Sulfacetamide and prednisolone are used together in ophthalmic preparations for steroid-responsive inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists. Sulfacetamide is an antimicrobial agent that exerts a bacteriostatic effect by restricting the synthesis of folic acid through competition with p-aminobenzoic acid. Sulfacetamide is active in vitro against susceptible strains of the following microorganisms: Enterobacter sp., Escherichia coli, Haemophilus influenza, Klebsiella sp., Staphylococcus aureus, Streptococcus pneumoniae, and Viridans streptococci. Prednisolone is a glucocorticoid antiinflammatory agent. Prolonged use of topical corticosteroids can lead to systemic absorption and increase the risk of secondary ocular infections.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Ophthalmic Administration
Ophthalmic Solution or Suspension:
-Sulfacetamide; prednisolone solution and suspension are indicated for topical administration to the eye; do NOT administer parenterally.
-Instruct patient on proper instillation of eye solution and suspension (see Patient Information).
-Do not touch the tip of the dropper to the eye, fingertips, or other surface to prevent contamination.
-Shake the suspension well prior to use.
-Wash hands before and after use.
-Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch. Close eyes to spread drops. To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 1 to 2 minutes following application to the eye.
-To avoid contamination or the spread of infection, do not use dropper for more than one person.
-Protect from light; product will darken upon prolonged exposure to heat and light. Do not use if product has darkened. Yellowing of solution or suspension does not affect activity and is acceptable.
Ophthalmic Ointment:
-Instruct patient on proper instillation of eye ointment (see Patient Information).
-Do not touch the tip of the tube to the eye, fingertips, or other surface to prevent contamination.
-Wash hands before and after use.
-Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Place a small amount (about one-half of an inch) of the ointment into the pouch. Look downward before closing eyes.
-To avoid contamination or the spread of infection, do not use tube for more than one person.
Adverse reactions reported with sulfacetamide; prednisolone include dizziness, ocular discharge, eyelid edema, eyelid erythema, ocular irritation, ocular pain, ocular pruritus, ocular hyperemia, blurred vision, and hypersensitivity reactions, including rash (unspecified), skin pruritus, and urticaria. Reactions most often occurring with the sulfacetamide component are allergic sensitizations. Serious, sometimes fatal reactions, have also occurred rarely and include Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. These reactions can develop irrespective of route and may recur with readministration.
Adverse reactions related to the corticosteroid component of sulfacetamide; prednisolone are mainly localized to the eyes. Reactions to the prednisolone component include an increased intraocular pressure leading very infrequently to ocular hypertension and possibly glaucoma, development of posterior subcapsular cataracts, acute anterior uveitis or perforation of the globe, mydriasis, loss of accommodation, ptosis, and rarely optic nerve damage. Prolonged administration may increase the risk of corticosteroid related effects. Administration of prednisolone to the eye may also result in impaired wound healing after ocular surgery or injury. Systemic adverse effects are uncommon after topical administration of corticosteroids such as prednisolone; however, hypercorticoidism has been rarely reported.
A superinfection may occur during sulfacetamide; prednisolone treatment. An ocular infection of the cornea resulting from viruses or fungi are particularly prone to develop with prolonged or repeated therapy. Consider the possibility of a fungal infection in patients with persistent corneal ulcerations.
This monograph discusses the use of sulfacetamide and prednisolone in combination for inflammatory conditions of the eyes. Clinicians may wish to consult the individual monographs for more information about specific contraindications and precautions of each agent.
Sulfacetamide; prednisolone ophthalmic products are only indicated for the treatment of ocular inflammatory conditions in the presence of, or with the possible risk of, superficial bacterial infection. These products are contraindicated in patients with an ocular viral infection such as herpes simplex virus epithelial keratitis, vaccinia, and varicella. In addition, sulfacetamide; prednisolone is contraindicated in the presence of an ocular fungal infection or mycobacterial infection.
Avoid sulfacetamide; prednisolone in patients with a known or suspected allergy to any component of these products. This precaution includes patients with a corticosteroid hypersensitivity, sulfonamide hypersensitivity, and in the case of 10% sulfacetamide solution; 0.25% prednisolone, thimerosal hypersensitivity. Sulfonamide hypersensitivity may occur irrespective of route and corticosteroid cross-sensitivity has been reported. Instruct patients to discontinue treatment if signs of hypersensitivity occur.
Use caution when administering sulfacetamide; prednisolone to patients with preexisting glaucoma as prolonged use may result in an increased intraocular pressure. It is recommended to monitor intraocular pressure frequently in these patients. Prolonged use of sulfacetamide; prednisolone may also lead to optic nerve damage, visual disturbance, and the development of posterior subcapsular cataracts. Susceptible patients, primarily Black patients, may develop acute anterior uveitis following treatment with sulfacetamide; prednisolone. Finally, sulfacetamide; prednisolone may mask or increase the risk of developing a secondary ocular infection and could delay healing in patients undergoing an ocular surgery.
Avoid abrupt discontinuation of sulfacetamide; prednisolone to prevent corticosteroid withdrawal. Discontinuation of therapy is achieved by gradually decreasing the application frequency.
Instruct patients to avoid wearing contact lenses during treatment with 10% sulfacetamide; 0.2% prednisolone ophthalmic suspension.
Sulfacetamide; prednisolone products are only indicated for topical administration to the eyes. Take measures to prevent parenteral administration (intravenous administration and intramuscular administration) of the preparations.
The safety and efficacy of sulfacetamide; prednisolone ophthalmic products have not been established in neonates, infants, or children less than 6 years of age.
