Sulfacetamide Sodium and Prednisolone Sodium Phosphate

Sulfacetamide Sodium and Prednisolone Sodium Phosphate is an FDA-registered drug product whose active ingredient is SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE. It is labelled by Bausch & Lomb Incoporated taken by ophthalmic and marketed as a human prescription drug product. Identifiers on file: NDC 24208-317, application ANDA074449, label effective 20230801. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE are most often described in connection with: ocular infection, usage sulfacetamide, prednisolone sodium, phosphate ophthalmic, solution indicated, corticosteroid-responsive inflammatory, superficial bacterial, bulbar conjunctiva. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is indicated for corticosteroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where 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 anti-infective 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. This product does not provide adequate coverage against: Neisseria species, Serratia marcescens . A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

DOSAGE AND ADMINISTRATION Instill two drops of sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution topically in the eye(s) every four hours. Not more than 20 mL should be prescribed initially. If signs and symptoms fail to improve after two days, patients should be re-evaluated (see PRECAUTIONS ). Care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of application. FOR OPHTHALMIC USE ONLY

CONTRAINDICATIONS Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. This product is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to other sulfonamides, or to other corticosteroids. (Hypersensitivity to the antimicrobial components occurs at a higher rate than for other components.)

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 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, 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 children 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.

ADVERSE REACTIONS Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. 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 ( see WARNINGS ) . Sulfacetamide sodium may cause local irritation. The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical corticosteroids. Corticosteroid-containing preparations can also cause acute anterior uveitis or perforation of the globe. Mydriasis, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids. Secondary Infection The development of secondary infection has occurred after use of combinations containing corticosteroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is Sulfacetamide Sodium and Prednisolone Sodium Phosphate used for?
INDICATIONS AND USAGE Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is indicated for corticosteroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and …

Who makes Sulfacetamide Sodium and Prednisolone Sodium Phosphate?
Bausch & Lomb Incoporated is the labeler of record for Sulfacetamide Sodium and Prednisolone Sodium Phosphate.

What form does Sulfacetamide Sodium and Prednisolone Sodium Phosphate come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Sulfacetamide Sodium and Prednisolone Sodium Phosphate prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Sulfacetamide Sodium and Prednisolone Sodium Phosphate been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.