Risponz/Risponz 1/Risponz 2/Risponz 3

Risponz 1/Risponz 2/Risponz 3 Treatment of schizophrenia & other psychoses; irritability associated w/ autistic disorder. Short-term treatment of acute manic or mixed episodes associated w/ bipolar disorder. Risponz Treatment of schizophrenia; moderate to severe manic episodes w/ bipolar disorder. Short-term symptomatic treatment (up to 6 wk) of persistent aggression in conduct disorder in childn from 5 yr & adolescent w/ sub-ave intellectual functioning or mental retardation diagnosed according to DSM-IV criteria.

Risponz 1/Risponz 2/Risponz 3 Dose may be given in 1 or 2 divided doses daily. Initially 2 mg on the 1st day, 4 mg on the 2nd day & 6 mg on the 3rd day. Dose adjustments may be needed & should be made at intervals of not <1 wk. Maintenance dose: 4-8 mg daily. Max: 16 mg daily. Elderly & patient w/ renal or hepatic impairment Initially 0.5 mg bid, slowly increased in 0.5 mg bid increments to 1-2 mg bid. Risponz Schizophrenia Adult Dose may be given once daily or bid. Initially 2 mg daily, may be increased to 4 mg on the 2nd day. Subsequently, dose can be maintained unchanged or further individualized if needed. Most patients benefit from 4-8 mg daily. Max: 16 mg daily. Elderly Initially 0.5 mg bid, may be adjusted in 0.5 mg bid increments to 1-2 mg bid. Manic episodes in bipolar disorder Adult Initially 2 mg once daily. Dose adjustments if indicated should occur at intervals of not <24 hr & in 1 mg daily increments. Max: 6 mg daily. Elderly Initially 0.5 mg bid, may be adjusted in 0.5 mg bid increments to 1-2 mg bid. Persistent, aggression in patient w/ moderate to severe Alzheimer's dementia Initially 0.25 mg bid, may be adjusted in 0.25 mg bid increments not more frequently than every other day if needed. Optimum dose: 0.5 mg bid. Some patients may benefit from up to 1 mg bid. Duration: Not >6 wk. Conduct disorder Childn & adolescent from 5-18 yr ≥50 kg Initially 0.5 mg once daily, may be adjusted in 0.5 mg once daily increments not more frequently than every other day if needed. Optimum dose: 1 mg once daily. Some patients 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, may be adjusted in 0.25 mg once daily increments not more frequently than every other day if needed. Optimum dose: 0.5 mg once daily. Some patients may benefit from 0.25 mg once daily while others may require 0.75 mg once daily. All indications Patient w/ renal or hepatic impairment Starting & consecutive doses should be halved & dose titration should be slower.

May be taken with or without food.

Hypersensitivity. Risponz 1/Risponz 2/Risponz 3 Pregnancy & lactation. Childn <5 yr w/ conduct & other disruptive behavioural disorders.

Risk of orthostatic hypotension. Caution in patients w/ known CV disease; w/ renal & hepatic impairment. Risponz 1/Risponz 2/Risponz 3 Caution in patients w/ Parkinson's disease. Refrain from excessive eating in view of possible wt gain. May impair mental alertness; do not drive or operate machinery until individual susceptibility is known. Elderly. Risponz Gradually w/draw upon discontinuation. Not for treatment of dementia-related behavioral disturbances. Not to be used to treat patients w/ other types of dementias than Alzheimer's. Should only be used short term for persistent aggression in patients w/ moderate to severe Alzheimer's dementia to supplement non-pharmacological approaches w/ limited or no efficacy & when there is potential risk of harm to self or others. Regularly reassess patients & the need for continuing treatment. Consider discontinuation if signs & symptoms of tardive dyskinesia appear. Discontinue use in event of NMS. Caution in patients w/ Parkinson's disease or dementia w/ Lewy bodies; w/ pre-existing hyperprolactinemia & w/ possible prolactin-dependent tumors; w/ family history of QT prolongation, bradycardia, or electrolyte disturbances (hypokalemia, hypomagnesemia); w/ history of seizures or other conditions that potentially lower seizure threshold; who will be experiencing conditions which may contribute to an elevation in core body temp (eg, exercising strenuously, exposure to extreme heat, concomitant treatment w/ anticholinergic activity, or dehydration). Clinical monitoring is advised in diabetic patients & patients w/ risk factors for development of DM. Priapism may occur. Identify all possible risk factors for VTE prior to & during treatment & take preventive measures. Caution in concomitant use w/ furosemide & other potent diuretics; drugs known to prolong the QT interval. Should not be used during pregnancy unless clearly necessary. Weigh advantage of breast-feeding against potential risks for the child. Not recommended in childn <18 yr w/ schizophrenia or bipolar mania; childn <5 yr w/ conduct disorder. Fully assess childn or adolescent w/ conduct disorder for physical & social causes of the aggressive behavior prior to treatment & closely monitor sedative effect. Consider regular clinical evaluation of endocrinological status in childn & adolescents & conduct regular exam for extrapyramidal symptoms & other movement disorders during treatment. Assess risks & benefits of use in elderly w/ dementia.

Risponz 1/Risponz 2/Risponz 3 Insomnia, agitation, extrapyramidal disorder, anxiety headache & sedation. Somnolence, fatigue, dizziness, impaired concentration, constipation, dyspepsia. Nausea, vomiting, abdominal pain, wt gain, blurred vision, priapism, erectile, ejaculatory & orgastic dysfunction, urinary incontinence, rhinitis, rash. Risponz Anxiety, dizziness, dystonic reactions, extrapyramidal reactions, headache, NMS, tardive dyskinesia; abnormal t-waves w/ prolonged ventricular repolarization, arrhythmias, orthostatic hypotension, amenorrhea, galactorrhea, gynecomastia, sexual dysfunction; wt gain, constipation, nausea, cholestatic jaundice, agranulocytosis, overflow incontinence, priapism, urinary retention, altered temp regulation.

May antagonize effect of levodopa & other dopamine agonists. Decreased plasma conc of the active antipsychotic fraction of risperidone w/ carbamazepine & other CYP3A4 & P-gp inducers eg, rifampicin, phenytoin & phenobarb. Increased plasma conc of risperidone & less so of the antipsychotic fraction w/ fluoxetine & paroxetine & other CYP2D6 inhibitors eg, quinidine. Plasma conc of risperidone (& not that of the active antipsychotic fraction) may be increased w/ phenothiazines, TCAs & some β‑blockers. Risponz 1/Risponz 2/Risponz 3 Caution w/ alcohol & other centrally acting medicines. Risponz Caution w/ medicinal products known to prolong the QT interval eg, class Ia (eg, quinidine, disopyramide, procainamide) & III (eg, amiodarone, sotalol) antiarrhythmics, TCAs (eg, amitriptyline), tetracyclic antidepressants (eg, maprotiline), some antihistaminics, other antipsychotics, some antimalarials (eg, chinice & mefloquine), & w/ medicines causing electrolyte imbalance (hypokalaemia, hypomagnesaemia), bradycardia, or those which inhibit the hepatic metabolism of risperidone. Increased risk of sedation w/ other centrally-acting substances including alcohol, opiates, antihistamines & benzodiazepine. Clinically significant hypotension w/ antihypertensive treatment. Increased plasma conc w/ verapamil (CYP3A4 & P-gp inhibitor). Increased bioavailability of risperidone & only marginally that of the active antipsychotic fraction w/ cimetidine & ranitidine. Increased mortality w/ furosemide in elderly w/ dementia. Concomitant use w/ paliperidone may lead to additive active antipsychotic fraction exposure.

Antipsychotics

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

Rx