Cefaclor

Generic name
Cefaclor
Brand name
ATC Code
J01DC04
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Infants and children

  • After application of 10mg/kg or 15mg/kg on an empty stomach peak serum levels of 10,8 mg/l or 13,1 mg/l were observed, respectively. 10-days treatment with Cefaclor didn't result in accumulation of the drug.
  • Results of pharmacokinetic investigations on children don't deviate from those on adults. E.g. half-life is the same order of magnitude.

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 infections, middle ear inflammation, and infections caused by less susceptible microorganisms
  • Oral
    • 1 month up to 10 years
      • 40 - 50 mg/kg/day in 2 - 4 doses. Max: 1 g/day.
    • 10 years up to 18 years
      • 2.000 - 3.000 mg/day in 2 - 4 doses.
    • 1 month up to 10 years
      [1] [7]
      • 40 - 50 mg/kg/day in 2 - 4 doses. Max: 1 g/day.
    • 10 years up to 18 years
      [2] [5] [7]
      • 2.000 - 3.000 mg/day in 2 - 4 doses.

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.

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

Serum disease-like reactions (multiform erythema and rash accompanied by arthralgia with and without fever) are more common in children than in adults. They usually occur after the second or third dose and are probably allergic. The symptoms disappear within a few days after discontinuation of the drug.

Cefaclor can lead to tooth discoloration in children. Good oral hygiene can help to prevent tooth discoloration [SmPC Cec Ftbl].

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.

Interactions

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

OTHER BETA-LACTAM ANTIBACTERIALS

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

First-generation cephalosporins
J01DB05
J01DB04
J01DB01
J01DB03
Second-generation cephalosporins
J01DC03
J01DC02
Third-generation cephalosporins
J01DD08
J01DD01
J01DD13
J01DD52
J01DD02
J01DD14
J01DD04
Fourth-generation cephalosporins
J01DE01
Monobactams
J01DF01
Carbapenems
J01DH03
J01DH51
J01DH02
MONOBACTAMS
J01DF01
Other cephalosporins and penems
J01DI02

References

  1. Eurocept BV, SPC Ceclor suspensie 25 mg/ml (RVG 08152) 14-4-2016, www.geneesmiddeleninformatiebank.nl, Geraadpleegd 28 okt 2016
  2. Aliud Pharma, SmPC Cefaclor AL 250/500 Hartkapseln (32827.00.00 / 32827.01.00), 02/2017
  3. Dr. Friedrich Eberth Arzneimittel GmbH, SmPC Panoral 500 mg Hartkapseln (28200.01.00), 11/2017
  4. Hexal, SmPC CEC 250/500 mg Filmtabletten (37023.00.00 / 6803213.00.00), 06/2015
  5. Hexal, SmPC CEC / CEC forte Trockensaft (24629.00.00 / 24629.01.00), 01/2016
  6. Dr. Friedrich Eberth Arzneimittel GmbH, SmPC Panoral Trockensaft 125/250 mg/ 5 mL (37.00.01/ 37.01.01), 12/2017
  7. InfectoPharm, SmPC InfectoCef 125/250/500 Saft (27.11.1996 / 27.11.1996 / 15.11.2005), 06/2016

Changes

Therapeutic Drug Monitoring


Overdose