GENTAMICIN- gentamicin sulfate injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Fresenius Kabi USA, LLC

प्रशासन का मार्ग:

INTRAMUSCULAR

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Injection, USP and other antibacterial drugs, Gentamicin Injection, USP 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 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 shown gentami

उत्पाद समीक्षा:

Gentamicin Injection, USP, containing gentamicin 40 mg/mL is supplied as follows: Product   No. NDC No. NP1020 63323-010-96    (40 mg/mL) 20 mL fill in a 20 mL flip-top vial, in packages of 25. Also available, Gentamicin Injection (Pediatric), 10 mg/mL, supplied in 2 mL (20 mg) vials in packages of 25. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. N+ and NOVAPLUS are registered trademarks of Novation, LLC.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

GENTAMICIN- GENTAMICIN SULFATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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GENTAMICIN INJECTION, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Gentamicin
Injection, USP and other antibacterial drugs, Gentamicin Injection,
USP should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
BOXED WARNING
Patients treated with aminoglycosides should be under close clinical
observation because of the
potential toxicity associated with their use.
As with other aminoglycosides, gentamicin injection is potentially
nephrotoxic. The risk of
nephrotoxicity is greater in patients with impaired renal function and
in those who receive high
dosage of prolonged therapy.
Neurotoxicity manifested by ototoxicity, both vestibular and auditory,
can occur in patients treated
with gentamicin, 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 (BUN), 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. Evidence of
ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears or
hearing loss) or nephrotoxicity
requires dosage adjustment or discontinuance of the drug. As with the
other