Formulary
Risperidone: Indications, Dosing, Side Effects and Interactions
Risperidone is a dopamine D 2 , 5-HT 2A , alpha 1 -adrenoceptor, and histamine-1 receptor antagonist.
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Risperidone: Indications, Dosing, Side Effects and Interactions
Risperidone is a dopamine D 2 , 5-HT 2A , alpha 1 -adrenoceptor, and histamine-1 receptor antagonist.
Drug action
Risperidone is a dopamine D 2 , 5-HT 2A , alpha 1 -adrenoceptor, and histamine-1 receptor antagonist.
Indications and dose
**Acute and chronic psychosis**
- **Adult** (By Mouth): 2 mg daily in 1-2 divided doses for day 1, then 4 mg daily in 1-2 divided doses for day 2, slower titration is appropriate in some patients, usual dose 4-6 mg daily, doses above 10 mg daily only if benefit considered to outweigh risk; maximum 16 mg per day.
- **Elderly** (By Mouth): Initially 500 micrograms twice daily, then increased in steps of 500 micrograms twice daily, increased to 1-2 mg twice daily.
**Mania**
- **Adult** (By Mouth): Initially 2 mg once daily, then increased in steps of 1 mg daily if required; usual dose 1-6 mg daily.
- **Elderly** (By Mouth): Initially 500 micrograms twice daily, then increased in steps of 500 micrograms twice daily, increased to 1-2 mg twice daily.
**Short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non-pharmacological interventions and when there is a risk of harm to self or others**
- **Adult** (By Mouth): Initially 250 micrograms twice daily, then increased in steps of 250 micrograms twice a day on alternate days, adjusted according to response; usual dose 500 micrograms twice daily (max. per dose 1 mg twice daily).
**Schizophrenia [in patients stabilised on oral risperidone 3 mg daily]**
- **Adult** (By Deep Intramuscular Injection): Initially 75 mg every 28 days, treatment to be initiated about 24 hours after the last oral risperidone dose. Before treatment initiation risperidone-nave patients should be titrated with oral risperidone for at least 14 days; patients stabilised on other oral antipsychotics, but with previous response to risperidone, should be titrated with oral risperidone for at least 6 days. Those stabilised on oral risperidone may be switched without titration; increased if necessary up to 100 mg every 28 days, dose to be adjusted at intervals of 28 days; usual maintenance 75 mg every 28 days, dose may be given up to 3 days before the 28-day time point.
**Schizophrenia [in patients stabilised on oral risperidone 4 mg daily or more]**
- **Adult** (By Deep Intramuscular Injection): Initially 100 mg every 28 days, treatment to be initiated about 24 hours after the last oral risperidone dose. Before treatment initiation risperidone-nave patients should be titrated with oral risperidone for at least 14 days; patients stabilised on other oral antipsychotics, but with previous response to risperidone, should be titrated with oral risperidone for at least 6 days. Those stabilised on oral risperidone may be switched without titration, dose to be adjusted as necessary at intervals of 28 days; usual maintenance 75 mg every 28 days, dose may be given up to 3 days before the 28-day time point.
**Schizophrenia [in patients switching from intramuscular risperidone 37.5 mg every 2 weeks]**
- **Adult** (By Deep Intramuscular Injection): 75 mg every 28 days, treatment to be initiated 2 weeks after the last bi-weekly injection, dose may be given up to 3 days before the 28-day time point.
**Schizophrenia [in patients switching from intramuscular risperidone 50 mg every 2 weeks]**
- **Adult** (By Deep Intramuscular Injection): 100 mg every 28 days, treatment to be initiated 2 weeks after the last bi-weekly injection, dose may be given up to 3 days before the 28-day time point.
**Schizophrenia [in patients stabilised on oral antipsychotics e.g. risperidone up to 4 mg daily**
- **Adult** (By Deep Intramuscular Injection): Schizophrenia [in patients stabilised on oral antipsychotics e.g. risperidone up to 4 mg daily for 2 weeks or more] Initially 25 mg every 2 weeks, oral antipsychotics should be continued during the first 3 weeks of treatment; increased if necessary up to 37.5-50 mg every 2 weeks, dose to be increased at intervals of at least 4 weeks; usual maintenance 25 mg every 2 weeks.
**Schizophrenia [in patients stabilised on oral antipsychotics e.g. risperidone over 4 mg daily]**
- **Adult** (By Deep Intramuscular Injection): Initially 37.5 mg every 2 weeks, oral antipsychotics should be continued during the first 3 weeks of treatment; increased if necessary up to 50 mg every 2 weeks, dose to be increased at intervals of at least 4 weeks.
**Acute and chronic psychosis for risperidone**
- **Child 12-17 years (under expert supervision)** (By mouth): 2 mg daily in 1-2 divided doses for day 1, then 4 mg daily in 1-2 divided doses for day 2, slower titration is appropriate in some patients; usual dose 4-6 mg daily, doses above 10 mg daily only if benefit considered to outweigh risk; maximum 16 mg per day.
