Paliperidon

Generic name
Paliperidon
Brand name
ATC Code
N05AX13
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Paliperidon

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Systemic exposure to paliperidone in adolescents (15 years and older) is similar to that in adults. In adolescents weighing < 51 kg, a 23% higher exposure was observed than in adolescents weighing ≥ 51 kg. Age alone does not affect paliperidone exposure.

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
    • ≥ 15 years and < 51 kg
      • Initial dose: 3 mg/day in 1 dose
      • Maintenance dose: If indicated based on effect and side effects, increase starting dose after at least 5 days to 6 mg/day in 1 dose
    • ≥ 15 years and ≥ 51 kg
      • Initial dose: 3 mg/day in 1 dose
      • Maintenance dose: If indicated based on effect and side effects, increase dose with 3 mg increments with an interval of at least 5 days after each increase to 6 - 12 mg/day in 1 dose

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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

The following adverse reactions were reported more frequently in adolescents than in adults (and more frequently than with placebo):
Very common (≥ 1/10): sedation/somnolence, parkinsonism, weight gain, upper respiratory tract infection, acathisia, and tremor 

Common (≥ 1/100, < 1/10): abdominal pain, galactorrhea, gynecomastia, acne, dysarthria,
gastroenteritis, epistaxis, ear infection, blood triglycerides elevated and vertigo 

Across all adolescent studies, extrapyramidal symptoms (EPS) were more common in adolescents than in adults for each dose. (SmPC Invega)

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 in children

The sedative effect should be closely monitored in children. A change in the time of administration may improve the impact of sedation on the patient.

Because of the potential effects of prolonged hyperprolactinaemia on growth and sexual maturation in adolescents, regular clinical evaluation of endocrinological status should be considered, including measurements of height, weight, sexual maturation, monitoring of menstrual functioning, and other potential prolactin-related effects.

During treatment with paliperidone regular examination for extrapyramidal symptoms and other movement disorders should also be conducted.

(SmPC Invega)

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
N05AE05
N05AE04
Diphenylbutylpiperidine derivatives
N05AG02
Diazepines, oxazepines, thiazepines and oxepines
N05AH02
N05AH03
N05AH04
Lithium
N05AN01
Other antipsychotics
N05AX12
N05AX08

Reference

  1. Janssen-Cilag International NV, SmPC Invega (EU/1/07/395) Rev 18. 19-05-2021, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose