neomyc-polym-gramicid eye drop generic neosporin

Uses

Bacterial Ophthalmic Infections

Neomycin is used in fixed combination with other anti-infectives (i.e., polymyxin B sulfate and bacitracin zinc; polymyxin B and gramicidin) for the topical treatment of superficial infections of the eye (e.g., conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, blepharoconjunctivitis) caused by susceptible bacteria.

Fixed-combination topical ophthalmic preparations containing neomycin sulfate, polymyxin B sulfate, and bacitracin zinc are considered active against Staphylococcus aureus, streptococci (including Streptococcus pneumoniae), Escherichia coli, Haemophilus influenzae, Enterobacter, Klebsiella, Neisseria, and Pseudomonas aeruginosa, but do not provide adequate coverage against Serratia marcescens.

Fixed-combination topical ophthalmic preparations containing neomycin sulfate, polymyxin B sulfate, and gramicidin are considered active against S. pneumoniae, E. coli, H. influenzae, Enterobacter, Klebsiella, Neisseria, and Ps. aeruginosa, but do not provide adequate coverage against S. marcescens.

Although mild, acute bacterial conjunctivitis often resolves spontaneously without anti-infective treatment, topical ophthalmic anti-infectives may shorten the time to resolution and reduce severity and risk of complications. Treatment of acute bacterial conjunctivitis generally is empiric and use of a broad-spectrum topical ophthalmic antibacterial usually is recommended; however, indiscriminate use of topical anti-infectives should be avoided. In vitro staining and/or cultures of conjunctival material may be indicated in the management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment.

Because many forms of bacterial keratitis are associated with subsequent loss of vision as the result of corneal scarring or topographic irregularities and because untreated or severe bacterial keratitis may result in perforation of the cornea with the potential for endophthalmitis and possible loss of the eye, optimal management involves rapid evaluation and diagnosis, timely initiation of treatment, and appropriate follow-up. Treatment of community-acquired bacterial keratitis generally is empiric and use of a broad-spectrum topical ophthalmic antibacterial usually is recommended. Subconjunctival therapy with an appropriate anti-infective may be necessary if scleral spread or perforation is imminent. In vitro staining and/or cultures are indicated in the management of keratitis involving corneal infiltrates that are central, large, and extending to the middle to deep stroma; when keratitis is chronic or unresponsive to broad-spectrum topical anti-infective treatment; or when atypical features are present suggesting fungal, amebic, or mycobacterial infection.

Bacterial Otic Infections

Neomycin is used in fixed combination with colistin and hydrocortisone acetate or in fixed combination with polymyxin B sulfate and hydrocortisone for the topical treatment of superficial infections of the external auditory canal (otitis externa) caused by susceptible bacteria. These fixed-combination otic preparations also are used for the topical treatment of infections of mastoidectomy or fenestration cavities caused by susceptible bacteria.

Diffuse, uncomplicated acute otitis externa in otherwise healthy patients usually should be treated initially with topical therapy (e.g., otic anti-infective or antiseptic with or without an otic corticosteroid). Topical therapy should be supplemented with systemic anti-infective therapy if the patient has a medical condition that could impair host defenses (e.g., diabetes mellitus, human immunodeficiency virus [HIV] infection) or if the infection has spread into the pinna, skin of the neck or face, or into deeper tissues such as occurs with malignant otitis externa. Malignant otitis externa is an invasive, potentially life-threatening infection, especially in immunocompromised patients, and requires prompt diagnosis and treatment with systemic anti-infectives.

Ocular Inflammation

Topical ophthalmic preparations containing neomycin sulfate in fixed combination with polymyxin B sulfate and a corticosteroid (i.e., dexamethasone) or neomycin sulfate in fixed combination with polymyxin B sulfate, bacitracin zinc, and a corticosteroid (i.e., hydrocortisone or hydrocortisone acetate) are used for the treatment of corticosteroid-responsive ocular conditions when a corticosteroid is indicated and superficial bacterial ocular infection or risk of such infection exists.

