Neomycin; polymyxin B; dexamethasone are used together in ophthalmic preparations to treat steroid-responsive inflammatory ocular conditions in which a corticosteroid is indicated and where bacterial infection or risk of bacterial infection exists. Neomycin and polymyxin B are antimicrobial agents used to treat or prevent ocular bacterial infections. Dexamethasone is a glucocorticoid anti-inflammatory agent. Neomycin; polymyxin B; dexamethasone was first approved by the FDA as a suspension on June 1963; in July of the same year, 1963, the ointment formulation was approved.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Ophthalmic Administration
Ophthalmic Suspension:
-Neomycin; polymyxin B; dexamethasone suspension is indicated for topical administration to the eye; do NOT administer parenterally.
-Instruct patient on proper instillation of eye solution and suspension.
-Wash hands before and after use.
-Do not touch the tip of the dropper to the eye, fingertips, or other surface to prevent contamination.
-Shake suspension well prior to each use.
-Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch. Close eyes to spread drops. To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 1 to 2 minutes following application to the eye.
-To avoid contamination or the spread of infection, do not use dropper for more than one person.
Ophthalmic Ointment:
-Instruct patient on proper application of eye ointment.
-Do not touch the tip of the tube to the eye, fingertips, or other surface to prevent contamination.
-Wash hands before and after use.
-Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Place a small amount (about one-half of an inch) of the ointment into the pouch. Look downward before closing eyes.
-To avoid contamination or the spread of infection, do not use tube for more than one person.
This monograph discusses the use of neomycin; polymyxin B; dexamethasone in combination for inflammatory conditions of the eyes. Clinicians may wish to consult the individual monographs for more information about specific adverse reactions of each agent.
Patients should be advised to consult a physician if ocular pain, redness, swelling, or irritation worsens or persists after use of neomycin; polymyxin B; dexamethasone. Adverse reactions related to the corticosteroid component of neomycin; polymyxin B; dexamethasone are also mainly localized to the eyes. These reactions include an increased intraocular pressure leading to ocular hypertension and possibly glaucoma, development of posterior subcapsular cataracts, perforation of the globe, conjunctivitis, conjunctival hyperemia, corneal ulcers, keratitis, and infrequently optic nerve damage. Administration of dexamethasone to the eye may also result in impaired wound healing after ocular surgery or injury. Ulcerative keratitis has also been noted in postmarketing reports. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure should be checked routinely and frequently.
A superinfection may occur during neomycin; polymyxin B; dexamethasone treatment. An ocular infection of the cornea resulting from viruses or fungi are particularly prone to develop with prolonged or repeated therapy. Consider the possibility of a fungal infection in patients with persistent corneal ulcerations.
According to the manufacturer, the most common adverse reactions associated with neomycin; polymyxin B; dexamethasone are allergic reactions related to the antibiotic components. Hypersensitivity reactions may vary from local effects to generalized reactions. Sensitivity to topically administered aminoglycosides may occur in some patients, and may manifest as ocular irritation or ocular pruritus. Other effects may include erythema, itching (pruritus), urticaria, skin rash (unspecified), anaphylaxis, anaphylactoid reactions, bullous reaction (bullous rash), and Stevens-Johnson syndrome.
Headache has been noted in postmarketing reports with neomycin; polymyxin B; dexamethasone.
The use of dexamethasone-containing products in excess of the recommended dose may result in Cushing's syndrome and adrenal suppression in patients who are predisposed, such as pediatric patients and patients receiving concurrent treatment with a CYP3A4 inhibitor.
This monograph discusses the use of neomycin, polymyxin B, dexamethasone in combination for inflammatory conditions of the eyes. Clinicians may wish to consult the individual monographs for more information about specific contraindications and precautions of each agent.
