Dexamethasone + Neomycin Sulphate + Polymyxin B Sulphate

Approved Indications

• Ophthalmic:
• Treatment of bacterial infections of the eye caused by susceptible organisms, including conjunctivitis, keratitis, blepharitis, and other superficial ocular infections accompanied by inflammation.
• Management of inflammatory ocular conditions with bacterial infection requiring corticosteroid and antibiotic combination therapy.
• Otic:
• Treatment of bacterial external ear infections (otitis externa) with inflammation due to susceptible bacteria.
• Inflammatory ear conditions complicated by bacterial infection.

Clinically Accepted Off-Label Uses

• Mixed ocular or auricular infections with significant inflammation.
• Postoperative prevention and treatment of infection and inflammation following eye or ear surgeries.

Ophthalmic Use (Eye Drops/Ointment)

• Adults and children >2 years:
• Drops: Instill 1-2 drops into the affected eye every 4 to 6 hours. Frequency may be adjusted based on clinical response.
• Ointment: Apply a small ribbon (approximately 0.5 inches) to the conjunctival sac 1 to 4 times daily.
• Duration:
• Typically not more than 10 days to reduce risk of corticosteroid-related adverse effects.
• Pediatrics <2 years: Use with caution; consult a specialist.

Otic Use (Ear Drops)

• Adults and children >2 years:
• Instill 3-4 drops into the affected ear 3 to 4 times daily.
• Special Populations:
• Avoid use if tympanic membrane is perforated unless directed by a physician.
• No dose adjustments required for renal or hepatic impairment due to topical use.

• Dexamethasone is a potent synthetic glucocorticoid that binds intracellular glucocorticoid receptors, modulating transcription of anti-inflammatory proteins and suppressing pro-inflammatory cytokines, leading to reduced inflammation, edema, and immune cell infiltration in ocular and auricular tissues.
• Neomycin Sulphate is an aminoglycoside antibiotic that binds irreversibly to the 30S ribosomal subunit in susceptible bacteria, inhibiting protein synthesis and leading to bactericidal effects against primarily Gram-negative and some Gram-positive bacteria.
• Polymyxin B Sulphate is a polypeptide antibiotic that disrupts the bacterial cell membrane integrity by binding to lipopolysaccharides and phospholipids of Gram-negative bacteria, causing leakage of cell contents and bacterial cell death.

Together, these agents provide effective antibacterial coverage with potent anti-inflammatory effects for treating infected inflammatory conditions of the eye and ear.

• Absorption:
• Minimal systemic absorption when applied topically to eye or ear.
• Minimal systemic exposure reduces risk of systemic toxicity.
• Distribution:
• Concentrated in ocular surface or external ear canal.
• Metabolism:
• Negligible systemic metabolism due to low absorption; if systemic absorption occurs, neomycin and polymyxin B are minimally metabolized and primarily excreted unchanged.
• Excretion:
• Mainly renal elimination for systemic neomycin/polymyxin B if absorbed.

• Pregnancy:
• Topical ophthalmic and otic corticosteroids (dexamethasone) and antibiotics are generally categorized as FDA Pregnancy Category C; use only if clearly needed and benefits outweigh risks.
• Safety data in pregnant women are limited; systemic exposure is minimal but caution is advised.
• Lactation:
• Minimal systemic absorption suggests low risk during breastfeeding; avoid direct contact with nipples during topical application.

• Dexamethasone: Corticosteroid, Glucocorticoid
• Neomycin Sulphate: Antibiotic, Aminoglycoside
• Polymyxin B Sulphate: Antibiotic, Polypeptide
• Combination: Topical corticosteroid and broad-spectrum antibiotic preparation

• Hypersensitivity to dexamethasone, neomycin, polymyxin B, or any excipients
• Viral infections of the eye or ear (e.g., herpes simplex keratitis, vaccinia)
• Fungal eye or ear infections
• Tuberculosis of the eye or ear
• Patients with perforated tympanic membrane (otic use) unless under medical supervision
• Neonates (due to neomycin risk of ototoxicity and systemic toxicity)

• Prolonged corticosteroid use may increase intraocular pressure, risk glaucoma, and cataracts; monitor if treatment exceeds 10 days.
• Risk of secondary bacterial or fungal infections due to corticosteroid-induced immunosuppression.
• Neomycin may cause ototoxicity and nephrotoxicity with systemic absorption; use topical only as directed.
• Risk of allergic contact dermatitis or hypersensitivity reactions; discontinue if signs occur.
• Use cautiously in patients with renal impairment or history of aminoglycoside hypersensitivity.
• Avoid use in perforated tympanic membrane unless advised by a physician.

Common

• Local irritation, burning, or stinging sensation on application
• Redness or itching of eye or ear
• Blurred vision (ophthalmic use)
• Mild skin rash or dermatitis

Serious (Rare)

• Increased intraocular pressure and glaucoma
• Secondary fungal or bacterial infections
• Allergic reactions including anaphylaxis
• Ototoxicity (with systemic absorption of neomycin)
• Nephrotoxicity (rare with topical use)

• Minimal systemic interactions due to topical administration.
• Caution when used with other topical corticosteroids or aminoglycosides to avoid additive toxicity.
• Avoid concurrent use with other ototoxic drugs if systemic absorption possible.

• Current clinical guidelines recommend limiting duration of corticosteroid-containing topical ocular and otic preparations to avoid adverse effects.
• Continued advisories on cautious use of neomycin-containing topical preparations due to rare risk of ototoxicity and contact sensitization.
• Emphasis on monitoring for secondary infections during corticosteroid therapy.

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from light and moisture
• Keep container tightly closed when not in use
• Do not freeze
• Keep out of reach of children
• Discard 28 days after opening to avoid contamination