Sulfacetamide Ophthalmic

What is Sulfacetamide Ophthalmic?

• Sulfacetamide Ophthalmic is a sterile, topical anti-bacterial agent for ophthalmic use.
• It is used to treat eye infections and to prevent them after injuries.

Sulfacetamide

Sulfacetamide molecule ball

Sulfacetamide molecule spacefill

What are the uses of this medicine?

• Sulfacetamide Ophthalmic is used for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma.

Topically applied sulfonamides are considered active against susceptible strains of the following common bacterial eye pathogens: 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.

How does this medicine work?

• The sodium salt form of sulfacetamide, a synthetic sulfanylacetamide derivative with bacteriostatic activity.
• Sulfonamides inhibit bacterial synthesis of dihydrofolic acid by preventing the condensation of the pteridine with aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase.
• Resistant strains have altered dihydropteroate synthetase with reduced affinity for sulfonamides or produce increased quantities of aminobenzoic acid.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• Yes, it was FDA approved.

How should this medicine be used?

Recommended dosage: 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 sacs of the affected eyes every two hours.
• Topical administration must be accompanied by systemic administration.

Administration:

• Ophthalmic sulfacetamide comes as a solution (liquid) to instill in the eyes, and an ointment to apply to the eyes.
• The eye drops usually are instilled every 2 to 3 hours during the day and less frequently at night; the ointment usually is applied four times a day and at bedtime.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a solution (liquid), an ointment

This medicine is available in fallowing brand namesː

• AK-Sulf
• Bleph-10
• Bleph-30
• Cetamide
• Sodium Sulamyd

What side effects can this medication cause?

The most common side effects of this medicine include:

• Bacterial and fungal corneal ulcers
• local irritation
• stinging
• burning
• non-specific conjunctivitis
• conjunctival hyperemia
• secondary infections
• 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.

What special precautions should I follow?

• 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.
• Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to sulfonamides may also develop.
• 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.
• The effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in purulent exudates.
• To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.
• Tell your doctor if you wear soft contact lenses. If the brand of sulfacetamide you are using contains benzalkonium chloride, wait at least 15 minutes after using the medicine to put in soft contact lenses.
• You should know that your vision may be blurred during your treatment with sulfacetamide eye ointment. Avoid rubbing your eyes even if your vision is blurred. Do not drive a car or operate machinery if you are unable to see clearly.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• Safety and effectiveness in infants below the age of two months have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• sulfacetamide sodium

Inactive ingredients:

• benzalkonium chloride
• edetate disodium
• polysorbate 80
• POLYVINYL ALCOHOL, UNSPECIFIED
• water
• sodium phosphate, dibasic, anhydrous
• sodium phosphate, monobasic
• sodium thiosulfate
• hydrochloric acid
• sodium hydroxide

Who manufactures and distributes this medicine?

Distributed for:

• Allergan USA, Inc.
• Madison, NJ

What should I know about storage and disposal of this medication?

• Store at 8°-25°C (46°-77°F).
• Protect from light.
• Sulfonamide solutions, on long standing, will darken in color and should be discarded.

• Dailymed label info on Sulfacetamide Ophthalmic
• FDA Sulfacetamide Ophthalmic

Sulfacetamide Ophthalmic Resources
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