Sulfacetamide Sodium And Prednisolone Sodium Phosphate Solution Recall
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Questions & Answers
Side Effects & Adverse Reactions
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 sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforation has 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 the product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.
A significant percentage of staphylococcal isolates are completely resistant to sulfonamides.
The use of steroids 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 treatment of herpes simplex requires great caution.
Topical steroids 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. Sensitization 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 has been demonstrated (See ADVERSE REACTIONS).
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where a superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular antibacterial drug in this product is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.
The product does not provide adequate coverage against: Neisseria species, Pseudomonas species, Serratia marcescens.
A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
There is currently no drug history available for this drug.
Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is a sterile topical ophthalmic solution combining an antibacterial and a corticosteroid.
Each mL Contains: Actives: sulfacetamide sodium (as the monohydrate) 100 mg, prednisolone sodium phosphate 2.5 mg (equivalent to prednisolone phosphate 2.3 mg). Preservative: thimerosal 0.1 mg. Inactives: edetate disodium, poloxamer 407, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection. pH range is 6.5 to 7.5.
The chemical name for sulfacetamide sodium, is N-sulfanilylacetamide monosodium salt monohydrate.
The chemical name for prednisolone sodium phosphate is 11β,17,21-trihydroxypregna-1,4-diene-3,20-dione,21-(disodium phosphate).
They have the following chemical structures: