; urinary incontinence; ejaculation failure; fatigue, asthenia, pyrexia, chest pain; increased blood creatine phosphokinase, increased heart rate. Pneumonia, cellulitis; decreased appetite; confusional state; transient ischemic attack, depressed level of consciousness, drooling, CVA; conjunctivitis; cough, rhinorrhea; dysphagia, fecaloma; erythema; abnormal posture, joint swelling; peripheral edema, gait disturbance, pitting edema; increased body temp. Rhinitis, influenza; increased appetite; middle insomnia, listless; headache, dysarthria, disturbance in attention, balance disorder, hypersomnia; palpitations; pharyngolaryngeal pain, pulmonary congestion; pruritus, acne; myalgia, neck pain; enuresis, urinary incontinence, pollakiuria; galactorrhea; abnormal feeling, sluggishness, chest discomfort; increased wt, increased blood prolactin.
Drug Interactions
Other centrally active drugs or alcohol; drugs known to prolong QT interval. May antagonize the effect of levodopa & other dopamine agonists. May influence the pharmacokinetics w/ substances that modify CYP2D6 activity or substances strongly inhibiting or inducing CYP3A4 &/or P-gp activity. Increased plasma conc w/ high doses of strong CYP2D6 inhibitor (eg, paroxetine, fluoxetine, TCAs). Increased plasma conc w/ CYP3A4 &/or P-gp inhibitors (eg, itraconazole, ketoconazole, phenothiazines, some β-blocker). May decrease plasma conc w/ strong CYP3A4 &/or P-gp inducer (eg, carbamazepine, rifampicin). Reduced bioavailability w/ topiramate. Increased plasma conc w/ moderate CYP3A4 & P-gp inhibitor (eg, verapamil). May increase mortality in elderly patient w/ dementia concomitantly receiving furosemide. Increased bioavailability w/ cimetidine & ranitidine.
MIMS Class
ATC Classification
N05AX08 - risperidone ; Belongs to the class of other antipsychotics.
Risperidex FC tab 1 mg
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