Product Monograph - Odan-Cide
ACTION AND CLINICAL PHARMACOLOGY
Corticosteroids suppress the inflammatory response to a variety of agents and they may delay or slow healing. Since corticosteroids may inhibit the body’s defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant.
The anti-infective component in the combination is included to provide action against specific organisms susceptible to it.
INDICATIONS
ODAN-CIDE is for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular 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 infective conjunctivitis when the inherent risk of steroid use is accepted to obtain a diminution in edema and inflammation. Corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies is also indicated.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Streptococci (including streptococcus pneumonia), Escherichia coli, Hemophilus influanzae and Klebsiella enterobacter species. The product does not provide adequate coverage against Neisseria species and Serratia marcescens.
ODAN-CIDE contains an antibacterial ingredient, sulfacetamide sodium. To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfacetamide sodium,
ODAN-CIDE should only be used for the authorized indication and clinical use.
PRECAUTIONS
The possibility of fungal infections of the cornea should be considered after prolonged steroid dosing.
Susceptibility/Resistance
Development of Drug Resistant bacteria
Prescribing ODAN-CIDE in the absence of the authorized indications is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
WARNINGS
Extended use may result in increased intraocular pressure in susceptible individuals with damage to the optic nerve, defects in visual acuity and fields or vision. It is advisable that intraocular pressure be checked frequently. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. 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. Prolonged use may cause posterior subcapsular cataracts. This product should be used with caution in narrow-angle glaucoma. Employment of steroid medication in the treatment of herpes simplex requires great caution.
ADVERSE REACTIONS
Adverse reactions have occurred with steroid / anti-infective combination drugs. The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage, posterior subcapsular cataract formation; and delayed wound healing. Secondary infection: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of the steroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.
DOSAGE AND ADMINISTRATION
For topical use only. Shake well before using. In treating ocular inflammatory conditions, one or two drops in the conjunctival sac every hour during the day and every two hours at night is usually adequate to reduce the inflammation. When improvement occurs, the dosage may be reduced to one drop three or four times daily.
AVAILABILITY
Each mL of sterile ophthalmic suspension contains: Sulfacetamide sodium USP 100 mg and prednisolone acetate USP 5 mg.
Non-medicinal Ingredients: Hydroxyethyl cellulose, polysorbate 80, sodium thiosulfate, sodium phosphate (monobasic and dibasic), edetate disodium and benzalkonium chloride 0.025% as preservative.
STORAGE CONDITIONS
Store between 15°C and 30°C. Keep container tightly closed and protected from light.