Risperidone Actavis

Risperidone

Treatment of schizophrenia. Treatment of moderate to severe manic episodes associated w/ bipolar disorders. Short-term symptomatic management of aggression or psychotic symptoms in patients w/ severe dementia of the Alzheimer type unresponsive to non-pharmacological approaches & when there is risk of harm to self or others. Short-term symptomatic treatment (up to 6 wk) of persistent aggression in conduct disorder in childn ≥5 yr & adolescents w/ subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment.

Schizophrenia Adult Initially 2 mg once daily or bd, may be increased to 4 mg on the 2nd day. Subsequently, dose can be maintained unchanged, or further individualised, if needed. Most patients will benefit from daily doses 4-6 mg. Elderly Initially 0.5 mg bd, can be individually adjusted to 1-2 mg bd in increments of 0.5 mg bd. Manic episode in bipolar disorder Adult Initially 2 mg once daily. If indicated, adjust dose at intervals of not less than 24 hr & in increments of 1 mg/day. Can be administered in flexible doses of 1-6 mg/day to optimize patient's level of efficacy & tolerability. Elderly Initially 0.5 mg bd, can be individually adjusted to 1-2 mg bd in increments of 0.5 mg bd. Persistent aggression in moderate to severe Alzheimer's dementia Initially 0.25 mg bd, can be individually adjusted in increments of 0.25 mg bd, not more frequently than every other day, if needed. Optimum dose is 0.5 mg bd for most patients. Some may benefit from doses up to 1 mg bd. Conduct disorder Childn & adolescent 5-18 yr weighing ≥50 kg Initially 0.5 mg once daily, can be individually adjusted in increments of 0.5 mg once daily, not more frequently than every other day, if needed. Optimum dose is 1 mg once daily for most patients. Some may benefit from 0.5 mg once daily, while others may require 1.5 mg once daily, <50 kg Initially 0.25 mg once daily, can be individually adjusted in increments of 0.25 mg once daily, not more frequently than every other day, if needed. Optimum dose is 0.5 mg once daily for most patients. Some may benefit from 0.25 mg once daily, while others may require 0.75 mg once daily.

May be taken with or without food.

Hypersensitivity.

Increased mortality & risk of cerebrovascular adverse events (CVAEs) in elderly patients w/ dementia. Increased mortality in elderly patients w/ dementia concomitantly receiving furosemide. Significantly higher risk of CVAEs in patients w/ mixed or vascular type of dementia. Not for treatment in patients w/ other types of dementia than the Alzheimer type. Assess risks & benefits of treatment in elderly patients w/ severe dementia of the Alzheimer type, taking into account risk predictors for stroke or existing CV comorbidities. Reports of leukopenia, neutropenia & agranulocytosis. Monitor patients w/ history of clinically significant low WBC count or drug-induced leukopenia/neutropenia during the 1st few mth of therapy, & consider treatment discontinuation at the 1st sign of clinically significant decline in WBC in the absence of other causative factors. Discontinue treatment in patients w/ severe neutropenia. Weigh risks versus benefits when prescribing to patients w/ Parkinson's disease or dementia w/ Lewy bodies. Disruption of body's ability to reduce core body temp. Caution when prescribing to patients who will be experiencing conditions which may contribute to elevation in core body temp eg, exercising strenuously, exposure to extreme heat, receiving concomitant treatment w/ anticholinergic activity, or being subject to dehydration. Intraoperative floppy iris syndrome has been observed during cataract surgery in patients treated w/ medicines w/ α_1a-adrenergic antagonist effect, including risperidone. Potential benefit of stopping α₁-blocking therapy prior to cataract surgery has not been established & must be weighed against risk of stopping antipsychotic therapy. Risk of orthostatic hypotension, especially during initial dose-titration period; tardive dyskinesia; NMS; hyperglycaemia, DM & exacerbation of pre-existing diabetes; significant wt gain; hyperprolactinaemia; QT prolongation; priapism; antiemetic effect; VTE. Caution in patients w/ risk factors for stroke; known CV disease (eg, heart failure, MI, conduction abnormalities, dehydration, hypovolaemia, or cerebrovascular disease); pre-existing hyperprolactinaemia & possible prolactin-dependent tumours; known CV disease, family history of QT prolongation, bradycardia, or electrolyte disturbances (hypokalaemia, hypomagnesaemia); history of seizures or other conditions that potentially lower the seizure threshold. Minor or moderate influence on ability to drive & use machines. Patients w/ renal impairment have less ability to eliminate the active antipsychotic fraction. Patients w/ hepatic impairment have increases in plasma conc of the free fraction of risperidone. Neonates exposed to antipsychotics during the 3rd trimester of pregnancy are at risk for extrapyramidal &/or w/drawal symptoms following delivery. Use during pregnancy only if potential benefit justifies potential risk to fetus. Weigh advantage of breast-feeding against potential risks for child. Closely monitor sedative effect in paed patients. Associated w/ mean increases in body wt & BMI in paed patients. Effect of long-term treatment on sexual maturation & height have not been adequately studied in paed patients. Conduct regular exam for extrapyramidal symptoms & other movement disorders during treatment in paed patients. Schizophrenia: Doses >10 mg/day have not demonstrated superior efficacy to lower doses & may cause increased incidence of extrapyramidal symptoms. Doses >16 mg/day are not recommended. Not recommended in childn <18 yr. Manic episodes in bipolar disorder: Daily doses >6 mg have not been investigated. Limited clinical experience in the elderly. Not recommended in childn <18 yr. Persistent aggression in Alzheimer's dementia: Do not use >6 wk. Frequently & regularly evaluate patients during treatment, & reassess need for continuing treatment. Conduct disorder: Not recommended in childn <5 yr.

