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Audiometric measurements and assessment of vestibular
function should be performed prior to initiation of therapy with Capastat
Sulfate and at regular intervals during treatment.
Renal injury, with tubular necrosis, elevation of the
blood urea nitrogen (BUN) or serum creatinine, and abnormal urinary sediment,
has been noted. Slight elevation of the BUN and serum creatinine has been observed
in a significant number of patients receiving prolonged therapy. The appearance
of casts, red cells, and white cells in the urine has been noted in a high
percentage of these cases. Elevation of the BUN above 30 mg/100 mL or any other
evidence of decreasing renal function with or without a rise in BUN levels
calls for careful evaluation of the patient, and the dosage should be reduced
or the drug completely withdrawn. The clinical significance of abnormal urine
sediment and slight elevation in the BUN (or serum creatinine) observed during
long-term therapy with Capastat Sulfate has not been established.
The peripheral neuromuscular blocking action that has
been attributed to other polypeptide antibiotics (colistin sulfate, polymyxin A
sulfate, paromomycin, and viomycin) and to aminoglycoside antibiotics
(streptomycin, dihydrostreptomycin, neomycin, and kanamycin) has been studied
with Capastat Sulfate. A partial neuromuscular blockade was demonstrated after
large intravenous doses of Capastat Sulfate. This action was enhanced by ether
anesthesia (as has been reported for neomycin) and was antagonized by
Caution should be exercised in the administration of
antibiotics, including Capastat Sulfate, to any patient who has demonstrated
some form of allergy, particularly to drugs.
Regular tests of renal function should be made throughout
the period of treatment, and reduced dosage should be employed in patients with
known or suspected renal impairment.
Renal function studies should be made both before therapy
with Capastat Sulfate is started and on a weekly basis during treatment.
Since hypokalemia, hypomagnesemia and hypocalcemia may
occur during therapy, these serum electrolyte levels should be determined
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Studies have not been performed to determine potential
for carcinogenicity, mutagenicity, or impairment of fertility.
Usage In Pregnancy - Pregnancy Category C
Capastat Sulfate has been shown to be teratogenic in rats
when given in doses 3 ½ times the human dose. There are no adequate and
well-controlled studies in pregnant women. Capastat Sulfate should be used
during pregnancy only if the potential benefit justifies the potential risk to
the fetus (see BOXED WARNINGS and Animal Pharmacology).
It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when Capastat Sulfate is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not
been established (see BOXED WARNINGS).
Clinical studies of Capastat Sulfate did not analyze the
safety and efficacy of patients aged 65 and over to determine whether they
respond differently from younger patients. 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.
Capastat Sulfate is known to be substantially excreted by
the kidney (see CLINICAL PHARMACOLOGY), 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 (see
PRECAUTIONS, Laboratory Tests). Patients with reduced renal
function should have dosage reduction based on creatinine clearance using the
guidelines included in Table 1 (see DOSAGE AND ADMINISTRATION).
The geriatric population is also more likely to have
impaired hearing at baseline. Audiometric measurements and assessment of
vestibular function should be performed prior to initiation of therapy with
Capastat Sulfate and at regular intervals during treatment (see PRECAUTIONS,