Paliperidone parenteral prolonged release
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Prolonged release injection containing paliperidone.
Drugs List
Therapeutic Indications
Uses
Maintenance treatment of schizophrenia
1-monthly paliperidone depot injection
Maintenance treatment of schizophrenia in adults stabilised with paliperidone or risperidone.
In treatment of schizophrenia in adults previously responsive to oral paliperidone or risperidone the prolonged release injection may be used without prior stabilisation with oral treatment if symptoms are mild to moderate and where long-acting injectable treatment is needed.
3-monthly paliperidone depot injection
Maintenance treatment of schizophrenia in adult patients who are clinically stable on 1-monthly paliperidone depot injection.
6-monthly paliperidone depot injection
Maintenance treatment of schizophrenia in adult patients who are clinically stable on 1-monthly or 3-monthly paliperidone depot injection.
Dosage
Adults
1-monthly paliperidone depot injection
Initially intramuscular injections into the deltoid comprising of 150mg on treatment day one and 100mg on day eight.
Maintenance dose is 75mg administered into the deltoid or gluteal muscle 1 month after the second dose and at monthly intervals thereafter. Some patients may benefit from doses between 25mg to 150mg depending on efficacy or patient tolerability. Overweight patients may require doses in the upper range.
Adjustments to the maintenance dose may be made monthly. Note that the full effect of maintenance doses may not be evident for several months.
3-monthly paliperidone depot injection
The 3-monthly paliperidone depot injection should be initiated in place of the next scheduled dose of the 1-monthly paliperidone depot injection.
If the last dose of the 1-monthly paliperidone depot injection was 50mg, the 3-monthly paliperidone depot injection at a dose of 175mg should be given initially.
If the last dose of the 1-monthly paliperidone depot injection was 75mg, the 3-monthly paliperidone depot injection at a dose of 263mg should be given initially.
If the last dose of the 1-monthly paliperidone depot injection was 100mg, the 3-monthly paliperidone depot injection at a dose of 350mg should be given initially.
If the last dose of the 1-monthly paliperidone depot injection was 150mg, the 3-monthly paliperidone depot injection at a dose of 525mg should be given initially.
Dose adjustment can be made every 3 months if necessary in increments within the range of 175mg to 525mg based on the individual patient tolerability and/or efficacy. Note that the patient's response to an adjusted dose may not be apparent for several months.
6-monthly paliperidone depot injection
Transitioning to 6-monthly paliperidone depot injection for patients adequately treated with 1-monthly paliperidone depot injection
The 6-monthly paliperidone depot injection should be initiated in place of the next scheduled dose of the 1-monthly paliperidone depot injection +/- 7 days. To establish a consistent maintenance dose, it is advised that the last two doses of 1-monthly paliperidone palmitate injection be the same dose strength before starting the 6-monthly regime.
If the last dose of the 1-monthly paliperidone depot injection was 100mg, the 6-monthly paliperidone depot injection at a dose of 700mg should be given initially.
If the last dose of the 1-monthly paliperidone depot injection was 150mg, the 6-monthly paliperidone depot injection at a dose of 1000mg should be given initially.
Transitioning to 6-monthly paliperidone depot injection for patients adequately treated with 3-monthly paliperidone depot injection
The 6-monthly paliperidone depot injection should be initiated in place of the next scheduled dose of the 3-monthly paliperidone depot injection.
If the last dose of the 3-monthly paliperidone depot injection was 350mg, the 6-monthly paliperidone depot injection at a dose of 700mg should be given initially.
If the last dose of the 3-monthly paliperidone depot injection was 525mg, the 6-monthly paliperidone depot injection at a dose of 1000mg should be given initially.
Following the initial dose, doses should be administered once every 6 months. If necessary, patients may be given the injection up to 2 weeks before or up to 3 weeks after the 6-month scheduled timepoint.
Dose adjustment can be made every 6 months if necessary between 700mg and 1000mg based on the individual patient tolerability and/or efficacy. Note that the patient's response to an adjusted dose may not be apparent for several months.