Ophthalmic corticosteroids may be indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. Ophthalmic corticosteroids also may be indicated in the treatment of chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies.

Although the manufacturers state that use of a fixed-combination ophthalmic preparation containing anti-infectives and a corticosteroid may be indicated in ocular inflammatory conditions when the risk of superficial ocular infection is high or when there is an expectation that potentially dangerous numbers of bacteria will be present in the eye, experts state that such preparations should be avoided in patients with bacterial conjunctivitis because of the risk of potentiating the infection.

Clinicians should consider that use of fixed-combination ophthalmic preparations containing anti-infectives and a corticosteroid may mask the clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infectives; and/or increase intraocular pressure.(See Precautions Related to Use of Fixed Combinations Containing Corticosteroids under Cautions: Precautions and Contraindications.)

For other uses of neomycin, see 8:12.02 and see 84:04.04.

Dosage and Administration

Administration

Ophthalmic Administration

Neomycin sulfate in fixed combination with polymyxin B sulfate and bacitracin zinc is applied topically to the eye as an ophthalmic ointment.

Neomycin sulfate in fixed combination with polymyxin B sulfate and gramicidin is applied topically to the eye as an ophthalmic solution.

Neomycin sulfate also is commercially available in fixed combination with polymyxin B sulfate and a corticosteroid (i.e., dexamethasone) or in fixed combination with polymyxin B sulfate, bacitracin zinc, and a corticosteroid (i.e., hydrocortisone or hydrocortisone acetate) for topical application to the eye as ophthalmic ointments or suspensions.

Ophthalmic preparations containing neomycin sulfate and other anti-infectives with or without a corticosteroid are for topical ophthalmic use only; these preparations are not for subconjunctival injection and should not be introduced directly into the anterior chamber of the eye.

Care should be taken to avoid contaminating the container tip with material from the eye, eyelids, fingers, or other source.

Otic Administration

Neomycin sulfate in fixed combination with colistin and hydrocortisone acetate is instilled topically into the ear canal as an otic suspension.

Neomycin sulfate in fixed combination with polymyxin B sulfate and hydrocortisone is instilled topically into the ear canal as an otic solution or suspension.

Otic solutions and suspensions containing neomycin sulfate are for topical otic use only; these preparations should not be used in the eyes.

Prior to topical otic instillation, the ear canal should be thoroughly cleaned and dried.

The otic preparation may be warmed in the hand, but should not be heated above body temperature since this may affect potency.

Otic suspensions should be shaken well prior to each use.

The patient should lie with the affected ear upward. The appropriate amount of otic solution or suspension should be instilled into the ear; this position should be maintained for 5 minutes to facilitate penetration into the ear canal. The procedure should be repeated for the opposite ear if necessary.

If the ear canal is narrow or edematous and there are concerns that this might impede drug delivery, consideration can be given to inserting a cotton wick into the canal and saturating the wick with the otic preparation. The manufacturers state that the wick should be kept moist by adding additional otic solution or suspension every 4 hours and should be replaced once every 24 hours. Experts state that a wick is unnecessary after ear canal edema subsides, which may occur within 24 hours or a few days after topical otic treatment is initiated.

Care should be taken to avoid contaminating the tip of the container with material from the ear, fingers, or other source.

Dosage

Dosage of neomycin sulfate is expressed in terms of the base.

Bacterial Ophthalmic Infections

When a fixed-combination ophthalmic ointment containing neomycin sulfate, polymyxin B sulfate, and bacitracin zinc is used for the topical treatment of superficial bacterial infections of the eye in adults, the ophthalmic ointment should be applied to the affected eye(s) every 3 or 4 hours for 7-10 days, depending on the severity of the infection.

When a fixed-combination ophthalmic solution containing neomycin sulfate, polymyxin B sulfate, and gramicidin is used for the topical treatment of superficial bacterial infections of the eye in adults, 1 or 2 drops of the solution should be instilled in the affected eye(s) every 4 hours for 7-10 days. For severe infections, up to 2 drops may be instilled every hour.

The usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5-10 days; some experts state that 5-7 days of such treatment usually is adequate for mild bacterial conjunctivitis.

Bacterial Otic Infections

When fixed-combination otic suspensions containing neomycin sulfate, colistin, and hydrocortisone acetate are used for the topical treatment of superficial bacterial infections of the external auditory canal (otitis externa) in adults, 5 drops should be instilled into the canal of the affected ear(s) 3 or 4 times daily for up to 10 days. When used in children 1 year of age or older, 4 drops of the otic suspension should be instilled into the canal of the affected ear(s) 3 or 4 times daily for up to 10 days.

When fixed-combination otic solutions or suspensions containing neomycin sulfate, polymyxin B sulfate, and hydrocortisone are used for the topical treatment of superficial bacterial infections of the external auditory canal (otitis externa) in adults, 4 drops should be instilled into the canal of the affected ear(s) 3 or 4 times daily for up to 10 days. When used in children 2 years of age or older, 3 drops of the otic solution or suspension should be instilled into the canal of the affected ear(s) 3 or 4 times daily for up to 10 days. One manufacturer does not include an age restriction for use of the otic suspension in pediatric patients.

Topical otic therapy should not be continued for longer than 10 days.(See Precautions Related to Otic Administration under Cautions: Precautions and Contraindications.) The optimal duration of topical therapy for the treatment of acute otitis externa has not been determined, but 7-10 days is usually recommended. Some experts state that appropriate treatment of acute otitis externa should result in improvement in symptoms (otalgia, pruritus, fullness) within 48-72 hours, although resolution of symptoms may take up to 2 weeks.

Ocular Inflammation

When a fixed-combination ophthalmic ointment containing neomycin sulfate, polymyxin B sulfate, and dexamethasone is used in adults, approximately 1.25 cm (½ inch) of the ointment should be applied in the conjunctival sac of the affected eye(s) up to 3 or 4 times daily.

When a fixed-combination ophthalmic suspension containing neomycin sulfate, polymyxin B sulfate, and dexamethasone is used in adults and pediatric patients 2 years of age or older with mild disease, 1 or 2 drops of the suspension should be instilled in the conjunctival sac of the affected eye(s) up to 4-6 times daily. In severe disease, 1 or 2 drops of the suspension may be instilled every hour initially and dosage tapered by decreasing the frequency of administration as inflammation subsides.

When a fixed-combination ophthalmic ointment containing neomycin sulfate, polymyxin B sulfate, bacitracin zinc, and hydrocortisone or hydrocortisone acetate is used in adults, the ointment should be applied to the affected eye(s) every 3 or 4 hours, depending on the severity of the condition.

If there is no improvement after 48 hours of treatment with a fixed-combination preparation containing anti-infectives and a corticosteroid, the patient should be reevaluated.(See Precautions Related to Use of Fixed Combinations Containing Corticosteroids under Cautions: Precautions and Contraindications.)

Cautions

Adverse Effects

Local irritation and allergic reactions may occur when fixed-combination topical preparations containing neomycin sulfate are used. More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

Topical anti-infectives, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical anti-infectives is not known.

Local irritation and allergic reactions reported in patients receiving topical ophthalmic preparations containing neomycin sulfate and other anti-infectives include pruritus, edema of the conjunctiva and eyelid, and conjunctival erythema.(See Precautions Related to Sensitivity Reactions under Cautions: Precautions and Contraindications.)

There have been reports of bacterial keratitis developing in patients using topical ophthalmic preparations. These infections occurred because the patients inadvertently contaminated the multiple-dose container of the ophthalmic preparation; in most reported cases, the patient had concurrent corneal disease or disruption of the ocular epithelial surface.(See Precautions Related to Ophthalmic Administration under Cautions: Precautions and Contraindications.)

Precautions and Contraindications

Fixed-combination ophthalmic preparations containing neomycin sulfate and other anti-infectives (i.e., polymyxin B sulfate and bacitracin zinc; polymyxin B and gramicidin) are contraindicated in patients hypersensitive to any ingredient in the formulation.

