Kanamycin

 Kanamycin Sulphate (Km)

Kanamycin/
Kanamycin is an aminoglycoside antibiotic used to treat several bacterial infections. It is used to treat multi-drug resistant TB as well.

Kanamycin, discovered in 1957, 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.

Kanamycin is used as part of South Africa’s standard regimen for treatment of MDR TB.

 

Dosage:

Adults:

Adults with liver damage -

creatinine clearance < 30 ml/min:

Children:

15 – 20 mg/kg daily

(max dose 1000 mg)

12 – 15 mg/kg two or three times per week

15 – 30 mg/kg daily

(max dose 1000 mg)

Kanamycin is administered via injection for at least six months during the intensive phase of treatment. When necessary, Kanamycin may be continued during the continuation phase, administering the same dose 2 to 3 times weekly.

 

How it works:

Kanamycin is an aminoglycoside antibiotic isolated from Streptomyces kanamyceticus. Kanamycin inhibits protein synthesis by binding to the 70S ribosomal unit, making TB unable to grow.

 

Side effects:

Injectables including kanamycin can cause damage to the kidneys. Creatine levels should be monitored in patients with kidney damage. Kanamycin is generally safe in patients with liver disease; however, it should be used with caution, as it may cause rapid progression of hepatorenal syndrome (kidney failure in a person with cirrhosis of the liver) in patients with severe liver disease.Kanamycin can cause also cause loss of hearing, dizziness, peripheral neuropathy, pain at the injection site and rashes.

Kanamycin should not be taken during pregnancy, unless as a last resort, as it may cause deafness in the infant. Kanamycin is secreted in breast milk but is not contraindicated during breastfeeding.

 

Clinical evidence and approval:

Kanamycin is indicated for short term treatment of serious infections including chronic bacterial infections.

A prospective, uncontrolled study of 39 pulmonary tuberculosis patients found that a regimen consisting of ethionamide, isoniazid, PAS and cycloserine and kanamycin appears to be effective and safe. Out of 39 patients, 29 (74.3%) achieved sputum conversion within six months and remained so at the end of two years.1

The use of kanamycin is recommended after failure of capreomycin but before treatment with amikacin. Isolates acquiring resistance to kanamycin show different levels of cross-resistance to amikacin and capreomycin.2

 

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

SA Public sector

1g/ 3 ml

R11.50

SA Private sector

100mg/5ml suspension

R88.71

1 g/3ml

R17.00

Global Drug Facility3

1 g/4ml injection

R17.47 US$2.58

* 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 in 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:

Today, only three kanamycin products approved by a stringent regulatory authority have been identified. No sources of kanamycin are approved through WHO Prequalification, although one manufacturer (Macleods) has submitted a dossier to WHO Prequalification and has been accepted for evaluation.

Despite this, the supply of kanamycin remains vulnerable to disruption. Only one company (APP Pharma) has an active registration in the US - but they have not had any production since February 2009 due to the relocation of the API manufacturer. In the EU, there is only one approved manufacturer (Panpharma) but in 2010 they had a problem with the API, resulting in an interruption in supply. As this was the only quality-assured source available to GDF at the time, this resulted in a significant problem for GLC-approved programmes and other treatment providers. The problem has been rectified but capacity issues remain.

In reaction to the potential shortage of quality-assured kanamycin, GDF identified an alternative source in Japan (Meiji). While this has helped to ensure continual supply while Panpharma was not in production, Meiji has limited production capacity and the price is considerably more than the Panpharma product. The supply is also reserved for GDF, leaving other treatment providers with no alternative quality-assured sources.

Additional manufacturers may exist in China, India, the former Soviet Union, and other countries, but whether they comply with WHO quality standards is unknown.4

Source: MSF

1 R Prasad et al. Efficacy and safety of kanamycin, ethionamide, PAS and cycloserine in multidrug-resistant pulmonary tuberculosis patients. Indian J Chest Dis Allied Sci. 2006 Jul-Sep;48(3):183-6.

2 JA Caminero et al. Best drug treatment for multidrug-resistant and extensively drug-resistant tuberculosis. Lancet Infect Dis. 2010 Sep;10(9):621-9.

3 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.

4 MSF. DR TB drugs under the microscope. March 2011.

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By Catherine Tomlinson

Published: July 1, 2011, 6:20 p.m.

Last updated: Sept. 6, 2011, 4:06 p.m.

Tags: Treatment

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