Elderly
(see Dosage; Adult)
Patients with Renal Impairment
1-monthly paliperidone depot injection
The manufacturer advises that patients with mild renal impairment (creatinine clearance of 50 to 80 ml/minute) be given an initial dose of 100mg on treatment day 1 and 75mg on day 8, administered into the deltoid muscle. The recommended monthly maintenance dose is 50mg with a range of 25mg to 100mg based on efficacy or patient tolerability.
3-monthly paliperidone depot injection
The manufacturer advises that for patients with mild renal impairment (creatinine clearance of 50 to 80 ml/minute), dose should be adjusted and the patient stabilised using the 1-monthly paliperidone depot injection and then transitioned to the 3-monthly paliperidone depot injection.
6-monthly paliperidone depot injection
The manufacturer advises that for patients with mild renal impairment (creatinine clearance of 50 to 80 ml/minute) who are stabilised on either 100mg 1-monthly paliperidone depot injection or 350mg 3-monthly paliperidone depot injection, transitioning to the 6-monthly dose should only occur at 700mg. Patients with mild renal impairment should not receive the 1000mg 6-monthly paliperidone depot injection.
Additional Dosage Information
1-monthly paliperidone depot injection
Switching from oral paliperidone or oral risperidone
Previous oral paliperidone or oral risperidone can be discontinued at the time of initiation of paliperidone prolonged release injections.
Begin therapy as normal starting with the first initial dosage (see Dosage; Adults).
Gradual withdrawal may be appropriate for some patients. Switching from higher doses of oral paliperidone, such as 9mg to 12mg daily, to gluteal injections of paliperidone may result in lower plasma levels during the first 6 months following the switch. Therefore consider administration by deltoid injections for the first 6 months as an alternative.
Patients previously stabilised on different doses of oral paliperidone can attain similar paliperidone steady-state exposure by injection. As a guide, maintenance doses needed to attain similar steady-state exposure are:
Paliperidone therapy of 3mg daily is 25mg to 50mg paliperidone monthly.
Paliperidone therapy of 6mg daily is 75mg paliperidone monthly.
Paliperidone therapy of 9mg daily is 100mg paliperidone monthly.
Paliperidone therapy of 12mg daily is 150mg paliperidone monthly.
Switching from risperidone long acting injection
Start paliperidone in place of the next scheduled injection of risperidone using the following conversions:
Risperidone therapy of 25mg every 2 weeks is switched to 50mg paliperidone monthly.
Risperidone therapy of 37.5mg every 2 weeks is switched to 75mg paliperidone monthly.
Risperidone therapy of 50mg every 2 weeks is switched to 100mg paliperidone monthly.
Avoiding missed doses
To avoid a missed dose, the second initiation dose may be given up to 4 days before or after treatment day 8. Monthly maintenance doses may be administered up to 7 days before or after the monthly time point.
Missed second initiation dose less than 4 weeks from first injection
Administer the second initiation dose of 100mg into the deltoid muscle as soon as possible. A third injection of 75mg should be made into either the deltoid or gluteal muscle 5 weeks after the first initial dose regardless of when the second injection was given. The normal monthly maintenance doses of 25mg to 150mg should be followed thereafter.
Missed second initiation dose 4 to 7 weeks from first injection
Administer the second initiation dose of 100mg into the deltoid muscle as soon as possible followed by another one week later. The normal monthly maintenance doses of 25mg to 150mg should be followed thereafter.
Missed second initiation dose by more than 7 weeks from first injection
Restart and continue therapy beginning with the first initial dose (see Dosage; Adults).
Missed monthly maintenance dose 1 month to 6 weeks since latest injection
The previous stabilised dose should be administered as soon as possible followed by monthly maintenance doses as normal.
Patients maintained on 25mg to 100mg: missed monthly maintenance dose by 6 weeks to 6 months since latest injection
The previous stabilised dose should be administered into the deltoid as soon as possible followed by an identical dose one week later. The normal monthly maintenance dose into the deltoid or gluteal muscle should be followed thereafter.
Patients maintained on 150mg: missed monthly maintenance dose by 6 weeks to 6 months since latest injection
Administer a dose of 100mg into the deltoid muscle as soon as possible followed by another one week later. The normal monthly maintenance dose into the deltoid or gluteal muscle should be followed thereafter.
