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Therapeutic indications
Amikacin Injection is indicated in the short-term treatment of serious infections
caused by susceptible strains of Gram-negative bacteria
Staphylococcus aureus, including methicillin-resistant strains is the principal Gram-positive organism sensitive to amikacin.
The use of amikacin in the treatment of staphylococcal infections should be restricted to second-line therapy, and should be confined to patients suffering from severe infections caused by susceptible strains of stapylococcus who have failed to respond or are allergic to other available antibiotics
Clinical studies have shown amikacin to be effective in treating bacteraemia, septicaemia including neonatal sepsis and serious infections of the respiratory tract, bones and joints, central nervous system, skin and skin structures (including those resulting from burns), intraabdominal organs, post-operative infections and complicated and recurrent urinary tract infections, when caused by susceptible organisms.
Dose and method of administration
Intramuscular or Intravenous Administration
The intramuscular route is preferred for most infections, but in life-threatening infections or when an intramuscular injection is not feasible, an intravenous infusion (0.25% over 30 to 60 minutes) may be used. The compatible diluents for intravenous use if required are as follows: 5% Glucose Intravenous Infusion B.P. in Water for Injections B.P. and Sodium Chloride Intravenous Infusion B.P. (0.9%). Use solutions for I.V. administration within 12 hours after preparation.
Dosage
Dosage of amikacin sulfate is expressed in terms of amikacin and calculated on a body weight basis. Dosage is identical for both routes of administration.
Adults and Children:
The usual recommended dose of amikacin is 15mg/kg daily given in two or three equally divided doses.
Neonates and Premature Infants:
Dosage given for patients with normal renal function. Initiate treatment with a loading dose of 10 mg/kg followed by 7.5 mg/kg every 12 hours. The maximum total daily dose should not exceed 15 mg/kg. Solution infusions via the I.V. route should be given over a 1 to 2 hour period.
Elderly:
Amikacin is excreted by the renal route. Since renal function could be failing in the elderly, it should be assessed whenever possible and the dosage adjusted accordingly, if necessary. Refer to "Impaired renal function" of dosage description.
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Pharma Sources Insight June 2024: Globalization on the Go
