A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Pediatric Gentamicin Warnings, Precautions, Pregnancy, Nursing, Abuse - Pediatric Gentamicin
Pediatric Gentamicin Warnings, Precautions, Pregnancy, Nursing, Abuse - Pediatric Gentamicin
WARNINGS
(See DESCRIPTION
: WARNINGS
Box.)
Aminoglycosides can cause
fetal harm when administered
to a pregnant women.
Aminoglycoside antibiotics cross
the placenta, and there
have been several reports of total irreversible
bilateral congenital
deafness in children
whose mothers received streptomycin during pregnancy. Animal reproduction
studies have not been conducted with gentamicin
sulfate. It is also not known whether gentamicin
sulfate can cause
fetal harm when administered
to a pregnant woman
or can affect reproduction
capacity. Serious side
effects to mother, fetus,
or newborn have not
been reported in the treatment
of pregnant women with other aminoglycosides. If gentamicin
is used during pregnancy or if the patient
becomes pregnant while
taking gentamicin, she should be apprised of the potential
hazard to the fetus. Gentamicin Sulfate Injection contains sodium
metabisulfite. a sulfite that may cause
allergic-type reactions including anaphylactic symptoms and life-threatening
or less severe asthmatic episodes in certain susceptible
people. The overall prevalence of sulfite sensitivity
in the general population
is unknown and probably low. Sulfite sensitivity
is seen more frequently in asthmatic than in nonasthmatic people.
PRECAUTIONS
Neurotoxic and nephrotoxic antibiotics may be absorbed in significant
quantities from body surfaces
after local irri gation
or application. The potential toxic
effect of antibiotics
administered in this fashion should be considered. Increased nephrotoxicity
has been reported following concomitant administration of aminoglycoside
antibiotics and cephalosporins.
Neuromuscular blockade
and respiratory
paralysis have been
reported in the cat receiving high doses (40 mg/kg) of gentamicin.
The possibility of these phenomena occurring in man
should be considered if aminoglycosides are administered by any
route to patients receiving anesthetics, or to patients receiving
neuromuscular
blocking agents, such
as succinylcholine, tubocurarine, or decamethonium, or in patients
receiving massive transfusions
of citrate-anticoagulated blood. If neuromuscular
blockade occurs, calcium
salts may reverse it.
Aminoglycosides should be used with caution in patients with neuromuscular
disorders such as myasthenia
gravis or parkinsonism, since these drugs may aggravate muscle
weakness because of
their potential curare-like
effects on the neuromuscular
junction.
Cross-allergenicity among aminoglycosides has been demonstrated.
Patients should be well hydrated
during treatment.
Although the in vitro mixing of gentamicin
and carbenicillin results in a rapid and significant
inactivation of
gentamicin, this interaction has not been demonstrated in patients
with normal renal
function who received
both drugs by different routes of administration. A reduction
in gentamicin serum half-life
has been reported in patients with severe renal
impairment receiving carbenicillin concomitantly with gentamicin.
Treatment with gentamicin
may result in overgrowth
of nonsusceptible organisms. If this occurs, appropriate
therapy is indicated.
See DESCRIPTION
: WARNINGS
Box regarding
concurrent use of potent
diuretics and regarding concurrent and/or sequential use of other
neurotoxic and/or nephrotoxic antibiotics and for other essential
information.
Usage in Pregnancy
Safety for use in pregnancy
has not been established-Gentamicin crosses the placental
barrier. prolonged use during pregnancy
may result in otological damage to the fetus.
Breast Feeding
Problems in humans have not been documented; however, risk-benefit
must be considered.
Pediatric Use
The 10 mg/mL strength
is normally restricted to Pediatric use.
Gentamicin Sulfate Injection should not be used in ophthalmic
surgery since the preservatives present
may be irritating to the ocular
tissues.
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