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

Interactions
PK
Renal impairment
References

Linezolid

Generic name
Linezolid
Brand name
ATC Code
J01XX08

Pharmacokinetics in children

The review by Jungbluth et al. shows that linezolid is cleared more rapidly and has a shorter elimination half-life in children aged < 12 years than in comparison to children aged > 12 years. The clearance in premature neonates is comparable to that in adults and increases considerably during the first week of life.

The following pharmacokinetic parameters have been found [Jungbluth 2003, Kearns 2003]:

Age Cmax (mcg/ml) t½ (hours) Cl (ml/min/kg)
Premature < 1 week 12.7 5.6 2.0
Premature 1-4 weeks 9.8 2.0 5.2
Full-term < 1 week 11.5 2.9 3.8
Full-term, 1-4 weeks 12.8 1.5 5.2
1-2 months 11.0 1.8 5.4
3 months to 11 years 15.1 2.9 3.8
12-17 yrs 16.7 4.1 2.1

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

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Available formulations

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Dosages

Pneumonia, infections of the skin and soft tissues
  • Oral
    • Premature infants Postconceptional age < 34 weeks
      [8] [16]

      • postnatal age < 7 days: 20 mg/kg/day in 2 doses, max. 30 mg/kg/day in 3 doses
        postnatal age ≥ 7 days: 30 mg/kg/day in 3 doses.

      • Duration of treatment:

        Maximum 28 days

    • Term neonate
      [16]
      • 30 mg/kg/day in 3 doses.
      • Duration of treatment:

        Maximum 28 days

    • 1 month up to 12 years
      [16]
      • 30 mg/kg/day in 3 doses. Max: 1.200 mg/day.
      • Duration of treatment:

        Maximum 28 days

    • 12 years up to 18 years
      [16]
      • 1.200 mg/day in 2 doses.
      • Duration of treatment:

        Maximum 28 days

  • Intravenous
    • Premature infants Postconceptional age < 34 weeks
      [8] [16]

      • Postnatal age < 7 days: 20 mg/kg/day in 2 doses, max. 30 mg/kg/day in 3 doses
        postnatal age ≥ 7 days: 30 mg/kg/day in 3 doses.

      • Duration of treatment:

        Maximum 28 days

    • Term neonate
      [16]
      • 30 mg/kg/day in 3 doses.
      • Duration of treatment:

        Maximum 28 days

    • 1 month up to 12 years
      [16]
      • 30 mg/kg/day in 3 doses. Max: 1.200 mg/day.
      • Duration of treatment:

        Maximum 28 days

    • 12 years up to 18 years
      [16]
      • 1.200 mg/day in 2 doses.
      • Duration of treatment:

        Maximum 28 days
Multi-drug resistant tuberculosis
  • Oral
    • 3 months up to 12 years
      [15] [18]
      • 20 mg/kg/day in 2 doses.

      • Monitor monthly: reduce the dose by 33-50% in peripheral neuropathy.

    • ≥ 12 years
      [18]
      • 10 mg/kg/day in 1 dose. Max: 600 mg/day.

      • In severe diseases or TB meningitis, max 600 mg/day; in other cases 300 mg/day.
        Monitor monthly, in peripheral neuropathy reduce the dose by 33-50%.

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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.

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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

Diarrhoea, nausea, vomiting, abdominal pain, candidiasis (oral or vaginal), headaches, dizziness, neutropenia, thrombocytopenia, leukopenia, anaemia, fever, peripheral and optic neuropathy, abnormal liver enzyme values, disturbed sense of taste (a metallic taste), tingling, paraesthesias, skin reactions, rash, tinnitus, hypertension, dyspepsia, discoloration of the tongue/teeth. Infections, dyspnoea, convulsions, hypokalaemia, apnoea, gastrointestinal bleeding, oedema [SmPC for Zyvox]. Lactic acidosis appears to occur more often in children [Ozkaya-Parlakay A et al.].

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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 in children

Hypersensitivity to linezolid.

 

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

Linezolid should only be prescribed in consultation with a paediatrician/infectiologist and/or a medical microbiologist. The treatment should be starting in the clinic and based on an antibiogram.
The maximum length of treatment is 28 days. When used for longer than 28 days, there is a risk of permanent peripheral neuropathy.
Linezolid can increase the blood pressure when combined with foods that contain a large amount of the amino acid tyramine. It is therefore advisable to avoid such foods.
Caution is needed in cases of impaired liver function. The vision should be tested regularly in prolonged use. The overall blood counts (including haemoglobin levels, blood platelets and the total and differentiated leukocyte counts) should be checked carefully.