Neomycin; polymyxin B; dexamethasone ophthalmic products are only indicated for the treatment of ocular inflammatory conditions in the presence of, or with the possible risk of, superficial bacterial infection. These products are contraindicated in patients with an ocular viral infection such as herpes simplex virus epithelial keratitis, vaccinia, and varicella. In addition, neomycin; polymyxin B; dexamethasone is contraindicated in the presence of an ocular fungal infection or mycobacterial infection.
Avoid neomycin; polymyxin B; dexamethasone in patients with a known or suspected allergy to any component of the medication. This precaution includes patients with corticosteroid hypersensitivity, aminoglycoside hypersensitivity (including neomycin hypersensitivity), and/or polymyxin hypersensitivity. According to the manufacturer, allergies to the antibiotic components occur with greater frequency than other components within the formulation. Instruct patients to discontinue treatment if signs of hypersensitivity occur. Cross-hypersensitivity to other aminoglycosides can occur; therefore, patients who become sensitized to topical neomycin may also be sensitive to other topical and/or systemic aminoglycosides.
It is recommended to monitor intraocular pressure frequently in patients at risk for increased ocular pressure from corticosteroid use. Use caution when administering neomycin; polymyxin B; dexamethasone to patients with preexisting glaucoma as prolonged use may result in an increased intraocular pressure. Prolonged use of neomycin; polymyxin B; dexamethasone in any patient may lead to optic nerve damage, visual disturbance, and the development of posterior subcapsular cataracts. Topically applied corticosteroids, such as dexamethasone, have caused corneal and scleral thinning; thus, patients with preexisting thin corneal or scleral tissue may experience perforation following treatment with neomycin; polymyxin B; dexamethasone. Neomycin; polymyxin B; dexamethasone could delay healing in patients undergoing an ocular surgery and may increase the risk of developing a secondary ocular infection; administer this medication with great caution in patients with a herpes infection history. Acute purulent or parasitic infections of the eye may be masked or activity may be enhanced by the presence of corticosteroids.
Avoid abrupt discontinuation of neomycin; polymyxin B; dexamethasone to prevent corticosteroid withdrawal and rebound inflammation. Discontinuation of therapy is achieved by gradual tapering as the inflammation subsides.
Neomycin; polymyxin B; dexamethasone products are only indicated for topical administration to the eyes. Take measures to prevent intravenous administration and intramuscular administration.
The safety and efficacy of neomycin; polymyxin B; dexamethasone ophthalmic products have not been established in neonates, infants, or children less than 2 years of age.
No adequate studies in pregnant women are available with neomycin; polymyxin B; dexamethasone. In animal studies, ophthalmic administration of corticosteroids, such as dexamethasone, have been shown to be teratogenic in rabbits and mice. In mice, corticosteroids resulted in fetal resorption and an increased incidence of cleft palate; rabbits receiving corticosteroids experienced fetal resorption and abnormalities involving the head, ears, limbs, and palate. Administer neomycin; polymyxin B; dexamethasone during pregnancy only when the benefits clearly outweigh the potential risk to the fetus. Consider monitoring for signs of hypoadrenalism in infants born to mothers who received substantial doses during pregnancy.
Neomycin; polymyxin B; dexamethasone ophthalmic formulations may be used with caution during breast-feeding. According to the manufacturer, it is not known if ophthalmic administered dexamethasone is detectable in human milk; however, systemically administered corticosteroids do appear in human milk and may suppress infant growth and endogenous corticosteroid production. Topically applied dexamethasone to the eye in the mother is unlikely to cause significant concern to the infant with limited dosage and duration of use. Neomycin and polymyxin B are both poorly absorbed orally, so whatever minor systemic exposure may occur maternally would be unlikely to cause infant harm during nursing. Short term use of usual moderate ocular doses for milder eye conditions probably poses little risk to the nursing infant. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to maternally administered neomycin; polymyxin B; dexamethasone, health care providers are encouraged to report the adverse effect to the FDA.
Patients with signs and symptoms of a bacterial ocular infection should not wear contact lenses.
