Amikacin

Dosage:

How it works:

Amikacin is an aminoglycosideantibiotic. It inhibits protein synthesis by binding to the 70S ribosomal unit, making TB unable to grow.

Side effects:

Injectables including amikacin can cause damage to the kidneys. Creatine levels should be monitored in patients with kidney damage. Amikacin can cause also cause loss of hearing, dizziness, peripheral neuropathy, pain at the injection site and rashes.

Amikacin may cause hypokaelemia (abnormally low levels of potassium in the blood) hypomagnesemia (abnormally low levels of magnesium in the blood). Symptoms can include muscle weakness, cramps, paralysis, tremors and an abnormal heart beat.

Amikacin should not be taken during pregnancy, unless as a last resort, as it may cause deafness in the foetus. Small amounts of amikacin are secreted in breast milk but it is not contraindicated during breast feeding.

Clinical evidence and approval:

Amikacin is indicated in the short term treatment of serious infections due to susceptible strains of Gram negative bacteria [MSF]. Theuse of amikacin for the treatment of MDR TB was first suggested in Hungary in 1993. Successful in-vitro studies led doctors to suggest using amikacin combined with amoxicillin-clavulanic acid in the treatment of MDR TB.[1] In 1994 the Center for disease control stated that amikacin showed strong in-vitro activity against MDR TB.[2]

Of the three injectables recommended for drug resistant TB, amikacin is the most widely available. However it is the least preferred because of possible cross resistance and the increased risk of adverse events compared with other injectables.[3]

Most isolates acquiring amikacin resistance are also resistant to kanamycin and capreomycin. Isolates acquiring resistance to capreomycin are usually susceptible to kanamycin and amikacin and isolates acquiring resistance to kanamycin show different levels of cross-resistance to amikacin and capreomycin.[4]

Pricing (per lowest unit, i.e. single tablet or injection)

* Private sector prices sourced on 26/07/11. Global Drug Facility prices converted to rands on 26/07/11.

* Private and public sector prices may vary between suppliers. The lowest available prices are shown here.

Advocacy issues:

·         Further research is needed to establish safety and efficacy of infants. Further research is needed to establish safety and efficacy when combined with antiretrovirals that may cause renal failure such as tenofovir. [MSF]

Manufacturers and suppliers:

Several companies have amikacin approved by stringent regulatory authorities. In addition, in January2011, the first generic amikacin from Cipla was prequalified by WHO. A further Indian manufacturer (Micro Labs) is expected to submit a dossier to WHO Prequalification during the course of 2011. There are multiple sources of quality assured amikacin, possibly because other approved indications of use exist for the drug. The supply of amikacin is therefore secure.[6]