Risperidone-Chanelle

Risperidone-Chanelle

risperidone

Manufacturer:

Chanelle

Distributor:

Medicell Pharma
Concise Prescribing Info
Contents
Risperidone
Indications/Uses
Schizophrenia. Short-term treatment of persistent aggression in moderate to severe dementia of the Alzheimer's type unresponsive to non-pharmacological approaches & when there is a risk of harm to self or others. Conduct & other disruptive behavior disorders in childn >5 yr, adolescent & adult w/ subaverage intellectual functioning or mental retardation in whom destructive behaviors (eg, aggression, impulsivity & self-injurious behaviors) are prominent. Adjunctive therapy to mood stabilizers for manic episodes associated w/ bipolar disorders.
Dosage/Direction for Use
Schizophrenia Adult Initially 2 mg daily, may be increased on the 2nd day to 4 mg. May be given once daily or bd. Max: 16 mg daily. Elderly Initially 0.5 mg bd, may individually adjust w/ 0.5 mg bd increments to 1-2 mg bd. Manic episodes in bipolar mania Adult Initially 2 mg once daily, may adjust dosage at intervals of not <24 hr & in increments of 1 mg daily. Max: 6 mg daily. Persistent aggression in moderate to severe Alzheimer's dementia Initially 0.25 mg bd, may individually adjust by increments of 0.25 mg bd, not more frequently than every other day, if needed. Optimum dose: 0.5 mg bd, may increase up to 1 mg bd. Conduct disorders Childn & adolescent 5-18 yr weighing >50 kg Initially 0.5 mg once daily, may individually adjust by increments of 0.5 mg once daily not more frequently than every other day, if needed. Optimum dose: 1 mg once daily, may increase up to 1.5 mg once daily, <50 kg Initially 0.25 mg once daily, may individually adjust by increments of 0.25 mg once daily not more frequently than every other day, if needed. Optimum dose: 0.5 mg once daily, may increase up to 0.75 mg once daily.
Administration
May be taken with or without food: Administer directly from the syringe or mix w/ a beverage (eg, water, coffee, orange juice, low-fat milk) prior to administration.
Special Precautions
Patients w/ risk factors for stroke. Significantly higher risk of CV adverse events in patients w/ mixed or vascular type of dementia. Not for other types of dementia than Alzheimer's. Signs & symptoms of potential CV adverse events (eg, sudden weakness; numbness in the face, arms or legs; speech or vision problems) should be reported immediately. Regularly reassess patients & the need for continuing treatment. Possible orthostatic hypotension; patients w/ known CV disease (eg, heart failure, MI, conduction abnormalities, dehydration, hypovolaemia, cerebrovascular disease). Consider discontinuation of all antipsychotics if w/ signs & symptoms of tardive dyskinesia appear; neuroleptic malignant syndrome. Patients w/ Parkinson's disease or dementia w/ Lewy bodies. Monitor for symptoms of hyperglycemia & DM. Possible intraoperative floppy iris syndrome during cataract surgery. Patients w/ pre-existing hyperprolactinaemia & in those w/ possible prolactin-dependent tumors. Possible QT prolongation; priapism. Patients w/ history of seizures or other potential seizure threshold-lowering conditions. Disrupted body's ability to reduce core body temp. Advise patients not to drive or operate machinery due to potential nervous system & visual effects. Renal & hepatic impairment. Pregnancy. Women receiving risperidone should not breast-feed. Fully assess for physical & social causes of aggressive behavior; closely monitor sedative effect; associated w/ mean increases in body wt & BMI; potential effects of prolonged hyperprolactinemia on growth & sexual maturation; regularly examine for extrapyramidal symptoms during treatment; identify possible risk factors for venous thromboembolism in childn & adolescent. Not recommended in childn <18 yr w/ schizophrenia & bipolar mania; childn <5 yr w/ conduct disorders. Elderly w/ dementia.
Adverse Reactions
Parkinsonism, headache; insomnia. Increased blood prolactin & wt; tachycardia; akathisia, dizziness, tremor, dystonia, somnolence, sedation, lethargy, dyskinesia; blurred vision; dyspnoea, epistaxis, cough, nasal congestion, pharyngolaryngeal pain; vomiting, diarrhoea, constipation, nausea, abdominal pain, dyspepsia, dry mouth, stomach discomfort; enuresis; rash, erythema; arthralgia, back & extremity pain; increased & decreased appetite; pneumonia, flu, bronchitis, upper resp tract infection, UTI; pyrexia, fatigue, peripheral oedema, asthenia, chest pain; anxiety, agitation, sleep disorder.
Drug Interactions
Caution during concomitant use w/ QT interval-prolonging medications eg, class Ia antiarrhythmics (eg, quinidine, disopyramide, procainamide), class III antiarrhythmics (eg, amiodarone, sotalol), TCAs (ie, amitriptyline), tetracyclic antidepressants (ie, maprotiline), some antihistaminics, other antipsychotics, some antimalarials, medicines causing electrolyte imbalance & bradycardia. Increased risk of sedation in combination w/ other centrally acting substances including alcohol, opiates, antihistamines & benzodiazepines. May antagonize the effect of levodopa & other dopamine-agonists. Clinically significant hypotension when used concomitantly w/ antihypertensives. Plasma conc may be decreased by carbamazepine; rifampicin, phenytoin, phenobarb. Plasma conc may be increased by fluoxetine & paroxetine; phenothiazine, TCAs & some β-blockers. Increased plasma conc w/ verapamil. Bioavailability may be increased by cimetidine & ranitidine. Increased mortality in the elderly w/ dementia when used concomitantly w/ furosemide. Not recommended to concomitantly use w/ paliperidone.
MIMS Class
Antipsychotics
ATC Classification
N05AX08 - risperidone ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Risperidone-Chanelle oral soln 1 mg/mL
Packing/Price
30 mL x 1's
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