What is the minimum age to use Linezolid (oxazolidinone antibiotic)?

From the Guidelines

Linezolid can be used in children of all ages, but the minimum age is not explicitly limited, and dosing must be adjusted based on age and weight. For children under 12 years old, the recommended dose is 10 mg/kg every 8 hours, while children 12 years and older typically receive 600 mg every 12 hours 1. Linezolid is an oxazolidinone antibiotic that works by inhibiting bacterial protein synthesis, making it effective against resistant gram-positive bacteria including MRSA, VRE, and certain streptococci. When prescribing linezolid to children, careful monitoring is essential as they may experience different side effects than adults, such as bone marrow suppression and peripheral neuropathy, especially with prolonged use or higher doses 1. Some key points to consider when using linezolid in children include:

• Monitoring for adverse events, particularly hematologic toxicity and peripheral neuropathy
• Adjusting the dose based on age and weight
• Considering alternative treatments or close clinical monitoring due to the risk of adverse events
• Using linezolid as part of a treatment regimen for multidrug-resistant tuberculosis (MDR-TB) in children, as recommended by the WHO 1. It is also important to note that linezolid has excellent penetration into the cerebrospinal fluid, making it a potential option for MDR-TB meningitis 1. Overall, the use of linezolid in children requires careful consideration of the potential benefits and risks, as well as close monitoring for adverse events.

From the FDA Drug Label

The safety and effectiveness of ZYVOX for the treatment of pediatric patients with the following infection have been established in a comparator-controlled study in pediatric patients ranging in age from 5 through 17 years Recommendations for the dosage regimen for pre-term neonates less than 7 days of age (gestational age less than 34 weeks) are based on pharmacokinetic data from 9 pre-term neonates. The dosage for pediatric patients up to 11 years of age should be 10 mg/kg q8h. Pediatric patients 12 years and older should receive 600 mg q12h All neonatal patients should receive 10 mg/kg q8h by 7 days of life

The minimum age to use Linezolid is not explicitly stated in the label for all possible indications, but it has been studied and used in patients from birth in certain situations, with specific dosing recommendations for pre-term neonates and neonatal patients. However, for some infections, the safety and effectiveness have been established in pediatric patients ranging in age from 5 through 17 years.

From the Research

Minimum Age to Use Linezolid

The minimum age to use Linezolid is not explicitly stated in the provided studies. However, based on the available evidence, Linezolid has been used in pediatric patients, including infants and children, for the treatment of Gram-positive infections.

• The study by 2 included pediatric patients with community-acquired pneumonia, otitis media, and skin and skin structure infections, and found that Linezolid was safe and well-tolerated in these patients.
• The study by 3 reported on the use of Linezolid in 50 children aged 1 month to 18 years, and found that the drug was effective and safe, although lactic acidosis was a common side effect.
• The study by 4 analyzed the use of Linezolid in 75 pediatric patients, including infants as young as 7 days old, and found that the drug was safe and effective, with a similar frequency of adverse events in younger and older children.
• The study by 5 included data on 126 Linezolid treatment courses administered to 108 patients, including preterm infants and pediatric oncology patients, and found that the drug seemed to contribute to a favorable outcome in 70% of all treatment courses.

Age-Related Considerations

While the minimum age to use Linezolid is not explicitly stated, the available evidence suggests that the drug can be used in pediatric patients, including infants and children. However, the following age-related considerations should be taken into account:

• The study by 6 found that a higher clearance of Linezolid was observed in children compared to adults, and therefore higher daily dosages per kg bodyweight may be required in children.
• The study by 4 found that children aged <2 years received Linezolid for a shorter duration than older children, although the frequency of adverse events was similar in the two age groups.
• The study by 5 found that in 39% of treatment courses administered to children older than 1 week and younger than 12 years of age, the dose was not adjusted to age-related pharmacokinetic parameters.