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
Bactocill Warnings, Precautions, Pregnancy, Nursing, Abuse - Oxacillin Sodium
Bactocill Warnings, Precautions, Pregnancy, Nursing, Abuse - Oxacillin Sodium
WARNINGS
Serious and occasionally fatal
hypersensitivity (analphylactic shock with collapse) reactions have
occurred in patients receiving penicillin. The incidence
of analphylactic shock
in all penicillin-treated patients is between 0.015 and 0.04 percent.
Analphylactic shock resulting
in death has occurred in approximately 0.002 percent
of the patients treated. Although anaphylaxis is more frequent following
parenteral administration,
it has occurred in patients receiving oral
penicillins.
When penicillin
therapy is indicated, it should be initiated only after a comprehensive
patient drug
and allergy history has been obtained. If an allergic
reaction occurs, the
drug should be discontinued
and the patient should receive supportive treatment, eg, artificial
maintenance of ventilation, pressor amines, antihistamines, and
corticosteroids. Individuals with a history of penicillin
hypersensitivity may also experience
allergic reactions
when treated with a cephalosporin.
PRECAUTIONS
General
Penicillinase-resistant penicillins should generally not be administered
to patients with a history of sensitivity to any penicillin.
Penicillin should be used with caution in individuals with histories
of significant allergies
and/or asthma. Whenever allergic
reactions occur, penicillin should be withdrawn unless, in the opinion
of the physician, the condition
being treated is life-threatening and amenable only to penicillin
therapy.
The oral route of administration
should not be relied upon in patients with severe illness
or with nausea vomiting
gastric dilation, cardiospasm,
or intestinal hypermotility.
Occasionally patients will
not absorb therapeutic
amounts of orally administered penicillin.
The use of antibiotics may result in overgrowth
of nonsusceptible organisms. If new infections due to bacteria
or fungi occur the drug
should be discontinued and appropriate
measures taken.
Laboratory Tests
Bacteriologic studies to determine the causative organisms and
their susceptibility to the penicillinase-resistant penicillins
should be performed (See CLINICAL
PHARMACOLOGY - Microbiology). In the treatment
of suspected staphylococcal
infections, therapy should be changed to another active agent
if culture tests fail
to demonstrate the presence of staphylococci.
Periodic assessment
of organ system
function including
renal, hepatic, and hematopoietic
should be made during prolonged therapy with the penicillinase-resistant
penicillins.
Blood cultures, white
blood cell, and differential
cell counts should be obtained
prior to initiation of therapy and at least weekly during therapy
with penicillinase-resistant penicillins.
Periodic urinalysis, blood
urea nitrogen, and creatinine
determinations should be performed during therapy with the penicillinase-resistant
penicillins and dosage
alterations should be considered if these values become elevated.
If any impairment
of renal function
is suspected or known to exist a reduction in the total dosage
should be considered and blood
levels monitored to avoid possible neurotoxic reactions (See DOSAGE
AND ADMINISTRATION). SGOT
and SGPT values should
be obtained periodically during therapy to monitor
for possible liver function
abnormalities.
Drug Interactions
Tetracycline, a bacteriostatic
antibiotic, may antagonize the bactericidal effect of penicillin
and concurrent use of these drugs should be avoided.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal
studies have been conducted with these drugs.
Studies on reproduction
(nafcillin) in rats and rabbits reveal no fetal or maternal
abnormalities before conception
and continuously through weaning (one generation).
Pregnancy Category B
Reproduction studies performed in the mouse, rat, and rabbit have
revealed no evidence
of impaired fertility or harm to the fetus
due to the penicillinase-resistant penicillins. Human experience
with the penicillins during pregnancy has not shown any positive
evidence of adverse
effects on the fetus. There are, however, no adequate or well-controlled
studies in pregnant
women showing conclusively that harmful effects of these drugs on
the fetus can be excluded.
Because animal reproduction
studies are not always predictive of human
response, this drug should
be used during pregnancy only if clearly needed.
Nursing Mothers
Penicillins are excreted in breast
milk. Caution should be exercised when penicillins are administered
to a nursing woman.
Pediatric Use
Because of incompletely developed renal function in newborns, penicillinase-resistant
penicillins (especially methicillin) may not be completely excreted with abnormally
high blood levels resulting. Frequent blood levels are advisable in this group
with dosage adjustments when necessary. All newborns treated with penicillins
should be monitored closely for clinical and laboratory evidence of toxic or
adverse effects (See DOSAGE AND ADMINISTRATION).
Geriatric Use
Clinical studies of Oxacillin Injection did not include sufficient numbers
of subjects aged 65 and over to determine whether they respond differently from
younger subjects. Other reported clinical experience has not identified differences
in responses between the elderly and younger patients. In general, dose selection
for an elderly patient should be cautious, usually starting at the low end of
the dosing range, reflecting the greater frequency of decreased hepatic, renal,
or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk
of toxic reactions to this drug may be greater in patients with impaired renal
function. Because elderly patients are more likely to have decreased renal function,
care should be taken in dose selection, and it may be useful to monitor renal
function.
Oxacillin Injection contains 92.4 mg (4.02 mEq) of sodium per gram. At the
usual recommended doses, patients would receive between 92.4 and 554 mg/day
(4.02 and 24.1 mEq) of sodium. The geriatric population may respond with a blunted
natriuresis to salt loading. This may be clinically important with regard to
such diseases as congestive heart failure.
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