TOBRAMYCIN injection

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Baxter Healthcare Corporation

INN (Algemene Internationale Benaming):

TOBRAMYCIN SULFATE

Samenstelling:

TOBRAMYCIN 40 mg in 1 mL

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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. aeruginosa , 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 , Provi

Product samenvatting:

Tobramycin Injection, USP, in multiple dose vials, is supplied as follows: For Intravenous or Intramuscular Multiple‑Dose Use: AIN00238 NDC 36000-244-25;  40 mg/mL, 2 mL vial; Open blister pack of 25 Vials For Intravenous or Intramuscular Multiple‑Dose Use: AIN00239 NDC 36000-242-01;  40 mg/mL, 30 mL vial; Individual; pack of 01 Vials

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

TOBRAMYCIN- TOBRAMYCIN INJECTION
BAXTER HEALTHCARE CORPORATION
----------
TOBRAMYCIN
INJECTION, USP
Rx only
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.
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. Peak
and
trough serum concentrations of aminoglycosides should be monitored
periodically
during therapy to assure adequate levels and to avoid potentially
toxic levels