Fixed-combination ophthalmic preparations containing neomycin sulfate, other anti-infectives, and a corticosteroid (i.e., dexamethasone, hydrocortisone, or hydrocortisone acetate) are contraindicated in patients hypersensitive to any ingredient in the formulation. In addition, these fixed-combination preparations are contraindicated in patients with viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella) and in patients with mycobacterial infections of the eye or fungal diseases of ocular structures.

Fixed-combination otic preparations containing neomycin sulfate, colistin, and hydrocortisone acetate are contraindicated in patients hypersensitive to any ingredient in the formulation. In addition, these fixed combinations are contraindicated in patients with known or suspected viral infections of the external ear canal (e.g., herpes simplex, varicella zoster).

Fixed-combination otic preparations containing neomycin sulfate, polymyxin B sulfate, and hydrocortisone are contraindicated in patients hypersensitive to any ingredient in the formulation. In addition, these fixed combinations are contraindicated in patients with known or suspected viral infections of the external ear canal (e.g., herpes simplex, vaccinia, varicella zoster).

Prolonged use of ophthalmic or otic preparations containing neomycin sulfate and other anti-infectives may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate therapy should be initiated if superinfection occurs. Resistance to neomycin or other anti-infectives in fixed-combination preparations (i.e., bacitracin, colistin, gramicidin, polymyxin B) may develop.

Serious adverse reactions, including ototoxicity, nephrotoxicity, and neuromuscular blockade, have occurred following topical application of neomycin, especially in patients receiving the drug via peritoneal instillation or irrigation of wounds or surgical sites and in those receiving topical treatment for skin ulcers, granulating wounds, burns, or extensive areas of denuded skin. Instillation of neomycin into the ear of patients undergoing tympanoplasty has caused ototoxicity. The possibility of cumulative toxicity should be considered if neomycin is applied topically in conjunction with systemic aminoglycoside therapy.

Precautions Related to Sensitivity Reactions

During long-term use of topical ophthalmic or otic anti-infectives, patients should be examined periodically for signs of sensitization.

In patients receiving topical ophthalmic preparations, sensitization may manifest as rash, pruritus, edema of the conjunctiva and eyelid, or conjunctival erythema; in patients receiving topical otic preparations, sensitization may manifest as swelling, dry scaling, and pruritus. Sensitization to topical ophthalmic or otic preparations may also manifest as failure to heal in some patients.

Patients should be advised to discontinue ophthalmic or otic preparations if any signs of sensitivity or allergic reactions occur. Symptoms usually subside quickly after the preparation is discontinued.

Patients allergic to one of the fixed-combination preparations should avoid preparations containing any of the component drugs. Cross-allergenicity occurs among the aminoglycosides, and patients allergic to topical neomycin may also be allergic to other aminoglycosides (e.g., gentamicin, paromomycin, streptomycin).

Precautions Related to Ophthalmic Administration

Patients should be informed that ophthalmic preparations, if handled improperly, can become contaminated by common bacteria known to cause ocular infections and that serious damage to the eye and subsequent loss of vision may occur if contaminated ophthalmic preparations are used. Patients should be advised to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface and to not share ophthalmic preparations with others.

Patients should be advised that their vision may be temporarily blurred after administration of topical ophthalmic preparations. Care should be taken in operating machinery or driving a motor vehicle.

Some manufacturers caution that ophthalmic ointments may delay corneal healing.

Precautions Related to Otic Administration

Fixed-combination otic preparations containing neomycin sulfate, colistin, and hydrocortisone acetate should be used with caution in patients with a perforated tympanic membrane.

Fixed-combination otic preparations containing neomycin sulfate, polymyxin B sulfate, and hydrocortisone should not be used in patients with a perforated tympanic membrane.

Neomycin, especially with prolonged use, can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti.

Patients being treated with otic preparations containing neomycin should be under close clinical observation and such preparations should not be used for longer than 10 consecutive days.

