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Vasocidin

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Vasocidin

Vasocidin

WARNINGS

NOT FOR INJECTION INTO THE EYE. Prolonged use of corticosteroids may result in ocular hypertension/glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.

Acute anterior uveitis may occur in susceptible individuals, primarily Blacks.

Prolonged use of VASOCIDIN (sulfacetamide and prednisolone) may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

The use of corticosteroids after cataract surgery may delay healing and increase the incidence of filtering blebs.

The use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.

A significant percentage of staphylococcal isolates are completely resistant to sulfonamides.

Topical corticosteroids are not effective in mustard gas keratitis and Sjögren's keratoconjunctivitis.

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitizations may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of hypersensitivity or other serious reactions occur, discontinue use of this preparation. Cross-sensitivity among corticosteroids have been demonstrated (see ADVERSE REACTIONS).

Do not administer this product to patients who are sensitive/allergic to thimerosal or any other mercury-containing ingredient.

PRECAUTIONS

General

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 effectiveness.

Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity.

Laboratory Tests

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

Teratogenic effects

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.

Nursing Mothers

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.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of six years have not been established.

Last reviewed on RxList: 4/8/2009
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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