Version May 2024
Inflammatory ocular conditions: Ophthalmic:
Ointment: Apply ~1/2 inch ribbon to lower conjunctival sac 3 to 4 times daily and 1 to 2 times at night.
Solution: Instill 2 drops every 4 hours.
Suspension: Instill 2 drops every 4 hours during the day and at bedtime.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Inflammatory ocular conditions: Children ≥6 years and Adolescents: Ophthalmic: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.
Frequency not defined:
Dermatologic: Stevens-Johnson syndrome, toxic epidermal necrolysis
Hematologic & oncologic: Agranulocytosis, aplastic anemia
Hepatic: Fulminant hepatic necrosis
Hypersensitivity: Hypersensitivity reaction
Infection: Secondary infection (bacterial, fungal)
Local: Local irritation
Ophthalmic: Accommodation disturbance, anterior uveitis (acute), blepharoptosis, eye perforation, glaucoma, increased intraocular pressure, mydriasis, optic nerve damage (infrequent), subcapsular posterior cataract
Miscellaneous: Wound healing impairment
<1%, postmarketing, and/or case reports: Hypercorticoidism (systemic)
Hypersensitivity to sulfacetamide, prednisolone, other sulfonamides or corticosteroids, or any component of the formulation; viral diseases (including epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella) of the cornea or conjunctiva; fungal diseases of ocular structures; mycobacterial ocular infections
Note: Although the FDA-approved product labeling states this medication is contraindicated in patients with hypersensitivity to sulfonamide-containing drugs, the scientific basis of this cross-sensitivity has been challenged. See “Warnings/Precautions” for more detail.
Canadian labeling: Additional contraindications (not in US labeling): Purulent untreated ocular infections; ocular tuberculosis.
Concerns related to adverse effects:
• Blood dyscrasias: Severe reactions including agranulocytosis, aplastic anemia, and other blood dyscrasias have occurred with sulfonamides (regardless of route); fatalities have occurred (rare). Discontinue at the first sign of serious reaction.
• Dermatologic reactions: Severe reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have occurred with sulfonamides (regardless of route); fatalities have occurred (rare). Discontinue at first sign of rash.
• Hepatic necrosis: Severe reactions, including fulminant hepatic necrosis have occurred with sulfonamides (regardless of route); fatalities have occurred (rare). Discontinue at first sign of serious reaction.
• Hypersensitivity reactions: Hypersensitivity reactions, skin rash, or other serious reactions may occur; discontinue at the first sign of hypersensitivity reaction. Cross sensitivity among corticosteroids has occurred.
• Infection: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), or prolong or exacerbate viral infections. Corticosteroids should not be used to treat ocular herpes simplex; use extreme caution in patients with a history of ocular herpes simplex. Fungal infection should be suspected in any patient with persistent corneal ulceration who has received corticosteroids.
• Ocular effects: Prolonged use of steroids may result in posterior subcapsular cataract formation and may increase intraocular pressure, resulting in ocular hypertension/glaucoma with damage to the optic nerve, defects in visual acuity, and fields of vision. Acute anterior uveitis may occur in susceptible patients, primarily black patients. Use with caution in patients with glaucoma (steroids increase intraocular pressure). Perforation may occur with topical steroids in diseases which thin the cornea or sclera. Intraocular pressure should be monitored if this product is used >10 days.
• Sulfonamide ("sulfa") allergy: Traditionally, concerns for cross-reactivity have extended to all compounds containing the sulfonamide structure (SO2NH2). An expanded understanding of allergic mechanisms indicates cross-reactivity between antibiotic sulfonamides and nonantibiotic sulfonamides may not occur, or at the very least this potential is extremely low (Brackett 2004; Johnson 2005; Slatore 2004; Tornero 2004). In particular, mechanisms of cross-reaction due to antibody production (anaphylaxis) are unlikely to occur with nonantibiotic sulfonamides and antibiotic sulfonamides. A nonantibiotic sulfonamide compound which contains the arylamine structure and therefore may cross-react with antibiotic sulfonamides is sulfasalazine (Zawodniak 2010). T-cell–mediated (type IV) reactions (eg, maculopapular rash) are less understood and it is not possible to completely exclude this potential based on current insights. In cases where prior reactions were severe (Stevens-Johnson syndrome/TEN), some clinicians choose to avoid exposure to these classes.
