AMIKACIN KABI

What it is

Amikacin Kabi is a solution for injection containing amikacin as sulfate. The solution is a clear colourless aqueous solution. Amikacin Kabi is for intravenous use only and should only be administered by intravenous infusion. Amikacin is a semisynthetic aminoglycoside antibiotic derived from kanamycin.

Approved indications

— Short-term treatment of serious infections caused by susceptible strains of Gram-negative bacteria. — Treatment of Staphylococcus aureus infections, including methicillin-resistant strains, as second-line therapy in severe infections caused by susceptible strains in patients who have failed to respond or are allergic to other available antibiotics. — Treatment of neonatal sepsis when sensitivity testing indicates that other aminoglycosides cannot be used.

Dosing overview

The usual recommended intravenous dose of amikacin for adults and children is 15 mg/kg daily given in two or three equally divided doses. Solution infusions should be given over a 1 to 2 hour period. For neonates and premature infants, initiate treatment with a loading dose of 10 mg/kg followed by 7.5 mg/kg every 12 hours, with the maximum total daily dose not exceeding 15 mg/kg. For urinary tract infections other than pseudomonal infections, 500 mg/day in two equally divided doses is recommended.

Key safety warnings

Caution should be applied to patients with pre-existing renal insufficiency, pre-existing hearing or vestibular damage and diminished glomerular filtration. Treatment with amikacin for more than 14 days has not been established as being safe. Patients undergoing treatment with parenteral aminoglycosides should be under close clinical observation and evaluation because of the potential ototoxicity and nephrotoxicity associated with their use. Neurotoxicity manifested as vestibular and/or bilateral ototoxicity can occur in patients treated with aminoglycosides, with other manifestations including numbness, skin tingling, muscle twitching and convulsions. In patients treated at higher doses or those whose therapy is prolonged over 5-7 days of treatment, ototoxicity can occur even in healthy patients. Patients with impaired renal function have the highest risk of developing amikacin-induced ototoxicity. Amikacin Kabi contains trace amounts of sodium metabisulfite, which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is uncommon and probably low, although sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic subjects.

Contraindications

Aminoglycosides may impair neuromuscular transmission and should not be given to patients with myasthenia gravis. Amikacin Kabi is contraindicated in patients with a known history of hypersensitivity to amikacin, any constituents of the solution or in patients who may have subclinical renal or eighth nerve damage induced by prior administration of nephrotoxic and/or ototoxic agents. Amikacin Kabi is contraindicated in pregnancy and lactation.

Regulatory history

Amikacin Kabi received initial ARTG approval on 9 April 2024. Three strengths were registered: 250 mg/50 mL, 500 mg/100 mL, and 1000 mg/200 mL solution for injection bottles.