RiteMed Risperidone

RiteMed Risperidone

risperidone

Manufacturer:

Micro Labs

Distributor:

RiteMED
Concise Prescribing Info
Contents
Risperidone
Indications/Uses
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. Effective dose range: 1-6 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 Childn & adolescent 5-18 yr ≥50 kg Starting dose: 0.5 mg once/day, may be adjusted by increments of 0.5 mg/day. 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, may adjust in increments of 0.25 mg bid. Optimum dose: 0.5 mg bid may be increased up to 1 mg bid. Patient w/ severe renal (ClCr <30 mL/min) or hepatic impairment (10- 15 points on Child Pugh System) Initially, 0.5 mg bid, may be increased in increments of ≤0.5 mg bid. Patient prone to hypotension 0.25 mg-0.5 mg bid. Elderly Adjust slowly from 0.25 mg bid. Max daily dose: 3 mg bid.
Administration
May be taken with or without food.
Special Precautions
Patients at risk for aspiration pneumonia. Close supervision & appropriate clinical management of high-risk patients w/ possibility of suicide or attempted suicide. NMS; history of seizures or other predisposing factors; akathisia; CV diseases (eg, heart failure, history of MI or ischemia, cerebrovascular disease, conduction abnormalities) & other conditions eg, dehydration, hypokalemia & hypovolemia; history of cardiac arrhythmias, in patients w/ congenital long QT syndrome. VTE; priapism. May increase CV/cerebrovascular risk due to metabolic changes including hyperglycemia, dyslipidemia, & body wt gain. Discontinue if signs and symptoms of tardive dyskinesia develop during treatment. Patients w/ established diagnosis of DM should be monitored regularly for worsening of glucose control. May cause orthostatic hypotension & tachycardia. Monitor WBC count during the 1st few mth of therapy in patients w/ history of low WBC or drug-induced leukopenia/neutropenia; discontinue use at the 1st sign of decline in WBC in the absence of other causative factors; severe neutropenia (ANC <1 x 109/L). Disruption of the body's ability to reduce core body temp. May mask signs of toxicity due to overdosage w/ other drugs, or symptoms of disease eg, brain tumor, or intestinal obstruction or Reye's syndrome. Intraoperative floppy iris syndrome. Increased sensitivity in patients w/ Parkinson's disease or dementia w/ Lewy bodies. Concomitant use w/ furosemide & drugs known to prolong the QT interval. May affect the ability to drive & use machine. Pregnancy & lactation. Childn <13 yr w/ schizophrenia; < 10 yr w/ bipolar disorder. Elderly patients w/ dementia-related psychosis treated w/ atypical antipsychotic drugs are at an increased risk of death; associated w/ increased incidence of CVAEs eg, stroke & transient ischemic attacks, including fatalities. Associated w/ esophageal dysmotility & aspiration.
Adverse Reactions
Localized infection, infection, flu, viral infection; pituitary adenoma; agranulocytosis, anemia, eosinophil count increased, granulocytopenia, hematocrit decreased, neutropenia, thrombocytopenia, TTP, WBC count decreased; anaphylactic reaction, hypersensitivity; hyperprolactinemia, inappropriate antidiuretic hormone secretion; anorexia, appetite decreased, appetite increased, blood cholesterol increased, blood triglycerides increased, diabetic ketoacidosis, DM, hyperglycemia, hyperinsulinemia, hypoglycemia, polydipsia, wt decreased/increased, water intoxication; agitation, aggressive reaction, akathisia, anorgasmia, anxiety, blunted affect, confusional state, depression, dysarthria, hypersomnia, insomnia, middle insomnia, listlessness, mania, nervousness, nightmare, psychosis, sleep disorder, suicide attempt; balance disorder, cerebral ischemia, CVA/disorder, convulsion, coordination abnormal, depressed level of consciousness, diabetic coma, disturbance in attention, dizziness, dizziness postural, drooling, dysgeusia, dyskinesia, dystonia, head titubation, headache, hypoesthesia, hyperkinesia, hypokinesia, lethargy, loss of consciousness, muscle contractions involuntary, NMS, oculogyric crisis, paresthesia, parkinsonism, psychomotor hypersensitivity, rigidity, sedation, sleep apnea syndrome, somnolence, speech disorder, syncope, tardive dyskinesia, tremor, unresponsive to stimuli; blepharospasm, conjunctivitis, dry eye, eye discharge, eye edema, eye infection, eye movement disorder, eye rolling, eye swelling, eyelid margin crusting, floppy iris syndrome (intraoperative), glaucoma, lacrimation increased, ocular hyperemia, photophobia, vision blurred, visual acuity reduced; ear infection, ear pain, tinnitus, vertigo; atrial fibrillation, AV block, bradycardia, bundle branch block left, bundle branch block right, chest discomfort, conduction disorder, ECG abnormal, ECG QT prolonged, palpitations, postural orthostatic tachycardia syndrome, sinus arrhythmia/bradycardia/tachycardia, tachycardia, transient ischemic attack; flushing, HTN, hypotension, orthostatic hypotension, venous thrombosis; bronchitis, bronchopneumonia, cough, dysphonia, dyspnea, epistaxis, hyperventilation, nasal congestion, nasal edema, nasopharyngitis, otitis media chronic, pharyngitis, pharyngolaryngeal pain, pneumonia, pneumonia aspiration, pulmonary congestion/embolism, rales, resp disorder, resp tract congestion, rhinitis, rhinorrhea, sleep apnea syndrome, sinus congestion, sinusitis, URTI, tracheobronchitis, wheezing; GI disorders; hepatobiliary disorders; acarodermitis, acne, alopecia, angioedema, cellulitis, dandruff, drug eruption, dry skin, eczema, erythema, hyperkeratosis, onychomycosis, pruritus, rash, seborrhoeic dermatitis, skin discoloration/disorder, skin lesion, urticaria; arthralgia, back pain, button pain, joint stiffness/swelling, muscle spasms, muscular weakness, musculoskeletal pain, myalgia, neck pain, pain in extremity, posture abnormal, rhabdomyolysis; cystitis, dysuria, enuresis, pollakiuria, urinary incontinence, urinary retention, UTI; drug w/drawal syndrome neonatal; amenorrhea, breast discharge/discomfort/engorgement/enlargement/pain, ejaculation disorder/failure, erectile dysfunction, galactorrhea, gynecomastia, lactation nonpuerperal, libido decreased, menstrual disorder (menstruation delayed, oligomenorrhea), precocious puberty, priapism, retrograde ejaculation, sexual dysfunction, vag discharge; asthenia, body temp increased, body temp 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; blood creatinine phosphokinase increased, blood prolactin increased, body temp decreased/increased, glucose urine present; fall, procedural pain.
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, antipsychotics (eg, phenothiazines, aripiprazole), ritonavir, β-blockers, Ca-channel blockers, Na channel blockers (eg, quinidine). May decrease plasma conc w/ CYP3A4 &/or P-gp inducers eg, carbamazepine; rifampicin. Decreased clearance w/ clozapine. May antagonize effects of levodopa & dopamine agonists. Reduced bioavailability w/ antiepileptics (eg, topiramate).
MIMS Class
Antipsychotics
ATC Classification
N05AX08 - risperidone ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
RiteMed Risperidone FC tab 2 mg
Packing/Price
30's (P66.96/film-coated tab, P2,008.93/box)
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