Amikacin

1) - Hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) - Complicated Urogenital tract infections including pyelonephritis - Complicated Intraabdominal infections - Endocarditis (only in combination with other antibiotics), - Infected burns Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.

Amikacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

AND CLINICAL USE

Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Pseudomonas species, Escherichia coli, Proteus species, Klebsiella - Enterobacter - Serratia species, Providencia species, Salmonella species, Citrobacter species and Staphylococcus aureus.

Clinical effectiveness has been shown in bacteremia, septicemia (including neonatal sepsis), osteomyelitis, septic arthritis; respiratory tract, urinary tract, intra-abdominal (including peritonitis) infections and soft tissue abscesses.

Appropriate bacteriological studies should be performed in order to identify and determine the susceptibility of the causative organism. Relevant surgical procedures should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amikacin Sulfate Injection and other antibacterial drugs, Amikacin Sulfate Injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

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).

Clinical studies have shown amikacin also to be effective in serious complicated and recurrent urinary tract infections due to these organisms. Aminoglycosides, including Amikacin Sulfate Injection are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity.

1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. ARIKAYCE liposomal should be used in conjunction with other antibacterial agents active against Mycobacterium avium Complex lung infections.