• Documents: GMP,COPP,CTD



Gentamicin is an aminoglycoside antibiotic with broad-spectrum bactericidal activity. It is indicated to treat severe infections caused by bacteria susceptible to gentamicin such as, but not limited to:

• Urinary tract infections

• Respiratory tract infections

• Intra-abdominal infections

• CNS infections

• Severe neonatal infections

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.

Consideration should be given to official local guidance on the appropriate use of antibacterial agents.

Dosage and Administration:

The dose depends on the severity of the clinical picture, the setting, the patient's renal function and the type of infection.  The dose is expressed in terms of the patient's body weight.

The recommended daily dose in adolescents and adults with normal renal function should preferably be given as a single dose, or else divided into 2 separate doses.

Recommended dose for adults and adolescents is 3-6 mg gentamicin / kg / day

Precautions & Warning:

Ototoxicity and nephrotoxicity

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.


Pseudomembranous colitis

Severe subcutaneous adverse reactions (SCARs)


Hypersensitivity to the active substance or to any of the excipients listed in the product

Myasthenia gravis

Drug interactions:

Ototoxicity and nephrotoxicity

Concurrent administration of gentamicin and other potentially ototoxic or nephrotoxic drugs should be avoided.

Neuromuscular blockade

Neuromuscular blockade and respiratory paralysis have been reported from administration of aminoglycosides to patients who have received curare-type muscle relaxants during anaesthesia.

The following combinations with gentamicin may require dose adjustment:

• Concomitant use of indomethacin possibly increases plasma concentrations of gentamicin in neonates.

• Concomitant use with oral anticoagulants may decrease thrombin levels and increase the risk of bleeding.

• Concomitant use of bisphosphonates with gentamicin may increase the risk of hypocalcaemia.

Storage instructions:

Do not Store above 25°C. Do not refrigerate or freeze. Store in the original package in order to protect from light.