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Enterobacter sp., Escherichia coli, Haemophilus influenzae (beta-lactamase negative), Haemophilus influenzae (beta-lactamase positive), Klebsiella sp., Neisseria sp., Pseudomonas aeruginosa, Staphylococcus aureus (MSSA)
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
For the treatment of corticosteroid-responsive ocular inflammation where superficial bacterial ophthalmic infection or a risk of bacterial infection exists, such as allergic conjunctivitis, dry eye disease*, eyelid acne rosacea, superficial punctate keratitis, herpes zoster ocular infection associated keratitis, iritis, cyclitis, uveitis, and selected infective bacterial conjunctivitis and viral conjunctivitis, where the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation and for corneal abrasion, corneal ulcer, or corneal injury from chemical, radiation, or thermal ocular burns or penetration of foreign bodies:
-for the treatment of corticosteroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where a superficial bacterial ophthalmic infection or a risk of bacterial infection exists:
Ophthalmic dosage (ophthalmic suspension):
Adults: 1 to 2 drops in the affected eye(s) every 4 to 6 hours for mild disease and every hour for severe disease. Reduce dose gradually as warranted by clinical improvement.
Children and Adolescents 2 to 17 years: 1 to 2 drops in the affected eye(s) every 4 to 6 hours for mild disease and every hour for severe disease. Reduce dose gradually as warranted by clinical improvement.
Ophthalmic dosage (ophthalmic ointment):
Adults: 0.5 inch ribbon in the affected eye(s) up to 3 to 4 times daily.
-for the treatment of dry eye disease* with known or suspected ophthalmic infection:
Ophthalmic dosage (ophthalmic ointment):
Adults: 0.5 inch ribbon in each eye 4 times daily, initially. Reduce dose to 0.5 inch ribbon in each eye twice daily after 1 to 2 weeks if positive response in signs and/or symptoms and start cyclosporine, then taper or discontinue steroid therapy after 2 to 4 weeks. Consider extending duration to 4 weeks if no response at 2 weeks, especially in patients with moderate to severe disease.
Maximum Dosage Limits:
-Adults
48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).
-Geriatric
48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).
-Adolescents
48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).
-Children
2 years and older: 48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).
less than 2 years: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
No dosage adjustments are needed.
Patients with Renal Impairment Dosing
No dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Neomycin; Polymyxin B; Dexamethasone products.
Neomycin; polymyxin B; dexamethasone is indicated for the treatment of inflammatory ocular conditions where a risk of superficial bacterial infection exists. Clinicians may wish to consult the individual monographs for more information about each component.
-Neomycin: Neomycin is bacteriocidal. It is actively transported into the bacterial cell where it binds to receptors present on the 30S ribosomal subunit of susceptible bacteria. This binding interferes with the initiation complex between the messenger RNA (mRNA) and the subunit. As a result, abnormal, nonfunctional proteins are formed due to misreading of the bacterial mRNA. Eventually, susceptible bacteria die because of the lack of functional proteins.
-Polymyxin B: Polymyxin B binds to gram-negative bacterial cell membrane phospholipids. This binding destroys bacterial membranes with a surface detergent-like mechanism and increases the permeability of the cell membrane, which results in loss of metabolites essential to bacterial existence. Polymyxin B is bactericidal against most gram-negative bacilli. Polymyxin B has no in vitro activity against gram-positive organisms.
-Dexamethasone: Dexamethasone is a corticosteroid with anti-inflammatory action. Corticosteroids are naturally occurring hormones that bind to specific protein receptors on targeted tissues. This binding induces a response by modifying transcription and, ultimately, protein synthesis to achieve the steroid's intended action. The anti-inflammatory action of dexamethasone results from the inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, and suppression of humoral immune responses. The end result of treatment with dexamethasone includes reduction in edema or scar tissue as well as a general suppression of the immune response.
Neomycin; polymyxin B; dexamethasone is administered topically to the eyes. No pharmacokinetic information is available from the manufacturers of the combination ophthalmic products. See individual drug monographs for additional information.