Product Monograph - Dioptimyd Ointment
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.
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 Dioptimyd Ointment, 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
Dioptimyd Ointment contains an antibacterial ingredient, sulfacetamide sodium. To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfacetamide sodium, Dioptimyd Ointment should only be used for the authorized indication and clinical use.
CONTRAINDICATIONS
Dioptimyd Ointment 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 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
Prolonged use may predispose to secondary fungal or bacterial ocular infection. Systemic adverse reactions may occur following prolonged use of steroids with occlusive dressings.
Dioptimyd Ointment is incompatible with silver solutions. Non-susceptible organisms may proliferate with the use of Sulfacetamide sodium. 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 Dioptimyd Ointment 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 of Dioptimyd Ointment may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved following 2 days of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.
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 subcapsular cataract formation and delayed wound healing may also occur.
Dioptimyd 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
Apply about 1 cm of ointment into the space between the lower eyelid and the eye 3 or 4 times daily. Patients should be advised to avoid contamination of the applicator tip during use and to replace the cap after use. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.
AVAILABILITY
Dioptimyd Ointment contains: Sulfacetamide sodium 10% w/v (100 mg/g) and prednisolone acetate 0.5% w/v (5 mg/g) and the following non-medicinal ingredients: Lanolin alcohol, mineral oil, petrolatum and white petrolatum.
Dioptimyd Ointment is supplied in a 5 g metal tube with an applicator tip.
STORAGE CONDITIONS
Dioptimyd Ointment should be stored between 15º to 25ºC. Protect from freezing, heat and light. Store in an upright position.
Sulfonamide solutions, on long standing and exposure to heat and light, will darken in color and should be discarded if they become dark brown. Yellowing does not affect activity.
Keep out of reach and sight of children.