Product Monograph - Prednisolone/Sulfacetamide
ACTION AND CLINICAL PHARMACOLOGY
Prednisolone acetate is a potent synthetic corticosteroid with anti-inflammatory properties, useful in the treatment of inflammatory conditions of the eye, particularly the anterior segment. Corticosteroids suppress the inflammatory response to a variety of agents. Since they may inhibit the body’s defense mechanism against infection. A concomitant antibacterial drug may be used when there is the risk of ocular infection. Corticosteroids probably also delay healing.
Sulfacetamide sodium is a sulfonamide with bacteriostatic action, except at very high concentrations as may occur with ophthalmic use, when it may be bactericidal. It interferes with the utilization of para-aminobenzoic acid by bacteria, thus preventing the essential biosynthesis of folic acid, and inhibiting growth of a wide variety of gram- negative and gram-positive bacteria. It is particularly suited to the eye because it is freely soluble in water and less alkaline, and therefore less irritating to the eye, than other sulfonamides.
NON-MEDICINAL INGREDIENTS
Benzalkonium Chloride 0.025%, Disodium Edetate. Hydroxypropyl Methylcellulose, Polysorbate 80, Sodium
Phosphate Dibasic, Sodium Phosphate Monobasic, Sodium Thiosulphate and Purified Water.
INDICATIONS
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or risk of bacterial infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis and selected types of infective conjunctivitis when the inherent risk of steroid use is
acceptable in order to obtain a diminution of edema and inflammation. Use in corneal injury from chemical, radiation and thermal bums or penetration of foreign bodies is also indicated.
The use of a combination drug with an antibacterial component is indicated where there is risk of infection.
Sulfacetamide sodium, the particular antibacterial drug in Prednisolone/Sulfacetamide, is effective against many strains of the following organisms commonly found in eye infections: S.aureus, Streptococci, E. coli, H. influenzae,
Klebsiella, and Enterobacter species.
A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs. It is not effective against Neisseria species and Serratia marcescens
Prednisolone/Sulfacetamide contains an antibacterial ingredient, sulfacetamide sodium. To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfacetamide sodium,
Prednisolone/Sulfacetamide should only be used for the authorized indication and clinical use.
CONTRAINDICATIONS
It is contraindicated if individual is hypersensitive to any of Its components. Should not be used in the presence of viral diseases of the cornea and conjunctiva; tuberculosis of the eye; fungal disease of the eye; acute purulent untreated infections of the eye, which, like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid.
WARNINGS
Prolonged use may result in glaucoma. with damage to the optic nerve, defects in visual acuity and fields of vision.
If these products are used for 10 days or longer, intraocular pressure should be routinely monitored.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.
Use of ocular steroid medication in the treatment of herpes simplex requires great caution.
PRECAUTIONS
The initial prescription and renewal of the medication beyond 20 ml of suspension should be made by a physician only after examination of the patient with the aid of magnification, such as slit-lamp bio-microscopy and, where appropriate, fluorescein staining. Systemic adverse reactions may occur following prolonged use of steroids with occlusive dressings.
Prednisolone/Sulfacetamide is incompatible with silver solutions. Sulfonamides are inactivated by the para-aminobenzoic acid present in purulent exudates. Sensitization may recur when a sulfonamide is re-administered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. If signs of hypersensitivity or other untoward reactions occur, discontinue use.
Susceptibility/Resistance
Development of Drug Resistant bacteria
Prescribing Prednisolone/Sulfacetamide in the absence of the authorized indications is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
Potential for Microbial Overgrowth
Prolonged use may predispose to secondary fungal or bacterial ocular infection. Non-susceptible organisms may proliferate with the use of Sulfacetamide sodium. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
ADVERSE REACTIONS
Adverse effects observed with corticosteroid/antibacterial combination drugs can be attributed to the steroid component, the antibacterial or other ingredients.
Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea, perforation has been known to occur. Posterior sub capsular cataract formation and delayed wound healing may also occur.
Prednisolone/Sulfacetamide Ointment may cause local irritation; transient burning and stinging may occur.
Although sensitivity reactions to Sulfacetamide sodium rare, an isolated incident of Stevens-Johnson syndrome was reported in a patient who had experienced a previous bullous drug reaction to an orally administered
sulfonamide and a single instance of local hypersensitivity was reported which progressed to a fatal syndrome resembling systemic lupus erythematosus.
DOSAGE AND ADMINISTRATION
Dosage should be adjusted to the specific needs of the patient. One or two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, the dose being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used four to six times daily. Not more than 20 ml should be prescribed initially and the prescription should not be refilled without further evaluation as outlined In PRECAUTIONS above.
Patients should be advised to avoid contamination of the applicator tip during use and to replace the cap after use. Shake well before using (Cloudiness of this suspension is to be expected.).
AVAILABILITY
Prednisolone/Sulfacetamide contains: sulfacetamide sodium 10.0% w/v and prednisolone acetate
0.5% w/v and the following non-medicinal ingredients: Benzalkonium Chloride 0.025% as, Disodium
Edetate. Hydroxypropyl Methylcellulose, Polysorbate 80, Sodium Phosphate Dibasic, Sodium
Phosphate Monobasic, Sodium Thiosulphate and Purified Water.
Prednisolone/Sulfacetamide Sterile Ophthalmic Suspension is supplied in 5 ml and 10 ml plastic squeeze bottles with an applicator tip.
STORAGE CONDITIONS
Store at controlled room temperature (15° - 30°C). Protect from freezing.