TOBRAMYCIN injection

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Xellia Pharmaceuticals ApS

Designación común internacional (DCI):

TOBRAMYCIN SULFATE

Composición:

TOBRAMYCIN 1200 mg in 30 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Tobramycin for Injection, USP 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   spp Lower respiratory tract infections caused by P. aeruginosa, Klebsiella   spp, Enterobacter spp, Serratia spp, 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   spp, and Enterobacter spp Skin, bone, and skin structure infections caused by P. aeruginosa , Proteus spp, E. coli , Klebsiella spp, Enterobacter s pp, and S. aureus Complicated and recurrent urinary tract infections caused by P. aeruginosa , Proteus spp (indole-positive and indole-negative), E. coli , Klebsiella spp, Enterobacter spp, Serratia spp, S. aureus , P

Resumen del producto:

Tobramycin for Injection, USP Pharmacy Bulk Package, contains tobramycin sulfate equivalent to 1200 mg of tobramycin and supplied as follows: 45932-0027-1           1 bottle per carton 45932-0027-2           6 bottles per carton Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

TOBRAMYCIN - TOBRAMYCIN INJECTION
XELLIA PHARMACEUTICALS APS
----------
RX ONLY
THIS BOTTLE IS INTENDED FOR USE BY THE HOSPITAL PHARMACIST IN THE
EXTEMPORANEOUS PREPARATION OF INTRAVENOUS SOLUTIONS.
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF TOBRAMYCIN FOR INJECTION, 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.
WARNING
Patients treated with Tobramycin for Injection 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 preexisting
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 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