Gentamicin Ampoules
U.S.P.XXII
Aminoglycosides Composition:
- Each 0.5 ml ampoule contains:
Gentamicin (as sulphate) 20 mg.
- Each 1 ml ampoule contains:
Gentamicin ( as sulphate) 40 mg.
- Each 2 ml ampoule contains:
Gentamicin (as sulphate) 80 mg. Properties :
Gentamicin is an aminoglycoside antibiotic with a bactericidal activity interfering with the synthesis of bacterial protein.
Antimicrobial action:
Gentamicin is active against:
Gram negative bacteria : Brucella, Citrobacter, Enterobacter,
Escherichia coli, Klebsiella, Pseudomonads , Proteus, Serratia, Vibrio
and Yersinia.
Gram positive bacteria: many strains of staphylococcus aureus are
highly sensitive. Pharmacokinetics :
Gentamicin is rapidly and completely absorbed after I.M. injection.
Diffusion occurs mainly in extracellular fluids but C.S.F. diffusion is
poor.
Half life of gentamicin is about 2-3 hours but may be much longer
in neonates and in renal impairment .
Plasma protein binding is usually low.
Excretion is mainly renal as unchanged drug within 24 hours, thus
providing high concentrations in urine. Indications & usage :
Gentamicin is used principally for the treatment of severe systemic
life threatening infections or infections caused by organisms resistant to
other antibiotics:
Neonatal sepsis and septicemia .
Urinary tract infections .
Biliary tract and gastro - intestinal infections
Otitis media and pneumonia
Skin, bone and soft tissue infections including burns, peritoneal
infections and pelvic infections.
[
Cat scratch disease and brucellosis
Gentamicin is usually used in combination with other antibiotics as
in the treatment and prophylaxis of endocarditis or infections due to
Pseudomonas aeruginosa .
In meningitis intrathecal , gentamicin is indicated as an adjunctive
therapy with systemic Gentamicin . Contra-indications :
In patients allergic to gentamicin
Patients hypersensitive to other amino glycosides may contraindicate
the use of Gentamicin , because of cross sensitivity. Side effects :
Nephrotoxicity is unusual
Neurotoxicity, manifested as ototoxicity, is rare in normal
individuals.
The incidence of such side effects is directly related to the duration of
treatment ( > 10 days ) and to the amount of drug used .
Hypersensitivity reaction may occur Drug interactions :-
Use of other nephrotoxic drugs , including other amino glycosides , vancomycin , some cephalosporins , cyclosporine , cisplatin and fludarabine , or potentially ototoxic drugs such as etacrynic acid , and perhaps furosemide may increase the risk of gentamycin toxicity
An antiemetic such as dimethyldrinate may mask the early symptoms of vestibular toxicity .
Neuromuscular – blocking properties of gentamycin may be provoke sever respiratory depression in patients receiving general anesthetics . or opoids Warnings & precautions:
In renal impairment the dosage should be adjusted , and monitoring
of blood level is necessary.
Gentamicin should be discontinued if ringing, a sensation of fullness
in the ears or any hearing loss occurs.
Pregnancy: damage to the 8th cranial nerve of the fetus may occur.
Caution should be observed in patients with dehydration, myasthenia
gravis, parkinsonism or muscular weakness.
The product contains sodium metabisulphite , in sensitive individual
and particularity in asthmatics this substance may cause allergic reactions
and severe asthmatic attacks .
Antibacterial effects of gentamycin could be reduced by bacteriostatic
antibacterial .
Gentamycin exhibits a synergistic action with a number of beta lactams in vivo. Dosage & administration:
Adults:
Usual dose : Intramuscular or intravenous infusion
3 to 5 mg / kg B.W. / day in divided doses every 8 hours
( 1 to l.7mg /kg B.W. every 8 hours)
- Urinary tract infections : 80 mg every 12 hours.
- Serious systemic infections : 80 mg every 8 hours.
- Life threatening infections : 80 mg every 6 hours,
and up to 5 mg /kg b. w. day.
Reduce dosage as soon as clinically indicated . Pediatric dose:
- Intramuscular or intravenous infusion .
- Premature or full term neonates up to 1 week of age:
2.5 mg/ kg B.W. every 12 or 8 hours
- Older neonates or infants:
7.5 mg/ kg B.W. / day (2.5 mg /kg every 8 hours)
Children:
6 to 7.5 mg /kg B.W /day (2.0 to2.5 mg / kg every 8hours)
The course of treatment , generally, should be limited to 7 - 10 days
Packing
Gentamicin 20 mg. Box of 3 or 100 ampoules each 0.5 ml.
Gentamicin 40 mg. Box of 3 or 100 ampoules each 1 ml.
Gentamicin 80 mg. Box of 3 or 100 ampoules each 2 ml. | 