If otic infections have not improved after 1 week of topical otic treatment, cultures should be obtained to guide further treatment.

When using fixed-combination otic preparations containing neomycin sulfate to control secondary infection in chronic otitis externa, clinicians should consider that skin in this condition is more liable than normal skin to become sensitized to many substances, including neomycin. Sensitization to topical neomycin usually manifests as a low-grade reddening with swelling, dry scaling, and pruritus; it may manifest simply as failure to heal.(See Precautions Related to Sensitivity Reactions under Cautions: Precautions and Contraindications.)

Commercially available fixed-combination otic solutions containing neomycin sulfate, polymyxin B sulfate, and hydrocortisone 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.

Precautions Related to Use of Fixed Combinations Containing Corticosteroids

When ophthalmic or otic preparations containing neomycin sulfate in fixed combination with other anti-infectives and a corticosteroid (i.e., dexamethasone, hydrocortisone, or hydrocortisone acetate) are used, the usual cautions, precautions, and contraindications associated with the corticosteroid also must be considered.

Initial prescriptions for fixed-combination ophthalmic preparations containing a corticosteroid or renewal prescriptions (beyond 8 g of ophthalmic ointment or beyond 20 mL of ophthalmic suspension) should be made only after examining the patient with slit lamp microscopy and, when appropriate, fluorescein staining.

Patients should be advised to discontinue the fixed-combination ophthalmic preparation and contact a clinician if inflammation or pain persists for more than 48 hours or becomes aggravated.

Prolonged use of fixed-combination ophthalmic preparations containing a corticosteroid may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. If an ophthalmic preparation containing a corticosteroid is used for 10 days or longer, intraocular pressure should be routinely monitored, even though this may be difficult in children and uncooperative patients. Such preparations should be used with caution in patients with glaucoma and intraocular pressure should be checked frequently in such patients.

Use of fixed-combination ophthalmic preparations containing a corticosteroid after cataract surgery may delay healing and increase the incidence of bleb formation.

Various ocular diseases and long-term use of topical ophthalmic corticosteroids have caused corneal and scleral thinning. Use of topical ophthalmic corticosteroids in patients with thin corneal and scleral tissue may result in perforation.

Prolonged use of fixed-combination ophthalmic preparations containing a corticosteroid may suppress host responses and increase the risk of secondary ocular infections. Use of such preparations in patients with acute purulent or parasitic infections of the eye may mask infection or enhance existing infection.

Use of ophthalmic preparations containing a corticosteroid may prolong the course and exacerbate severity of many viral infections of the eye (including herpes simplex). Such preparations should be used with great caution in patients with herpes simplex and frequent slit lamp microscopy is recommended.

The possibility of fungal infections of the cornea should be considered after prolonged use of ophthalmic preparations containing a corticosteroid, especially in patients with persistent corneal ulceration. Fungal cultures should be taken when appropriate.

Pediatric Precautions

Fixed combinations of neomycin sulfate, polymyxin B sulfate, and bacitracin zinc (ophthalmic): Safety and efficacy have not been established in pediatric patients.

Fixed combinations of neomycin sulfate, polymyxin B sulfate, and gramicidin (ophthalmic): Safety and efficacy have not been established in pediatric patients.

Fixed combinations of neomycin sulfate, polymyxin B sulfate, and dexamethasone (ophthalmic): Safety and efficacy of the suspension have not been established in children younger than 2 years of age; safety and efficacy of the ointment have not been established in pediatric patients.

Fixed combinations of neomycin sulfate, polymyxin B sulfate, bacitracin zinc, and either hydrocortisone or hydrocortisone acetate (ophthalmic): Safety and efficacy have not been established in pediatric patients.

Fixed combinations of neomycin sulfate, colistin, and hydrocortisone acetate (otic): Safety and efficacy have not been established in children younger than 1 year of age. Safety and efficacy in those 1 year of age or older have been demonstrated in a controlled clinical trial.

