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

Interactions
PK
Renal impairment
References

Aztreonam

Generic name
Aztreonam
Brand name
ATC Code
J01DF01

Pharmacokinetics in children

Phase 2 and 3 studies into children 6-17 years of age who received 75 mg Cayston three times daily showed minimal differences between the various age groups in average plasma concentrations of aztreonam.

The pooled data for sputum concentrations from the phase 2 and 3 studies showed some indications of lower average sputum concentrations in patients 13 to 17 years of age after single doses of 75 mg Cayston three times daily. All the average values for sputum concentrations involved relatively high standard deviations, however

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

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Suppressive treatment of chronic lung infections caused by Pseudomonas aeruginosa in CF
  • Inhalation
    • 6 years up to 18 years
      • 225 mg/day in 3 doses.
      • Duration of treatment:

        alternating between 28 days on and 28 days off

      • Use a bronchodilator before the inhalation
        Interval between 2 doses of at least 4 hours

Bacterial infections
  • Intravenous
    • 1 week up to 2 years
      • 90 - 120 mg/kg/day in 3 - 4 doses.
    • 2 years up to 18 years
      • 90 - 200 mg/kg/day in 3 - 4 doses. Max: 8 g/day.
      • In serious infections: 150-200 mg/kg/day

Infections caused by pseudomonoas aeruginosa
  • Intravenous
    • 1 week up to 18 years
      • 150 - 200 mg/kg/day in 3 - 4 doses. Max: 8 g/day.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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

Fever occurs more often in children aged 6 to 12 (resp. 17[4]) years

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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 use of Aztreonam in paediatric CF patients has been associated with haemoptysis during treatment cycles and could have aggravated underlying conditions. Administration of Aztreonam in CF patients with active haemoptysis should be undertaken only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.[1]

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Interactions

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

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References

  1. Gilead Sciences International Limited, SPC Cayston (EU/1/09/543/001-2) , http://www.ema.europa.eu, Geraadplaagd 27 okt 2016
  2. Gilead, SmPC Cayston 75mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler (EU/1/09/543/001/EU/1/09/543/002), 05/2016
  3. Bristol-Myers Squibb GesmbH, SmPC Azactam (1-18328), https://aspregister.basg.gv.at/aspregister/faces/aspregister.jspx, 10-2022
  4. Gilead Sciences International Limited, SPC Cayston (EU/1/09/543/001-2), http://www.ema.europa.eu, Geraadplaagd 27 okt 2016

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Changes

Changes