Risperidone parenteral depot
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Prolonged release powder for suspension for injection containing risperidone.
Drugs List
Therapeutic Indications
Uses
Maintenance treatment of schizophrenia
Maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics. Some brands are indicated for patients whom tolerability and effectiveness has been established with oral risperidone.
Dosage
Adults
Bi-weekly risperidone injection
Starting dose
The recommended dose is 25mg risperidone injected intramuscularly every two weeks.
For those patients stabilised on a fixed dose of oral risperidone for two weeks or more, the following conversion scheme should be considered:
Patients treated with a dosage of 4mg or less oral risperidone should receive risperidone injection 25mg.
Patients treated with higher oral doses should be considered for the higher dose of 37.5mg risperidone injection.
When patients are not currently taking oral risperidone, the oral pre-treatment dosage should be considered when choosing the injection starting dose. The recommended starting dose is 25mg risperidone injected intramuscularly every two weeks. Patients on higher dosages of the used oral antipsychotic should be considered for the higher dose of 37.5mg risperidone injection.
Ensure sufficient antipsychotic coverage with oral risperidone or the previous antipsychotic during the three-week lag period following the first risperidone injection. Risperidone injections should not be used in acute exacerbations of schizophrenia without this.
Maintenance dose
The recommended dose is 25mg risperidone injected intramuscularly every two weeks.
Some patients may benefit from the higher doses of 37.5mg or 50mg. Should a dosage adjustment be required, dose increments from 25mg to 37.5mg or from 37.5mg to 50mg should be considered, after a minimum of four weeks after the previous dose adjustment. The effect of this dosage adjustment on the patient's clinical status should not be anticipated earlier than 3 weeks after the first injection with the higher dose.
The maximum dose should not exceed 50mg every two weeks.
Monthly risperidone injection
Switching from oral risperidone to monthly risperidone injection
Risperidone monthly injection must be initiated 24 hours after the last dose of oral risperidone. If the patient previously received oral risperidone at a dose of 3mg daily, risperidone monthly injection should be initiated at 75mg every 28 days, by intramuscular injection. If the patient previously received oral risperidone at a dose of 4mg daily, risperidone monthly injection should be initiated at 100mg every 28 days, by intramuscular injection. Dose adjustments may be made every 28 days. The recommended maintenance dose is 75mg every 28 days. However, some patients may benefit from a dose of 100mg every 28 days.
Elderly
Bi-weekly risperidone injection
No dose reduction is required. The recommended dose for elderly patients is 25mg risperidone injected intramuscularly every two weeks.
When patients are not currently taking oral risperidone, the recommended dose is 25mg risperidone injected intramuscularly every two weeks.
For those patients stabilised on a fixed dose of oral risperidone for two weeks or more, the following conversion scheme should be considered:
Patients treated with a dosage of 4mg or less oral risperidone should receive risperidone injection 25mg.
Patients treated with higher oral doses should be considered for the higher dose of 37.5mg risperidone injection.
Sufficient oral risperidone cover should be ensured for at least three weeks during the lag period following the first risperidone injection.
Monthly risperidone injection
Before initiating risperidone monthly injection, tolerability to at least 3mg daily oral risperidone must be established.
Patients with Renal Impairment
Bi-weekly risperidone injection
If patients with renal impairment require treatment with risperidone injection a starting dose of 0.5mg twice daily of oral risperidone is recommended during the first week. In the second week 1mg twice a day or 2mg once daily may be given. If an oral dose of at least 2mg daily is well tolerated, risperidone injection 25mg may be administered every two weeks.
Monthly risperidone injection
75mg and 100mg risperidone injection in contraindicated in patients with severe renal impairment (creatinine clearance less than 60ml/min).
Patients with Hepatic Impairment
Bi-weekly risperidone injection
If patients with hepatic impairment require treatment with risperidone injection a starting dose of 0.5mg twice daily of oral risperidone is recommended during the first week. In the second week 1mg twice a day or 2mg once daily may be given. If an oral dose of at least 2mg daily is well tolerated, risperidone injection 25mg may be administered every two weeks.
Monthly risperidone injection
In patients with hepatic impairment, a careful titration of oral risperidone should be carried out before initiating risperidone monthly injection. It is recommended that if at least a 3mg oral dose is tolerated, risperidone monthly injection can be initiated at 75mg.
Additional Dosage Information
Monthly risperidone injection
Switching from other oral antopsychotics in patients who are stabilised on other antipsychotics
Patients switching from other oral antipsychotics to risperidone monthly injection should be titrated with oral risperidone for at least 6 days before initiating treatment with risperidone injection to establish tolerability and responsiveness to risperidone.
Patients never treated before with oral risperidone
Patients who have never received oral risperidone but be titrated with oral risperidone for at least 14 days to establish tolerability and responsiveness to risperidone.
Switching from bi-weekly risperidone injection to monthly risperidone injection
When switching from bi-weekly risperidone injection, the initial dose of 75mg or 100mg monthly risperidone injection should be administered at the next scheduled injection and continued at 28 days intervals. If the patient previously received bi-weekly risperidone at a dose of 37.5mg, risperidone monthly injection should be initiated at 75mg every 28 days, by intramuscular injection. If the patient previously received bi-weekly risperidone at a dose of 50mg, risperidone monthly injection should be initiated at 100mg every 28 days, by intramuscular injection.
Switching from monthly risperidone injection to oral risperidone
When switching patients back to oral risperidone from risperidone monthly injections, the prolonged release characteristics of monthly risperidone must be considered. It is recommended that oral risperidone should be initiated 28 days after the last dose of risperidone monthly injection.
Avoiding missed doses
To avoid a missed dose of risperidone monthly injection, patients may be given the injection up to 3 days before the 28 days time point.
