Product Monograph - Odan-Spor
INDICATIONS
ODAN-SPOR is used for the prophylaxis and treatment of eye infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ODAN-SPOR and other antibacterial drugs, ODAN-SPOR should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
CONTRAINDICATIONS
Hypersensitivity to any of the components.
The presence of preexisting nerve deafness is a contraindication to the use of any topical aminoglycoside in circumstances where significant systemic absorption could occur.
WARNINGS AND PRECAUTIONS
The manifestations of sensitization to neomycin are usually itching, reddening and edema of the conjunctiva and eyelid. It may be manifested simply as a failure to heal. During long-term use of neomycin-containing products, periodic examination for such signs is advisable and the patient should be told to discontinue the product if they are observed. These symptoms subside quickly on withdrawing the medication. Neomycin-containing applications should be avoided for the patient thereafter.
Susceptibility/Resistance
Development of Drug Resistant Bacteria
Prescribing ODAN-SPOR in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
Potential for Microbial Overgrowth
The use of ODAN-SPOR may promote the selection of non-susceptible organisms. Should superinfection occur during therapy, appropriate measures should be taken.
Articles in current medical literature indicate an increase in the incidence of allergies to neomycin in patients with stasis ulcers or eczema. The possibility of an allergic reaction to neomycin should be borne in mind.
As with any antibiotic-containing medication, prolonged use may result in the overgrowth of nonsusceptible organisms, including fungi. Should superinfection occur, the preparation should be discontinued and/or appropriate therapy instituted.
Because of the potential hazard of nephrotoxicity and ototoxicity due to neomycin, care should be exercised when treating extensive burns, trophic ulceration and other extensive conditions where absorption of neomycin is possible.
The eye solution should not be given subconjunctivally or intraocularly, nor should it be used for the irrigation of fistulous tracts in or about the eye or its socket.
Treatment should be continued until at least 48 hours after the eye has apparently recovered.
ADVERSE EFFECTS
Topical neomycin occasionally causes skin sensitization, especially when used for prolonged periods of time. Sensitivity to topical neomycin has been reported to occur in 5 15% of patients treated with the drug. Hypersensitivity reactions including contact conjunctivitis, burning, erythema, rash, and urticaria have occurred following topical application of neomycin to patients who are sensitive to the drug or other ingredients in the formulations.
Ototoxicity and nephrotoxicity have also been reported (see PRECAUTIONS).
Polymyxin B has a low order of toxicity when applied topically. Allergic hypersensitivity reactions to polymyxin B are rare but have been reported.
DOSAGE AND ADMINISTRATION
The suggested dosage is one or two drops in the affected eye two to four times a day or more frequently as required.
If the infection does not subside within a few days, medical consultation is indicated.
To avoid contaminating the sterile solution, be sure not to touch the infected area with the dropper, when administering the drops.
To prevent the eye drops from being drained from the eye, apply a gentle pressure to the inside corner of the eye with your fingers for one minute.
AVAILABILITY
Each mL contains: polymyxin B sulfate 10 000 units, neomycin sulfate equivalent to 1.75mg neomycin base and gramicidin 0.025mg with ethyl alcohol 0.5%, thimerosal 0.001% (added as a preservative) and the inactive ingredients poloxamer 185, propylene glycol, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. Supplied as 10 mL sterile plastic bottles with applicator tip, individually packaged.
STORAGE CONDITIONS
Store between 15°C and 30°C and protect from light.