Descriptiojn: 

This product is clarity, or almost colorless clarity liquid.

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 its most important effects is inhibition of protein synthesis at the level of the 30s ribosomal subunit.

Therapeutic indications:

Gentamicin is an aminoglycoside antibiotic with broad-spectrum bactericidal activity. It is usually active against most strains of the following organisms: Escherichia coli, Klebsiella spp., Proteus spp. (indole positive and indole negative), Pseudomonas aeruginosa, Staphylococci, Enterobacter spp., Citrobacter spp and Providencia spp. Gentamicin injection and gentamicin paediatric injection are indicated in urinary-tract infections, chest infections, bacteraemia, septicaemia, severe neonatal infections and other systemic infections due to sensitive organisms.

Adverse drug reactions:

Side-effects include vestibular damage or hearing loss, particularly after exposure to ototoxic drugs or in the presence of renal dysfunction. Nephrotoxicity (usually reversible) and occasionally acute renal failure, hypersensitivity, anaemia, blood dycrasias, purpura, stomatitis, convulsions and effects on liver function occur occasionally. Rarely hypomagnesia on prolonged therapy and antibiotic–associated colitis have been reported.

Nausea, vomiting and rash have also been reported. Central neurotoxicity, including encephalopathy, confusion, lethargy, mental depression and hallucinations, has been reported in association with gentamicin therapy but this is extremely rare.

Contra-indications:

Hypersensitivity; Myasthenia Gravis.

Precautions and warnings

Ototoxicity has been recorded following the use of gentamicin. Groups at special risk include patients with impaired renal function, infants and possibly the elderly. Consequently, renal, auditory and vestibular functions should be monitored in these patients and serum levels determined so as to avoid peak concentrations above 10mg/l and troughs above 2mg/l. As there is some evidence that risk of both ototoxicity and nephrotoxicity is related to the level of total exposure, duration of therapy should be the shortest possible compatible with clinical recovery. In some patients with impaired renal function there has been a transient rise in blood-urea-nitrogen which has usually reverted to normal during or following cessation of therapy. It is important to adjust the frequency of dosage according to the degree of renal function. Gentamicin should only be used in pregnancy if considered essential by the physician.

Gentamicin should be used with care in conditions characterised by muscular weakness. In cases of significant obesity gentamicin serum concentrations should be closely monitored and a reduction in dose should be considered.

Interactions with other pharmaceuticals and other interactions

Concurrent administration of gentamicin and other potentially ototoxic or nephrotoxic drugs should be avoided. Potent diuretics such as etacrynic acid and furosemide are believed to enhance the risk of ototoxicity whilst amphotericin B, cisplatin and ciclosporin are potential enhancers of nephrotoxicity. Any potential nephrotoxicity of cephalosporins, and in particular cephaloridine, may also be increased in the presence of gentamicin. Consequently, if this combination is used monitoring of kidney function is advised. Neuromuscular blockade and respiratory paralysis have been reported from administration of aminoglycosides to patients who have received curare-type muscle relaxants during anaesthesia. Indometacin possibly increases plasma concentrations of gentamicin in neonates. Concurrent use with oral anticoagulants may increase the hypothrombinanaemic effect. Concurrent use of bisphosphonates may increase the risk of hypocalcaemia.

Concurrent use of the Botulinum Toxin and gentamicin may increase the risk of toxicity due to enhanced neuromuscular block. Antagonism of effect may occur with concomitant administration of gentamicin with either neostigmine or pyridostigmine.

Pregnancy and lactation:

There are no proven cases of intrauterine damage caused by gentamicin. However, in common with most drugs known to cross the placenta, usage in pregnancy should only be considered in life threatening situations where expected benefits outweigh possible risks.

In the absence of gastro-intestinal inflammation, the amount of gentamicin ingested from the milk is unlikely to result in significant blood levels in breast-fed infants.

Overdosage and other misuse:

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.

Storage:

Store in a dry place below 25 °C.

Protect from light.

Keep out of reach of children.

 

 

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