Poly-Pred(5 mg+3.5 mg+10000 IU)/ml

Poly-Pred is a topical corticosteroid-antibiotic combination indicated for steroid-responsiveinflammatory conditions of the eye and, in appropriate formulations, the external ear, where superficialbacterial infection or a risk of bacterial infection is present.

Established/labeled uses

• Steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anteriorsegment of the eye, when a bacterial infection or risk of bacterial infection exists (e.g. allergicconjunctivitis, vernal conjunctivitis, episcleritis, anterior uveitis (iritis/cyclitis)).
• Corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies, whereinflammation control and infection prophylaxis are both required.
• Superficial bacterial infections of the external ear canal (otitis externa) accompanied by inflammation,when the tympanic membrane is intact (otic formulations only).

Adjunct / commonly-used-off-label

• As an adjunct after certain ophthalmic surgical procedures to control postoperative inflammation whilecovering susceptible bacteria, under specialist supervision.

Poly-Pred should be prescribed only after a qualified clinician has examined the eye or ear andexcluded infections for which a corticosteroid would be harmful (see Contraindications).

Each formulation of Prednisolone + Neomycin Sulphate + Polymixin B Sulphate combines three active ingredients for topical (ophthalmic or otic)use:

• Prednisolone (as prednisolone acetate/prednisolone sodium phosphate) - a syntheticcorticosteroid that suppresses local inflammation.
• Neomycin Sulphate - an aminoglycoside antibiotic effective mainly against gram-positiveand many gram-negative organisms.
• Polymixin B Sulphate - a polypeptide antibiotic effective mainly against gram-negativeorganisms, including Pseudomonas aeruginosa.

The exact strength of each component and the base (suspension, solution, or ointment) varies by brand andmarket; the labeled strength should always be confirmed on the product packaging.

Poly-Pred is a fixed-dose, topical combination product that pairs a corticosteroid with twoantibiotics of complementary antibacterial spectrum. It is formulated as sterile eye/ear drops or asuspension intended for instillation into the conjunctival sac or the external ear canal, and is not intendedfor injection, ingestion, or use in the middle ear (behind an intact eardrum should not be assumed; seeContraindications for perforated eardrum).

The combination is designed to reduce inflammation, itching, and tissue damage from an ocular or oticinflammatory process while simultaneously providing antibacterial cover for susceptible organisms that may bepresent or at risk of causing secondary infection.

Poly-Pred belongs to the class of ophthalmic/otic corticosteroid-antibioticcombinations, combining a glucocorticoid (anti-inflammatory) with two antibiotics (an aminoglycosideand a polypeptide antibiotic) for topical use.

Prednisolone + Neomycin Sulphate + Polymixin B Sulphate combines three agents with distinct mechanisms:

• Prednisolone is a synthetic glucocorticoid that inhibits the inflammatory response tomechanical, chemical, or immunological agents. It reduces capillary dilation, fibrin deposition, leukocytemigration, capillary proliferation, fibroblast proliferation, and deposition of collagen, thereby limitinginflammation, edema, redness, and scarring.
• Neomycin Sulphate is a bactericidal aminoglycoside that binds the bacterial 30S ribosomalsubunit, inhibiting protein synthesis. It is active against many gram-negative organisms (e.g.Escherichia coli, Haemophilus influenzae, Klebsiella and Enterobacterspecies) and some gram-positive organisms (e.g. Staphylococcus aureus), but has minimal activityagainst Pseudomonas aeruginosa.
• Polymixin B Sulphate is a bactericidal polypeptide antibiotic that disrupts the bacterialcell membrane, producing rapid killing of many gram-negative organisms, notably Pseudomonasaeruginosa, which neomycin does not reliably cover.

Together, the antibiotic pair provides broad gram-negative and partial gram-positive coverage, whileprednisolone controls the accompanying inflammatory response.

Poly-Pred is for topical use only, in the eye or the external ear canal as prescribed. Shakewell before use, tilt the head back (for eye use) or tilt the head to the side (for ear use), instill thedrop(s) without letting the applicator tip touch the eye/ear/lashes/skin, and close the eye gently or keep theear tilted briefly to allow the drop to spread. Replace the cap tightly after use.

Formal drug-drug interaction studies with Poly-Pred are limited because systemic absorptionfrom topical ocular or otic use is generally low. The following are the main points of clinical relevance:

• Other topical ophthalmic products: concurrent use of other topical corticosteroids orantibiotics in the same eye may increase the risk of additive local side effects; space different eyemedicines at least 5 minutes apart and inform the physician of all products used.
• Systemic aminoglycosides or other ototoxic/nephrotoxic drugs: although systemicabsorption of neomycin from topical use is normally minimal, concurrent systemic aminoglycosides couldtheoretically add to ototoxic/nephrotoxic risk, particularly if used on broken skin, a perforated eardrum, orover large areas; avoid such combinations unless directed by a physician.
• Live vaccines: significant systemic absorption of prednisolone is unlikely with normaltopical use, but if extensive or prolonged use is required, the immunosuppressive potential of corticosteroidsshould be kept in mind before live vaccines are given; discuss with the physician.

