Summary of medicine characteristics - GENTAMICIN EYE/EAR DROPS 0.3%W/V
4.1. Therapeutic Indications
4.9. Overdose
Haemodialysis and peritoneal dialysis will aid the removal from blood but the former is probably more efficient. Calcium salts given intravenously have been used to counter the neuromuscular blockade caused by gentamicin.
PHARMACOLOGICAL PROPERTIES
5.1. 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.
5.2 Pharmacokinetic properties
Topical application of Gentamicin can result in some systemic absorption. Treatment of large areas can result in plasma concentrations of up to 1 Lig/ml.
Gentamicin is not readily absorbed from the gastro-intestinal tract < 10% is bound to plasma protein.following administration and is excreted 90% in the urine by glomerular filtration. The half-life for its elimination in normal patients is 2 to 3 hours, but can be increased in cases of renal insufficiency.
Effective plasma concentration is 4 – 8ug/ml
The volume of distribution (VD) is 0.3 1/kg
5.3. Pre-clinical Safety Data
Nothing of relevance which is not included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium Chloride
Disodium Edetate
Sodium Metabisulphite
Borax
Benzalkonium Chloride solution
Water for Injection
Sodium Hydroxide soluion (pH adjuster)
Hydrochloric acid (pH adjuster)
6.2 Incompatibilities
None known.
6.3
Unopened:
Opened:
24 months
28 days
6.4. Special Precautions for Storage
Protect from light.
Store below 25°C
6.5 Nature and contents of container
10ml low density polyethylene bottle with polystyrene spiked cap.
6.6 Special precautions for disposal and other handling Not applicable.