Amikacin
Amikacin is used as part of a treatment regimen, usually involving 5 medicines to treat MDR TB. It is part of a group of medicines called injectables. The discovery of amikacin was published in 1976 by the Bristol-Banyu research institute in Japan.
Dosage:
Adults: |
Adults with liver damage - creatinine clearance < 30 ml/min: |
Children: |
15 – 20 mg/kg |
12 – 15 mg/kg two or three times per week |
N/A |
Rotate the injection site to avoid discomfort. |
||
When necessary it is possible to give the medicine 2 or 3 times weekly at the same total dose, with close monitoring for adverse events. |
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)
SA Public sector |
|
500mg/2ml for injection |
R5.31 |
SA Private sector |
|
500mg/2ml for injection |
R50.57 |
100mg/2ml for injection |
R17.79 |
250 mg/2ml for injection |
R34.43 |
Global Drug Facility[5] |
|
500mg/2ml solution for injection |
R8.13 US$1.20 |
* 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]
[1] F Tamas. Use of Amikacin and Amoxicillin-Clavulanic Acid Against Mycrobaterium Tuberculosis. Chest 1993;104;328b-328
[2] American Thoracic Society. Treatment of Tuberculosis Infection in Adults and Children. Journal of Respiratory and Critical Care Medicine Vol 149 1994.
[3] Best treatment
[4] JA Caminero et al. Best drug treatment for multidrug-resistant and extensively drug-resistant tuberculosis. Lancet Infect Dis. 2010 Sep;10(9):621-9.
[5] The procurement arm of the Green Light Committee, a mechanism started by the World Health Organisation and partners to expand access to quality assured TB medicines.
[6] MSF. DR TB drugs under the microscope. March 2011.