Most adverse effects of Poly-Pred are local and related to the site of application.

Common

• Transient burning, stinging, itching, or a foreign-body sensation at the site of instillation.
• Temporary blurring of vision immediately after ophthalmic use.

Less common but important

• Allergic/hypersensitivity reactions, including contact sensitization to the neomycin component (itching,redness, swelling, worsening irritation).
• With prolonged or repeated use: raised intraocular pressure/glaucoma with possible optic nerve damage,posterior subcapsular cataract formation, delayed wound/epithelial healing, and secondary ocular infection(bacterial or fungal) due to suppression of the local immune response.
• Thinning or perforation of the cornea or sclera in eyes with pre-existing thinning disorders.

Patients should stop the medicine and seek medical advice promptly if irritation, pain, redness, or visionchanges worsen or persist.

There are no adequate, well-controlled studies of Poly-Pred in pregnant women. Systemicabsorption from topical ophthalmic or otic use is generally low, but is not zero, particularly withextensive, prolonged, or high-frequency use, or when applied to broken skin or mucosa. Poly-Predshould be used during pregnancy only if clearly needed and if the potential benefit justifies the potentialrisk to the fetus; consult a physician before use.

It is not known whether topical use of Poly-Pred results in clinically significant amounts inhuman breast milk. Caution is advised, and a physician should be consulted before use during breastfeeding,particularly for prolonged courses.

Poly-Pred should be used only under medical supervision, for the shortest effective duration.Key precautions include:

• Ocular effects of prolonged steroid use: extended or repeated use can raise intraocularpressure/cause glaucoma with optic nerve damage, cause posterior subcapsular cataract, and delay woundhealing; intraocular pressure should be monitored if treatment continues beyond about 10 days.
• Masking or worsening infection: the corticosteroid component can mask signs of infectionor suppress the host response, permitting the establishment or progression of fungal, viral, or bacterialinfection; do not use in undiagnosed "red eye" without a professional diagnosis.
• Corneal/scleral thinning: in diseases causing thinning of the cornea or sclera,perforation has been reported with topical corticosteroid use.
• Neomycin sensitization: the neomycin component carries a meaningful risk of contactsensitization/allergy; discontinue if a hypersensitivity reaction develops.
• Perforated eardrum (otic use): avoid instilling into the ear canal if the eardrum isknown or suspected to be perforated.
• Complete the full course as directed; discontinue and seek medical advice promptly if irritation worsensor vision changes occur.
• Take/use exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicinewith others without medical advice.
• Not for injection. Avoid contaminating the dropper/applicator tip.

Topical overdose or excessive use of Poly-Pred is unlikely to cause serious systemic toxicitybut may increase the risk of local side effects such as irritation, raised intraocular pressure, or delayedhealing. If the product is accidentally swallowed, or if excessive amounts have been applied, seek immediatemedical attention or contact a poison control center/emergency services rather than attempting hometreatment. If accidental eye exposure to a non-ocular formulation occurs, rinse the eye gently with cleanwater and seek medical advice.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children. Do not use after the expiry date. Discard any opened eye/ear drop bottle after the period stated on the label (commonly around 4 weeks after opening) even if some product remains, to avoid contamination.

Pediatric

Use of Poly-Pred in children should be under close medical supervision; long-term effects oftopical corticosteroid use on ocular development have not been fully established in this group. See PediatricUses.

Elderly

No specific dose adjustment is generally required in elderly patients, but they should be monitored forraised intraocular pressure and cataract with prolonged use.

Renal and hepatic impairment

Because systemic absorption from topical ophthalmic/otic use is minimal, specific dose adjustment is notgenerally required for renal or hepatic impairment; however, caution is still advised with extensive orprolonged use.

Treatment with Poly-Pred should be limited to the shortest duration needed to controlinflammation and infection, typically not exceeding 7-10 days without medical reassessment. If no improvementis seen within a few days, or if the condition worsens, the patient should return to the prescribing physicianrather than continuing or extending treatment independently.

Prednisolone + Neomycin Sulphate + Polymixin B Sulphate is classified as a corticosteroid + aminoglycoside antibiotic + polypeptideantibiotic fixed-dose topical combination (ophthalmic/otic anti-inflammatory and antimicrobialagent).

Prednisolone + Neomycin Sulphate + Polymixin B Sulphate acts through three complementary mechanisms: prednisolone suppresses the localinflammatory cascade (capillary dilation, leukocyte migration, fibroblast and collagen deposition); neomycinsulphate binds the bacterial 30S ribosomal subunit to block protein synthesis, killing susceptiblegram-negative and some gram-positive bacteria; and polymixin B sulphate disrupts the bacterial cell membraneof gram-negative organisms, including Pseudomonas aeruginosa. Together they reduce inflammation whilecovering a broad range of bacteria that could cause or complicate the condition being treated.

C

Safety and efficacy of Poly-Pred have not been formally established in neonates and very younginfants. In older children, it may be used for the same indications as in adults, at the physician'sdiscretion, using the lowest effective dose and shortest necessary duration, because of the theoretical riskof topical corticosteroid effects on ocular growth and development with prolonged use. Pediatric use shouldalways be supervised by a physician.