DESCRIPTION

Sulfacetamide salt Ophthalmic equipment 10% is a sterile object antibacterial agents because that ophthalmic use. The energetic ingredient is stood for by the adhering to structural formula:


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C8H9N2Na03S • H2O

MW = 254.24

Chemical Name:

N-Sulfanilylacetamide monosodium salt monohydrate.

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Contains:

Active: sulfacetamide salt 10% (100 mg/mL).

Preservative: methylparaben and propylparaben

Inactives: salt thiosulfate, methylcellulose, and monobasic salt phosphate


CLINICAL PHARMACOLOGY

Microbiology: The sulfonamides are bacteriostatic agents and also the spectrum of task is similar for all. Sulfonamides inhibit bacter synthesis the dihydrofolic acid by avoiding the condensation that the pteridine with aminobenzoic acid v competitive inhibition the the enzyme dihydropteroate synthetase. Resistant strains have transformed dihydropteroate synthetase with diminished affinity for sulfonamides or develop increased amounts of aminobenzoic acid.

Topically used sulfonamides room considered energetic against susceptible strains that the following usual bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Topically applied sulfonamides carry out not carry out adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A far-reaching percentage the staphylococcal isolates are totally resistant come sulfa drugs.


INDICATIONS and USAGE

Sulfacetamide sodium Ophthalmic equipment USP, 10% is shown for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as one adjunctive in systemic sulfonamide treatment 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 far-reaching percentage the staphylococcal isolates are fully resistant to sulfa drugs.


Contraindications

Sulfacetamide salt Ophthalmic equipment is contraindicated in people who have actually a hypersensitivity to sulfonamides or to any type of ingredient the the preparation.


WARNINGS

FOR topical EYE USE only - no FOR INJECTION.

FATALITIES have actually OCCURRED, although RARELY, as result of SEVERE reaction TO SULFONAMIDES consisting of STEVENS-JOHNSON SYNDROME, toxic EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA and OTHER BLOOD DYSCRASIAS. Sensitizations may recur once a sulfonamide is readministered, regardless of whether of the course of administration. Sensitivity reactions have actually been reported in individuals with no prior background of sulfonamide hypersensitivity. In ~ the an initial sign the hypersensitivity, skin decision or other serious reaction, discontinue use of this preparation.


General

Prolonged usage of object antibacterial agents may provide rise come overgrowth the nonsusceptible organisms consisting of fungi. Bacterial resistance come sulfonamides may likewise develop.

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

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

At the very first sign that hypersensitivity, increase in purulent discharge, or aggravation that inflammation or pain, the patient need to discontinue use of the medication and consult a medical professional (See WARNINGS).


Information for Patients

To prevent contamination, do not touch pointer of container to the eye, eyelid or any type of surface.


Carcinogenesis, Mutagenesis, disability of Fertility

No studies have been conducted in animals or in humans to evaluate the possibility of these results with ocularly administered sulfacetamide. Rats show up to be particularly susceptible to the goitrogenic results of sulfonamides, and long-term oral management of sulfonamides has resulted in thyroid malignancies in these animals.


Pregnancy

Pregnancy group C. Pet reproduction studies have not been carried out with sulfonamide ophthalmic preparations. Kernicterus may take place in the newborn as a an outcome of therapy of a pregnant mrs at term through orally administered sulfonamides. There are no adequate and well regulated studies that sulfonamide ophthalmic prepare in pregnant women and also it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product have to be offered in pregnancy just if the potential benefit justifies the potential threat to the fetus.


Nursing Mothers

Systematically administered sulfonamides are capable of creating kernicterus in infants of lactating women. Because of the potential for the development of kernicterus in neonates, a decision have to be made even if it is to discontinue parenting or discontinue the drug taking into account the prestige of the drug to the mother.


Pediatric Use

Safety and effectiveness in children below the period of two months have actually not been established.


ADVERSE REACTIONS

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

The most typically reported reaction are regional irritation, stinging and burning. Less frequently reported reactions include non-specific conjunctivitis, conjunctival hyperemia, an additional infections and allergic reactions.

Fatalities have actually occurred, back rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxicity epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and also other blood dyscrasias (See WARNINGS).


DOSAGE and also ADMINISTRATION

For conjunctivitis and other superficial ocular infections:

Instill one or two drops right into the conjunctival sac(s) of the influenced eye(s) every 2 to three hrs initially. Dosages may be tapered by enhancing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For trachoma:

Instill 2 drops right into the conjunctival sac(s) the the affected eye(s) every two hours. Topical administration must it is in accompanied by systemic administration.


HOW SUPPLIED

Sulfacetamide salt Ophthalmic solution USP, 10% is gave sterile in plastic party in the complying with sizes:

15 mL: NDC 61314-701-01

Note: Store in between 8°-25°C (46°-77°F). Safeguard from light. Sulfonamide solutions, on lengthy standing, will darken in color and also should it is in discarded.

Rx Only


Dist. By:

FALCON Pharmaceuticals, Ltd

Fort Worth, Texas 76134

Mfd. By:

ALCON LABORATORIES, INC.

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Fort Worth, Texas 76134

Printed in USA

340192-1102


PRINCIPAL display PANEL

NDC 61314-701-01 Rx Only

Sulfacetamide

Sodium

Ophthalmic

Solution USP

10%

15 mL STERILE

AFFILIATE OF

ALCON LABORATORIES, INC.

QUALITY RX

Repacked by:H.J. Harkins Company, Inc.Nipomo, CA 93444

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