GENTAMICIN SULFATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medical Purchasing Solutions, LLC

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin and other antibacterial drugs, gentamicin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Gentamicin Sulfate Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa , Proteus species (indole-positive and indole-negative), Escherichia coli , Klebsiella-Enterobacter-Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative). Clinical studies have

Product summary:

Gentamicin Sulfate Injection, USP containing gentamicin 40 mg/mL is supplied as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GENTAMICIN SULFATE- GENTAMICIN SULFATE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
GENTAMICIN SULFATE
Injection, USP
80 MG/2 ML
(40 MG/ML AS GENTAMICIN)
FOR INTRAVENOUS INFUSION OR
INTRAMUSCULAR INJECTION
CAUTION: MUST BE DILUTED FOR INTRAVENOUS USE.
FLIPTOP VIAL
Rx only
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF GENTAMICIN AND OTHER ANTIBACTERIAL DRUGS, GENTAMICIN
SHOULD
BE USED ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR
STRONGLY
SUSPECTED TO BE CAUSED BY BACTERIA.
WARNINGS
Patients treated with aminoglycosides should be under close clinical
observation
because of the potential toxicity associated with their use.
As with other aminoglycosides, Gentamicin Sulfate Injection, USP is
potentially
nephrotoxic. The risk of nephrotoxicity is greater in patients with
impaired renal
function and in those who receive high dosage or prolonged therapy.
Neurotoxicity manifested by ototoxicity, both vestibular and auditory,
can occur in
patients treated with Gentamicin Sulfate Injection, USP, primarily in
those with pre-
existing renal damage and in patients with normal renal function
treated with higher
doses and/or for longer periods than recommended.
Aminoglycoside-induced
ototoxicity is usually irreversible. Other manifestations of
neurotoxicity may include
numbness, skin tingling, muscle twitching and convulsions.
Renal and eighth cranial nerve function should be closely monitored,
especially in
patients with known or suspected reduced renal function at onset of
therapy and
also in those whose renal function is initially normal but who develop
signs of renal
dysfunction during therapy. Urine should be examined for decreased
specific
gravity, increased excretion of protein, and the presence of cells or
casts. Blood
urea nitrogen, serum creatinine, or creatinine clearance should be
determined
periodically. When feasible, it is recommended that serial audiograms
be obtained in
patients old enough to be tested, particularly high-risk patients.
Eviden