TOBRAMYCIN injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fosun Pharma USA Inc

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Tobramycin for injection, USP, is available as: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. This container closure is not made with natural rubber latex. Distributed by: Fosun Pharma USA Inc. Princeton, NJ 08540 Made in India. April 2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TOBRAMYCIN- TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
FOSUN PHARMA USA INC
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TOBRAMYCIN FOR INJECTION USP
PHARMACY BULK PACKAGE —NOT FOR DIRECT INFUSION
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.
BOXED WARNING
Patients treated with Tobramycin for 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 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 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
perio