GENTAMICIN SULFATE- gentamicin solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

VetTek

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 disc 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 SOLUTION
VETTEK
----------
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 aminoglycoside 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. 1Gentamicin
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.2 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
gentamicin sulfate
20 mg/kg/day for 24 days; in cats given 10
mg/kg/day for 40 days. G