Sulfacetantide Sodium
`Ophthalmic Solution USP, 10%
`(Sterile)
`
`lililili
`
`Rx only
`FOR USE IN THE EYES ONLY
`DESCRIPTION:
`Sullacetantrde Sodrurn ilphthairnic Soiution USP, 10%, is a sterile, topical, anti-bacterial agent for nplrthalmic use. The
`active ingredient is represented hythe following structural formula:
`Na
`l
`so ZNCOCH 3 - H ,0
`
`NH,
`
`In;
`C H N Na0JS 'H,0
`
`Mo|.Wt. 254.24
`
`Ghcmicai name: N-Sullanrlylacetamide monosodiurri salt monohydrate.
`
`INACTIVES: Methycellulose. Sodium Thlosulfale,
`Each ntl. Contains: ACTIVE: Suliacetamide Sodium, 100 mg I1[i%];
`Purified Water. Sodium Phosphate Monobasic maybe added to adjust pl-l lfi.8 - 8.0].
`PRESEHVATIVES ADBED: Methylparnben 0.05% and Propyiparaben 0.01%. The osrnolality range is i'lJI]-l3llD mtisrnfltg.
`CLINICAL PIEABMAGDLOGY:
`Microbiology: The suifonamides are bacteriostatic agents and the spectrum of activity is similar for all. Sulfonamides
`inhibit bacterial synthesis of dihydrofolic acid by preventing the condensation at the pteridine with aminobenzoic acid
`through competitive inhibition of the enzyme diltydropteroate synthetase. Flesistant strains have altered dihydropteroete
`synthetase with reduced alfinity for sulfonarnides or produce increased quantities of aminohenzoic acid.
`Topically applied sulfonarnides are considered active against susceptible strains of the following common bacterial eye
`pathogens: Escherichia coir", Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus ivrridans group),
`Haemophiius rnfluenzae, Kleltsiella species. and Enterobacterspecies.
`Topically applied sulfonarnides do not provide adequate coverage against Neisseria species, Serraria rrrarcescens and
`Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
`IhlEllcATiDNS AND USAGE:
`For the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms. and as an
`adjunclive in systemic sulfooarnide therapy of tracltama‘.
`Escherr‘clrio coir‘, Staphylococcus aureus, Streptococcuspneumorriae, Streptococcus [viridans group].
`Haemophilus influenzae, Ktebsieila species. and Errterobacterspecies.
`Topically applied suttonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and
`Pseudernonas aeruginosa. A significant percentage of staphyiococcel isolates are completely resistant to sulfa drugs.
`CBNTBAINDICATIONS:
`Hypersensitivity to sulfonamides or to any ingredient of the preparation.
`WAHNENGS:
`FURTOPICAL EYE USE ClNL‘!— NDT FER INJECTION.
`FATALITIES HAVE OCCURRED, ALTHOUGH HARELY, DUE TO SEVERE REACTIONS T0 SULFGNAMIIJES ENCLUDENE
`STEVENS-JOHNSON SYNDROME, TGXIC EPIDERMAL NECFIULYSIS, FULMINANT HEFATEC NECRUSIS, AGfiANULOCY-
`T0513. APLASTEC ANEMIA AND DTHER BLGUD 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 sulfonamrde hypersensitivity. At the first sign of hypersensitivity. skirt rash or other serious reaction,
`discontinue use oftltis preparation.
`
`PRECMJTIUNS:
`General: Prolonged use of topical ant:-bacterial agents may give rise 10 overgrowth of nonsusceptible organisms
`including fungi. Bacterial resistance to sulionamicles may also develop.
`The effectiveness of suifcrtamides may be reduced by the para-aminobenzoic acid present in purulent exudates.
`Sensitization may recur when a sulionarnide is readministered irrespective of the route of administration, and cross-
`sensirivity between differentsulfonamides may occur.
`
`
`
`
`
`SENJU EXHIBIT 2328
`Ltlpitt v Scttjtr,
`IPRZUIS-01097, IPRZDIS-D1099,
`lPR2015-01109 & lI’R2lJ15—ll] Illfi
`
`

`
`llll llll
`
`At the first sign of hypersensitivity, increase in purulent discharge, or aggravation of inflammation or pain, the patient
`should discontinue use otthe medication and consult a physician lseeWA:‘-lNlNGS].
`
`Information for patients: To avoid contamination, do nottooch tip of containerto eye, eyelid or any surface.
`Drug Interactions: Sulfacetamide preparations are incompatible with silver preparations.
`
`Carcinogenesis. Mutagenosis. Impairment of Fertility: No studies have been conducted in animais or in humans to
`evaluate the possibility of these effects with oculariy administered suliacetamide.
`l-‘tats appear to be especially
`susceptibte 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 sulfonarnide ophthalmic
`preparations. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally
`administered suifonamides. There are no adequate and well-controlled studies of sulfonamide ophthalmic preparations
`in pregnant women and it is not known whethertopically applied suifonamities can cause fetal harm when administered
`to a pregnant woman. This product should he used in pregnancy only if the potential henelitjustifies the potential risk
`to the fetus.
`
`Nursing Mothers: systemically administered sulfonamides arecapable of producing lternicterus in infants of lactating
`women. Because of the potential torthe development of kernicteros in neonates, a decision should be made whether
`to discontinue nursing or discontinue the drug taking into account the importance olthe drug to the mother.
`
`Pediatric Use: Safety and effectiveness in children befowthe age oftwo months have not been established.
`ADVERSE liEACTiDNS:
`Bacteria! and fungal corneal ulcers have developed during treatmentwith sulfonamide ophthatmic preparations.
`The most trequently reported reactions are local irritation, stinging and burning. Less commonly reported reactions
`include non-specific coniunctivitis, conjunctival hyperemia, secondary infections and aiiergic reactions.
`Fatalities have occurred, although rarely, due to severe reactions to suttonamlries including Stevens-Johnson syndrome,
`toxic epidermal necroiysis. lulminant hepatic necrosis, agranulotzytosis, aplastic anemia. and other btood dyscrasias
`lsee WARNINGSI.
`DOSAGE AND ADMIMSTBATIDN:
`For ooniunctivitis and other superficial ocular infections:
`Instill one or two drops into the coniunctival saclsl ofthe affected eyels] every two to three hours initially. Dosages may
`be tapered byincreasing the time interval between doses as the condition responds. The usual duration oftreatrnent is
`seven toten days.
`For Trachnrna:
`Instill two drops into the conienctival seals] of the affected eyelsl every two hours. Topical administration must be
`accompanied by systemic administration.
`HOW SUPPLIED:
`Suiiacatan-ride Sodium flphthalmic Solution USP, 10%, is supplied in a plastic squeeze bottle with a controlled drup tip
`in the following size:
`15 mL bottle - Prod. No. D3011
`
`DD NOT USE IF JMPRINTED "Protective Sea!" WITH YELLOW i [S NOTINTACT.
`
`Storage: Store between 2° - 30°C l3E" - HE'Fl.
`Sulfonamide sotutions, on fang standing, will darken in color and should be discarded.
`KEEP DU? OF REACH OF CHELDHEN.
`
`Revised November zoo?
`
`Bausch 8: Lomb Incorporated
`
`©Bausch 8: Lomb Incorporated