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Prednisolone Sodium Opht (RX)
Prednisolone Sodium Opht (RX)
Prednisolone Sodium Opht (RX)


 
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Sulfacetamide sodium is used topically for the treatment of conjunctivitis, corneal ulcers, and other superficial infections of the eye caused by susceptible organisms. Sulfacetamide sodium has also been used to prevent infections after removal of foreign bodies or injuries to the eye. Some experts believe topical antibiotics may be more effective than topical sulfonamides for the treatment and prophylaxis of ophthalmic infections, with the exception of acute and chronic conjunctivitis. SUPPLIER VARIES

Item# Item Name Our Price Qty Add
71-PRED-SOD-1-15 Prednisolone Sodium Opht (RX) 1% 15 ML.
$42.46
71-PRED-SOD-1-5 Prednisolone Sodium Opht (RX) 1% 5 ML.
$24.95
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Features:
Sulfacetamide sodium is used topically for the treatment of conjunctivitis, corneal ulcers, and other superficial infections of the eye caused by susceptible organisms. Sulfacetamide sodium has also been used to prevent infections after removal of foreign bodies or injuries to the eye. Some experts believe topical antibiotics may be more effective than topical sulfonamides for the treatment and prophylaxis of ophthalmic infections, with the exception of acute and chronic conjunctivitis. Except for the treatment of very superficial infections, concomitant systemic anti-infective therapy may also be required. Sulfacetamide sodium has also been used topically as an adjunct to oral sulfonamide or oral tetracycline therapy for the treatment of trachoma and inclusion conjunctivitis, but tetracyclines are considered by many experts to be superior for topical therapy and are generally used in adults and children 8 years of age or older. For the treatment of these ophthalmic chlamydial infections in younger children and neonates, oral erythromycin or oral sulfonamide therapy, with or without topical erythromycin, a topical sulfonamide, or a topical tetracycline is generally used; however, optimum therapy for trachoma has not been established and treatment may be difficult. Sulfacetamide sodium is also used in combination with other drugs such as corticosteroids and vasoconstrictors. Concomitant therapy with a corticosteroid may be used for steroid-responsive ocular inflammatory conditions for which a corticosteroid is indicated and where a superficial ocular bacterial infection or risk of ocular bacterial infection exists. Concomitant topical corticosteroids may mask the clinical signs of bacterial, fungal, or viral infections and prevent recognition of ineffectiveness of sulfacetamide; suppression of hypersensitivity reactions to substances in the product and/or increased intraocular pressure may also occur. However, in one controlled study, the treatment of blepharitis with a combination of sulfacetamide and a corticosteroid resulted in a reduced healing time as compared to the use of sulfacetamide alone; some patients who received only sulfacetamide required subsequent steroid therapy for the management of continued and severe inflammation.



Extended Information:
DEFINED
Sulfacetamide sodium is a sulfonamide that has a broad antimicrobial spectrum in vitro against gram-positive and gram-negative organisms.

PRODUCT USE

Sulfacetamide sodium is used topically for the treatment of conjunctivitis, corneal ulcers, and other superficial infections of the eye caused by susceptible organisms. Sulfacetamide sodium has also been used to prevent infections after removal of foreign bodies or injuries to the eye. Some experts believe topical antibiotics may be more effective than topical sulfonamides for the treatment and prophylaxis of ophthalmic infections, with the exception of acute and chronic conjunctivitis. Except for the treatment of very superficial infections, concomitant systemic anti-infective therapy may also be required. Sulfacetamide sodium has also been used topically as an adjunct to oral sulfonamide or oral tetracycline therapy for the treatment of trachoma and inclusion conjunctivitis, but tetracyclines are considered by many experts to be superior for topical therapy and are generally used in adults and children 8 years of age or older. For the treatment of these ophthalmic chlamydial infections in younger children and neonates, oral erythromycin or oral sulfonamide therapy, with or without topical erythromycin, a topical sulfonamide, or a topical tetracycline is generally used; however, optimum therapy for trachoma has not been established and treatment may be difficult.

Sulfacetamide sodium is also used in combination with other drugs such as corticosteroids and vasoconstrictors. Concomitant therapy with a corticosteroid may be used for steroid-responsive ocular inflammatory conditions for which a corticosteroid is indicated and where a superficial ocular bacterial infection or risk of ocular bacterial infection exists. Concomitant topical corticosteroids may mask the clinical signs of bacterial, fungal, or viral infections and prevent recognition of ineffectiveness of sulfacetamide; suppression of hypersensitivity reactions to substances in the product and/or increased intraocular pressure may also occur. However, in one controlled study, the treatment of blepharitis with a combination of sulfacetamide and a corticosteroid resulted in a reduced healing time as compared to the use of sulfacetamide alone; some patients who received only sulfacetamide required subsequent steroid therapy for the management of continued and severe inflammation.

Dosage and Administration

Sulfacetamide sodium is applied topically to the eye as an ophthalmic ointment, solution, or suspension containing 10% of the drug.

When the 10% ointment is used, a ribbon of the ointment (approximately 1.25–2.5 cm in length) may be applied in the conjunctival sac every 3–4 hours and at bedtime. Alternatively, the ointment may be applied at night in conjunction with the daytime use of the ophthalmic solution or before an eye is patched. When the 10% solution is used, 1 or 2 drops may be instilled into the lower conjunctival sac every 2–3 hours during the day and less frequently at night.

When the 10% fixed-combination suspension containing fluorometholone is used, 1 drop may be instilled into the lower conjunctival sac 4 time daily. Dosing may be reduced, but therapy should not be discontinued prematurely. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. In chronic conditions, therapy should be withdrawn gradually by decreasing the application frequency. The suspension should be shaken well before using.

