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neomycin-polymyxin-hc ear soln

In stock Manufacturer VALEANT/BAUSCH 24208063110
$106.50 / 10 Milliliters Drop Btl

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Uses

Polymyxin B sulfate is used topically and subconjunctivally in the treatment of ocular infections caused by susceptible strains of Pseudomonas aeruginosa.

Polymyxin B sulfate is used topically in combination with other anti-infective agents in the treatment of superficial infections of the eye caused by susceptible bacteria.

Polymyxin B sulfate is used in combination with other anti-infective agents and corticosteroids for the treatment of corticosteroid-responsive ocular conditions when a corticosteroid is indicated and a bacterial infection or risk of infection exists.

Polymyxin B sulfate is used in combination with other anti-infective agents and corticosteroids for the treatment of otitis externa caused by susceptible bacteria.

For other uses of polymyxin B, see 8:12.28.28.

Dosage and Administration

Reconstitution and Administration

Polymyxin B is applied topically to the eye as an ophthalmic solution or administered by subconjunctival injection. In combination with various drugs, polymyxin B sulfate is applied to the eye in the form of ophthalmic ointments, solutions, or suspensions.Only solutions prepared aseptically from the sterile powder should be used for subconjunctival injection; commercially available ophthalmic solutions containing polymyxin B should not be injected subconjunctivally.

For ophthalmic administration, polymyxin B sulfate sterile powder is reconstituted by adding 20-50 mL of sterile water for injection or 0.9% sodium chloride injection to a vial labeled as containing 500,000 units of polymyxin B, to provide solutions containing approximately 25,000-10,000 units/mL.

Polymyxin B sulfate, in combination with other drugs, is instilled into the external ear in the form of otic solutions or suspensions. For topical therapy of the external ear to be most effective, the ear canal should be clean and dry.

Dosage

Potency and dosage of polymyxin B sulfate are expressed in terms of polymyxin B activity.

Total systemic administration and topical (including ophthalmic and otic) application of polymyxin B should not exceed 2,000,000 units daily for adults; in general, total systemic administration and ophthalmic instillation should not exceed 25,000 units/kg daily.

Ophthalmic Infections

For the treatment of infections of the eye caused by susceptible strains of Pseudomonas aeruginosa, 1-3 drops of an ophthalmic solution containing 10,000-25,000 units/mL may be instilled onto the eye every hour; the interval between doses may be increased if a favorable therapeutic response occurs. If subconjunctival injection of polymyxin B is indicated (see Uses), up to 100,000 units of the sterile solution for injection may be administered daily.

When solutions or suspensions containing polymyxin B sulfate in combination with other drugs are used, 1 or 2 drops is instilled onto the affected eye every 3-4 hours, or more frequently as necessary; when ointments are used, a small amount of the ointment may be placed into the conjunctival sac 1 or more times daily every 3-4 hours. Therapy should be limited to 10 days.

Otic Infections

Otic preparations should be used sparingly to prevent an accumulation of excess debris in the ear canal and are usually administered 3 or 4 times daily.

Cautions

Adverse Effects

Polymyxin B has a low order of toxicity when applied topically to the eyes or ears; however, the drug is irritating to the eyes and low-grade conjunctivitis has occurred following repeated application of polymyxin B ophthalmic ointments. Hypersensitivity reactions to polymyxin B are rare; however, some commercially available combination products contain other ingredients such as neomycin and/or preservatives that frequently induce allergic contact dermatitis.

Precautions and Contraindications

Serious adverse reactions including nephrotoxicity and neurotoxicity have occurred in patients receiving systemic polymyxin B therapy. If polymyxin B is administered topically in conjunction with systemic polymyxin B therapy, the possibility of cumulative toxicity should be considered.

If itching, burning, inflammation, or other signs of sensitivity to polymyxin B occur, the drug should be discontinued.

Topical corticosteroids, when used in combination with topical polymyxin B, may mask the clinical signs of bacterial, fungal, or viral infections, or may suppress hypersensitivity reactions to the antibiotic or other ingredients in the formulations. The possibility of corticosteroid-induced adverse ocular effects, including increased intraocular pressure, glaucoma, papilledema, pseudotumor cerebri, ptosis, scleral malacia, and cataract formation, must also be considered.

The use of polymyxin B may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the drug should be discontinued and appropriate therapy instituted. Although some ophthalmic ointment vehicles used in the past were reported to retard corneal wound healing, currently used ophthalmic ointment vehicles do not appear to slow the rate of corneal wound healing; in addition, ointments may provide a protective effect if the cornea is exposed. However, the manufacturers caution that ophthalmic ointments have retarded corneal healing.

Some commercially available otic formulations of polymyxin B sulfate contain potassium metabisulfite, a sulfite that can cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in certain susceptible individuals. The overall prevalence of sulfite sensitivity in the general population is unknown but probably low; such sensitivity appears to occur more frequently in asthmatic than in nonasthmatic individuals.

Polymyxin B sulfate is contraindicated in patients with a history of hypersensitivity to any of the polymyxins or to any of the ingredients in the formulation.

Pregnancy

Pregnancy

The safety of polymyxin B for topical use during pregnancy has not been established.

Pharmacokinetics

One report suggests polymyxin B is not absorbed from the conjunctival sac. Systemically administered polymyxin B does not penetrate into the aqueous humor of the eye, even in the presence of inflammation. The drug does not appear to be absorbed to an appreciable extent from mucous membranes or intact or denuded skin.

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