pms-Risperidone

pms-Risperidone

risperidone

Manufacturer:

Pharmascience

Distributor:

T-BOMA
Concise Prescribing Info
Contents
Risperidone
Indications/Uses
Acute treatment & maintenance treatment of schizophrenia & related psychotic 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 a risk of harm to self or others. Monotherapy for the acute management of manic episodes associated w/ bipolar I disorder.
Dosage/Direction for Use
Adult Schizophrenia & related psychotic disorders Initially 1-2 mg/day once daily or bd; adjust dose gradually over several days based on clinical response to a target dose of 4-6 mg/day. Further dose adjustments, if indicated, should be at 1 mg increments/decrements at intervals of not less than 1 wk. Severe dementia of the Alzheimer type Initially 0.25 mg bd; adjust dose by increments of 0.25 mg/day approx every 2-4 days. Bipolar mania 2-3 mg once daily; adjust dose at intervals of not less than 24 hr & in increments/decrements of 1 mg/day. Elderly Schizophrenia Initially 0.25 mg bd; adjust slowly to a max daily dose of 3 mg. Patient prone to hypotension Initially 0.25-0.5 mg bd. Patient w/ hepatic impairment Schizophrenia & related psychotic disorders Initially 0.25-0.5 mg bd; adjust dose in 0.5 mg bd increments to 1-2 mg bd. Increases to >1.5 mg bd should generally occur at intervals of at least 1 wk. Patients w/ renal impairment Initially 0.5 mg bd; increase dose in increments of no more than 0.5 mg bd. Increases to >1.5 mg bd should generally occur at intervals of at least 1 wk.
Administration
May be taken with or without food: Oral soln: Administer directly from the syringe or mix w/ a beverage (eg, water, coffee, orange juice, low-fat milk) prior to administration.
Special Precautions
Increased mortality in elderly patients w/ dementia. Disruption of the body's ability to reduce core body temp. May cause somnolence, postural hypotension, motor & sensory instability which may lead to falls & consequently, fractures or other fall-related injuries. Risk of orthostatic hypotension & tachycardia; hyperglycemia, DM, exacerbation of pre-existing diabetes; dyslipidemia; hyperprolactinemia; wt gain; intraoperative floppy iris syndrome; leukopenia, neutropenia, agranulocytosis; venous thromboembolism; neuroleptic malignant syndrome; tardive dyskinesia especially in elderly women; extrapyramidal symptoms w/ concomitant psychostimulants (eg, methylphenidate); drug reaction w/ eosinophilia & systemic symptoms (DRESS). May have an antiemetic effect that may mask signs of toxicity due to overdosage of other drugs or may mask symptoms of disease eg, brain tumour, intestinal obstruction or Reye's syndrome. May induce priaprism. Caution in patients w/ history of cardiac arrhythmias, patients w/ congenital long QT syndrome & in concomitant use w/ drugs known to prolong the QT interval; patients w/ CV diseases & other conditions eg, dehydration & hypovolemia; patients w/ history of seizures or other predisposing factors; patients w/ Parkinson's disease or dementia w/ Lewy Bodies (DLB). Monitor patients for suicidal ideation/behavior. Potential effect on cognitive & motor performance; caution against driving a car or operating hazardous machinery. Contains aspartame; caution in phenylketonurics. Patients w/ renal or hepatic impairment. Pregnancy. Risk of extrapyramidal &/or w/drawal symptoms following delivery in neonates exposed to antipsychotics during 3rd trimester of pregnancy. Avoid breast-feeding while on treatment. Not recommended in childn <18 yr. Elderly.
Adverse Reactions
Extrapyramidal disorder. Schizophrenia & related psychotic disorders: Insomnia, agitation, anxiety, headache, rhinitis. Bipolar mania: Hyperkinesia, dystonia, somnolence.
Drug Interactions
Caution when used in combination w/ other centrally acting drugs & alcohol; drugs known to prolong the QT interval. May antagonize the effects of levodopa & dopamine agonists. May enhance the hypotensive effects of other therapeutic agents. Higher incidence of mortality w/ furosemide in elderly patients w/ dementia. Increased plasma conc of risperidone w/ strong CYP2D6 inhibitor (eg, fluoxetine); TCAs; phenothiazines; β-blockers. Decreased exposure w/ topiramate. Increased plasma conc of risperidone active antipsychotic fraction w/ strong CYP3A4 &/or P-gp inhibitor (eg, itraconazole, ritonavir & ritonavir-boosted PIs); higher doses of paroxetine; sertraline or fluvoxamine at doses >100 mg/day. Decreased plasma conc of risperidone active antipsychotic fraction w/ strong CYP3A4 &/or P-gp inducer (eg, rifampicin, carbamazepine). Increased plasma conc of risperidone & decreased plasma conc of 9-hydroxyrisperidone w/ ketoconazole. Decreased clearance w/ clozapine. Increased plasma conc of risperidone & the active antipsychotic fraction w/ verapamil. Reports of adverse events w/ valproate. Combined use of psychostimulants (eg, methylphenidate) w/ risperidone can lead to the emergence of extrapyramidal symptoms upon change of either or both treatments. Not compatible w/ cola or tea.
MIMS Class
Antipsychotics
ATC Classification
N05AX08 - risperidone ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
pms-Risperidone FC tab 0.25 mg
Packing/Price
100's;6 × 10's
Form
pms-Risperidone FC tab 0.5 mg
Packing/Price
100's;6 × 10's
Form
pms-Risperidone FC tab 1 mg
Packing/Price
100's;6 × 10's
Form
pms-Risperidone FC tab 2 mg
Packing/Price
100's;6 × 10's
Form
pms-Risperidone FC tab 4 mg
Packing/Price
100's;6 × 10's
Form
pms-Risperidone oral soln 1 mg/mL
Packing/Price
30 mL x 1's
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