Sulf-10

Name: Sulf-10

Sulf 10

Sulf-10®

(SULFACETAMIDE SODIUM

Ophthalmic Solution, USP) 10%

Warnings

FOR TOPICAL EYE USE ONLY – NOT FOR INJECTION. 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. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other serious reaction, discontinue use of this preparation.

Precautions

General

Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to sulfonamides may also develop.

The effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in purulent exudates.

Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur.

At the first sign of hypersensitivity, increase in purulent discharge, or aggravation of inflammation or pain, the patient should discontinue use of the medication and consult a physician (see WARNINGS).

Information for patients

To avoid contamination, do not touch tip of container to eye, eyelid or any surface.

Drug Interactions

Sulfacetamide preparations are incompatible with silver preparations.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted in animals or in humans to evaluate the possibility of these effects with ocularly administered sulfacetamide. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term oral administration of sulfonamides has resulted in thyroid malignancies in these animals.

Pregnancy

Pregnancy Category C.

Animal reproduction studies have not been conducted with sulfonamide ophthalmic preparations. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamides. There are no adequate and well controlled studies of sulfonamide ophthalmic preparations in pregnant women and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for the development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of two months have not been established.

Adverse Reactions

Bacterial and fungal corneal ulcers have developed during treatment with sulfonamide ophthalmic preparations.

The most frequently reported reactions are local irritation, stinging and burning. Less commonly reported reactions include non-specific conjunctivitis, conjunctival hyperemia, secondary infections and allergic reactions.

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).

For Healthcare Professionals

Applies to sulfacetamide sodium ophthalmic: ophthalmic ointment, ophthalmic solution

General

The side effects reported most often were local/conjunctival irritation, stinging, and burning.[Ref]

Ocular

Frequency not reported: Local/conjunctival irritation, stinging, burning, nonspecific conjunctivitis, conjunctival hyperemia, bacterial corneal ulcers, fungal corneal ulcers[Ref]

Hypersensitivity

At least 1 case of local hypersensitivity has been reported that progressed to a SLE-like fatal syndrome.[Ref]

Rare (less than 0.1%): Sensitivity reactions
Frequency not reported: Allergic reactions/hypersensitivity, local hypersensitivity progressing to fatal syndrome resembling systemic lupus erythematosus (SLE)[Ref]

Other

Frequency not reported: Secondary infections[Ref]

Dermatologic

Sulfonamides:
-Frequency not reported: Stevens-Johnson syndrome, toxic epidermal necrolysis[Ref]

Fatalities reported rarely due to severe reactions to sulfonamides (including toxic epidermal necrolysis, Stevens-Johnson syndrome, fulminant hepatic necrosis, aplastic anemia, agranulocytosis, other blood dyscrasias).

Stevens-Johnson syndrome was reported in a patient with history of blistering drug reaction to an oral sulfonamide.[Ref]

Hematologic

Sulfonamides:
-Frequency not reported: Agranulocytosis, aplastic anemia, other blood dyscrasias[Ref]

Fatalities reported rarely due to severe reactions to sulfonamides (including toxic epidermal necrolysis, Stevens-Johnson syndrome, fulminant hepatic necrosis, aplastic anemia, agranulocytosis, other blood dyscrasias).[Ref]

Hepatic

Sulfonamides:
-Frequency not reported: Fulminant hepatic necrosis[Ref]

Fatalities reported rarely due to severe reactions to sulfonamides (including toxic epidermal necrolysis, Stevens-Johnson syndrome, fulminant hepatic necrosis, aplastic anemia, agranulocytosis, other blood dyscrasias).[Ref]

Some side effects of Sulf-10 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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