Product Monograph - Optimyxin Plus
INDICATIONS
Optimyxin Plus is used for the prophylaxis and treatment of eye and ear infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of OPTIMYXIN PLUS and other antibacterial drugs, OPTIMYXIN PLUS 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 manifest 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 OPTIMYXIN PLUS 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 OPTIMYXIN PLUS 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 and ear 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. In patients with perforated eardrums or long-standing otitis media, treatment should be restricted to 10 days.
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 dose is one or two drops in the affected eye or ear, 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.
To administer the drops into the ear, tilt the head or lie on the side, remain in this position for two minutes after administering the drops. For therapy to be most effective, the ear canal should be clean and dry.
AVAILABILITY OF DOSAGE FORMS
Each mL contains Polymyxin B sulfate 10 000 units, gramicidin 0.025 mg and neomycin 1.75 mg (as neomycin sulfate 2.5 mg). Also contains ethyl alcohol and benzalkonium chloride 0.005% (preservative).
Available in plastic dropper bottles of 10 mL, boxes of 1.
Store between 15 and 30oC.