Is Tigecycline (Tigecycline) suitable for a 4-month-old patient?

From the Guidelines

Tigecycline is not recommended for use in infants aged 4 months. According to the provided evidence 1, there are no recommendations available for the use of Tigecycline in patients under 18 years of age, and it is suggested that pediatric infectious diseases specialists consultation is recommended prior to the use of certain antibiotics in children. The evidence also states that the use of tigecycline is not recommended in patients <18 years of age unless no alternative antimicrobial agents are available.

Some key points to consider when treating infants with serious infections include:

• The potential for permanent tooth discoloration and effects on bone growth associated with tetracycline-class antibiotics like Tigecycline
• The need for careful antibiotic selection and dosing based on the suspected pathogens and local resistance patterns
• The importance of consulting with a pediatric infectious disease specialist when treating serious infections in infants

Alternative antibiotics such as appropriate combinations of beta-lactams, aminoglycosides, or other age-appropriate antimicrobials should be considered for infants with serious infections requiring broad-spectrum coverage, as outlined in the evidence for other antibiotics like Imipenem, Linezolid, Meropenem, and Piperacillin/tazobactam 1.

From the FDA Drug Label

1. 4 Pediatric Use Use in patients under 18 years of age is not recommended. Safety and effectiveness in pediatric patients below the age of 18 years have not been established. Because of the increased mortality observed in tigecycline-treated adult patients in clinical trials, pediatric trials of tigecycline to evaluate the safety and efficacy of tigecycline were not conducted In situations where there are no other alternative antibacterial drugs, dosing has been proposed for pediatric patients 8 to 17 years of age based on data from pediatric pharmacokinetic studies [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)]. Because of effects on tooth development, use in patients under 8 years of age is not recommended [see Warnings and Precautions (5. 7)].

Tigecycline is not recommended for use in patients under 18 years of age, and specifically, use in patients under 8 years of age is not recommended due to effects on tooth development. Since the patient is 4 months old, use of tigecycline is not recommended 2.

From the Research

Tigecycline Use in Pediatric Patients

• The use of tigecycline in pediatric patients, especially those under the age of 4 months, is not well-established due to limited clinical trials and studies 3, 4, 5, 6, 7.
• However, there are some studies that have investigated the use of tigecycline in pediatric patients, including those with multidrug-resistant infections 4, 5, 6.
• A study published in 2017 found that tigecycline may be a considerable option in life-threatening infections in pediatric patients, with a favorable clinical response achieved in 74.2% of cases 3.
• Another study published in 2019 found that pharmacokinetic simulations predicted that tigecycline 1.2 mg/kg (maximum dose 50 mg) every 12 hours would achieve exposure similar to adults receiving 50 mg every 12 hours in children 8-11 years old 4.
• A study published in 2022 found that tigecycline can be used as salvage therapy in resistant infections where options are limited, although definitive conclusions about the efficacy and safety of tigecycline in children cannot be reached 5.
• A study published in 2017 found that tigecycline, given at the range of administered doses as salvage therapy and in combination with other antimicrobial agents, seemed to be well tolerated in a series of mainly critically ill pediatric patients and demonstrated relatively good clinical response in nonbacteremic patients 6.
• A phase II clinical trial published in 2012 found that a tigecycline dosage of ∼1.2 mg/kg q12h may represent the most appropriate dosage for subsequent evaluation in Phase III clinical trials in children aged 8 to 11 years with selected serious bacterial infections 7.

Dosage and Administration

• The dosage of tigecycline for pediatric patients is not well-established, but studies suggest that a dosage of 1.2 mg/kg every 12 hours may be appropriate for children aged 8-11 years 4, 7.
• However, the dosage and administration of tigecycline for pediatric patients under the age of 4 months is not established, and more studies are needed to determine the safety and efficacy of tigecycline in this age group.

Safety and Efficacy

• The safety and efficacy of tigecycline in pediatric patients are not well-established, but studies suggest that tigecycline may be well tolerated and effective in treating multidrug-resistant infections in children 3, 4, 5, 6.
• However, more studies are needed to determine the long-term safety and efficacy of tigecycline in pediatric patients, especially those under the age of 4 months.