Sulfacetamide and Prednisolone
Medically reviewed by Drugs.com. Last updated on Aug 2, 2020.
(sul fa SEE ta mide & pred NIS oh lone)
- Prednisolone and Sulfacetamide
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]
Brand Names: U.S.
- Antibiotic/Corticosteroid, Ophthalmic
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
Use: Labeled Indications
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
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 with other sulfonamide-containing drug classes, the scientific basis of this statement has been challenged. See "Warnings/Precautions" for more detail.
Canadian labeling: Additional contraindications (not in US labeling): Purulent untreated ocular infections.
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
Refer to adult dosing.
Inflammatory ocular conditions: Children ≥6 years and Adolescents: Ophthalmic: Refer to adult dosing.
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.
Ointment: Store at 15°C to 25°C (59°F to 77°F).
Solution, suspension: Do not freeze; protect from light. May darken on prolonged standing or exposure to heat and light. Do not use if darkened; yellowing does not affect activity.
Solution: Store at 15°C to 25°C (59°F to 77°F).
Suspension: Store at 8°C to 24°C (46°F to 75°F) in upright position.
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. Monitor therapy
Frequency not defined. Also see individual agents.
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)
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.
• Dry eye: Use with caution in patients with severe dry eye.
• 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.
• 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.
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
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.
What is this drug used for?
• It is used to treat or prevent eye infections.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• A severe sulfonamide reaction like rash; red, swollen, blistered, or peeling skin; red or irritated eyes; mouth, throat, nose, or eye sores; fever, chills, or sore throat
• Cough that is new or worse
• Loss of strength and energy
• Bruising or bleeding
• Liver problems like dark urine, fatigue, lack of appetite, nausea or abdominal pain, light-colored stools, vomiting, or yellow skin
• Sensitivity to light
• Vision changes
• Eye pain
• Severe eye irritation
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- During Pregnancy
- Dosage Information
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