Imipenem + cilastatin (combination preparation)

Generic name
Imipenem + cilastatin (combination preparation)
Brand name
ATC Code
J01DH51

Imipenem + cilastatin (combination preparation)

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Mean clearance (CL) and volume of distribution (Vdss) of imipenem were approximately 45% higher in pediatric patients (3 months to 14 years) than in adults. [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

Bacterial infections
  • Intravenous
    • 1 month up to 12 years
      • 60/60 - 100/100 mg/kg/day in 4 doses, max 4.000 /4.000 mg/day

      • Upper dose range intended for less sensitive bacterial species (such as Pseudomonas aeruginosa) and/or very serious infections.

    • 12 years up to 18 years
      • 2,000/2,000 mg/day in 4 doses, max. 4,000/4,000 mg/day

      • Upper dose range intended for less sensitive bacterial species (such as Pseudomonas aeruginosa) and/or very serious infections.

Infection in cystic fibrosis
  • Intravenous
    • 1 month up to 18 years
      • 100/100 mg/kg/day in 4 doses, max: 4,000/4,000 mg/day

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
Dose adjustment not needed
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
A general recommendation is not 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

 

 

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

Imipenem / cilastatin accumulates in patients with renal impairment. If the dose is not adjusted to kidney function, side effects to the central nervous system may occur. Special attention should be paid to neurological symptoms or convulsions in children with known risk factors for seizures, or who use concomitant drugs that lower the seizure threshold.

Use is not recommended for CNS infections. [Ref.]

 

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
J01DC04
J01DC03
J01DC02
Third-generation cephalosporins
J01DD08
J01DD01
J01DD13
J01DD52
J01DD02
J01DD14
J01DD04
Fourth-generation cephalosporins
J01DE01
Monobactams
J01DF01
Carbapenems
J01DH03
J01DH02
MONOBACTAMS
J01DF01
Other cephalosporins and penems
J01DI02

References

  1. Hartwig NC, et al, Vademecum pediatrische antimicrobiële therapie, 2005
  2. Merck Sharp & Dohme B.V., SPC Tienam (RVG 11089) 19-11-2020, www.geneesmiddeleninformatiebank.nl
  3. AVOXA ABDA-Datenbank, Interaktionen Impinemen_Cilastatin, accessed 07-2018
  4. MSD SHARP & DOHME GMBH, SmPC Zienam 500mg/500mg Pulver zur Herstellung einer Infusionslösung (4697.01.00), 11/2015
  5. Fresenius Kabi, SmPC Imipenem/Cilastatin 500mg/500mg Pulver zur Herstellung einer Infusionslösung (71957.00.00), 08/2012
  6. UpToDate® Pediatric Drug information, Imipenem/Cilastatin Lexicomp® Version 132.0, accessed 07/2018
  7. AVOXA ABDA-Datenbank, Interaktionen Impinemen_Cilastatin, accessed 07-2018

Changes

Therapeutic Drug Monitoring


Overdose