Insomnia; sedation/somnolence, parkinsonism, headache. Pneumonia, bronchitis, URTI, sinusitis, UTI, ear infection, flu; hyperprolactinaemia; increased wt/appetite, decreased appetite; sleep disorder, agitation, depression, anxiety; akathisia, dystonia, dizziness, dyskinesia, tremor; blurred vision, conjunctivitis; tachycardia; HTN; dyspnoea, pharyngolaryngeal pain, cough, epistaxis, nasal congestion; abdominal pain/discomfort, vomiting, nausea, constipation, diarrhoea, dyspepsia, dry mouth, toothache; rash, erythema; muscle spasms, musculoskeletal pain, back pain, arthralgia; urinary incontinence; oedema, pyrexia, chest pain, asthenia, fatigue, pain; fall.

Caution when co-administering w/ medicinal products known to prolong the QT interval eg, antiarrhythmics (eg, quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), TCA (ie, amitriptyline), tetracyclic antidepressants (ie, maprotiline), some antihistamines, other antipsychotics, some antimalarials (ie, quinine, mefloquine), & w/ medicines causing electrolyte imbalance (hypokalaemia, hypomagnesaemia), bradycardia, or those which inhibit hepatic metabolism of risperidone. Increased risk of sedation w/ other centrally-acting substances eg, alcohol, opiates, antihistamines & benzodiazepines. Antagonised effect of levodopa & other dopamine agonists. Combined use of psychostimulants (eg, methylphenidate) & risperidone can lead to extrapyramidal symptoms. Clinically significant hypotension w/ concomitant use of risperidone & antihypertensive treatment. Combination of risperidone & paliperidone may lead to additive active antipsychotic fraction exposure. Decreased plasma conc of active antipsychotic fraction w/ strong CYP3A4 & P-gp inducers (eg, rifampicin, carbamazepine, phenytoin, phenobarb). Increased plasma conc of active antipsychotic fraction w/ itraconazole (strong CYP3A4 & P-gp inhibitor). Increased plasma conc of risperidone & decreased plasma conc of 9-hydroxy-risperidone w/ ketoconazole (strong CYP3A4 & P-gp inhibitor). Increased plasma conc of risperidone & active antipsychotic fraction w/ verapamil (moderate CYP3A4 & P-gp inhibitor). Potentially raised conc of active antipsychotic fraction w/ ritonavir (strong CYP3A4 inhibitor & weak CYP2D6 inhibitor) & ritonavir-boosted PIs. Topiramate modestly reduced the bioavailability of risperidone, but not that of the active antipsychotic fraction. Phenothiazines, some β-blockers, & TCAs may increase the plasma conc of risperidone but not those of the active antipsychotic fraction. Cimetidine & ranitidine (weak CYP2D6 & CYP3A4 inhibitors) increased the bioavailability of risperidone, but only marginally that of the active antipsychotic fraction. Strong CYP2D6 inhibitors (eg, paroxetine, quinidine, fluoxetine) may increase the plasma conc of risperidone, but less so of the active antipsychotic fraction. Higher doses of paroxetine (strong CYP2D6 inhibitor), sertraline (weak CYP2D6 inhibitor), & fluvoxamine (weak CYP3A4 inhibitor) may elevate conc of the active antipsychotic fraction.

Antipsychotics

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

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