Fixed combinations of neomycin sulfate, polymyxin B sulfate, and hydrocortisone (otic): Most manufacturers state that safety and efficacy have not been established for the treatment of otitis external in children younger than 2 years of age because of insufficient data in this age group. One manufacturer states that safety and efficacy have been established in pediatric patients and does not specify an age range.

Geriatric Precautions

Fixed combinations of neomycin sulfate, polymyxin B sulfate, and gramicidin (ophthalmic): Clinical studies did not include sufficient numbers of patients 65 years of age or older to determine whether they respond differently than younger adults. Other reported clinical experience has not identified differences in responses between geriatric and younger patients.

Fixed combinations of neomycin sulfate, polymyxin B sulfate, and dexamethasone (ophthalmic): No overall differences in safety or efficacy have been observed between geriatric and younger patients.

Fixed combinations of neomycin sulfate, polymyxin B sulfate, bacitracin zinc, and hydrocortisone acetate (ophthalmic): No overall differences in safety or efficacy have been observed between geriatric and younger adults.

Fixed combinations of neomycin sulfate, colistin, and hydrocortisone acetate (otic): No overall differences in safety or efficacy have been observed between geriatric and younger adults.

Fixed combinations of neomycin sulfate, polymyxin B sulfate, and hydrocortisone (otic): Clinical studies did not include sufficient numbers of patients 65 years of age or older to determine whether they respond differently than younger adults. Other reported clinical experience has not identified differences in responses between geriatric and younger patients.

Pregnancy and Lactation

Pregnancy

Animal reproduction studies have not been conducted with neomycin sulfate. It is not known whether ophthalmic or otic preparations containing neomycin sulfate can cause fetal harm when administered to a pregnant woman.

Fixed-combination ophthalmic preparations containing neomycin sulfate, polymyxin B sulfate, and either bacitracin zinc or gramicidin should be used during pregnancy only if clearly needed.

Fixed-combination ophthalmic preparations containing neomycin sulfate, other anti-infectives (i.e., polymyxin B sulfate, bacitracin zinc), and a corticosteroid (i.e., dexamethasone, hydrocortisone, hydrocortisone acetate) should be used during pregnancy only if potential benefits justify potential risks to the fetus.

Fixed-combination otic preparations containing neomycin sulfate, colistin, and hydrocortisone acetate should be used during pregnancy only if potential benefits justify potential risks to the fetus. Although aminoglycosides can cause congenital deafness in humans if administered during pregnancy, the manufacturers state that clinically important systemic concentrations of neomycin are not anticipated when otic preparations containing neomycin are used as directed.

Fixed-combination otic preparations containing neomycin sulfate, polymyxin B sulfate, and hydrocortisone should be used during pregnancy only if potential benefits justify potential risks to the fetus.

Lactation

It is not known whether neomycin is distributed into milk.

Fixed-combination ophthalmic preparations containing neomycin sulfate and other anti-infectives (i.e., bacitracin zinc, gramicidin, polymyxin B sulfate) should be used with caution in nursing women.

Fixed-combination ophthalmic preparations containing neomycin sulfate, polymyxin B sulfate, and dexamethasone should be used with caution in nursing women.

The manufacturers of fixed-combination ophthalmic preparations containing neomycin sulfate, polymyxin B sulfate, bacitracin zinc, and hydrocortisone or hydrocortisone acetate state that a decision should be made whether to discontinue nursing or the ophthalmic preparation, taking into account the importance of the drug to the woman.

Fixed-combination otic preparations containing neomycin sulfate, colistin, and hydrocortisone acetate and fixed-combination otic preparations containing neomycin sulfate, polymyxin B sulfate, and hydrocortisone should be used with caution in nursing women.

Pharmacokinetics

Studies in rabbits suggest that neomycin is absorbed into the aqueous humor following topical instillation onto the eye of a neomycin sulfate solution containing 40 mg/mL; absorption of the drug is greatest when the cornea is abraded. In dogs, neomycin is absorbed through the ear, especially when applied to the ear canals of dogs with perforated tympanic membranes.