Missed monthly maintenance by more than 6 months since latest injection
Restart and continue therapy beginning with the first initial dose (see Dosage; Adults).
3-monthly paliperidone depot injection
Switching from other antipsychotic medicinal products
The 3-monthly paliperidone depot injection should only to be used after the patient has been adequately treated with the 1-monthly paliperidone depot injection for 4 months or more.
Switching from the 3-monthly paliperidone depot injection to other antipsychotic medicinal products
If the 3-monthly paliperidone depot injection is discontinued, the prolonged release characteristics should be considered.
Switching from the 3-monthly paliperidone depot injection to the 1-monthly paliperidone depot injection
Administer the 1-monthly paliperidone depot injection at the next time the 3-monthly paliperidone depot injection was due but using a 3.5 fold lower dose as follows:
If the last dose of the 3-monthly paliperidone depot injection was 175mg, the 1-monthly paliperidone depot injection at a dose of 50mg should be given initially.
If the last dose of the 3-monthly paliperidone depot injection was 263mg, the 1-monthly paliperidone depot injection at a dose of 75mg should be given initially.
If the last dose of the 3-monthly paliperidone depot injection was 350mg, the 1-monthly paliperidone depot injection at a dose of 100mg should be given initially.
If the last dose of the 3-monthly paliperidone depot injection was 525mg, the 1-monthly paliperidone depot injection at a dose of 150mg should be given initially.
The 1-monthly paliperidone depot injection should then continue to be dosed at monthly intervals as described within its prescribing information.
Switching from the 3-monthly paliperidone depot injection to oral daily paliperidone prolonged release tablets
The daily dosing of paliperidone prolonged release tablets should be started 3 months after the last 3-monthly paliperidone depot injection dose and treatment continued with paliperidone prolonged release tablets as follows:
If the last dose of the 3-monthly paliperidone depot injection is 175mg, the daily dose of paliperidone prolonged release tablets at week 12 to week 18 inclusive, at week 19 to week 24 inclusive and from week 25 onwards is 3mg.
If the last dose of the 3-monthly paliperidone depot injection is 263mg, the daily dose of paliperidone prolonged release tablets at week 12 to week 18 inclusive and at week 19 to week 24 inclusive is 3mg and from week 25 onwards is 6mg.
If the last dose of the 3-monthly paliperidone depot injection is 350mg, the daily dose of paliperidone prolonged release tablets at week 12 to week 18 inclusive is 3mg, at week 19 to week 24 inclusive is 6mg and from week 25 onwards is 9mg.
If the last dose of the 3-monthly paliperidone depot injection is 525mg, the daily dose of paliperidone prolonged release tablets at week 12 to week 18 inclusive is 6mg, at week 19 to week 24 inclusive is 9mg and from week 25 onwards is 12mg.
Avoiding missed doses
To avoid a missed dose the 3-monthly paliperidone depot injection patients may be given the injection up to 2 weeks before or after the 3-month time point.
Missed doses
If the scheduled dose is missed and the time since the last injection is over 3.5 months and up to 4 months then the injection should be administered as soon as possible and then resume the 3-monthly injection schedule.
If the scheduled dose is missed and the time since the last injection is between 4 to 9 months then the injection should be administered using the recommended re-initiation regimen below.
If the scheduled dose is missed and the time since the last injection is over 9 months, then re-initiate treatment with the 1-monthly paliperidone depot injection as described in the prescribing information for that product and then the 3-monthly paliperidone depot injection can be resumed after the patient has been adequately treated with the 1-monthly paliperidone depot injection preferably for 4 months or more.
Recommended re-initiation regimen after missing 4 months to 9 months of the 3-monthly paliperidone depot injection
If the last dose of the 3-monthly paliperidone depot injection was 175mg, then administer the 1-monthly paliperidone depot injection as two 50mg doses 1 week apart (day 1 and day 8) into the deltoid muscle. One month after day 8 administer 175mg of the 3-monthly paliperidone depot injection into the deltoid or gluteal muscle.
If the last dose of the 3-monthly paliperidone depot injection was 263mg, then administer the 1-monthly paliperidone depot injection as two 75mg doses 1 week apart (day 1 and day 8) into the deltoid muscle. One month after day 8 administer 263mg of the 3-monthly paliperidone depot injection into the deltoid or gluteal muscle.
