Lurasidon

Generic name
Lurasidon
Brand name
ATC Code
N05AE05
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The pharmacokinetics of lurasidone in pediatric patients aged 6-17 years were generally similar to those observed in adults.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Schizophrenia
  • Oral
    • ≥ 13 years
      • Initial dose: 37 mg/day in 1 dose
      • Maintenance dose: if necessary increase to max. 74 mg/day in 1 dose

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Adjustment is not necessary.
GFR 30-50 ml/min/1.73 m2
Initially 18.5 mg once daily, if necessary increase the dose to max. 74 mg once daily.
GFR 10-30 ml/min/1.73 m2
Initially 18.5 mg once daily, if necessary increase the dose to max. 74 mg once daily.
GFR < 10 ml/min/1.73 m2
A general recommendation is not given.
Clinical consequences

In renal impairment, lurasidone exposure is increased. This increases the risk of side effects.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Very common (> 10%): akathisia, headache, somnolence. Nausea.

Common (1-10%): hyperprolactinaemia. Decreased or increased appetite. Abnormal dreams, agitation, anxiety, depression, insomnia, psychotic disorder, schizophrenia, tension. Attention disorder, dizziness, dyskinesia, dystonia, parkinsonism. Tachycardia. Dry mouth, salivation, vomiting, constipation. Hyperhidrosis. muscle stiffness. erectile dysfunction. Fatigue, asthenia, irritation. Increase in CK, increase in C-reactive protein. weight change.

Uncommon (0.1-1%): nasopharyngitis, rhinitis, upper respiratory tract infection. Neutropenia. Hypersensitivity. Autoimmune thyroiditis, hypothyroidism, hyperandrogenism. Aggression, apathy, confusion, depressed mood, dissociation, auditory and visual hallucinations, homicidal ideation, mental status change, mental disorder, impulsive behavior, sleep disturbance, libido decreased or increased, listlessness, obsessive thoughts, panic attack, restlessness, sleep disorder, suicidal ideation and behaviour, poor sleep, abnormal thinking. Postural dizziness, tension headache, dysgeusia, memory impairment, migraine, paresthesia, psychomotor hyperactivity, hyperkinesia, tardive dyskinesia, restless legs syndrome, gait disorder. Accommodation disorder, blurred vision. hyperacusis. Palpitations, supraventricular extrasystoles. Orthostatic hypotension. Oropharyngeal pain. Dyspnea. Dry lips, toothache, decreased salivation, dyspepsia, (upper) abdominal pain, diarrhoea. Skin rash, urticaria, alopecia, abnormal hair growth. Arthralgia, myalgia, muscle tension, stiff muscles and joints, pain in extremity, jaw pain. Bilirubinuria, dysuria, micturition disorder, polyuria, proteinuria, renal disorder. Amenorrhea, oligomenorrhea, menstrual irregularities, breast pain, galactorrhea, gynecomastia, ejaculation disorder, sexual dysfunction. Gilles de la Tourette syndrome. Chills, fever, non-cardiac chest pain, malaise. ALT and AST increase, AF increase or decrease, cholesterol and triglycerides increase, HDL and LDL decrease, testosterone increase, blood glucose increase, blood insulin increase, TSH increase, hemoglobin decrease, thyroid positive antibodies, shortened PR-interval on ECG.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTIPSYCHOTICS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Phenothiazines with aliphatic side-chain
N05AA02
Butyrophenone derivatives
N05AD01
N05AD05
Indole derivatives
N05AE04
Diphenylbutylpiperidine derivatives
N05AG02
Diazepines, oxazepines, thiazepines and oxepines
N05AH02
N05AH03
N05AH04
Lithium
N05AN01
Other antipsychotics
N05AX12
N05AX13
N05AX08

Reference

  1. AndersonBrecon Ltd UK, SmPC Latuda rev. 20 EUI1/14/913/015- 021 24-9-2020, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose