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

Interactions
PK
Renal impairment
References

Cephalexin

Generic name
Cephalexin
Brand name
ATC Code
J01DB01

Pharmacokinetics in children

Simon 1970, Autmizguine 2013:

age t1/2 (h) t max (h) Cl/F (L/h/kg) V/F (L/kg) initial blood concentration (µg/ml) (1)
preterm 1. - 4. week 3,7 ± 0,4 4,0     30,0 ± 3,4
1. - 2. week 3,4 ± 0,2 2,0     20,4 ± 2,1
3. week - 12. month 1,5 ± 0,2 1,5     28,0 ± 4,3
2. - 6. year 1,3 ± 0,1 2,0 0,27 0,36 35,9 ± 8,5
7. - 12. year 1,1 ± 0,1 1,5 0,29 0,44 46,0 ± 13,0

(1) after one oral dose of 25 mg/kg

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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

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Dosages

Infections of the respiratory tract, urogenital system, skin and soft tissues
  • Oral
    • 1 month up to 12 years
      [1] [5]
      • 25 - 50 mg/kg/day in 2 - 4 doses. Max: 100mg/kg/day, but not exceeding 4 g/day.

      • In severe infections, the dose can be raised to the maximum.

    • Term neonate
      [5]
      • 50 mg/kg/day in 4 doses.
    • ≥ 12 years
      [1] [5]
      • 25 - 50 mg/kg/day in 2 - 4 doses. Max: 100mg/kg/day, but not exceeding 6 g/day.

      • In severe infections, the dose can be raised to the maximum

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Dose adjustment not needed
GFR 30-50 ml/min/1.73 m2
100 percentage of single dose and dosing interval : 12 uur
GFR 10-30 ml/min/1.73 m2
100 percentage of single dose and dosing interval : 12 uur
GFR < 10 ml/min/1.73 m2
100 percentage of single dose and dosing interval : 24 uur
Clinical consequences

With impaired renal function, the half-life of cephalexin is prolonged. This increases the risk of adverse reactions.

Clinical effects:
Nephrotoxic manifestations (renal function impairment, tubular necrosis, interstitial nephritis) occur mainly with high doses, with pre-existing renal function impairment, and with concomitant treatment with other nephrotoxic agents.

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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

Hematuria without impairment of renal function was observed in children who took more than 3,5 g Cefalexin/day accidentally. Substitution of volume resulted in stabilisation.

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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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First-generation cephalosporins
J01DB04
Second-generation cephalosporins
J01DC02
Third-generation cephalosporins
J01DD08
J01DD01
J01DD52
J01DD02
J01DD04
Carbapenems
J01DH02

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References

  1. Eurocept BV, SPC Keforal (RVG 06325), www.cbg-meb.nl, Geraadpleegd 07 januari 2011, http://db.cbg-meb.nl/IB-teksten/h06325.pdf
  2. Simon, C, et al., Zur Pharmakokinetik von Cephalexin bei Erwachsenen und Kindern, Deut Med Wochenschr, 1970, 95(42), 2103-8
  3. Arcana, SmPC Keflex 1000 mg Ftbl. (16085), 05/2018
  4. Autmizguine, J, et al., Pharmacokinetics and pharmacodynamics of oral cephalexin in children with osteoarticular infections, Pediatr Infect Dis J., 2013, 32(12), 1340-4
  5. Sandoz, SmPC Ospexin 250 mg/5 ml Gran. f. orale Susp. (16132), https://www.univadis.at/, 05/2018
  6. NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021

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Changes

Changes