If the last dose of the 3-monthly paliperidone depot injection was 350mg, then administer the 1-monthly paliperidone depot injection as two 100mg doses 1 week apart (day 1 and day 8) into the deltoid muscle. One month after day 8 administer 350mg of the 3-monthly paliperidone depot injection into the deltoid or gluteal muscle.
If the last dose of the 3-monthly paliperidone depot injection was 525mg, then administer the 1-monthly depot injection as two 100mg doses 1 week apart (day 1 and day 8) into the deltoid muscle. One month after day 8 administer 525mg of the 3-monthly paliperidone depot injection into the deltoid or gluteal muscle.
6-monthly paliperidone depot injection
Switching from other antipsychotic medicinal products
Switching patients directly from other antipsychotics should not occur as the 6-monthly paliperidone depot injection should be initiated only once the patient has been stabilised on 1-monthly or 3-monthly paliperidone depot injections.
Switching from the 6-monthly paliperidone depot injection to other antipsychotic medicinal products
If the 6-monthly paliperidone depot injection is discontinued, the prolonged release characteristics should be considered.
Switching from the 6-monthly paliperidone depot injection to the 1-monthly paliperidone depot injection
Administer the 1-monthly paliperidone depot injection at the next time the 6-monthly paliperidone depot injection was due but using the following doses:
If the last dose of the 6-monthly paliperidone depot injection was 700mg, the 1-monthly paliperidone depot injection at a dose of 100mg should be given initially.
If the last dose of the 6-monthly paliperidone depot injection was 1000mg, the 1-monthly paliperidone depot injection at a dose of 150mg should be given initially.
Switching from the 6-monthly paliperidone depot injection to the 3-monthly paliperidone depot injection
Administer the 3-monthly paliperidone depot injection at the next time the 6-monthly paliperidone depot injection was due but using the following doses:
If the last dose of the 6-monthly paliperidone depot injection was 700mg, the 3-monthly paliperidone depot injection at a dose of 350mg should be given initially.
If the last dose of the 6-monthly paliperidone depot injection was 1000mg, the 1-monthly paliperidone depot injection at a dose of 525mg should be given initially.
Switching from the 6-monthly paliperidone depot injection to oral daily paliperidone prolonged release tablets
The daily dosing of paliperidone prolonged release tablets should be started 6 months after the last 6-monthly paliperidone depot injection dose and treatment continued with paliperidone prolonged release tablets as follows:
If the last dose of the 6-monthly paliperidone depot injection is 700mg, the daily dose of paliperidone prolonged release tablets between 6 months and 9 months after the last dose is 3mg daily. Between 9 months and 12 months after the last dose of paliperidone depot injection, the daily oral dose is 6mg. More than 12 months after the last dose of 6-monthly paliperidone depot injection, the daily oral dose is 9mg.
If the last dose of the 6-monthly paliperidone depot injection is 1000mg, the daily dose of paliperidone prolonged release tablets between 6 months and 9 months after the last dose is 6mg daily. Between 9 months and 12 months after the last dose of paliperidone depot injection, the daily oral dose is 9mg. More than 12 months after the last dose of 6-monthly paliperidone depot injection, the daily oral dose is 12mg.
Avoiding missed doses
To avoid a missed dose the 6-monthly paliperidone depot injection patients may be given the injection up to 2 weeks before or up to 3 weeks after the scheduled time point.
Missed doses
If the scheduled dose is missed and the time since the last injection is up to 6 months and 3 weeks then the injection should be administered as soon as possible and then resume the 6-monthly injection schedule.
If the scheduled dose is missed and the time since the last injection is between 6 months and 3 weeks and 8 months then the injection should be administered using the recommended re-initiation regimen below.
If the scheduled dose is missed and the time since the last injection is between 8 months and 11 months then the injection should be administered using the recommended re-initiation regimen below.
If the scheduled dose is missed and the time since the last injection is over 11 months, then re-initiate treatment with the 1-monthly paliperidone depot injection as described in the prescribing information for that product and then the 6-monthly paliperidone depot injection can be resumed after the patient has been adequately treated with the 1-monthly paliperidone depot injection preferably for 4 months or more.
