Nitrazepam

Generic name
Nitrazepam
Brand name
ATC Code
N05CD02
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Nitrazepam

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

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

West’s syndrome
  • Oral
    • 1 month up to 18 years
      • 0.5 mg/kg/day in 2 doses. Max: 1mg/kg/day, but not exceeding 30 mg/day.

      • If necessary, increase to the maximum dose (dosing frequency = in 3 doses)
Insomnia
  • Oral
    • 1 year up to 6 years
      • 2.5 - 5 mg/day in 1 dose
    • 6 years up to 18 years
      • 5 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

Psychiatric and paradoxical reactions can occur in children in particular, with restlessness, agitation, aggression, delusions, fits of anger, nightmares, hallucinations, inappropriate behaviour and changes in the mental condition. Rare: in infants and young children: bronchial hypersecretion leading to aspiration/lung inflammation

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

Use with caution in infants and young children. Monitor for signs of hypersalivation and increased bronchial secretions. Caution is also advised in the case of pre-existing conditions such as dysphagia, gastroesophageal reflux and aspiration tendencies.

Interactions

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

HYPNOTICS AND SEDATIVES

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

Barbiturates, plain
N05CA01
Aldehydes and derivatives
N05CC01
Benzodiazepine derivatives
N05CD08
N05CD07
Other hypnotics and sedatives
N05CM18
N05CM21
Melatonin receptor agonists
N05CH01

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Kamps WA et al, Werkboek ondersteundende behandeling kinderoncologie, VU Uitgeverij, 2005
  3. Ratiopharm Nederland BV, SPC Nitrazepam (RVG 52656), www.cbg-meb.nl, Geraadpleegd 29 oktober 2010, http://db.cbg-meb.nl/IB-teksten/h52656.pdf
  4. Accord Healthcare B.V., SmPC Nitrazepam (RVG 08687) 1-02-2019 , www.geneesmiddeleninformatiebank.nl
  5. Actavis Group PTC ehf, SmPC Apodorm (MT 0000-05989) 17-11-2020, www.legemiddelsok.no
  6. Accord Healthcare B.V., SmPC Nitrazepam (RVG 08687) 1-02-2019, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose