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

Interactions
PK
Renal impairment
References

Ceftibuten

Generic name
Ceftibuten
Brand name
ATC Code
J01DD14

Pharmacokinetics in children

No information for use in children

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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

Pharyngitis with or without tonsillitis, middle ear inflammation, complicated or uncomplicated lower urinary tract infections
  • Oral
    • ≥ 3 months and < 45 kg
      • 9 mg/kg/day in 1 dose. Max: 400 mg/day.
      • Directions for administration:

        The tablets and the suspension should both be taken at least 2 hours before a meal.

    • ≥ 45 kg
      • 400 mg/day in 1 dose
      • Directions for administration:

        The tablets and the suspension should both be taken at least 2 hours before a meal.

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Dose adjustment is not required
GFR 30-50 ml/min/1.73 m2
50 percentage of single dose and dosing interval : 24 uur
Maximum 200 mg/day
GFR 10-30 ml/min/1.73 m2
25 percentage of single dose and dosing interval : 24 uur
Maximum 100 mg/day
GFR < 10 ml/min/1.73 m2
Generalized recommendations cannot be given.

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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

Uncommon (0.1-1%): Diaper dermatitis. Dysuria, hematuria.
Very rare (<0.01%): : irritability, agitation, somnolence, insomnia, chills

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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 safety and efficacy in children younger than 3 months have not been determined.

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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. Merck Sharp & Dohme BV, SPC Cedax (RVG 15747) 30-1-2015, www.geneesmiddeleninformatiebank.nl, Geraadpleegd 28 okt 2016
  2. Nederlandse Vereniging voor Kindergeneeskunde, Richtlijn Urineweginfecties bij kinderen, www.nvk.nl, 09 juni 2010

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Changes

Changes