TOBRAMYCIN- tobramycin sulfate injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

TOBRAMYCIN SULFATE (UNII: HJT0RXD7JK) (TOBRAMYCIN - UNII:VZ8RRZ51VK)

Tilgjengelig fra:

Fresenius Kabi USA, LLC

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: Septicemia in the neonate, child, and adult caused by P. aeruginosa , E. coli , and Klebsiella sp. Lower respiratory tract infections caused by P. aeruginos a, Klebsiella sp, Enterobacter sp, Serratia sp, E. coli , and S. aureus (penicillinase- and non-penicillinase-producing strains). Serious central-nervous-system infections (meningitis) caused by susceptible organisms. Intra-abdominal infections, including peritonitis, caused by E. coli , Klebsiella sp, and Enterobacter sp. Skin, bone, and skin-structure infections caused by P. aeruginosa , Proteus sp, E. coli , Klebsiella sp, Enterobacter sp, and S. aureus. Complicated and recurrent urinary tract infections caused by P. aeruginosa , Proteus sp (indole-positive and indole-negative), E. coli , Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus , Providencia sp, and Citrobacter sp. Aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the WARNINGS box above. To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. A hypersensitivity to any aminoglycoside is a contraindication to the use of tobramycin. A history of hypersensitivity or serious toxic reactions to aminoglycosides may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs in this class.

Produkt oppsummering:

Tobramycin Injection USP, in the Pharmacy Bulk Package, is supplied as follows: 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. Tobramycin Injection, USP, is also available in multiple dose vials: Lake Zurich, IL 60047 www.fresenius-kabi.com/us 45964H Revised: October 2023

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TOBRAMYCIN - TOBRAMYCIN SULFATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
TOBRAMYCIN INJECTION, USP
Rx only
PHARMACY BULK PAGKAGE---NOT FOR DIRECT INFUSION
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF TOBRAMYCIN AND OTHER ANTIBACTERIAL DRUGS, TOBRAMYCIN
SHOULD
BE USED ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR
STRONGLY
SUSPECTED TO BE CAUSED BY BACTERIA.
THIS VIAL IS INTENDED FOR USE BY THE HOSPITAL PHARMACIST IN THE
EXTEMPORANEOUS PREPARATION OF IV SOLUTIONS.
WARNINGS
Patients treated with Tobramycin Injection, USP and other
aminoglycosides should
be under close clinical observation, because these drugs have an
inherent potential
for causing ototoxicity and nephrotoxicity.
Neurotoxicity, manifested as both auditory and vestibular ototoxicity,
can occur.
The auditory changes are irreversible, are usually bilateral, and may
be partial or
total. Eighth-nerve impairment and nephrotoxicity may develop,
primarily in patients
having pre-existing renal damage and in those with normal renal
function to whom
aminoglycosides are administered for longer periods or in higher doses
than those
recommended. Other manifestations of neurotoxicity may include
numbness, skin
tingling, muscle twitching, and convulsions. The risk of
aminoglycoside-induced
hearing loss increases with the degree of exposure to either high peak
or high
trough serum concentrations. Patients who develop cochlear damage may
not
have symptoms during therapy to warn them of eighth-nerve toxicity,
and partial
or total irreversible bilateral deafness may continue to develop after
the drug has
been discontinued.
Rarely, nephrotoxicity may not become apparent until the first few
days after
cessation of therapy. Aminoglycoside-induced nephrotoxicity usually is
reversible.
Renal and eighth-nerve function should be closely monitored in
patients with known
or suspected renal impairment and also in those whose renal function
is initially
normal but who develop signs of renal dysfunction during therapy