For the treatment of trachoma, 2 drops of the 10% solution may be instilled every 2 hours in conjunction with systemic sulfonamide or tetracycline therapy; alternatively, a small amount of sulfacetamide sodium ophthalmic ointment† may be applied to each eye twice daily for 2 months or twice daily for the first 5 days of each month for 6 months.

Cautions

•Adverse Effects

Topical application of sulfonamides may produce sensitization and preclude later systemic use of these drugs. In addition, patients who have been sensitized by systemic sulfonamide administration may exhibit hypersensitivity reactions following topical application of the drugs. Stevens-Johnson syndrome occurred following use of sulfacetamide sodium ophthalmic ointment in one patient who had a history of bullous lesions with systemic sulfonamide therapy. In addition, a case of local hypersensitivity that progressed to a fatal syndrome resembling systemic lupus erythematosus has occurred.

The most frequently reported adverse effects following topical application of sulfacetamide sodium ophthalmic preparations are local irritation, stinging, and burning. Conjunctivitis, conjunctival hyperemia, and secondary infections have been reported less frequently.

•Precautions and Contraindications

The possibility of adverse reactions associated with systemic use of sulfonamides should be considered in patients receiving topical sulfonamides. If hypersensitivity reactions occur during sulfonamide therapy, the drug should be discontinued immediately. Sulfonamides are contraindicated in patients who have previously exhibited hypersensitivity to sulfonamides or other ingredients in the formulations.

The use of sulfonamides may result in the overgrowth of nonsusceptible organisms including fungi. The manufacturers also caution that sulfonamides are inactivated by purulent exudates. (See Mechanism of Action.)

Although some ophthalmic ointment vehicles used in the past were reported to retard corneal wound healing, currently used ophthalmic ointment vehicles do not appear to slow the rate of corneal wound healing; in addition, ointments may provide a protective effect if the cornea is exposed. However, the manufacturers caution that ophthalmic ointments have retarded corneal healing.

When combination products containing sulfacetamide sodium are used, the precautions applicable to all ingredients should be observed.

•Pediatric Precautions

Topical application of sulfacetamide sodium is not recommended by the manufacturers in infants younger than 2 months of age.
Drug Interactions

Sulfonamides should not be used with preparations containing silver. (See Chemistry and Stability: Stability).

Because of reported in vitro antagonism, sulfacetamide sodium should not be used concomitantly with gentamicin sulfate.

Mechanism of Action

Sulfonamides are usually bacteriostatic; however, in extremely high concentrations, they may be bactericidal. Sulfonamides interfere with utilization of para-aminobenzoic or para-aminobenzoic glutamic acids by bacteria, thus inhibiting the biosynthesis of folic acid which is essential for the growth of susceptible organisms. Only organisms that synthesize their own folic acid are inhibited by sulfonamides; animal cells and bacteria that are capable of utilizing folic acid precursors or preformed folic acid are not affected by these drugs. The antibacterial activity of the sulfonamides is decreased in the presence of blood or purulent exudates which contain para-aminobenzoic acid.

Spectrum

Sulfonamides have a broad antimicrobial spectrum in vitro against gram-positive and gram-negative organisms; however, the increasing incidence of resistance in organisms formerly susceptible to the sulfonamides has decreased the range of clinical usefulness of these anti-infective agents.

Resistance

Resistance in organisms initially susceptible to sulfonamides may develop in vitro and in vivo. Organisms resistant to one sulfonamide are usually cross-resistant to other sulfonamides. Organisms that are highly resistant to sulfonamides are usually permanently resistant; however, a slight or moderate degree of resistance may be reversible.

Pharmacokinetics

Sulfonamides do not appear to be appreciably absorbed from mucous membranes.

Chemistry and Stability

•Chemistry

Sulfonamides are synthetic derivatives of para-aminobenzenesulfonamide (sulfanilamide). Sulfacetamide sodium is suitable for ophthalmic use because it is freely soluble in water and less alkaline, and therefore less irritating to the conjunctiva, than are other sulfonamides.

Sulfacetamide sodium occurs as a white, odorless, crystalline powder with a bitter taste and is freely soluble in water and sparingly soluble in alcohol. Commercially available ophthalmic solutions of sulfacetamide sodium have a pH of 7.4.
 
•Stability

Sulfacetamide sodium ophthalmic ointment should be stored in tight, light-resistant containers away from heat, at 15–30°C. Sulfacetamide sodium ophthalmic solutions should be stored in tight, light-resistant containers; while the manufacturers state that such storage should be at 8–25°C, USP recommends that it be at 8–15°C. Ophthalmic suspensions should be stored at 15–30°C, protected from light; freezing should be avoided. Fixed-combination suspensions that contain fluorometholone should not be used if dark brown. Commercially available ophthalmic preparations of sulfacetamide sodium have expiration dates of 2–4 years following the date of manufacture, depending on the manufacturer.

If exposed to air or sterilized by heat, solutions of sulfacetamide sodium may undergo hydrolysis to form a sulfanilamide precipitate; oxidation may subsequently occur with the development of a yellowish-brown to deep reddish-brown color. Solutions of sulfacetamide sodium which are discolored should not be used. Commercial preparations of sulfacetamide sodium contain antioxidants to minimize color changes.

Sulfacetamide sodium is incompatible with preparations containing silver. Precipitation may occur when zinc sulfate is added to sulfacetamide sodium solutions, depending on the concentration of each drug.




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