The use of Linezolid in children for the empirical treatment of CNS infections cannot be recommended. Patients with ventriculo-peritoneal shunts did not reach constant concentrations in the cerebrospinal fluid.

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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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Glycopeptide antibacterials
J01XA01
Polymyxins
J01XB01
Nitrofuran derivatives
J01XE01
Other antibacterials
J01XX01

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References

  1. Deville JG, et al, Linezolid versus vancomycin in the treatment of known or suspected resistant gram-positive infections in neonates., Pediatr Infect Dis J, 2003, 22, S158-63
  2. French G., Safety and tolerability of linezolid., J Antimicrob Chemother, 2003, 51, Suppl 2:ii45-53
  3. Jantausch BA, et al, Linezolid for the treatment of children with bacteremia or nosocomial pneumonia caused by resistant gram-positive bacterial pathogens., Pediatr Infect Dis J., 2003, 22, S164-71
  4. Jungbluth GL, et al, Linezolid pharmacokinetics in pediatric patients: an overview., Pediatr Infect Dis J, 2003, 22, S153-7
  5. Kaplan SL, et al, Linezolid for the treatment of methicillin-resistant Staphylococcus aureus infections in children, Pediatr Infect Dis J, 2003, 22, S178-85
  6. Kaplan SL, et al, Linezolid versus vancomycin for treatment of resistant Gram-positive infections in children., Pediatr Infect Dis J., 2003, 22, 677-86
  7. Kearns GL, et al, Single dose pharmacokinetics of linezolid in infants and children, Pediatr Infect Dis J, 2000, 19, 1178-84
  8. Kearns GL, et al, Impact of ontogeny on linezolid disposition in neonates and infants., Clin Pharmacol Ther, 2003, 74, 413-22
  9. Meissner HC, et al, Hematologic effects of linezolid in young children., Pediatr Infect Dis J., 2003, 22, S186-92
  10. Saiman L, et al, Safety and tolerability of linezolid in children., Pediatr Infect Dis J, 2003, 22, S193-200
  11. Tan TQ, Update on the use of linezolid: a pediatric perspective, Pediatr Infect Dis J, 2004, 23, 955-6
  12. Velissariou IM, Use of linezolid in children: an overview of recent advances., Expert Rev Anti Infect Ther., 2006, 4, 947-52
  13. Wible K, et al, Linezolid versus cefadroxil in the treatment of skin and skin structure infections in children, Pediatr Infect Dis J, 2003, 22, 315-23
  14. Yogev R, et al, Linezolid for the treatment of complicated skin and skin structure infections in children., Pediatr Infect Dis J, 2003, 22, S172-7
  15. Garcia-Prats AJ et al., Linezolid for the treatment of drug-resistant tuberculosis in children: a review and recommendations., Tuberculosis (Edinb). , 2014, Mar;94(2):, 93-104
  16. Pfizer Inc. , FDA Productinformation Zyvox , https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/57a5e8e4-7f01-4786-bfc5-4656c7dca249/spl-doc?hl=linezolid, 02-2022
  17. Ozkaya-Parlakay A et al., Early lactic acidosis associated with linezolid therapy in paediatric patients, Int J Antimicrob Agents, 2014, 44(4), 334-6
  18. Swaminathan A et al., Treating children for drug-resistant tuberculosis in Tajikistan with Group 5 medications, Int J Tuberc Lung Dis., 2016, Apr;20(4), 474-8
  19. 1A Pharma, SmPC Linezolid - 1 A Pharma® 600 mg Filmtabletten (90203.00.00), 07/2016
  20. Pfizer, SmPC, Zyvoxid® 600 mg Filmtabletten (51712.01.01), 04/17
  21. Pfizer, SmPC, Zyvoxid® 100mg/5ml Granulat zur Herstellung einer Suspension zum Einnehmen (51712.00.02), 09/16
  22. Pfizer, SmPC, Zyvoxid® 2mg/ml Infusionslösung (51712.00.00), 06/16
  23. Pfizer, SmPC Zyvoxid 600 mg Ftbl. (1-24229), https://www.univadis.at/, 08/2017

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Changes

Changes