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HIGHLIGHT
Rosemide

Rosemide

risperidone

Manufacturer:

Kusum Healthcare

Distributor:

Kusum Healthcare
Concise Prescribing Info
Contents
Risperidone
Indications/Uses
Schizophrenia; moderate to severe manic episodes associated w/ bipolar disorders. Short-term treatment (up to 6 wk) of persistent aggression in patients w/ moderate to severe Alzheimer's dementia unresponsive to non-pharmacological approaches & when there is a risk of harm to self or others; conduct disorder in childn from 5 yr & adolescents w/ subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria.
Dosage/Direction for Use
Schizophrenia Adult Initially 2 mg once daily or bid. May be increased to 4 mg on the 2nd day. Elderly Initially 0.5 mg bid. May be individually adjusted w/ 0.5 mg bid increments to 1-2 mg bid. Manic episodes in bipolar disorder Adult Initially 2 mg once daily. May be adjusted in increments of 1 mg/day at intervals not <24 hr. Dose range: 1-6 mg daily. Elderly Initially 0.5 mg bid. May be individually adjusted w/ 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. Can be individually adjusted by increments of 0.25 mg bid not more frequently than every other day. Optimum dose: 0.5 mg bid. Max: 6 wk. Conduct disorder Childn & adolescent 5-18 yr weighing ≥50 kg Initially 0.5 mg once daily. Can be individually adjusted by increments of 0.5 mg once daily not more frequently than every other day. Optimum dose: 1 mg once daily, <50 kg Initially 0.25 mg once daily. Can be individually adjusted by increments of 0.25 mg once daily not more frequently than every other day. Optimum dose: 0.5 mg once daily.
Administration
May be taken with or without food: Place tab on tongue & allow to disintegrate w/in sec. Water may be used if desired.
Contraindications
Special Precautions
Consider discontinuation of therapy at the 1st sign of clinically significant decline in WBC in the absence of other causative factors. Discontinue in patients w/ severe neutropenia; NMS. Consider discontinuing use if signs & symptoms of tardive dyskinesia appear. Not to be treated in patients w/ other types of dementia than Alzheimer's. Patients w/ risk factors for cerebrovascular adverse events; stroke; known CV disease (eg, heart failure, MI, conduction abnormalities, dehydration, hypovolaemia, or cerebrovascular disease); Parkinson's disease or dementia w/ Lewy bodies; pre-existing hyperprolactinaemia & w/ possible prolactin-dependent tumours; history of seizures or other conditions potentially lowering the seizure threshold; intraoperative floppy iris syndrome. Orthostatic hypotension. Priapism. Body temp regulation. Antiemetic effect. VTE. Monitor during the 1st few mth in patients w/ history of clinically significant low WBC. Regularly monitor for worsening of glucose control in patients w/ DM; wt. Concomitant use w/ other potent diuretics; medicines prolong QT interval. Minor or moderate influence on the ability to drive & use machines due to potential nervous system & visual effects. Renal & hepatic impairment. Pregnancy & lactation. Not recommended in childn <18 yr w/ bipolar mania; childn <5 yr w/ conduct disorder. Increased mortality in elderly w/ dementia.
Adverse Reactions
Insomnia; sedation/somnolence, parkinsonism, headache. Pneumonia, bronchitis, URTI, sinusitis, UTI, ear infection, flu; hyperprolactinaemia; increased wt, increased/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 & back pain, arthralgia; urinary incontinence; oedema, pyrexia, chest pain, asthenia, fatigue, pain; fall.
Drug Interactions
Caution in concomitant use w/ medicinal products known to prolong QT interval eg, antiarrhythmics, TCAs, tetracyclic antidepressants, some antihistamines, other antipsychotics, some antimalarials & medicines causing electrolyte imbalance bradycardia, or those inhibiting hepatic metabolism of risperidone. Increased risk of sedation w/ centrally-acting substances notably alcohol, opiates, antihistamines & benzodiazepines. May antagonise the effect of l-dopa & other dopamine agonists. Clinically significant hypotension w/ antihypertensive treatment. Additive active antipsychotic fraction exposure w/ paliperidone. Increase plasma conc w/ strong CYP2D6 (eg, fluoxetine, paroxetine); strong CYP3A4 &/or P-gp inhibitor (eg, itraconazole, ketoconazole); verapamil. Decrease plasma conc w/ strong CYP3A4 &/or P-gp inducer (eg, rifampicin, carbamazepine, phenytoin & phenobarb). Increase plasma conc but not those of active antipsychotic fraction w/ antipsychotics; β-blockers; TCAs. May potentially raise conc w/ ritonavir. Increased bioavailability w/ H2-receptor antagonists.
MIMS Class
Antipsychotics
ATC Classification
N05AX08 - risperidone ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Rosemide orodispersible tab 1 mg
Packing/Price
20's (P2,100/box)
Form
Rosemide orodispersible tab 2 mg
Packing/Price
60's (P2,520/box)
Form
Rosemide orodispersible tab 4 mg
Packing/Price
60's (P2,760/box)
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