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

Interactions
PK
Renal impairment
References

Ketotifen oral

Generic name
Ketotifen oral
Brand name
ATC Code
R06AX17

Pharmacokinetics in children

The clearance in children is greater than in adults.

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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

Allergic skin conditions, allergic rhinitis and prophylaxis for allergic asthma
  • Oral
    • 6 months up to 3 years
      • 1 mg/day in 2 doses.
    • 3 years up to 6 years
      • 1 - 2 mg/day in 2 doses.
    • 6 years up to 18 years
      • 2 - 4 mg/day in 2 doses.
      • Directions for administration:

        Patients who easily become drowsy should start on ½ tablet of 1 mg (in the evening), then ½ tablet twice daily before then reaching the usual daily dose in about 5 days

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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.

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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

Common (1-10%): primarily in children, there can be symptoms of stimulation of the central nervous system (such as agitation, irritability, sleeplessness and nervousness).

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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

No information available on specific warnings and precautions in children.

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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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Reference

  1. Sigma-Tau Industrie Farmaceutiche Riunite S.p.A., SmPC Zaditen (RVG 09520) 23-09-2015, www.geneesmiddeleninformatiebank.nl

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Changes

Changes