Risperidone oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing risperidone
Drugs List
Therapeutic Indications
Uses
Short term treatment of aggression in mod to severe Alzheimer's dementia
Short term treatment of persistent aggression in conduct disorder in child
Treatment of manic episodes associated with bipolar disorder
Treatment of schizophrenia
Treatment of schizophrenia.
Treatment of moderate to severe manic episodes associated with bipolar disorders.
Short term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia (when unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others)
Short term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacological treatment.
Unlicensed Uses
Severe aggression in childhood autism (short term treatment)
Dosage
Adults
Schizophrenia
Risperidone may be given once or twice daily. All patients, whether acute or chronic.
Initial dose: 2mg daily. The dosage may be increased to 4mg daily on the second day.
Some patients, such as first episode patients, may benefit from a slower rate of titration.
The dosage can be maintained unchanged, or further individualised.
Maintenance dose: between 4mg and 6mg daily.
Doses above 10mg daily generally have not been shown to provide additional efficacy to lower doses and may increase the risk of extrapyramidal symptoms. Doses above 10mg daily should only be used in individual patients if the benefit is considered to outweigh the risk.
Doses above 16mg daily have not been extensively evaluated for safety and therefore should not be used.
Bipolar Mania
Risperidone should be administered once daily.
Initial dose: 2mg once a day
Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1mg per day.
Maintenance dose: Range between 1mg and 6 mg per day.
Doses over 6mg per day have not been investigated in patients with manic episodes.
As with all symptomatic treatments, the continued use of risperidone must be evaluated and justified on an on going basis.
Persistent aggression in moderate to severe Alzheimer's dementia
Risperidone should be administered twice daily.
Initial dose: 250micrograms twice a day.
Dosage adjustments, if indicated, should occur at intervals not more frequently than every other day and in dosage increments of 250micrograms twice daily.
Maintenance dose: 500micrograms twice daily.
Some patients may benefit from doses up to 1mg twice daily.
Patients must be evaluated frequently and regularly, and the need for continuing treatment reassessed. Treatment should not be used for more than 6 weeks in persistent aggression in Alzheimer's dementia.
Elderly
Schizophrenia
Initial dose: 500micrograms twice a day. This dosage can be adjusted with increments of 500 micrograms twice a day to a dosage of 1 to 2 mg twice a day.
Bipolar Mania
Initial dose: 500micrograms twice a day. This dosage can be adjusted with increments of 500 micrograms twice a day to a dosage of 1 to 2 mg twice a day. Use with caution as clinical experience in the elderly is limited in this indication.
Persistent aggression in moderate to severe Alzheimer's dementia
Initial dose: 250micrograms twice daily. Dosage adjustments, if indicated, should occur at intervals not more frequently than every other day and in dosage increments of 250 micrograms twice daily.
Maintenance dose: 500 micrograms twice daily.
Some patients may benefit from doses up to 1 mg twice daily.
Patients must be evaluated frequently and regularly, and the need for continuing treatment reassessed. Treatment should not be used for more than 6 weeks in persistent aggression in Alzheimer's dementia.
Children
Conduct disorder
Children aged 5 to 18 years and body weight over 50 kg
Initial dose: 500micrograms once daily.
This dosage can be individually adjusted by increments of 500 micrograms once daily not more frequently than every other day.
Maintenance dose: 1 mg once daily.
Though some patients may benefit from 500micrograms once daily or 1.5mg once daily.
Children aged 5 to 18 years and body weight under 50 kg
Initial dose: 250micrograms once daily.
This dosage can be individually adjusted by increments of 250 micrograms once daily not more frequently than every other day.
Maintenance dose: 500micrograms once daily.
Though some patients may benefit from 250micrograms once daily or 750micrograms once daily.
As with all symptomatic treatments, the continued use of risperidone must be evaluated and justified on an on-going basis.
Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and education intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents.
The following unlicensed doses may be suitable:
Acute and chronic psychosis (under specialist supervision) (Unlicensed)
Children aged 12 to 18 years
Initial dose: 2mg in one to two divided doses on the first day.
Then 4mg in one to two divided doses on the second day (slower titration may be appropriate in some children).
Maintenance dose: 4mg to 6mg daily.
Doses above 10mg daily should only be used if the benefits are considered to outweigh the risks (max. 16mg daily).
Short-term monotherapy of mania in bipolar disorder (under specialist supervision) (Unlicensed)
Children aged 12 to 18 years
Initially 500micrograms once daily adjusted in steps of 500micrograms to 1mg daily according to response.
Maintenance dose: 2.5mg daily in one to two divided doses (max. 6mg daily).
Short-term treatment of severe aggression in autism (under specialist supervision) (Unlicensed)
Children over 5 years and bodyweight over 20 kg
Initial dose: 500micrograms daily, increased if necessary after at least 4 days to 1 mg daily.
Thereafter increased by 500micrograms daily at 2 week intervals.
