GENTAMICIN SULFATE- gentamicin intra-uterine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)

Available from:

MWI/VetOne

INN (International Name):

GENTAMICIN SULFATE

Composition:

GENTAMICIN 100 mg in 1 mL

Administration route:

INTRAUTERINE

Prescription type:

PRESCRIPTION

Therapeutic indications:

Gentamicin Sulfate Solution is recommended for the control of bacterial infections of the uterus (metritis) in horses and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.  Bacteriologic studies should be conducted to identify the causative organism and to determine its sensitivity to gentamicin sulfate. Sensitivity discs of the drug are available for this purpose. There are no known contraindications to this drug when used as directed.

Product summary:

Gentamicin Sulfate Solution, 100 mg per mL for intrauterine use, is available in 100 mL and 250 mL multiple dose vials.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

GENTAMICIN SULFATE- GENTAMICIN INTRA-UTERINE SOLUTION
MWI/VETONE
----------
GENTAMICIN SULFATE SOLUTION 100 MG/ML
FOR USE IN HORSES ONLY
NOT FOR USE IN HUMANS
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
DESCRIPTION
Each mL of Gentamicin Sulfate Solution contains gentamicin sulfate
veterinary equivalent
to 100 mg gentamicin base; 2.4 mg sodium metabisulfite; 0.8 mg sodium
sulfite,
anhydrous; 0.1 mg edetate disodium; 10 mg benzyl alcohol as
preservative; water for
injection q.s.
CHEMISTRY: GENTAMICIN IS A MIXTURE OF AMINGLYCOSIDE ANTIBIOTICS
DERIVED
FROM THE FERMENTATION OF_ MICROMONOSPORA PURPUREA_. GENTAMICIN SULFATE
IS A
MIXTURE OF SULFATE SALTS OF THE ANTIBIOTICS PRODUCED IN THIS
FERMENTATION. THE
SALTS ARE WEAKLY ACIDIC, FREELY SOLUBLE IN WATER, AND STABLE IN
SOLUTION.
ANTIBACTERIAL ACTIVITY:_ In Vitro_ antibacterial activity has shown
that gentamicin is
active against most gram-negative and gram-positive bacteria isolated
from domestic
animals.
Gentamicin is active against _Pseudomonas aeruginosa_, indole-positive
and -
negative_ Proteus_ species, _Escherichia coli_,_ Klebsiella_ species,
_Enterobacter _species,
_Alcaligenes _species, _Staphylococcus _species, and _Streptococcus
_species.
PHARMACOLOGY: Studies in man indicate that recommended doses of
gentamicin
produce serum concentrations bactericidal for most bacteria sensitive
to gentamicin
within an hour after intramuscular injection; these concentrations
last for 6 to 12
hours.
Some 30% of the administered dose of gentamicin is bound by serum
proteins
and released as the drug is excreted.
Gentamicin is excreted almost entirely by glomerular filtration. High
concentrations of
the active form are found in the urine. Fifty to 100% of the
gentamicin injected can be
recovered unchanged within 24 hours from the urine of patients with
normal renal
function. A small amount is excreted into the bile.
TOXICITY STUDIES: No toxic effects were observed in rats given
getnamicin sulfate 20
mg/kg/day for 24 days; in ca