There are no adequate studies of sulfacetamide; prednisolone use in pregnant women. In mice, prednisolone doses of 1 to 10 times the human ocular dose resulted in an increased incidence of cleft palate; rabbits receiving corticosteroids experienced fetal resorption and abnormalities involving the head, ears, limbs, and palate. Consider monitoring for signs of hypoadrenalism in infants born to mothers who received substantial doses of corticosteroids during pregnancy. The fetal effects of sulfacetamide are unknown; however, sulfonamides are known to cause kernicterus in infants when administered during the third trimester. Administer sulfacetamide; prednisolone during pregnancy only when the benefits clearly outweigh the potential risk to the fetus.
According to the manufacturer, it is not known if ophthalmic administered prednisolone is detectable in human milk; however, systemically administered corticosteroids do appear in human milk and may suppress infant growth and endogenous corticosteroid production. Due to lowered systemic absorption, ophthalmic use of prednisolone poses little concern to the nursing infant, and previous American Academy of Pediatrics recommendations considered ophthalmic prednisolone compatible with breast-feeding. Sulfonamides, when administered topically, can produce kernicterus in breast-fed infants. Short term use of usual moderate ocular doses of these products for milder eye conditions probably poses little risk to the nursing infant. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Enterobacter sp., Escherichia coli, Haemophilus influenzae (beta-lactamase negative), Klebsiella sp., Staphylococcus aureus (MSSA), Streptococcus pneumoniae, Viridans streptococci
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
For steroid-responsive inflammatory ocular inflammation conditions (e.g., uveitis, bacterial conjunctivitis, corneal abrasion) for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists:
NOTE: Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.
Ophthalmic dosage (10% sulfacetamide sodium; 0.25% prednisolone sodium phosphate solution):
Adults, Geriatric, Adolescents, Children >= 6 years: Instill 2 drops topically to affected eye(s) every 4 hours. Re-evaluate patient if signs and symptoms do not improve after 48 hours of treatment. Withdrawal therapy gradually by decreasing administration frequency; do not discontinue abruptly or prematurely. Prescribe no more than 20 mL initially; examination by physician is recommended prior to renewal of medication.
Ophthalmic dosage (10% sulfacetamide sodium; 0.2% prednisolone acetate suspension):
Adults, Geriatric, Adolescents, and Children >= 6 years: Instill 2 drops topically into the conjunctival sac of the affected eye(s) every 4 hours during the day and at bedtime. Re-evaluate patient if signs and symptoms do not improve after 48 hours of treatment. Withdrawal therapy gradually by decreasing administration frequency; do not discontinue abruptly or prematurely. Prescribe no more than 20 mL initially; examination by physician is recommended prior to renewal of medication.
Ophthalmic dosage (10% sulfacetamide sodium; 0.2% prednisolone acetate ointment):
Adults, Geriatric, Adolescents, and Children >= 6 years: Apply a half-inch ribbon of ointment topically in the conjunctival sac of the affected eye(s) 3 to 4 times daily and once or twice at bedtime. Re-evaluate patient if signs and symptoms do not improve after 48 hours of treatment. Withdrawal therapy gradually by decreasing administration frequency; do not discontinue abruptly or prematurely. Prescribe no more than 8 g initially; examination by physician is recommended prior to renewal of medication.
Maximum Dosage Limits:
-Adults
12 drops/day per affected eye of the suspension or solution (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to six times daily (dispense no more than 8 grams without re-evaluation).
-Geriatric
12 drops/day per affected eye of the suspension or solution (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to six times daily (dispense no more than 8 grams without re-evaluation).
-Adolescents
12 drops/day per affected eye of the suspension or solution (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to six times daily (dispense no more than 8 grams without re-evaluation).
-Children
6 years or older: 12 drops/day per affected eye of the suspension or solution (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to six times daily (dispense no more than 8 grams without re-evaluation).
Younger than 6 years: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
No dosage adjustments are needed.
Patients with Renal Impairment Dosing
No dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Sulfacetamide; Prednisolone products.
Sulfacetamide; prednisolone is indicated for the treatment of inflammatory ocular conditions where a risk of superficial bacterial infection exists. Clinicians may wish to consult the individual monographs for more information about each component.
-Sulfacetamide: Sulfacetamide interferes with bacterial synthesis of folic acid by competitively blocking the incorporation of p-aminobenzoic acid (PABA) into tetrahydropteroic acid. Folic acid is a coenzyme required by bacterial cells for the synthesis of nucleotides and ultimately bacterial cell growth. Sulfacetamide does not affect bacterial cells that use preformed (dietary) folic acid or mammalian cells. Sulfacetamide displays in vitro bacteriostatic activity against Enterobacter species, Escherichia coli, Haemophilus influenzae, Klebsiella species, Staphylococcus aureus, Streptococcus pneumoniae, and Streptococcus viridans group.
-Prednisolone: Prednisolone is a corticosteroid with anti-inflammatory action. Corticosteroids are naturally occurring hormones that bind to specific protein receptors on targeted tissues. This binding induces a response by modifying transcription and, ultimately, protein synthesis to achieve the steroid's intended action. The anti-inflammatory action of prednisolone results from the inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, and suppression of humoral immune responses. The end result of treatment with prednisolone includes reduction in edema or scar tissue as well as a general suppression of the immune response.
Sulfacetamide; prednisolone is administered topically to the eyes. No pharmacokinetic information is available from the manufacturers of these combination ophthalmic products.