GENTAMICIN- gentamicin sulfate injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

Gentamicin Sulfate (UNII: 8X7386QRLV) (Gentamicin - UNII:T6Z9V48IKG)

Διαθέσιμο από:

General Injectables & Vaccines, Inc

INN (Διεθνής Όνομα):

Gentamicin Sulfate

Σύνθεση:

Gentamicin 40 mg in 1 mL

Οδός χορήγησης:

INTRAMUSCULAR

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 seps

Περίληψη προϊόντος:

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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

GENTAMICIN - GENTAMICIN SULFATE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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GENTAMICIN 40 MG/ML INJECTION, USP 20 ML MULTI DOSE VIAL
BOXED WARNING
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 highrisk 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 aminoglycosides, on rare occasions changes in renal and
eighth cranial
nerve function may not become manifest until soon after completion of
therapy.
Serum concentrations of aminoglycosides should be