Chloramphenicol - intravenös

Generic name
Chloramphenicol - intravenös
Brand name
ATC Code
J01BA01
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Chloramphenicol - intravenös

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

In infants and children aged 3 days to 16 years, the half-life was extremely variable, ranging from 1.7 to 12.0 hours [SmPC].

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

Severe bacterial infections
  • Intravenous
    • Term neonate
      [1]
      • 25 mg/kg/day in 4 doses.
        • Chloramphenicol should be reserved for serious infections caused by organisms susceptible to its antimicrobial effects when less toxic antibiotics are ineffective or contraindicated.
        • Chloramphenicol is to be administered only under the direction of a pediatric infectiologist
    • 1 month up to 18 years
      [1]
      • 50 mg/kg/day in 4 doses. Max: 4 g/day.
        • Chloramphenicol should be reserved for serious infections caused by organisms susceptible to its antimicrobial effects when less toxic antibiotics are ineffective or contraindicated.
        • Chloramphenicol is to be administered only under the direction of a pediatric infectiologist.

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

Neonatal Grey Syndrom [SmpC]

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

Due to the toxic properties of chloramphenicol, it is necessary to carry out serum measurements and adjust the dose accordingly, especially in premature infants and newborns. [SmPC Chloramphenicol 1g Powder for Solution for Injection]

Grey syndrome: Toxic reactions, including deaths, have occurred in premature infants and newborns. Symptoms of grey baby syndrome occurred in the following order: abdominal distension with or without vomiting, grayish discoloration of the skin to cyanosis, circulatory collapse, often accompanied by irregular breathing, death within a few hours of the onset of symptoms.

The progression of symptoms from onset to death was accelerated with higher dose schedules. Serum levels showed unusually high concentrations of chloramphenicol (>90 µg/mL after repeated doses). Immediate discontinuation of therapy at the first sign of these symptoms may lead to complete recovery. [SmPC Chloramphenicol 1g Powder for Solution for Injection]

Interactions

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

AMPHENICOLS

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

Reference

  1. Eramol (UK) Ltd , SmPC Chloramphenicol 1 g Powder for Solution for Injection (PL49160/0001), 08/2022

Changes

Therapeutic Drug Monitoring


Overdose