Maximum daily dose of 2.5mg daily if under 45 kg or maximum daily dose of 3mg if over 45kg.
Children over 5 years and bodyweight 15 to 20 kg
Initial 250micrograms daily, increased if necessary after at least 4 days to 500micrograms daily.
Thereafter increased by 250micrograms daily at 2 week intervals to a maximum of 1mg daily.
Review effectiveness and any side-effects after 3 to 4 weeks; stop if no response at 6 weeks.
Patients with Renal Impairment
Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower.
Patients with Hepatic Impairment
Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower.
Additional Dosage Information
Switching from other antipsychotics: When medically appropriate, gradual discontinuation of the previous treatment while risperidone is initiated is recommended. When switching patients from depot antipsychotics, consider initiating risperidone therapy in place of the next scheduled injection. The need for continuing existing anti-Parkinson medication should be re-evaluated periodically.
Contraindications
Children under 5 years
Neutrophil count below 1.0 x 10 to the power of 9 / L
Breastfeeding
Long QT syndrome
Porphyria
Torsade de pointes
Precautions and Warnings
Elderly
Family history of long QT syndrome
Predisposition to hypotension
Predisposition to venous thromboembolism
Risk of cerebrovascular accident
Bradycardia
Cardiovascular disorder
Cerebrovascular disorder
Dehydration
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of breast cancer
History of cerebrovascular accident
History of seizures
History of torsade de pointes
History of transient ischaemic attack
Hyperprolactinaemia
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Hypovolaemia
Lactose intolerance
Leucopenia
Neutropenia
Parkinson's disease
Peri-operative period in cataract surgery
Phenylketonuria
Pregnancy
Prolactin-dependent neoplasm
Renal impairment
Correct electrolyte disorders before treatment
May mask nausea and vomiting associated with organic disease
Not indicated in dementia other than Alzheimer's dementia
Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Some formulations contain aspartame - caution in phenylketonuria
Advise ability to drive/operate machinery may be affected by side effects
May reduce seizure threshold
Not all available brands are licensed for all age groups
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Some formulations contain sunset yellow (E110); may cause allergic reaction
Monitor blood glucose closely in patients with diabetes mellitus
Monitor closely patients who develop neutropenia
Monitor ECG in patients at risk of QT prolongation
Monitor patient's weight
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor patients with existing or tendency towards diabetes mellitus
Monitor periodically for signs or symptoms of hyperglycaemia
Monitor prolactin levels where prolactin related side effects occur
Monitor serum electrolytes
Reduce dose or discontinue if excessive hypotension occurs
Consider discontinuation if signs of tardive dyskinesia occur
Increased risk for venous thromboembolism - take preventive measures
Intraoperative Floppy Iris Syndrome has been reported in cataract surgery
May cause postural hypotension
May cause weight gain
May impair ability to reduce core body temperature
Potential for withdrawal symptoms
Seek medical advice if priapism does not resolve within 4 hours
Avoid abrupt withdrawal
Discontinue if neutrophil count below 1 x 10 to the power of 9/L
Discontinue if patient develops neuroleptic malignant syndrome
Reduce dose in elderly
Advise patient not to take St John's wort concurrently
Advise patient that the effects of alcohol may be potentiated
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient grapefruit products may increase plasma level
Patients should be reassessed regularly and the need for continuing treatment reassessed.
Caution should be exercised when prescribing to elderly patients with dementia as an increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical antipsychotic drugs, including risperidone, was noted.
If further sedation is required, an additional drug (such as a benzodiazepine) should be used rather than increasing the dose of risperidone. The sedative effect of risperidone should be closely monitored in children and adolescents because of possible consequences on learning ability.
Use with caution in patients who may experience an elevation in core body temperature and dehydration.
Evaluation of the prolactin plasma level is recommended in patients with evidence of possible prolactin-related side-effects (e.g. gynaecomastia, menstrual disorders, anovulation, fertility disorder, decreased libido, erectile dysfunction, and galactorrhoea). In children and adolescents, regular monitoring should be considered, including measurements of height, weight, sexual maturation, monitoring of menstrual functioning, and other potential prolactin-related effects.
In elderly patients with dementia, antipsychotic drugs are associated with a small increased risk of mortality and an increased risk of stroke or transient ischaemic attack. Furthermore, elderly patients are particularly susceptible to postural hypotension and to hyper and hypothermia in hot or cold weather. It is recommended that: Antipsychotic drugs should not be used in elderly patients to treat mild to moderate psychotic symptoms.
Initial doses of antipsychotic drugs in elderly patients should be reduced (to half the adult dose or less), taking into account factors such as the patient's weight, co-morbidity, and concomitant medication.
Treatment should be reviewed regularly.
Pregnancy and Lactation
Pregnancy
Use risperidone with caution during pregnancy.
