- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations containing lurasidone.
Initial dose: 37mg once a day.
Maintenance dose: 37mg to 148mg once a day.
Children aged 13 years and older
Initial dose: 37mg once a day.
Maintenance dose: 37mg to 74mg once a day. Maximum dose 74mg daily. Dose increases should be based upon clinical response and judgement of the physician.
Children doses should be prescribed by a paediatric psychiatrist.
Patients with Renal Impairment
Creatinine clearance below 50ml/minute initial dose: 18.5mg once a day, increased according to response, to a maximum dose of 74mg once a day.
Patients with Hepatic Impairment
Child pugh score greater than 7 initial dose: 18.5mg once a day. The maximum daily dose in moderate hepatic impairment is 74mg once a day and in severe hepatic impairment the maximum dose is 37mg once a day.
Additional Dosage Information
Patients on doses higher than 111mg once a day: Patients who miss more than 3 days should be restarted on 111mg once a day and titrated to their optimal dose.
Children under 13 years
Precautions and Warnings
Family history of long QT syndrome
Patients over 65 years
Predisposition to diabetes mellitus
Predisposition to orthostatic hypotension
Predisposition to venous thromboembolism
Hepatic impairment - Child-Pugh score greater than 7
History of seizures
Reduced seizure threshold
Renal impairment - creatinine clearance below 50ml/minute
Consider preventative measures in patients at risk of thromboembolism
Patients at risk of suicide should be closely supervised
Reduce dose in patients with moderate hepatic impairment
Reduce dose in patients with moderate renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Consider monitoring ECG in patients at risk of QT prolongation
Monitor patient initially- response may take 2 or more weeks
Monitor patient's weight
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor patients for signs and symptoms of Neuroleptic Malignant Syndrome
Monitor patients for signs and symptoms of Serotonin Syndrome
Monitor patients with existing or tendency towards diabetes mellitus
Monitor serum electrolytes
Monitor serum prolactin during long-term use
When used with SSRIs, risk of Serotonin syndrome
Advise patient to report signs of elevated prolactin levels
Consider discontinuation if signs of tardive dyskinesia occur
Consider dose reduction or discontinuation if serotonin syndrome suspected
May cause or exacerbate extrapyramidal symptoms
May cause postural hypotension
Advise patient not to take St John's wort concurrently
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient grapefruit products may increase plasma level
Caution should be exercised when treating patients aged 65 and above with higher doses of lurasidone as experience is limited.
Use of antipsychotics in patients with dementia is associated with an increased risk of cerebrovascular adverse reactions. Use caution in patients with dementia who have risk factors for stroke.
Lurasidone should not be used in patients with ESRD unless the potential benefits outweigh the potential risks. If used in ESRD, clinical monitoring is advised.
Pregnancy and Lactation
Use lurasidone with caution in pregnancy.
There is limited data regarding the use of lurasidone in pregnancy. The potential risk for humans is unknown.
Animal studies are insufficient with respect to effects on pregnancy, embryo foetal development, parturition and postnatal development.
The manufacturer recommends only using lurasidone when clearly necessary.
Neonates exposed to antipsychotics (including lurasidone) during the third trimester are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Use lurasidone with caution in breastfeeding.
Lurasidone was excreted in milk of rats during lactation. It is not known whether lurasidone or its metabolites are excreted in human milk. Breastfeeding in women receiving lurasidone should be considered only if the potential benefit of treatment justifies the potential risk to the child.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Alanine aminotransferase increased
Changes in libido
Creatine phosphokinase increased
Elevated blood glucose (transient)
First degree AV block
Increased blood pressure
Increased serum androgens
Neuroleptic malignant syndrome
Serum creatinine increased
Sudden cardiac death
Upper abdominal pain
Upper respiratory tract infection
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 ).
Last Full Review Date: September 2018
Summary of Product Characteristics: Latuda 18.5mg film coated tablets. Takeda Pharma. Revised July 2020.
Summary of Product Characteristics: Latuda 37mg film coated tablets. Takeda Pharma. Revised July 2020.
Summary of Product Characteristics: Latuda 74mg film coated tablets. Takeda Pharma. Revised July 2020.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Lurasidone Last revised: 01 March 2018
Last accessed: 08 August 2018
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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.