GENTAMICIN SULFATE injection solution concentrate

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)

Verfügbar ab:

Hospira, Inc.

INN (Internationale Bezeichnung):

GENTAMICIN SULFATE

Zusammensetzung:

GENTAMICIN 10 mg in 1 mL

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

GENTAMICIN SULFATE- GENTAMICIN SULFATE INJECTION, SOLUTION,
CONCENTRATE
HOSPIRA, INC.
----------
GENTAMICIN SULFATE
Injection, USP
10 MG GENTAMICIN/ML
FOR INTRAVENOUS INFUSION
ONLY AFTER DILUTION
THE VIAL CONTAINS GENTAMICIN SULFATE INJECTION, USP
EQUIVALENT TO 60, 80, OR 100 MG GENTAMICIN.
ADD-VANTAGE™ VIAL
Rx only
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
GENTAMICIN AND OTHER ANTIBACTERIAL DRUGS, GENTAMICIN SHOULD BE USED
ONLY TO TREAT OR PREVENT
INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY
BACTERIA.
WARNINGS
Patients treated with aminoglycosides should be under close clinical
observation because of the
potential toxicity associated with their use.
As with other aminoglycosides, gentamicin sulfate is potentially
nephrotoxic. The risk of
nephrotoxicity is greater in patients with impaired renal function and
in those who receive high
dosage or prolonged therapy.
Neurotoxicity manifested by ototoxicity, both vestibular and auditory,
can occur in patients treated
with gentamicin sulfate primarily in those with pre-existing renal
damage and in patients with
normal renal function treated with higher doses and/or for longer
periods than recommended.
Aminoglycoside-induced ototoxicity is usually irreversible. Other
manifestations of
neurotoxicity may include numbness, skin tingling, muscle twitching
and convulsions.
Renal and eighth cranial nerve function should be closely monitored,
especially in patients with
known or suspected reduced renal function at onset of therapy and also
in those whose renal
function is initially normal but who develop signs of renal
dysfunction during therapy. Urine
should be examined for decreased specific gravity, increased excretion
of protein, and the
presence of cells or casts. Blood urea nitrogen, serum creatinine, or
creatinine clearance should
be determined periodically. When feasible, it is recommended that
serial audiograms be obtained
in patients old enough to be tested, particularly high-risk patients.
Evidence of