Recommended re-initiation regimen after missing between 6 months and 3 weeks and 8 months of the 6-monthly paliperidone depot injection
If the last dose of the 6-monthly paliperidone depot injection was 700mg, then administer the 100mg 1-monthly paliperidone depot injection into the deltoid muscle. After one month administer 700mg of the 6-monthly paliperidone depot injection into the gluteal muscle.
If the last dose of the 6-monthly paliperidone depot injection was 1000mg, then administer the 150mg 1-monthly paliperidone depot injection into the deltoid muscle. After one month administer 1000mg of the 6-monthly paliperidone depot injection into the gluteal muscle.
Recommended re-initiation regimen after missing between 8 months and 11 months of the 6-monthly paliperidone depot injection
If the last dose of the 6-monthly paliperidone depot injection was 700mg, then administer the 1-monthly paliperidone depot injection as two 100mg doses 1 week apart (day 1 and day 8) into the deltoid muscle. One month after day 8 administer 700mg of the 6-monthly paliperidone depot injection into the gluteal muscle.
If the last dose of the 6-monthly paliperidone depot injection was 1000mg, then administer the 1-monthly depot injection as two 100mg doses 1 week apart (day 1 and day 8) into the deltoid muscle. One month after day 8 administer 1000mg of the 6-monthly paliperidone depot injection into the gluteal muscle.
Administration
1-monthly paliperidone depot injection and 3-monthly paliperidone depot injection
For intramuscular injection only to the deltoid or gluteal muscles.
6-monthly paliperidone depot injection
For intramuscular injection only to the gluteal muscles.
Contraindications
Children under 18 years
Neutrophil count below 1.0 x 10 to the power of 9 / L
Breastfeeding
Long QT syndrome
Renal impairment - creatinine clearance below 50ml/minute
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Females of childbearing potential
Patients over 65 years
Predisposition to gastrointestinal obstruction
Predisposition to hypotension
Predisposition to venous thromboembolism
Risk of cerebrovascular accident
Cardiovascular disorder
Cerebrovascular disorder
Dehydration
Dementia
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
History of seizures
History of torsade de pointes
Hypovolaemia
Parkinson's disease
Peri-operative period in cataract surgery
Pregnancy
Prolactin-dependent neoplasm
Renal impairment - creatinine clearance 50-80ml/minute
Severe hepatic impairment
Correct electrolyte disorders before treatment
May mask nausea and vomiting associated with organic disease
Reduce dose in patients with creatinine clearance of 50-80ml/min
Advise ability to drive/operate machinery may be affected by side effects
May reduce seizure threshold
May contain polysorbate
Consider monitoring ECG in patients at risk of QT prolongation
Monitor blood glucose closely in patients with diabetes mellitus
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 serum electrolytes
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
Avoid abrupt withdrawal
Discontinue if anaphylactoid reaction occurs
Discontinue if neutrophil count below 1 x 10 to the power of 9/L
Discontinue if patient develops neuroleptic malignant syndrome
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
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 paliperidone should be discontinued at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Paliperidone prolonged release injection is not suitable for acutely agitated patients or those in a severe psychotic state requiring immediate symptom control.
Anaphylactic reactions in patients who have previously tolerated oral risperidone or oral paliperidone have been rarely reported.
Switching to alternative antipsychotic medications if clinically indicated should be supervised closely by a physician.
Evaluate the risks and benefits of therapy when treating patients with Parkinson's disease or Dementia with Lewy Bodies (DLB). Patients with these conditions may have an increased risk of developing Neuroleptic Malignant Syndrome and may be more sensitive to antipsychotic medications. Increased sensitivity to paliperidone may include symptoms of confusion, obtundation, postural instability with frequent falls, and extrapyramidal symptoms.
Use with caution in patients who may experience an elevation in core body temperature and dehydration.
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.
Treatment should be reviewed regularly.
Pregnancy and Lactation
Pregnancy
Use paliperidone with caution in pregnancy.
There is no adequate data from the use of paliperidone during human pregnancy. Paliperidone was not teratogenic in animal studies. However, other types of reproductive toxicity were observed.
