Sulfacetamide Sodium Solution/ Drops

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Sulfacetamide Sodium Solution/ Drops Recall

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Side Effects & Adverse Reactions

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.

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Legal Issues

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

For the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma:

Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

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History

There is currently no drug history available for this drug.

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Other Information

Sulfacetamide Sodium Ophthalmic Solution USP, 10%, is a sterile, topical, anti-bacterial agent for ophthalmic use. The active ingredient is represented by the following structural formula:

Chemical name: N-Sulfanilylacetamide monosodium salt monohydrate.

Each mL Contains: ACTIVE: Sulfacetamide Sodium, 100 mg (10%); INACTIVES: Methycellulose, Sodium Thiosulfate, Purified Water. Sodium Phosphate Monobasic may be added to adjust pH (6.8 - 8.0).

PRESERVATIVES ADDED: Methylparaben 0.05% and Propylparaben 0.01%. The osmolality range is 700-1300 mOsm/kg.

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Sulfacetamide Sodium Solution/ Drops Manufacturers

Direct Rx

Sulfacetamide Sodium Solution/ Drops | Direct Rx

For conjunctivitis and other superficial ocular infections:

Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For Trachoma:

Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration

No Recall
Bausch & Lomb Incorporated

Sulfacetamide Sodium Solution/ Drops | Cardinal Health

do not take more than directed (see Overdose warning) adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years: do not use

No Recall
Stat Rx Usa Llc

Sulfacetamide Sodium Solution/ Drops | Stat Rx Usa Llc

For conjunctivitis and other superficial ocular infections:

Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For trachoma:

Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

No Recall
Preferred Pharmaceuticals, Inc

Sulfacetamide Sodium Solution/ Drops | Preferred Pharmaceuticals, Inc

For conjunctivitis and other superficial ocular infections:

Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For Trachoma:

Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

No Recall
Lake Erie Medical Dba Quality Care Products Llc

Sulfacetamide Sodium Solution/ Drops | Lake Erie Medical Dba Quality Care Products Llc

For conjunctivitis and other superficial ocular infections:

Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For Trachoma:

Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

No Recall
Remedyrepack Inc.

Sulfacetamide Sodium Solution/ Drops | Remedyrepack Inc.

For conjunctivitis and other superficial ocular infections:

Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For Trachoma:

Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

No Recall
Remedyrepack Inc.

Sulfacetamide Sodium Solution/ Drops | Remedyrepack Inc.

For conjunctivitis and other superficial ocular infections:

Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For Trachoma:

Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

No Recall
Akorn, Inc.

Sulfacetamide Sodium Solution/ Drops | Akorn, Inc.

For conjunctivitis and other superficial ocular infections:
Solution: Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.
For Trachoma:
Solution: Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

No Recall