AMIKACIN INJECTION 500MG

What is Amikacin injection? Amikacin injection contains the active substance amikacin, which belongs to a class of antibiotics called Aminoglycosides. It is used to treat certain serious bacterial infections.

ACTIVE INGREDIENT

Each 2ml ampoule contains 500mg Amikacin (as Amikacin sulfate BP)

INDICATIONS

It is indicated for the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. It is effective in bacterial septicemia (including neonatal sepsis); in serious infection of the respiratory tract, bones and joints, CNS (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis), complicated and recurrent urinary tract infection due to susceptible Gram-negative organisms.

CONTRAINDICATIONS

Amikacin injection is contraindicated in patients with hypersensitivity to aminoglycosides or any other component of this formulation.

DOSAGE AND ADMINISTRATION

Adults and children:

15mg/kg in two equally-divided doses (equivalent to 500mg bid in adults).

Neonates and premature children:

An initial loading dose of 10mg/kg followed by 15mg/kg/day in two equally divided doses

Elderly

Doses should be adjusted under impaired renal function

Life-threatening infection and/or those caused by pseudomonas

The adult dose may be increased to 500mg every eight hours but should neither exceed 1.5g/day not be administerd for a period longer than 10days. A maximum total adult dose of 1.5g should not be exceeded.

Urinary tract infection (other than pseudomonal infections):

7.5mg/kg/day in two equally divided doses (equivalent to 250mg bid in adults)

Renal impairment

Administration

Intramuscular (IM) or intravenous administration (IV)

Intramuscular route is preferred in most infections

Intravenous route may be used life threatening infections or in patients in who the IM route is not feasible.

Intraperitoneal use:

Amikacin may be used as an irrigant after recovery from anesthesia in concentration of 0.25%

Other routes:

Amikacin in concentration of 0.25% may be used satisfactorily as an irrigating solution in abscess cavities, the pleural space, the peritoneum and the cerebral ventricles

ADDED INFORMATION

Patients should be well hydrated to minimize chemical irritation of the renal tubules

Monitoring of renal function during treatment with aminoglycosides is very essential

CAUTION

The main side effects of the aminoglycosides are dose-related. Care must therefore be taken with dosage.

If possible, dehydration should be corrected by starting this medication and other aminoglycosides.

POSSIBLE SIDE EFFECTS

When the recommended precautions and dosages are followed the incidence of toxic reactions, such as tinnitus, vertigo, and partial reversible or irreversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting is low. Urinary signs of renal irritation, azotemia and oliguria have been reported.

STORAGE

Store at temperatures not exceeding 25°C.