The use of antipsychotic medication in the last trimester of pregnancy has resulted in long term, but reversible, neurological disturbances (e.g. extrapyramidal effects) in the infant. If paliperidone needs to be discontinued during pregnancy, the medicine should be withdrawn gradually.
Lactation
Paliperidone is contraindicated in breastfeeding.
Use of paliperidone when breastfeeding is contraindicated by the manufacturer. Since a single dose of paliperidone can remain for a long time in plasma, breastfed infants may be at risk even from paliperidone administration long before breastfeeding. Therefore, the manufacturer advises that patients currently under treatment or who may still have paliperidone present in plasma should not breastfeed.
Paliperidone is excreted in breast milk and effects on the infant are likely. Although there is insufficient data available for the use of paliperidone during breastfeeding, it is the active metabolite of risperidone. Risperidone data indicate that the concentrations of paliperidone in breast milk are low, and the amounts ingested by the infant are small. Because of the limited published experience with paliperidone during breastfeeding and little long term follow up data, other agents may be preferred, especially whilst nursing newborns or premature infants.
Counselling
Advise patients of the possibility of weight gain.
Paliperidone 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.
Advise patients that the CNS effects of paliperidone may be potentiated by alcohol.
Advise patients to seek urgent medical care if priapism has not been resolved within 3 to 4 hours.
Side Effects
Agitation
Akathisia
Amenorrhoea
Anaemia
Anaphylactic reaction
Anxiety
Arthralgia
Asthenia
Atrioventricular block
Attention disturbances
Back pain
Blurred vision
Bradycardia
Breast pain
Cardiac disorders
Catatonia
Cellulitis
Chest discomfort
Conjunctivitis
Cough
Creatine phosphokinase increased
Cystitis
Depression
Diabetes mellitus
Disturbances of appetite
Dizziness
Dry eyes
Dysarthria
Dysgeusia
Dyskinesia
Dyspnoea
Dystonia
Dysuria
Ear infection
Ejaculation disorders
Endocrine disturbances
Epistaxis
Erectile dysfunction
Eye disorder
Eye infection
Fatigue
Gait abnormality
Galactorrhoea
Gamma glutamyl transferase (GGT) increased
Gastrointestinal disorder
Gynaecomastia
Headache
Hepatobiliary disorders
Hyperglycaemia
Hyperprolactinaemia
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Increase in blood levels of insulin
Increase in plasma cholesterol
Increase in plasma triglyceride concentration
Increase of liver transaminases
Increases in hepatic enzymes
Influenza
Injection site reactions
Insomnia
Intraoperative floppy iris syndrome
Malaise
Menstrual disturbances
Muscle spasm
Musculoskeletal pain
Nasal congestion
Neck pain
Nervousness
Oedema
Palpitations
Paraesthesia
Parkinsonism
Pharyngolaryngeal pain
Pollakiuria
Postural dizziness
Prolongation of QT interval
Psychiatric disorders
Psychomotor hyperactivity
Pyrexia
Rash
Reduced libido
Respiratory disorders
Sinusitis
Skin disorder
Sleep disorders
Somnolence
Syncope
Tachycardia
Tardive dyskinesia
Thrombocytopenia
Tonsillitis
Tremor
Upper respiratory tract infection
Urinary incontinence
Urinary tract infections
Vascular disorders
Vertigo
Weight changes
White blood cell count decreased
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: Byannli 700mg prolonged release suspension for injection. Janssen-Cilag Ltd. Revised January 2022.
Summary of Product Characteristics: Byannli 1000mg prolonged release suspension for injection. Janssen-Cilag Ltd. Revised January 2022.
Summary of Product Characteristics: Trevicta 175mg, 263mg, 350mg, 525mg prolonged release suspension for injection. Janssen-Cilag Ltd. Revised September 2018.
Summary of Product Characteristics: Xeplion 50mg, 100mg and 150mg prolonged release suspension for injection. Janssen-Cilag Ltd. Revised September 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 November 2018
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://toxnet.nlm.nih.gov
Paliperidone Last revised: January 16, 2014
Last accessed: March 07, 2014
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.