Cephalexin

Generic name
Cephalexin
Brand name
ATC Code
J01DB01
Compare …

Cephalexin

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

Interactions
PK
Renal impairment
References

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

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

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

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.

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.

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

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

Changes

Therapeutic Drug Monitoring


Overdose