**Short-term monotherapy of mania in bipolar disorder (under expert supervision) for risperidone**
- **Child 12-17 years** (By mouth): Initially 500 micrograms once daily, then adjusted in steps of 0.5-1 mg daily, adjusted according to response; usual dose 2.5 mg daily in 1-2 divided doses; maximum 6 mg per day.
**Short-term treatment (up to 6 weeks) of persistent aggression in conduct disorder (under expert supervision) for risperidone**
- **Child 5-17 years (body-weight up to 50 kg)** (By mouth): Initially 250 micrograms once daily, then increased in steps of 250 micrograms once daily on alternate days, adjusted according to response; usual dose 500 micrograms once daily; maximum 750 micrograms per day.
- **Child 5-17 years (body-weight 50 kg and above)** (By mouth): Initially 500 micrograms once daily, then increased in steps of 500 micrograms once daily on alternate days, adjusted according to response; usual dose 1 mg once daily; maximum 1.5 mg per day.
**Short-term treatment of severe aggression in autism (under expert supervision) for risperidone**
- **Child 5-17 years (body-weight 15-20 kg)** (By mouth): Initially 250 micrograms daily for at least 4 days, then increased if necessary to 500 micrograms daily, then increased in steps of 250 micrograms daily, dose to be increased at intervals of 2 weeks, review effectiveness and any side-effects after 3-4 weeks; stop if no response at 6 weeks; maximum 1 mg per day.
- **Child 5-17 years (body-weight 20-45 kg)** (By mouth): Initially 500 micrograms daily for at least 4 days, then increased if necessary to 1 mg daily, then increased in steps of 500 micrograms daily, dose to be increased at intervals of 2 weeks, review effectiveness and any side-effects after 3-4 weeks; stop if no response at 6 weeks; maximum 2.5 mg per day.
- **Child 5-17 years (body-weight 45 kg and above)** (By mouth): Initially 500 micrograms daily for at least 4 days, then increased if necessary to 1 mg daily, then increased in steps of 500 micrograms daily, dose to be increased at intervals of 2 weeks, review effectiveness and any side-effects after 3-4 weeks; stop if no response at 6 weeks; maximum 3 mg per day.
Cautions
For all antipsychotic drugs Blood dyscrasias; cardiovascular disease; conditions predisposing to seizures; depression; diabetes (may raise blood glucose); epilepsy; history of jaundice; myasthenia gravis; Parkinson's disease (may be exacerbated); photosensitisation (may occur with higher dosages); prostatic hypertrophy; severe respiratory disease; susceptibility to angle-closure glaucoma Cautions, further information Cardiovascular disease An ECG may be required, particularly if physical examination identifies cardiovascular risk factors, personal history of cardiovascular disease, or if the patient is being admitted as an inpatient. Elderly Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information). Potentially inappropriate: for all antipsychotics (other than quetiapine and clozapine) in patients with parkinsonism or Lewy Body Disease (risk of severe extrapyramidal symptoms) in behavioural and psychological symptoms of dementia (BPSD), unless symptoms are severe and other non-pharmacological treatments have failed (increased risk of stroke) for use as a hypnotic, unless sleep disorder is due to psychosis or dementia (risk of confusion, hypotension, extrapyramidal side-effects, and falls) in patients prone to falls (may cause gait dyspraxia, parkinsonism) if prescribed a phenothiazine (other than prochlorperazine for nausea, vomiting, or vertigo; chlorpromazine for relief of persistent hiccups; levomepromazine as an antiemetic in palliative care) as first-line treatment (sedative, significant antimuscarinic (anticholinergic) toxicity in older people, and safer and more efficacious alternatives exist) if prescribed an antipsychotic drug with moderate or marked antimuscarinic effects (e.g. chlorpromazine, clozapine, flupenthixol, fluphenazine, pipothiazine, promazine, and zuclopenthixol) in patients with a history of prostatism or urinary retention (high risk of urinary retention) Cautions For risperidone Avoid in Acute porphyrias ; cataract surgery (risk of intra-operative floppy iris syndrome); dehydration; dementia with Lewy bodies; prolactin-dependent tumours
Side effects
For all antipsychotic drugs Common or very common Agitation; amenorrhoea; arrhythmias; constipation; dizziness; drowsiness; dry mouth; erectile dysfunction; fatigue; galactorrhoea; gynaecomastia; hyperglycaemia; hyperprolactinaemia; hypersalivation; hypotension (dose-related); insomnia; leucopenia; movement disorders; muscle rigidity; neutropenia; parkinsonism; postural hypotension (dose-related); QT interval prolongation; rash; seizure; tremor; urinary retention; vomiting; weight increased Uncommon Agranulocytosis; confusion; neuroleptic malignant syndrome (discontinue-potentially fatal) Rare or very rare Sudden death; withdrawal syndrome neonatal Side-effects, further information For depot antipsychotics-side-effects may persist until the drug has been cleared from its depot site. Overdose Phenothiazines cause less depression of consciousness and respiration than other sedatives. Hypotension, hypothermia, sinus tachycardia, and arrhythmias may complicate poisoning. For details