The initial prescription and
renewal of the medication order beyond 20 mL of VASOCIDIN (sulfacetamide and prednisolone) Ophthalmic Solution
should be made by a physician only after examination of the patient with the
aid of magnification, such as slit-lamp biomicroscopy and, where appropriate, fluorescein
staining. If signs and symptoms fail to improve after two days, the patient
should return to the office for further evaluation. The possibility of fungal
infections of the cornea should be considered after prolonged corticosteroid
dosing. Fungal cultures should be taken when appropriate.
The p-aminobenzoic acid present
in purulent exudates competes with sulfonamides and can reduce their
Sulfonamide solutions darken on
prolonged standing and exposure to heat and light. Do not use if solution has
darkened. Yellowing does not affect activity.
Eyelid cultures and tests to
determine the susceptibility of organisms to sulfacetamide may be indicated if
signs and symptoms persist or recur in spite of the recommended course of
treatment with VASOCIDIN (sulfacetamide and prednisolone) Ophthalmic Solution.
Carcinogenesis, Mutagenesis, and
Impairment of Fertility
Prednisolone has been reported
to be non-carcinogenic. Long-term animal studies for carcinogenic potential
have not been performed with prednisolone or sulfacetamide.
One author detected chromosomal
nondisjunction in the yeast Saccharomyces cerevisiae following
application of sulfacetamide sodium. The significance of this finding to the
topical ophthalmic use of sulfacetamide sodium in the human is unknown. Mutagenic
studies with prednisolone have been negative. Studies on reproduction and
fertility have not been performed with sulfacetamide. A long-term chronic
toxicity study in dogs showed that high oral doses of prednisolone prevented
estrus. A decrease in fertility was seen in male and female rats that were
mated following oral dosing with another glucocorticosteroid.
Pregnancy Category C
Prednisolone has been shown to
be teratogenic in rabbits, hamsters, and mice. In mice, prednisolone has been
shown to be teratogenic when given in doses 1 to 10 times the human ocular
dose. Dexamethasone, hydrocortisone and prednisolone were ocularly applied to
both eyes of pregnant mice five times per day on days 10 through 13 of gestation.
A significant increase in the incidence of cleft palate was observed in the
fetuses of the treated mice. There are no adequate, well-controlled studies in
pregnant women dosed with corticosteroids.
Kernicterus may be precipitated
in infants by sulfonamides given systemically during the third trimester of
pregnancy. It is not known whether sulfacetamide sodium can cause fetal harm
when administered to a pregnant woman or whether it can affect reproductive capacity.
VASOCIDIN (sulfacetamide and prednisolone) Ophthalmic Solution
should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
It is not known whether topical
administration of corticosteroids could result in sufficient systemic
absorption to produce detectable quantities in human milk. Systemically administered
corticosteroids appear in human milk and could suppress growth, interfere with
endogenous corticosteroid production, or cause other untoward effects.
Systemically administered sulfonamides are capable of producing kernicterus in
infants of lactating women. Because of the potential for serious adverse
reactions in nursing infants from VASOCIDIN (sulfacetamide and prednisolone) , a decision should be made whether
to discontinue nursing or to discontinue the medication.
Safety and effectiveness in
pediatric patients below the age of six years have not been established.