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Gentamicin Sulfate
( Ampoules )

Composition:
Each 1 ml ampoule contains:
Gentamicin ( as sulfate ) 40 mg
Each 2 ml ampoule contains Gentamicin ( as sulfate ) 80 mg

Properties:
Gentamicin is a bactericidal antibiotic, acting by inhibiting normal protein synthesis
in susceptible microorganisms. It is effective against many strains of Gm-ve bacteria, including species of Campylobacter, Escherichia, klebsiella, Proteus, Pseudomonas. Gentamicin is also active against some Gm+ve organisms as most strains of Staphylococcus aureus are highly sensitive to Gentamicin (including penicillin - resistant strains).

After intramuscular administration, peak plasma concentration occurs within 30 - 60 minutes, and serum levels remain for 6 - 8 hours. Similar concentrations are obtained following intravenous administration.
Following parenteral administration, Gentamicin diffuses mainly into extracellular fluids as perilymph of inner ear. However there is little diffusion into CSF and eye. The drug can cross the placenta & little amount is excreted in breast milk. The plasma half-life for Gentamicin is 2 - 3 Hours, it is longer in neonates and in patients with renal impairment. The drug is excreted virtually unchanged in the urine.

Indications:
Treatment of serious infections as bacterial neonatal sepsis, bacterial septicemia.
Serious bacterial infections of urinary tract, respiratory tract, GIT (including peritonitis), skin, bone and soft tissue.
Serious staphylococcal infections, as neonatal staphylococcal pneumonia.

Contraindications:
Known history of allergy to Gentamicin or other aminoglycosides.
Patients with myasthenia gravis.

Use during Pregnancy:
Gentamicin is contraindicated during pregnancy as it crosses the placenta causing congenital abnormalities.

Precautions:
The dose of Gentamicin should be reduced in patients with impaired renal function.
Patients should be well hydrated during treatment & dehydration should be excluded before therapy.

Side Effects:
Nephrotoxicity: mainly when large doses of Gentamicin are given.
Neurotoxicity : when very large doses are given for a long time in patients with renal impairment.
Ototoxicity : in the form of vestibular damage.
Other rare effects as lethargy, confusion, visual disturbances and decreased appetite may occur.

Dosage:
By intramuscular or by slow intravenous injection over at least 3 minutes or by intravenous infusion.
Adults:

2 - 5 mg / kg daily (in divided doses every 8 hours).
In renal impairment the interval between successive doses should be:
Every 12 hours when the rate of creatinine clearance is 30-70 ml/min.
Every 24 hours when the rate of creatinine clearance is 10 - 30 ml / min.
Every 48 hours when the rate of creatinine clearance is 5 - 10 ml / min.
Twice - weekly after dialysis at rate of creatinine clearance less than 5 ml / min.
Infants:
Up to 2-weeks : 3 mg / kg every 12 hours.
From 2 weeks up to 12 years: 2 mg / kg every 8 hours.

Storage:
Keep at temp. not exceeding 30ºC.
Keep medicine out of reach of children.

Presentation:
Box of 6 ampoules (1 ml) & 100 ampoules (1 ml) .
Box of 3 ampoules (2 ml) & 100 ampoules (2 ml) .
Box of 10 ampoules (2 ml).

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