- Name of the medicinal product
Amikacin 100 mg/2ml Vial
Amikacin 250 mg/2ml Vial
Amikacin 500 mg/2ml Vial
- Qualitative and quantitative composition
2 ml of solution for injection contains 100 mg of amikacin (as sulphate).
1 vial of 2 ml of solution for injection contains 500 mg of amikacin (as sulphate).
For excipients, see 6.1.
- Pharmaceutical form
Solution for Injection.
Vials containing a clear, colourless to pale yellow solution
- Clinical particulars
4.1 Therapeutic indications
Amikacin Injection is a semi-synthetic, aminoglycoside antibiotic which is active against a broad spectrum of Gram-negative organisms, including pseudomonas and some Gram-positive organisms.
Sensitive Gram-negative organisms include; 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 strains of these Gram-negative organisms resistant to gentamicin and tobramycin show sensitivity to amikacin in vitro.
The principal Gram-positive organism sensitive to amikacin is Staphylococcus aureus, including some methicillin-resistant strains. Amikacin has some activity against other Gram-positive organisms including certain strains of Streptococcus pyogenes, Enterococci and Diplococcus pneumoniae.
Amikacin is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species. Although amikacin is not the drug of choice for infections due to staphylococci, at times it may be indicated for the treatment of known or suspected staphylococcal disease. These situations include: the initiation of therapy for severe infections when the organisms suspected are either Gram-negative or staphylococci, patients allergic to other antibiotics, and mixed staphylococcal/Gram-negative infections.
Therapy with amikacin may be instituted prior to obtaining the results of sensitivity testing. Surgical procedures should be performed where indicated.
Consideration should be given to official guidance on the appropriate use of antibacterial Agents.
4.2 Posology and method of administration
Amikacin sulphate injection may be given intramuscularly or intravenously.
Amikacin should not be physically premixed with other drugs, but should be administered separately according to the recommended dose and route.
The patient’s pre-treatment bodyweight should be obtained for calculation of correct dosage.
The status of renal function should be estimated by measurement of the serum creatinine concentration or calculation of the endogenous creatinine clearance rate. The blood urea nitrogen (BUN) is much less reliable for this purpose. Reassessment of renal function should be made periodically during therapy.
Whenever possible, amikacin concentrations in serum should be measured to assure adequate, but not excessive levels. It is desirable to measure both peak and trough serum concentrations intermittently during therapy. Peak concentrations (30-90 minutes after injection) above 35 mcg/ml and trough concentrations (just prior to the next dose) above 10 mcg/ml should be avoided. Dosage should be adjusted as indicated. In patients with normal renal function, once-daily dosing may be used; peak concentrations in these cases may exceed 35 mcg/ml.
For most infections the intramuscular route is preferred, but in life-threatening infections, or in patients in whom intramuscular injection is not feasible, the intravenous route, either slow bolus (2 to 3 minutes) or infusion (0.25% over 30 minutes) may be used.