Formoterol + budesonide (combination preparation)

Generic name
Formoterol + budesonide (combination preparation)
Brand name
ATC Code
R03AK07
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Formoterol + budesonide (combination preparation)

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

Maintenance treatment for asthma
  • Inhalation
    • 6 years up to 12 years
      • 100/6: 2 puff(s)/dose twice daily.
    • 12 years up to 18 years

      • 100/3: 2-4 puffs, twice daily
        100/6: 1-2 puffs twice daily
        160/4.5: 1-2 puffs twice daily
        200/6: 1-2 puffs twice daily
        320/9: 1 puff twice daily
        400/12: 1 puff twice daily 

        In addition to the maintenance dose, additional inhalations may be used if needed to relieve acute bronchoconstriction.
        100/3: 2 puffs, if needed after several mintues 2 extra puffs, max. 12 at a time, max. 16 per day, if needed short-term max. 24 per day.
        100/6, 160/4,5 and 200/6: 1 puff, if needed after several minutes 1 extra puff, max. 6 at a time, max. 8 per day, if needed short-term max. 12 per day.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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 rare: depression, behavioural changes (mainly in children) [SmPC Symbicort]

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

It is recommended in children who are given long-term treatment that the growth should be checked regularly. If there is growth retardation, the treatment should be reassessed and the dose should be lowered if possible. Long-term use of high-dosage inhalation corticosteroids can result in systemic effects such as psychological disorders, e.g. aggression. 

Interactions

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

ADRENERGICS, INHALANTS

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

Alpha- and beta-adrenoreceptor agonists
R03AA01
Selective beta-2-adrenoreceptor agonists
R03AC13
R03AC02
R03AC12
R03AC03
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
R03AK08
R03AK11
R03AK10
R03AK06
Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
R03AL01
R03AL02

References

  1. AstraZeneca BV, SmPC Symbicort (RVG 25887/25886/27690/ 124841) 30-06-2020, www.geneesmiddeleninformatiebank.nl
  2. Teva Pharma B.V., SmPC DuoResp Spiromax (EU/1/14/920/001-003) 09-06-2021, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose