Aspidon/Aspidon OS

Risperidone

Aspidon 1 mg: Management of psychotic disorders & non-psychotic symptoms associated w/ dementia in the elderly. 2 mg: Schizophrenia, & for the short-term treatment of acute manic or mixed episodes associated w/ bipolar disorders. Aspidon OS Schizophrenia, moderate to severe manic episodes associated w/ bipolar disorders & for short-term treatment (up to 6 wk) of persistent aggression in patients w/ moderate to severe Alzheimer's dementia. Short-term symptomatic treatment (up to 6 wk) of persistent aggression in conduct disorder in childn from 5 yr & adolescents w/ subaverage intellectual functioning or mental retardation.

Aspidon 1 mg Schizophrenia Adult Initially 2 mg once daily or bid (acute or chronic condition). May be increased to 4 mg daily on the 2nd day. Elderly, patient w/ renal & liver disease Initially 0.5 mg bid. May be individually adjusted w/ 0.5 mg bid increments to 1-2 mg bid. Bipolar mania Adult 2 mg once daily. May be adjusted in increments of 1 mg daily at intervals not <24 hr. Dose range: 1-6 mg daily. Elderly, patient w/ renal & liver disease Initially 0.5 mg bid. May be individually adjusted w/ 0.5 mg bid increments to 1-2 mg bid. 2 mg Schizophrenia Adult Initially 2 mg once daily or bid. May be increased in increments of 1-2 mg daily at intervals of ≥24 hr to the recommended dose of 4-6 mg daily. Adolescent Initially 0.5 mg once daily. May be adjusted in increments of 0.5 or 1 mg daily at intervals of ≥24 hr to the recommended dose of 3 mg daily. Bipolar mania Adult Initially 2-3 mg daily. May be adjusted in increments of 1 mg daily at intervals of ≥24 hr. Ped Initially 0.5 mg once daily. May be adjusted in increments of 0.5 or 1 mg daily at intervals of ≥24 hr to the recommended dose of 1-2.5 mg daily. Severe renal (CrCl <30 mL/min) or hepatic impairment (Child Pugh system 10-15 points) Initially 0.5 mg bid. May be increased in increments of ≤0.5 mg bid or in intervals of ≥1 wk for doses >1.5 mg bid. Patient experiencing persistent somnolence May benefit from ½ the daily dose bid. Aspidon OS Schizophrenia Adult Initially 2 mg/day. May be increased to 4 mg on the 2nd day. Bipolar disorder Adult Initially 2 mg once daily. May be adjusted in increments of 1 mg/day at intervals of not <24 hr. Schizophrenia & bipolar disorder Elderly Initially 0.5 mg bid. Can be individually adjusted w/ 0.5 mg increments to 1-2 mg bid. Alzheimer's dementia Initially 0.25 mg bid. Can be individually adjusted by increments of 0.25 mg bid. Patient w persistent aggression in Alzheimer's dementia Max: 6 wk.

May be taken with or without food.

Hypersensitivity.

NMS, priapism. Pregnancy & lactation. Aspidon May induce orthostatic hypotension associated w/ dizziness, tachycardia, & syncope especially during the initial dose titration period, reflecting its α-adrenergic antagonists properties. Patients w/ known CV disease eg, MI, ischaemia, heart failure or conduction abnormalities, cerebrovascular disease & conditions which would predispose patients to hypotension eg, dehydration, hypovolemia & treatment w/ antihypertensive medicine. 1 mg: Childn <15 yr w/ schizophrenia. 2 mg: Not approved for the treatment of dementia-related psychosis. Discontinue use if signs & symptoms of tardive dyskinesia appear. May increase CV/cerebrovascular risk due to metabolic changes including hyperglycemia, dyslipidemia, & body wt gain. Regularly monitor patients w/ DM for worsening of glucose control. Frequently monitor CBC 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. Monitor patients w/ neutropenia for fever or other symptoms or signs of infection; discontinue use if severe neutropenia (ANC <1,000/mm³) occurs. Patients w/ history of seizures or at risk of for aspiration pneumonia. Disruption of body temp regulation (hyperthermia & hypothermia). Potential for cognitive & motor impairment. Childn (<13 yr w/ schizophrenia & <10 yr w/ bipolar mania). Elderly w/ dementia-related psychosis. Aspidon OS Patients w/ dementia, cerebrovascular disease, orthostatic hypotension, tardive dyskinesia/extrapyramidal symptoms, Parkinson's disease, dementia w/ lewy bodies, hyperglycemia & DM, hyperprolactinaemia, seizures, intestinal obstruction, Reye's syndrome, brain tumour, VTE, Intraoperative Floppy Iris syndrome. Renal & hepatic impairment. Not recommended in <5 yr or childn <18 yr w/ schizophrenia & bipolar mania. Abrupt discontinuation; w/draw gradually upon discontinuation.

Parkinsonism, headache, anxiety, fatigue, dizziness, vomiting, diarrhea, constipation, nausea, increased appetite, dry mouth, increased wt, blurred vision, nasal/nose congestion. Aspidon 1 mg: Insomnia, agitation. 2 mg: Parkinsonism, akathisia, dystonia, tremor, sedation, upper abdominal pain, stomach discomfort, dyspepsia, salivary hypersecretion, rash, upper resp tract infection, nasopharyngitis, & pharyngolaryngeal pain. Aspidon OS Difficulty falling or staying asleep. Drowsiness, restlessness, inability to sit still, irritability, sleepiness, poor attention, feeling exhausted, sleep disorder; abdominal pain or discomfort, sore throat; increase in body temp, decreased appetite; difficulty breathing, lung infection (pneumonia), flu, infection of the breathing passages, nose bleeding, cough; UTI, bed wetting; muscle spasm, involuntary movements of face or arms & legs, joint pain, back pain, swelling/pain of arms & legs; rash, skin redness; fast beating heart, chest pain; increased blood prolactin hormone level.

Aspidon 1 mg: Induced metabolism w/ carbamazepine. 2 mg: May enhance effects of other drugs w/ hypotensive effects. May antagonize the effects of levodopa & dopamine agonists. May decrease clearance w/ clozapine. CYP2D6 enzyme inhibitors (eg, fluoxetine & paroxetine) & inducers (eg, carbamazepine); other centrally-acting drugs & alcohol. Aspidon OS Concomitant use w/ medicinal products known to prolong the QT interval eg, quinidine, disopyramide, procainamide, amiodarone, sotalol, amitriptyline, maprotiline, some antihistaminics, other antipsychotics, quinine, mefloquine, & medicines causing electrolyte imbalance, bradycardia or those which inhibit the hepatic metabolism.

Antipsychotics

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

Rx