GENTAMICIN Eye / Ear drops Ref.[6851] Active ingredients: Gentamicin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: FDC International Ltd, Unit 6 Fulcrum 1, Solent Way, Whiteley, Fareham, Hants, PO15 7FE

Pharmacodynamic properties

Gentamicin is a mixture of antibiotic substances produced by the growth of micromonospora purpurea. It is bactericidal with greater antibacterial activity than streptomycin, neomycin or kanamycin.

Gentamicin exerts a number of effects on cells of susceptible bacteria. It affects the integrity of the plasma membrane and the metabolism of RNA, but it’s most important effect is inhibition of protein synthesis at the level of the 30s ribosomal subunit.

Pharmacokinetic properties

Gentamicin is not readily absorbed from the gastro-intestinal tract. Gentamicin is 70-85% bound to plasma albumin following administration and is excreted 90% unchanged in urine. The half-life for its elimination in normal patients is 2 to 3 hours.

Effective plasma concentration is 4-8ug/ml.

The volume of distribution (VD) is 0.3 1/kg.

The elimination rate constant is;

0.02 Hr-1 for anuric patients*

0.30 Hr-1 normal.

* Therefore in those with anuria care must be exercised.

Preclinical safety data

Nothing of relevance which is not included in other sections of the SPC.

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