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

Interactions
PK
Renal impairment
References

Celecoxib

Generic name
Celecoxib
Brand name
ATC Code
M01AH01

Pharmacokinetics in children

No information is present at this moment.

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

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Available formulations

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Dosages

Juvenile idiopathic arthritis (JIA)
  • Oral
    • ≥ 2 years and 10 up to 25 kg
      • 100 mg/day in 2 doses.
    • ≥ 2 years and ≥ 25 kg
      • 200 mg/day in 2 doses.

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Consider whether the use of an NSAID is justified.
When celecoxib is prescribed to children at risk: verify renal function prior to the start and within the first week after starting.
GFR 30-50 ml/min/1.73 m2
Consider whether the use of an NSAID is justified.
When celecoxib is prescribed to children at risk: verify renal function prior to the start and within the first week after starting.
GFR 10-30 ml/min/1.73 m2
Consider whether the use of an NSAID is justified.
When celecoxib is prescribed to children at risk: verify renal function prior to the start and within the first week after starting.
GFR < 10 ml/min/1.73 m2
A general recommendation is not given.
Clinical consequences

Risk-factors are: heart failure, liver cirrhosis, nephrotic syndrome, chronic kidney disease, causes leading to dehydration (e.g. summer heat), use of other drugs decreasing renal function, like diuretics or RAAS inhibitors.

NSAIDs (including COX-2 inhibitors) can cause acute renal failure by decreasing renal perfusion (by hypovolaemia). Normally, an increased prostaglandin synthesis in the kidneys prevents a rapid decrease in renal perfusion; however, NSAIDs disturb this compensating mechanism. Decreased renal perfusion also leads to water and salt retention, resulting in the occurrence or worsening of hypertension and heart failure.

Patients on dialysis

Haemodialysis / continuous venovenous haemodialysis or haemo(dia)filtration:

  • residual kidney function (urine production) PRESENT: avoid use to save residual kidney function
  • residual kidney function (urine production) NOT PRESENT: avoidance is not necessary

Patients undergoing dialysis have a higher bleeding risk, probably related to an abnormal platelet function. The bleeding risk can be increased by the use of low molecular weight heparines at the start of haemodialysis to prevent coagulation in the extracorporeal circulation.

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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

Headaches, fever, abdominal pain, nausea, arthralgia, diarrhoea and vomiting.

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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

In exceptional cases, varicella can lead to serious infectious complications of the skin and soft tissues. To date, it cannot be ruled out that NSAIDs contribute to the worsening of these infections. It is therefore recommended not to use celecoxib in cases of varicella (Prescrire Internat 2010).

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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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Acetic acid derivatives and related substances
M01AB05
M01AB01
Oxicams
M01AC01
Propionic acid derivatives
M01AE14
M01AE01
M01AE02
Fenamates
M01AG01

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References

  1. Pfizer, Product Label Celebrex (USA)- dec 2008, www.accessdata.fda.gov
  2. Acino, SmPC Celecoxib Acino 100 / 200 mg Hartkapseln (86065.00.00 / 86066.00.00), 01/2017
  3. Pfizer, SmPC CELEBREX® 100 mg/200 mg (48802.00.00 / 48802.01.00), 11/2017
  4. MMI, Gelbe Liste I Online, 06/2018
  5. AbZ, SmPC Celecoxib 100/200 mg Hartkapseln (83817.00.00/83818.00.00), 02/2016
  6. Pfizer, SmPC Celecoxib 100/200 mg Hartkapseln (48802.00.00/48802.01.00), 11/2017
  7. <No author listed>, Varicella, herpes zoster and nonsteroidal anti-inflammatory drugs: serious cutaneous complications., Prescrire Internat, 2010, 19, 72-73

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Changes

Changes