Plot 8, Block ‘M’, Abimbola Street, Isolo, P.O.Box, 3344, Mushin, Lagos State.
Lek Pharm. & Chem. Co. D. D., Verouskova 57, 1526 Ljubljana, Slovenia.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Injection (NRN: 04-0220): Gentamicin sulphate 80 mg per 2 mL.
Pack size: ampoules in boxes of 10's; 50's
Eye/Ear Drop (NRN: 04-0225): Gentamicin sulphate 3 mg per mL.
Pack size: 5 mL.
Ointment (NRN: 04-1067): Gentamicin.
Pack size: 15 g tube.
Gentamicin is a broad-spectrum bactericidal antibiotic in the aminoglycoside group active against gram-positive and gram-negative bacteria. It is particularly effective in the treatment of infections due to gram-negative organisms.
Gentamicin is readily absorbed, reaching peak plasma levels 30 to 90 minutes after IM injection. Therapeutic blood levels are measurable for 6 to 8 hours. About 90% of gentamicin is excreted unchanged in urine by glomerular filtration.
Gentamicin is indicated in the treatment of serious infections such as:
- Septicemia (including neonatal sepsis)
- Severe complicated and recurrent urinary tract
- Infections of the lower respiratory tract
- Infections of the gastrointestinal tract (including peritonitis)
- Infections of the skin, bones, soft tissues, and burns
- Infections of the central nervous system (including meningitis)
Gentamicin is the drug of choice in the treatment of severe bacterial infections caused by unknown or unidentified agents; mixed infections; infections accompanying diseases severely affecting the human resistance (leukemia, diabetes, corticosteroid therapy, etc).
Hypersensitivity to gentamicin.
Evidence of impaired renal function and auditory or vestibular damage requires discontinuation of gentamicin therapy or, exceptionally, dosage adjustment only.
Caution is required in the premature and neonates as their kidneys are not fully developed yet and may therefore prolong biological half-life of the drug.
In case of overdosage or toxic reactions, peritoneal dialysis or hemodialysis may be applied in the removal of gentamicin from the blood.
Serum concentrations of gentamicin should be monitored so that the levels above 10 micrograms per millilitre are avoided.
Concurrent or sequential use of other neurotoxic and nephrotoxic drugs, in particular streptomycin, neomycin, kanamycin, tobramycin, cephaloridine, paromomycin, viomycin, polymixin B or colistin, is not recommended. The concurrent use of gentamicin with potent diuretics should be avoided since they may enhance aminoglycoside toxicity.
Neuromuscular blockade and respiratory paralysis may occur following concomitant use of gentamicin and neuromuscular blocking agent. Calcium and neostigmine may reverse neuromuscular blockade caused by succinylcholine and tubocurarine, respectively. Gentamicin is administered to a pregnant woman only for the treatment of life-threatening infection.
Nephrotoxicity or neurotoxicity may occur in patients treated with higher doses of gentamicin or for longer periods.
Other reported side effects: increased levels of serum transaminases, bilirubin, anemia, granulocytopenia, fever, rash, itching, urticaria, nausea, vomiting, headache, somnolence.
Dosage & Administration
Gentamicin can be given intramuscularly, intravenously, or subconjunctivally. The correct dosage is calculated on the basis of the patient's body weight. The usual duration of treatment is 7 to 10 days. Intramuscular administration to patients with normal renal function:
The usual daily dosage of gentamicin for patients with serious infections is 3 mg/kg body weight administered in two equal doses.
For patients with life-threatening infections the daily dosage is 5 mg/kg body weight administered in three or four equal doses. This dosage should be reduced to 3 mg/kg body weight daily as soon as clinically indicated.
Patients with urinary tract infections and normal renal function are given 1 ampoule of 120 mg or 1 ampoule of 160 mg daily, depending on the patient's body weight, for 7 to 10 days.
Children over 2 years of age with normal renal function:
The identical regimen as for adults. Depending on severity of the infection, the recommended dosage is 3 to 5 mg/kg body weight daily, administered in three equal doses. The dosage should be reduced to 3 mg/kg body weight as soon as clinically indicated.
Premature and neonates:
6 mg/kg body weight daily divided in two doses.
Infants and children up to 2 years of age are given the same dosage divided in three doses.
Intramuscular administration in patients with impaired renal function: doses are reduced and the interval between administrations of doses is prolonged.
Recommended dosage schedule:
Body weight Dose Renal function test
(Serum creatinine mg%)
Over 60 kg 80 mg less than 1.4 every 8 hours
1.4 - 1.9 every 12 hours
2.0 - 2.8 every 18 hours
2.9 - 3.7 every 24 hours
3.8 - 5.3 every 36 hours
5.4 - 7.2 every 48 hours
≤60 kg 60 mg as above as above
Patients with bacterial infection and requiring hemodialysis are given 1 mg of gentamicin per kg body weight at the end of each dialysis.
The doses are identical as for intramuscular administration. The usual volume of the diluents (sterile saline solution or 5% dextrose) is 100 to 200 mL for adults; and in children the volume of the diluents should be proportionately lowered.
Diluted solution should be infused over 1 to 2 hours. The concentration of gentamicin in the solution should not exceed 1 mg/mL (0.1%).
In the syringe gentamicin should not be mixed with other drugs.
Subconjunctival application: 10 to 20 mg of gentamicin, non-diluted or diluted in the equal volume of sterile saline solution.
Store at room temperature.
Protect from direct sunlight.
Store at room temperature.
Protect from direct sunlight.