Amikacin Injection (DBL)

Generic Name: Amikacin sulfate
Product Name: Amikacin Injection (DBL)

Indication

Used for the short term treatment of severe infections caused by pathogens resistant to other aminoglycosides, such as Gram negative bacteria and S.aureus-including methicillin resistant strains.

Appropriate clinical scenarios might include: bacteraemia, septicaemia (including neonatal sepsis), and serious infections of the respiratory tract, bones and joints, central nervous system, skin and connective tissue, intra-abdominal organs, and urinary tract (complicated and recurrent).

Used for the treatment of Mycobacterial infections (tuberculous and non-tuberculous).

Action

Microbiology

Amikacin is a semisynthetic aminoglycoside antibiotic, and has a concentration dependent bactericidal effect. It is active against a variety of pathogens. Including:

Gram negative: Pseudomonas sp.; Proteus sp.; K.pneumoniae; E.cloacae; Serratia sp.; Providencia stuartii; Citrobacter freundii; E.coli.

Gram positive: Staphylococcus sp. (penicillinase and non-penicillinase producing, including methicillin resistant).

It is resistant to most of the bacterial enzyme inactivation responsible for poor sensitivity other aminoglycosides.

Pharmacology

Following intramuscular administration peak plasma concentrations are achieved with 45-120 minutes, and upon completion of intravenous infusion.

Amikacin distributes widely to most body compartments and fluids.

Plasma elimination half life in adults with normal renal function is 2-3 hours, and 30-86 hours in adults with severe renal impairment.Amikacin is almost entirely excreted, unchanged, in the urine within 24 hours.

Dose advice

Adult

16-24 mg/kg, once daily, OR in 2-3 divided doses.

Children > 10 years

18 mg/kg, once daily, OR 15 mg/kg/day in 2-3 divided doses.

Infants, Children < 10 years

22.5 mg/kg once daily, OR up to 7.5 mg/kg, daily, 5 times per week with other anti-infective agents.

Mycobacterial infections

15 mg/kg, daily, 5 times per week, with other anti-infective agents.

Urinary tract infections

500 mg/day, in two equally divided doses.

Patients with impaired renal function

Dose or dose interval should be adjusted to avoid drug accumulation. Dosage interval may be calculated using the formula below:

Dosage interval (hours) = Serum creatinine concentration (mmol/L) x 101.8

Amikacin should not be used in pregnant or breastfeeding women.

Schedule

S4

Common side effects

• Nausea
• Vomiting
• Vertigo
• Nystagmus
• Non-oliguric renal impairment
• Nephrotoxicity occurs in patients with prolonged exposure (>7-10 days), and is generally reversible
• Hearing loss
• Tinnitus
• Feeling of fullness in ear

Uncommon side effects

As above

For further information talk to your doctor.