Disease-related concerns:
• Dry eye: Use with caution in patients with severe dry eye.
Special populations:
• Cataract surgery patients: Use following cataract surgery may delay healing or increase the incidence of bleb formation.
• Contact lens wearers: May contain benzalkonium chloride, which may be adsorbed by contact lenses; contact lenses should not be worn during treatment of ophthalmologic infections.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Other warnings/precautions:
• Administration: For ophthalmic use only; not for injection into the eye. Do not use concurrently with silver preparations.
• Appropriate use: Re-evaluate if signs and symptoms do not improve after 2 days. Use of >20 mL (solution/suspension) or 8 g (ointment) should only be done following proper re-examination of the patient (eg, slit-lamp biomicroscopy, fluorescein staining). Not effective in Sjogren keratoconjunctivitis or mustard gas keratitis.
• Discontinuation of therapy: In chronic conditions, withdraw therapy with gradual tapering of dose.
• P-aminobenzoic acid: May be present in purulent exudates and may reduce the effectiveness of sulfonamides.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment, ophthalmic: Blephamide: Sulfacetamide sodium 10% and prednisolone acetate 0.2% (3.5 g)
Solution, ophthalmic [drops]: Sulfacetamide sodium 10% and prednisolone sodium phosphate 0.25% (5 mL, 10 mL)
Suspension, ophthalmic [drops]: Blephamide: Sulfacetamide sodium 10% and prednisolone acetate 0.2% (5 mL, 10 mL) [contains benzalkonium chloride]
Yes: Solution
Solution (Sulfacetamide-prednisoLONE Ophthalmic)
10-0.23% (per mL): $3.75
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
For topical ophthalmic use only; to avoid contamination, do not touch container tip to eyelids or other surfaces when placing drops or ointment in eyes. Do not apply with silver preparations. Discontinue if symptoms do not improve after 2 days. No more than 20 mL or 8 g should be prescribed without proper re-evaluation of the patient.
Ointment: Apply into pocket between eyeball and lower lid; patient should look downward before closing eye.
Solution/Suspension: Tilt head back, instill into the conjunctival sac and close eye(s). Apply light finger pressure on lacrimal sac for 1 minute following instillation. Shake the suspension well before using.
Ophthalmic: For topical ophthalmic use only; not for injection into the eye. To avoid contamination, do not touch container tip to eyelids or other surfaces when placing drops or ointment in eyes. Do not apply with silver preparations. Discontinue if symptoms do not improve after 2 days.
Ointment: Apply into pocket between eyeball and lower lid; patient should look downward before closing eye.
Solution/Suspension: Shake the suspension well before using. Instill drops into the conjunctival sac and close eye(s); it is not necessary to wipe away excess solution.
Inflammatory ocular conditions: Treatment of steroid-responsive inflammatory ocular conditions (where either a superficial bacterial ocular infection or the risk of bacterial ocular infection exists) of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe; chronic anterior uveitis; corneal injury from chemical, radiation, or thermal burns; penetration of foreign bodies
Blephamide may be confused with Bleph-10
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor therapy
Animal reproduction studies have not been conducted with this combination. Use of systemic sulfonamides during pregnancy may cause kernicterus in the newborn. See individual agents.
It is unknown if topical use results in sufficient absorption to produce detectable quantities in breast milk. Use of systemic sulfonamides while breast-feeding may cause kernicterus in the newborn; the amount of systemic absorption following ophthalmic administration is not known. Due to the potential for serious adverse reactions in the breast-feeding infant, the manufacturer recommends a decision be made whether to discontinue breast-feeding or to discontinue the drug, taking into account the importance of treatment to the mother. See individual agents.
Signs and symptoms of improvement after 2 days of therapy; signs and symptoms of secondary infection; intraocular pressure in patients with glaucoma or with prolonged use (≥10 days); periodic exam of lens with prolonged use
Interferes with bacterial growth by inhibiting bacterial folic acid synthesis through competitive antagonism of PABA; decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability; suppresses the immune system by reducing activity and volume of the lymphatic system
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