GENTAMICIN- gentamicin sulfate injection, solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Fresenius Kabi USA, LLC

INN (Medzinárodný Name):

GENTAMICIN SULFATE

Zloženie:

GENTAMICIN 40 mg in 1 mL

Spôsob podávania:

INTRAMUSCULAR

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 gentamicin injection to be effective in bacterial neonatal sepsis; bacterial septicemia and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns). Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity. Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin. Gentamicin injection may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection and the important additional concepts contained in the BOXED WARNINGS. If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted. In serious infections when the causative organisms are unknown, gentamicin injection may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued. Gentamicin injection has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for treatment of endocarditis caused by group D streptococci. Gentamicin injection has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, gentamicin injection may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use. It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms. In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin. Hypersensitivity to gentamicin is a contraindication to its use. A history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of the known cross-sensitivity of patients to drugs in this class.

Prehľad produktov:

Gentamicin Injection, USP, containing gentamicin 40 mg per mL is supplied as follows: Also available, Gentamicin Injection (Pediatric), 20 mg per 2 mL (10 mg per 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]. The container closure is not made with natural rubber latex. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 45855K Revised: October 2023

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

GENTAMICIN - GENTAMICIN SULFATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
GENTAMICIN INJECTION, USP
Rx only
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 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 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 wit