Missed doses
In the event of a missed dose, the next 28 days interval injection should be scheduled according to the last injection date.
Administration
For intramuscular administration only to the deltoid and gluteal region.
Contraindications
Children under 18 years
Neutrophil count below 1.0 x 10 to the power of 9 / L
Breastfeeding
Dementia
Long QT syndrome
Porphyria
Renal impairment - creatinine clearance below 60ml/minute
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
Dehydration
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Hepatic impairment
History of seizures
History of torsade de pointes
Hyperprolactinaemia
Leucopenia
Neutropenia
Parkinson's disease
Peri-operative period in cataract surgery
Pregnancy
Prolactin-dependent neoplasm
Renal impairment - creatinine clearance 60-89ml/minute
Correct electrolyte disorders before treatment
May mask nausea and vomiting associated with organic disease
Reduce dose in patients with hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Advise patient not to drive until they know how the medicine affects them
May reduce seizure threshold
Administer reconstituted solution immediately
Reconstitute only with the solvent supplied by the manufacturer
Consider monitoring ECG in patients at risk of QT prolongation
Monitor blood glucose closely in patients with diabetes mellitus
Monitor closely patients who develop neutropenia
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
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
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 anaphylactic / anaphylactoid reactions
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
Discontinue if hypersensitivity reactions occur
Discontinue if neutrophil count below 1 x 10 to the power of 9/L
Discontinue if patient develops neuroleptic malignant syndrome
Advise patient not to take St John's wort concurrently
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
In all patients the tolerability to oral risperidone should have been established prior to initiation of treatment with risperidone injection.
Patients with a history of a clinically significant low white blood cell (WBC) count or a drug induced leucopenia/neutropenia should be monitored during the first few months of treatment and risperidone should be discontinued at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
If further sedation is required, an additional drug (such as a benzodiazepine) should be administered rather than increasing the dose of risperidone injection.
It has been reported that the occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. However in patients treated with oral risperidone for a minimum of one year, the overall severity of extrapyramidal symptoms, as well as the occurrence of new onset tardive dyskinesia was reduced compared with patients treated with classic neuroleptics.
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 galactorrhea).
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 advises caution if risperidone is used during pregnancy. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out. Briggs (2015) notes that there is a risk of extrapyramidal and/or withdrawal symptoms in neonates if used during the third trimester. Agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder have all been reported. It is recommended that newborns are carefully monitored. Briggs (2015) also recommends prescribing folic acid to pregnant woman receiving atypical antipsychotics due to the increased risk of neural tube defects due to inadequate folic acid intake.
Lactation
Risperidone is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues risperidone or discontinues breastfeeding. LactMed (2022) notes that whilst limited data indicates risperidone is present in human breast milk, the quantity is not known. Effects on exposed infants are unknown and risks cannot be excluded.
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.
Advise patients of the possibility of weight gain.
Advise patients to seek urgent medical care if priapism has not been resolved within 3 to 4 hours.
Risperidone has minor or moderate influence on activities requiring mental alertness. Therefore advise patients not to drive or operate machinery until their individual susceptibility is known.
Side Effects
Acne
Agitation
Akathisia
Alopecia
Amenorrhoea
Anaphylactic reaction
Angioedema
Anxiety
Arthralgia
Asthenia
Atrial fibrillation
Atrioventricular block
Blood disorders
Blood pressure changes
Blurred vision
Bradycardia
Bronchitis
Bundle branch block
Conjunctivitis
Convulsions
Cough
Cystitis
Depression
Disturbances of appetite
Disturbances of sensation
Dizziness
Dry mouth
Dry skin
Dyskinesia
Dyspepsia
Dyspnoea
Dystonia
Ear infection
ECG changes
Eczema
Falls
Fatigue
Galactorrhoea
Gamma glutamyl transferase (GGT) increased
Gastritis
Gastro-enteritis
Gastro-intestinal disturbances
Gynaecomastia
Headache
Hyperglycaemia
Hyperprolactinaemia
Hypersensitivity reactions
Hypersomnia
Hypothermia
Inappropriate secretion of antidiuretic hormone
Increase in serum transaminases
Increases in hepatic enzymes
Infections
Influenza
Insomnia
Intestinal obstruction
Intraoperative floppy iris syndrome
Jaundice
Ketoacidosis
Lethargy
Local infection at injection site
Local reaction at injection site
Loss of libido
Lower respiratory tract infection
Mania
Muscle weakness
Myalgia
Nasal congestion
Nervousness
Pain
Palpitations
Pancreatitis
Parkinsonism
Peripheral oedema
Pharyngolaryngeal pain
Pneumonia
Postural dizziness
Priapism
Prolongation of QT interval
Pruritus
Pyrexia
Rash
Retinal artery occlusion
Sedation
Sexual dysfunction
Sinusitis
Sleep apnoea
Sleep disturbances
Somnolence
Syncope
Tachycardia
Tremor
Upper respiratory tract infection
Urinary incontinence
Urinary retention
Urinary tract infections
Vertigo
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 in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characterisitcs: Okedi 75mg powder and solvent for prolonged-released suspension for injection pre-filled syringes. ROVI Biotech Limited. Revised March 2022.
Summary of Product Characterisitcs: Okedi 100mg powder and solvent for prolonged-released suspension for injection pre-filled syringes. ROVI Biotech Limited. Revised March 2022.
Summary of Product Characteristics: Risperdal Consta. Janssen-Cilag Ltd. Revised June 2015.
MHRA Drug Safety Update November 2013
Available at: https://www.mhra.gov.uk
Last accessed: March 31, 2014
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: June 20, 2022.
Last accessed: July 06, 2022.
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