Risperdal/Risperdal Consta

Risperdal/Risperdal Consta

risperidone

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Risperidone
Indications/Uses
Risperdal Acute & maintenance treatment of schizophrenia in adults. Treatment of schizophrenia in adolescents (13-17 yr). Short-term treatment of acute manic or mixed episodes associated w/ bipolar I disorder in adults & adolescents (10-17 yr). In combination w/ lithium or valproate for short-term treatment of acute manic or mixed episodes associated w/ bipolar I disorder in adults. Treatment of irritability associated w/ autistic disorder in childn & adolescents (5-16 yr), including symptoms or aggression towards others, deliberate self-injuriousness, temper tantrums & quickly changing moods. Risperdal Consta Treatment of schizophrenia & schizoaffective disorder. Maintenance treatment of bipolar I disorder, as monotherapy or adjunctive therapy to lithium or valproate.
Dosage/Direction for Use
Risperdal Schizophrenia Adult Initially 2 mg/day as single or 2 divided doses. Dose increments by 1-2 mg/day of not <24 hr interval. Individualise to recommended dose: 4-8 mg/day. Adolescent Initially 0.5 mg/day as single daily dose either in morning/evening. Dose increments by 0.5 or 1 mg/day of not <24 hr interval. Recommended dose: 3 mg/day. Switching from other antipsychotics Gradual discontinuation of previous treatment while Risperdal is initiated may be appropriate for most. Bipolar mania Adult Initially 2 or 3 mg once daily. Dosage can be adjusted of not <24 hr interval in increments/decrements of 1 mg/day. Childn Initially 0.5 mg once daily either in morning/evening. Dose increments by 0.5 or 1 mg/day of not <24 hr interval. Recommended dose: 2.5 mg/day. Irritability associated w/ autistic disorders Administer once daily or half total daily dose administer bd. Patient ≥20 kg Initially 0.5 mg/day. Dosage may be increased to recommended dose of 1 mg/day after a min of 4 days from treatment initiation; <20 kg Initially 0.25 mg/day. Dosage may be increased to recommended dose of 0.5 mg/day after a min of 4 days from treatment initiation. Maintain this dose for at least 14 days. For patients not achieving sufficient clinical response, consider dose increment at ≥2 wk interval at 0.25 mg/day for patients <20 kg or 0.5 mg for patients ≥20 kg. Max: 1 mg in patients <20 kg, 2.5 mg in patients ≥20 kg or 3 mg in patients >45 kg. Elderly or w/ renal/hepatic disease Initially 0.5 mg bd. Dose increments at ≤0.5 mg bd. Increase dosage above 1.5 mg bd at ≥1 wk interval. Risperdal Consta Adult 25 mg IM every 2 wk. Non-responding patients may benefit from 37.5 mg or 50 mg. Max: 50 mg IM every 2 wk. Elderly 25 mg IM every 2 wk. Hepatic & renal impairment 1st wk: Initially 0.5 mg bd oral risperidone; 2nd wk: 1 mg bd or 2 mg once daily. If an oral dose of 2 mg is well tolerated, 25 mg inj can be administered every 2 wk. Ensure sufficient antipsychotic coverage during the 3-wk lag period following the 1st inj. Upward dosage adjustment should not be made more frequently than 4 wkly. Effect of dosage adjustment should not be anticipated earlier than 3 wk after 1st inj w/ higher dose. To be administer by deep IM deltoid or gluteal inj.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity.
Special Precautions
Increased mortality in elderly patients w/ dementia-related psychosis. Cerebrovascular adverse events. Discontinue treatment if neuroleptic malignant syndrome/tardive dyskinesia occurs. Parkinson's disease, dementia w/ Lewy bodies, CVD, history of cardiac arrhythmias, congenital long QT syndrome or seizures. Monitor for symptoms of hyperglycemia, DM & wt gain. Hyperprolactinemia, orthostatic hypotension (consider dose reduction), leukopenia/neutropenia/agranulocytosis. Dysphagia. Priapism. Thrombotic thrombocytopenic purpura (TTP). Body temperature regulation. Suicide. Renal or hepatic insufficiency. Paed w/ autistic disorder <5 yr. May impair ability to drive or operate machinery. Pregnancy & lactation. Risperdal Consta Avoid inadvertent inj into a blood vessel.
Adverse Reactions
Neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia, hyperglycemia & DM, wt gain, hyperprolactinemia, orthostatic hypotension & syncope. Leukopenia, neutropenia & agranulocytosis. Seizures, dysphagia, suicide, priapism, TTP. Somnolence, increased appetite, fatigue, insomnia, sedation, parkinsonism, akathisia, vomiting, cough, constipation, nasopharyngitis, drooling, rhinorrhea, dry mouth, upper abdominal pain, dizziness, nausea, anxiety, headache, nasal congestion, rhinitis, tremor & rash. Changes in body wt had been observed in clinical trials.
Drug Interactions
Centrally-acting drugs & alcohol. Drugs w/ hypotensive effects. Levodopa & dopamine agonists. Clozapine, fluoxetine & paroxetine. Carbamazepine & other CYP3A4 enzyme inducers (eg phenytoin, rifampin & phenobarb). Drugs known to prolong QT interval.
MIMS Class
ATC Classification
N05AX08 - risperidone ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Risperdal film-coated tab 1 mg
Packing/Price
60's
Form
Risperdal film-coated tab 2 mg
Packing/Price
60's
Form
Risperdal film-coated tab 3 mg
Packing/Price
60's
Form
Risperdal film-coated tab 4 mg
Packing/Price
60's
Form
Risperdal oral soln 1 mg/mL
Packing/Price
30 mL x 1's
Form
Risperdal Consta powd for inj 25 mg
Packing/Price
1's
Form
Risperdal Consta powd for inj 37.5 mg
Packing/Price
1's
Form
Risperdal Consta powd for inj 50 mg
Packing/Price
1's
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