TOBRAMYCIN injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Hospira, Inc.

INN (International Name):

TOBRAMYCIN SULFATE

Sammensetning:

TOBRAMYCIN 10 mg in 1 mL

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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 pediatric patient 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-sy

Produkt oppsummering:

Tobramycin Injection, USP is available as: NDC 0409-3577-01 20 mg/2 mL 25 multiple-dose fliptop vials (pediatric) in a tray (10 mg/mL) NDC 0409-3578-01 80 mg/2 mL 25 multiple-dose fliptop vials in a tray (40 mg/mL) Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature.]

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TOBRAMYCIN- TOBRAMYCIN INJECTION, SOLUTION
HOSPIRA, INC.
----------
TOBRAMYCIN
Injection, USP
MULTIPLE DOSE
FLIPTOP VIAL
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 pot