on the management of poisoning see Antipsychotics under Emergency treatment of poisoning . Side-effects For risperidone Common or very common Anaemia; anxiety; appetite abnormal; asthenia; chest discomfort; conjunctivitis; cough; depression; diarrhoea; dyspnoea; epistaxis; fall; fever; gastrointestinal discomfort; headache; hypertension; increased risk of infection; joint disorders; laryngeal pain; muscle spasms; nasal congestion; nausea; oedema; oral disorders; pain; sexual dysfunction; skin reactions; sleep disorders; urinary disorders; vision disorders; weight decreased Uncommon Alopecia; breast abnormalities; cardiac conduction disorders; cerebrovascular insufficiency; chills; coma; concentration impaired; consciousness impaired; cystitis; diabetes mellitus; dry eye; dysarthria; dysphagia; dysphonia; ear pain; eye disorders; feeling abnormal; flushing; gait abnormal; gastrointestinal disorders; induration; malaise; menstrual cycle irregularities; mood altered; muscle weakness; palpitations; polydipsia; posture abnormal; procedural pain; respiratory disorders; sensation abnormal; syncope; taste altered; thirst; thrombocytopenia; tinnitus; vaginal discharge; vertigo Rare or very rare Angioedema; catatonia; dandruff; diabetic ketoacidosis; embolism and thrombosis; eyelid crusting; glaucoma; hypoglycaemia; hypothermia; jaundice; pancreatitis; peripheral coldness; rhabdomyolysis; SIADH; sleep apnoea; water intoxication; withdrawal syndrome Frequency not known Cardiac arrest; severe cutaneous adverse reactions (SCARs)
Interactions
**Severe interactions:**
- Medicinal products with hypotensive effect Clinically significant hypotension has been observed post-marketing with concomitant use of risperidone and antihypertensive treatment.
- Amitriptyline does not affect the pharmacokinetics of risperidone or the active antipsychotic fraction.
**Other interactions (34):**
- The interaction data provided in this section are based on studies with oral risperidone.
- Pharmacodynamic-related interactions Medicinal products known to prolong the QT interval Caution is advised when prescribing OKEDI with medicinal products known to prolong the QT interval, such as...
- Centrally-acting medicinal products and alcohol OKEDI should be used with caution in combination with other centrally-acting substances, notably including alcohol, opiates, antihistamines and...
- Levodopa and dopamine agonists OKEDI may antagonise the effect of levodopa and other dopamine agonists.
- Paliperidone Concomitant use of OKEDI with paliperidone is not recommended as paliperidone is the active metabolite of risperidone and the combination of the two may lead to additive active moiety...
- Both risperidone and its active metabolite 9-hydroxy-risperidone are substrates of P-glycoprotein (P-gp).
Pregnancy
For all antipsychotic drugs Extrapyramidal effects and withdrawal syndrome have been reported occasionally in the neonate when antipsychotic drugs are taken during the third trimester of pregnancy. Following maternal use of antipsychotic drugs in the third trimester, neonates should be monitored for symptoms including agitation, hypertonia, hypotonia, tremor, drowsiness, feeding problems, and respiratory distress. Pregnancy For risperidone Use only if potential benefit outweighs risk.
Breast feeding
For all antipsychotic drugs There is limited information available on the short- and long-term effects of antipsychotic drugs on the breast-fed infant. Animal studies indicate possible adverse effects of antipsychotic medicines on the developing nervous system. Chronic treatment with antipsychotic drugs whilst breast-feeding should be avoided unless absolutely necessary. Phenothiazine derivatives are sometimes used in breast-feeding women for short-term treatment of nausea and vomiting. Breast feeding For risperidone Use only if potential benefit outweighs risk-small amount present in milk.
Hepatic impairment
Caution. M Dose adjustments With oral use: Dose reduction to half the usual dose, and slower dose titration. M Hepatic impairment For Okedi pre-filled syringes Caution (no information available)-increased risk of exposure. M Dose adjustments Careful titration with oral risperidone, by halving initial doses and slowing titration, is recommended; if an oral dose of at least 3 mg daily is tolerated, treatment with 75 mg as a deep intramuscular depot injection may be initiated. M Hepatic impairment For Risperdal Consta injection Caution (no information available). M Dose adjustments If an oral dose of at least 2 mg daily is tolerated, 25 mg as a deep intramuscular depot injection can be given every 2 weeks. M
Renal impairment
Caution. M Dose adjustments With oral use: Initial and subsequent doses should be halved, with slower dose titration. M Renal impairment For Okedi pre-filled syringes Avoid in moderate to severe impairment (no information available). M Renal impairment For Risperdal Consta injection Caution (no information available). M Dose adjustments If an oral dose of at least 2 mg daily is tolerated, 25 mg as a deep intramuscular depot injection can be given every 2 weeks. M
Medicinal forms
Solution,Tablet,Tablet,Solution,Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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