What is the use of topical amikacin (antibiotic)?

From the Guidelines

Topical amikacin should be used with caution and only in specific cases of nontuberculous mycobacterial pulmonary disease, particularly for treatment-refractory patients, due to its potential benefits and risks as seen in the recent Phase III trial 1. When considering the use of topical amikacin, it's essential to weigh the potential benefits against the risks, including local irritation, allergic reactions, and the theoretical concerns of nephrotoxicity and ototoxicity. The most recent and highest quality study, a Phase III trial, found that adding topical amikacin to guideline-based therapy for treatment-refractory MAC pulmonary disease resulted in a higher proportion of patients with negative cultures at 6 months compared to those who continued to take the standard regimen only 1. Some key points to consider when using topical amikacin include:

• Concentrations ranging from 250–500 mg once daily up to 15 mg/kg once daily have been used in treatment-refractory cases 1
• Clinical responses and sputum conversion rates have varied, but significant improvements have been reported in some studies 1
• Adverse events, including dysphonia, cough, and oropharyngeal discomfort, are common but often manageable 1
• Theoretical concerns of nephrotoxicity and ototoxicity remain, although the risk is minimized with topical application compared to systemic use In contrast to the specific context of nontuberculous mycobacterial pulmonary disease, other guidelines suggest against the use of topical antibiotics, including amikacin, for wound healing in diabetes-related foot ulcers due to low certainty of evidence and potential risks 1. However, these guidelines do not directly apply to the use of topical amikacin in pulmonary disease, and the decision to use it should be based on the individual patient's condition and the potential benefits and risks as seen in the most recent and highest quality studies 1.

From the FDA Drug Label

INDICATIONS AND USAGE Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter (Mima-Herellea) species Clinical studies have shown Amikacin Sulfate Injection to be effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and post-operative infections (including post-vascular surgery)

The FDA drug label does not answer the question about topical amikacin because it only discusses the use of amikacin for systemic infections, not topical use 2.

From the Research

Topical Amikacin Overview

• Topical amikacin is not explicitly mentioned in the provided studies as a commonly used topical antibiotic in dermatology 3, 4.
• However, the studies discuss the use of other topical antibiotics, such as mupirocin, fusidic acid, and gentamycin, for various skin infections and wound care 3, 4, 5.

Mechanism of Action and Delivery

• Amikacin is a hydrophilic antibiotic with a short half-life, making its delivery challenging, especially through oral or transdermal routes 6.
• Novel controlled and sustained release drug delivery platforms are being explored to improve the delivery of amikacin and overcome the development of drug-resistance 6.

Clinical Uses and Efficacy

• Topical antibiotics, including gentamycin, have been shown to be effective in prophylaxis and treatment of wound infections, with significant improvements in clinical efficacy and duration of wound healing 5.
• The use of topical antibiotics in combination with other therapies, such as negative pressure wound therapy, is being explored for refractory skin and soft tissue infections 7.

Challenges and Future Directions

• The increasing rates of bacterial resistance and local hypersensitivity reactions are challenges associated with the use of topical antibiotics 4.
• Further research is needed to develop novel and effective topical antibiotic formulations, such as amikacin, and to optimize their use in clinical practice 6, 7.