GENTAMICIN sulfate injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

INN (International Name):

GENTAMICIN SULFATE

Composition:

GENTAMICIN 40 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GENTAMICIN- GENTAMICIN SULFATE INJECTION, SOLUTION
CARDINAL HEALTH
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GENTAMICIN INJECTION USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Gentamicin
Injection, USP and other antibacterial drugs, Gentamicin Injection,
USP should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
BOXED 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 injection is potentially
nephrotoxic. The risk of
nephrotoxicity is greater in patients with impaired renal function and
in those who receive high
dosage of prolonged therapy.
Neurotoxicity manifested by ototoxicity, both vestibular and auditory,
can occur in patients treated
with gentamicin, 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 (BUN), 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
ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears or
hearing loss) or nephrotoxicity
requires dosage adjustment or discontinuance of the drug. As with the
other aminogl