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

Interactions
PK
Renal impairment
References

Ertapenem

Generic name
Ertapenem
Brand name
ATC Code
J01DH03

Pharmacokinetics in children

  3 months-12 years 13-17 years
Vd 0,2 l/kg 0,16 l/kg
2,5 hours 4 hours
Cmax 3-23 months: 103,8 microg/ml
2-12 years: 113,2 microg/ml
170,4 microg/ml

Source: SmpC Invanz

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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

Bacterial infections
  • Intravenous
    • 3 months up to 13 years
      • 30 mg/kg/day in 2 doses. Max: 1 g/day.
    • 13 years up to 18 years
      • 1 g/day in 1 dose

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
No dose adjustment needed
GFR 30-50 ml/min/1.73 m2
No dose adjustment needed
GFR 10-30 ml/min/1.73 m2
First dose: no dose adjustment, following dosis: 50% of normal single dose
GFR < 10 ml/min/1.73 m2
Avoid use.

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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%): diarrhea. Diaper dermatitis. Pain at the infusion site. Increase in liver enzyme levels. Decrease in neutrophil count.

Uncommon (0.1-1%): hypertension, hot flashes. Headache. Discoloration of feces, melena. Skin rash, erythema, petechiae. Burning sensation, itching or erythema at the infusion site. Decrease in hemoglobin concentration. Increase in platelet count, increase in prothrombin time and aPTT.

Furthermore, hallucination, altered mental states (such as aggression) have been reported.

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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. Merck Sharp & Dohme B.V., SmPC Invanz (EU/1/02/216) Rev 26; 25-10-2022, www.ema.europa.eu

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Changes

Changes