Western Medicine Gentamicin injection (Gentemycin sulfate)
A.20.1.1 broad and medium spectrum antibiotics.
Gentamicin is a potent bactericidal antibiotic with a wide range of
activity against both Gram-positive and Gram-negative organisms.
Pseudomonas and Proteus organisms are in the main particularly
susceptible to the action of gentamicin as also are strains of
Staphylococcus resistant to other antibiotics.
Gentamicin injectable are indicated in the treatment of systemic
injections due to sensitive organisms.
Urinary Tract Infections:
Here,gentamicin's activity aganist some of the
troublesome,generally resistant Gramnegative bacilli is invaluable.
Especially to be mentioned are Pseudomonas and Proteus spp.which
are often difficult to eradicate.
Especially in those conditions in which the causative drgansims is
Gram-negative or resistant to other antibiotics.
Gentamicin is indicated in those cases of septicaemia due to
organisms resistant to other antibiotics.
Pseudomonas septicaemia has been treated successfully with
Where the most serious invading organisms,Pseudomonas and
Staphylococcus spp.,are both covered by the bactericidal activity
Empyema,Peritonitism,Infected Traumatic and Surgical Wounds:
In these cases,gentamicin is indicated if the organism is sensitive
only to gentamicin.Infection of the Gentral Nervous System:
Gentamicin has been used successfully in the treatment of
meningitis and ventriculitis due to Gram-negative organisms.
Should not be used during pregnancy except in life-threatening
DOSAGE AND DIRECTIONS FOR USE
80mg 8 hours for 7-10 days is usually an effective dose.If body
mass is less than 60kg,then 60mg 8 hourly should be used.
Children up to 12 years of age:6mg/kg in three divided doses.
Infants up to two weeks: 6mg/kg daily in two divided doses.
When a longer course to therapy is necessary or higher doses are
used,or where impaired renal function exists.there may be an
increased risk of vestibulotoxicity.In these cases,it is mandatory
to monitor peak serum levels.
KNOWN SYMPTOMS OF OVERDOSAGE ABND PARTICULARS OF ITS TREATMENT
In patients with renal impairment blood levels of higher than 10-12
ug/ml can lead to ototoxicity.This is reversible if observed in
time and dose adjusted.
Gentamicin 80mg injection is available in multidose 2 ml ampoules
each containing 80mg gentamicin (as sulphate).
Store below 25°C .
Protect heat and light.
KEEP OUT OF THE REACH OF CHILDREN
|Characteristics||A clear colorless solution||Conforms|
|Thin layer chromatography||Should Positive reaction||Positive|
|Loading capacity||Should not be less than the marked amount||Conforms|
|Volume in container||Meet the requirement||Conforms|
|Bacterial endotoxin||Not more than0.71USP/mg gentamicin||Conforms|
|Visible particles||Meet the requirement||Conforms|
|Sub-visible particles||Meet the requirement||Conforms|
|Sterility||Meet the requirement||Conforms|
|Assay:||Should be contain gentamycin sulfate 90.0%~125.0%||96.2%|
|Conclusions: The product complies with the requirements of USP