The manufacturer recommends that risperidone should only be used during pregnancy if the benefits outweigh the risks, and, if used, should not be discontinued abruptly. Briggs (2011) notes that the number of recorded cases of use of risperidone during pregnancy is too small to make an assessment of safety, but the risk of the disease in the mother potentially outweigh the risk to the foetus. This reference adds that prescribing a folic acid supplement to women receiving atypical antipsychotics as they may have a higher risk of neural tube defects due to low dietary intake and obesity. Schaefer (2007) concludes that antipsychotics may be used during pregnancy but recommends observation of the neonate for adaptation problems, extrapyramidal and withdrawal symptoms for at least 2 days when neuroleptics have been used up to delivery. This author also suggests dose reduction or even treatment interruption in the days immediately preceding delivery if the clinical course allows.
Although in experimental animals risperidone did not show direct reproductive toxicity, some indirect prolactin and CNS-mediated effects were observed; typically delayed oestrus and changes in mating and nursing behaviour in rats. No teratogenic effect of risperidone was noted in any study. Neonates exposed to antipsychotics during the third trimester of pregnancy are at risk of extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress or feeding disorders. Monitor exposed neonates carefully.
Lactation
Risperidone is contraindicated during breastfeeding.
The manufacturer recommends that the advantage of breastfeeding should be weighed against the potential risks for the child. In animal studies, risperidone and 9-hydroxyrisperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxyrisperidone are also excreted in human breast milk.
Briggs (2011) suggests neuroleptics with weak or moderately strong action are preferable when their use is urgently needed. The author also suggests observing the infant for symptoms potentially associated with the drug therapy and contacting a paediatrician and teratology information centre if required.
Counselling
Advise patients to avoid taking St John's wort concurrently.
Advise patients to avoid grapefruit products.
Advise patients that the CNS effects of risperidone may be potentiated by alcohol.
As with other antipsychotics, patients should be advised of the potential for weight gain.
Advise patients to seek urgent medical care if priapism has not been resolved within 3 to 4 hours.
Warn patients that risperidone may interfere with activities requiring mental alertness, and so should not drive or operate machinery until their individual susceptibility is known.
Side Effects
Acne
Agitation
Akathisia
Alopecia
Altered temperature sensation
Amenorrhoea
Anaphylactic reaction
Angioedema
Anxiety
Arthralgia
Asthenia
Atrial fibrillation
Atrioventricular block
Attention disturbances
Blood disorders
Blood pressure changes
Blurred vision
Bronchitis
Bundle branch block
Conjunctivitis
Cough
Cystitis
Diabetes mellitus
Disturbances of appetite
Disturbances of sensation
Dizziness
Dry mouth
Dry skin
Dyskinesia
Dyspepsia
Dyspnoea
Dystonia
Ear infection
ECG changes
Erectile dysfunction
Eye disorder
Fatigue
Galactorrhoea
Gastritis
Gastro-enteritis
Gastro-intestinal disturbances
Glaucoma
Gynaecomastia
Headache
Hyperglycaemia
Hyperprolactinaemia
Hypersensitivity reactions
Hypersomnia
Hypoglycaemia
Hypothermia
Inappropriate secretion of antidiuretic hormone
Increase in serum transaminases
Infections
Influenza
Insomnia
Intestinal obstruction
Intraoperative floppy iris syndrome
Jaundice
Ketoacidosis
Lethargy
Loss of libido
Mania
Movement disturbances
Muscle weakness
Myalgia
Nasal congestion
Nervousness
Oedema
Pain
Palpitations
Pancreatitis
Parkinsonism
Peripheral oedema
Pharyngolaryngeal pain
Pneumonitis
Polydipsia
Postural dizziness
Priapism
Prolongation of QT interval
Pruritus
Pyrexia
Rash
Respiratory disorders
Sedation
Sexual dysfunction
Sinusitis
Skin disorder
Sleep apnoea
Sleep disturbances
Somnolence
Syncope
Tachycardia
Tremor
Upper respiratory tract infection
Urinary incontinence
Urinary retention
Urinary tract infections
Viral infection
Water intoxication
Weight changes
Withdrawal Symptoms and Signs
Acute withdrawal symptoms, including nausea, vomiting, sweating, and insomnia have been described after abrupt cessation of high doses of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders ( such as akathisia, dystonia, and dyskinesia) has been reported. Therefore gradual withdrawal is advisable.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: March 2014
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Risperdal Tablets, Liquid and Quicklets. Janssen-Cilag Ltd. Revised June 2015.
Summary of Product Characteristics: Risperidone 1mg/ml oral solution. Teva UK Ltd. Revised April 2015.
Summary of Product Characteristics: Risperidone 250microgram tablets. Glenmark Pharmaceuticals Europe Ltd. Revised February 2020.
MHRA Drug Safety Update November 2013
Available at: https://www.mhra.gov.uk
Last accessed: March 31, 2014
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 August 2020
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Risperidone Last revised: 20 July 2020
Last accessed: 05 August 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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