Amikacin Injection (Amikataj)
Title of the medicinal product
Qualitative and qualitative composition
2 teaspoons of solution for injection includes 100 mg of amikacin (as sulphate).
1 vial of 2 ml of solution for injection includes 500 mg of amikacin (as sulphate).
Vials containing a transparent, colourless to light yellow solution
4.1 Therapeutic indications
Amikacin Injection is a semi-synthetic, aminoglycoside antibiotic that is active against a wide array of Gram-negative organisms, such as pseudomonas and a few Gram-positive organisms.
Sensitive Gram-negative organisms comprise; Pseudomonas aeruginosa, Escherichia coli., indole-positive and indole-negative Proteus spp., Klebsiella, Enterobacter and Serratia spp., Minea-Herralae, Citrobacter freundii, Salmonella, Shigella, Acinetobacter and Providencia spp.
Many breeds of those Gram-negative organisms resistant to gentamicin and tobramycin reveal sensitivity to amikacin in vitro.
The primary Gram-positive receptor sensitive to amikacin is Staphylococcus aureus, such as some methicillin-resistant strains. Amikacin has some action against other Gram-positive organisms such as specific strains of Streptococcus pyogenes, Enterococci and Diplococcus pneumoniae.
Amikacin is suggested from the short-term treatment of acute infections due to susceptible strains of Gram-negative bacteria, such as Pseudomonas species. Though amikacin isn’t the drug of choice for infections due to staphylococci, at times it might be suggested for the treatment of suspected or known staphylococcal disease. These scenarios include: the initiation of treatment for acute infections once the organisms guessed are Gram-negative or staphylococci, patients allergic to alternative antibiotics, and combined staphylococcal/Gram-negative infections.
Treatment with amikacin can be instituted before receiving the results of sensitivity testing. Surgical procedures must be done where indicated.
Consideration ought to be given to official guidance on the appropriate usage of antibacterial agents.
4.2 Posology and method of administration
Amikacin sulphate shot may be given intramuscularly or intravenously.
Amikacin shouldn’t be premixed with different medications, but ought to be administered individually based on the dose and path.
The individual’s pre-treatment body weight ought to be obtained for calculation of proper dose.
The standing of renal function ought to be estimated by measurement of the serum creatinine concentration or calculation of this endogenous creatinine clearance rate. The blood urea nitrogen (BUN) is not as reliable for this purpose. Reassessment of renal function ought to be made periodically during treatment.
Whenever possible, amikacin concentrations in serum ought to be quantified to guarantee adequate, but not excessive amounts. It’s desired to measure both the peak and trough serum concentrations during treatment. Peak concentrations (30-90 minutes following injection) over 35 mcg/ml and trough concentrations (only before another dose) over 10 mcg/ml ought to be prevented. Dosage ought to be adjusted as suggested. In individuals with normal renal function, once-daily dosing might be utilized; summit concentrations in such instances can exceed 35 mcg/ml.
For many ailments the intramuscular route is preferred, however in life threatening illnesses, or in patients in whom intramuscular injection isn’t viable, the intravenous route, either slow bolus (2 to 3 minutes) or extract (0.25percent more than thirty minutes) could be utilized. AMIKACIN INJECTION