RiteMed Risperidone

RiteMed Risperidone



Micro Labs


Concise Prescribing Info
Acute & maintenance treatment of schizophrenia & related psychotic disorders. Monotherapy for the acute management of manic episodes associated w/ bipolar I disorder; in combination w/ lithium or valproate for acute manic or mixed episodes associated w/ bipolar I disorder. Short-term symptomatic management of aggression or psychotic symptoms in patients w/ severe dementia of the Alzheimer type unresponsive to nonpharmacological responses; conduct & other disruptive behavior disorder in adult, adolescent & childn >5 yr. Behavioral disorders associated w/ autism in childn & adolescent.
Dosage/Direction for Use
Schizophrenia Adult Initially 2 mg/day, dose increases should occur at intervals not ≤24 hr in increments of 1-2 mg/day. Recommended: 4-8 mg/day. Adolescent 13-17 yr Initially, 0.5 mg as a single-daily dose, maybe adjusted at intervals of ≥24 hr in increments of 0.5 or 1 mg/day. Recommended: 3 mg/day. Bipolar mania Adult Initially 2-3 mg once/day, may be adjusted at intervals of ≥24 hr in increments of 1 mg/day. Childn & adolescent 10-17 yr Initially, 0.5 mg once/day, may be adjusted at intervals of ≥24 hr in increments of 0.5 or 1 mg/day. Recommended: 1-2.5 mg/day. Conduct & other disruptive behavior disorders in childn & adolescent 5-18 yr ≥50 kg Starting dose: 0.5 mg once/day, may be adjusted by increments of 0.5 mg once daily. Optimum dose: 1 mg once/day. <50 kg Starting dose: 0.25 mg once/day, may be adjusted at increments of 0.25 mg once daily. Optimum dose: 0.5 mg once/day. Irritability associated w/ autistic disorder in childn & adolescents 5-16 yr ≥20 kg Initially 0.5 mg/day. Recommended dose: 1 mg/day. <20 kg Initially 0.25 mg/day. Recommended dose: 0.5 mg/day. Behavioral disturbances in patient w/ dementia Initially 0.25 mg bid. Patient w/ severe renal or hepatic impairment Initially, 0.5 mg bid, may be increased in increments of ≤0.5 mg. Patient prone to hypotension 0.25 mg-0.5 mg bid. Elderly Adjust slowly from 0.25 mg-3 mg bid.
May be taken with or without food.
Special Precautions
Discontinue use if neuroleptic malignant syndrome occurs. CV adverse events in elderly patients w/ dementia; dysphagia, tardive dyskinesia, seizures, akathasia; known history of CV disease (eg, heart failure, MI, conduction abnormalities, dehydration, hypovolemia or cerebrovascular disease); patients w/ Parkinson's disease or dementia. Metabolic changes. Dose reduction should be considered if hypotension occurs. Close supervision in high-risk patients w/ possibility of suicide. Concomitant use w/ furosemide. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn <13 yr w/ schizophrenia, <10 yr w/ bipolar disorder.
Adverse Reactions
Asthenia, body temp increased/decreased, chest discomfort & pain, chills, discomfort, drug w/drawal syndrome, edema (peripheral, face, pitting), fatigue, feeling abnormal, gait abnormal/disturbance, hypothermia, induration, malaise, pain, peripheral coldness, pyrexia, sluggishness, sudden death, thirst.
Drug Interactions
Centrally-acting drugs & alcohol; drugs known to prolong QT interval. May enhance hypotensive effects of other hypotensive drugs. May increase plasma conc w/ strong CYP2D6 inhibitors eg, paroxetine, CYP3A4 &/or P-gp inhibitors eg, itraconazole & ketoconazole, TCAs, SSRIs, ritonavir, Ca-channel blockers. May decrease plasma conc w/ CYP3A4 &/or P-gp inducers eg, carbamazepine., rifampicin Decreased clearance w/ clozapine. May antagonize effects of levodopa & dopamine agonists.
MIMS Class
ATC Classification
N05AX08 - risperidone ; Belongs to the class of other antipsychotics.
RiteMed Risperidone FC tab 2 mg
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