Polymix H(10 mg+3400 Units+10000 Units)/ml

Polymix H is a fixed-dose combination of a corticosteroid (hydrocortisone) with two antibiotics(neomycin sulphate and polymyxin B) used topically, in the ear, or in the eye, for infections thatare known or strongly suspected to be bacterial and are accompanied by inflammation.

Established/approved uses

• Otic (ear) use: Superficial bacterial infections of the external auditory canal(otitis externa) caused by susceptible organisms, when there is associated inflammation, in patientswith an intact tympanic membrane.
• Ophthalmic (eye) use: Steroid-responsive inflammatory conditions of the eye(e.g., allergic conjunctivitis, blepharitis, blepharoconjunctivitis) where superficial bacterialinfection or a risk of bacterial infection exists, and where inflammation is a significant feature.
• Dermatologic (skin) use: Corticosteroid-responsive skin conditions complicated by,or at risk of, superficial bacterial infection due to susceptible organisms (e.g., infected eczema,infected dermatitis, superficial infected wounds and burns).

Important notes on evidence and appropriate use

• Polymix H should only be used when a bacterial infection is present or strongly suspected; it isnot indicated for infections that are purely viral or fungal.
• Culture and susceptibility testing are recommended before starting therapy whenever practical,particularly for chronic or recurrent otitis externa.
• Use in the eye or ear should generally follow specialist (ENT/ophthalmology) or physicianassessment, since misdiagnosis (e.g., missed tympanic membrane perforation or viral keratitis) canlead to serious harm.

Hydrocortisone + Neomycin Sulphate + Polymixin B is a combination preparation. Each formulation (otic suspension, ophthalmic suspension,or topical cream/ointment) typically contains:

• Hydrocortisone (as a corticosteroid, usually 1%)
• Neomycin Sulphate (as an aminoglycoside antibiotic, equivalent to a stated amount of neomycin base)
• Polymyxin B Sulfate (as a polypeptide antibiotic, expressed in units)

Exact strengths vary by manufacturer and dosage form (drops, suspension, cream, or ointment);always check the product label of the specific pack dispensed.

Polymix H combines a low-potency topical corticosteroid (hydrocortisone) with two antibiotics(neomycin sulphate and polymyxin B) that together cover many common Gram-positive and Gram-negativebacteria implicated in superficial skin, ear, and eye infections.

The corticosteroid component reduces inflammation, redness, itching, and swelling, while the twoantibiotic components act to eliminate or suppress susceptible bacteria at the site of application.It is available as ear drops/suspension, eye drops/suspension, and topical cream or ointment,depending on the brand and intended use.

Topical/Otic/Ophthalmic Corticosteroid and Antibiotic Combination (Polymix H)

Hydrocortisone + Neomycin Sulphate + Polymixin B produces its effect through the combined actions of its three components:

• Hydrocortisone is a corticosteroid that binds intracellular glucocorticoidreceptors, suppressing the release of inflammatory mediators (including phospholipase A2 inhibitionvia lipocortin induction), reducing capillary permeability, and decreasing local inflammatory cellinfiltration, edema, redness, and itching.
• Neomycin Sulphate is an aminoglycoside antibiotic that binds the bacterial 30Sribosomal subunit, causing misreading of mRNA and inhibition of protein synthesis; it is bactericidaland mainly active against Gram-negative organisms and some Gram-positive organisms.
• Polymyxin B is a polypeptide antibiotic that binds to and disrupts the bacterialouter cell membrane of susceptible Gram-negative organisms (notably Pseudomonas aeruginosa),increasing membrane permeability and causing bacterial cell death.

Together, the antibiotic components provide broad coverage against common pathogens causingotitis externa, blepharitis/conjunctivitis, and infected dermatoses, while hydrocortisone limits theassociated inflammatory response.

Before using Polymix H, wash hands and clean the affected area gently if directed. For ear drops,warm the bottle briefly in the hand (do not use hot water) and lie with the affected ear upward whileinstilling drops; remain in this position for 1-2 minutes. For eye drops, tilt the head back, pulldown the lower eyelid, instill the drop into the pocket formed, and avoid touching the dropper tip tothe eye or any surface. For cream/ointment, apply a thin layer only to the affected area and avoidcovering with an occlusive (airtight) dressing unless specifically instructed. Do not use Polymix H inor near the eyes unless the product is labeled for ophthalmic use.

Polymix H is primarily applied locally, so clinically significant systemic drug interactions areuncommon with normal use. However, the following are recognized concerns:

• Other ototoxic or nephrotoxic drugs (e.g., other aminoglycosides such asgentamicin or systemic loop diuretics such as furosemide): concurrent use with Polymix H, especiallywhen applied to large areas of broken skin, an open wound, or for prolonged periods (increasingsystemic absorption of neomycin), may increase the risk of ototoxicity or nephrotoxicity.
• Other topical corticosteroids or antibiotics applied to the same site: concurrentuse may increase the risk of local side effects (skin atrophy, secondary infection) and is generallydiscouraged unless directed by a physician.
• Live vaccines: although systemic absorption from topical/otic/ophthalmic use isusually minimal, prolonged use over large areas could theoretically contribute to immune suppression;inform your physician about all products being used.

Side effects of Polymix H are usually local and generally mild, but can be more serious withprolonged or extensive use.

• Common: local burning, stinging, itching, or transient discomfort at the site ofapplication.
• Hypersensitivity reactions: neomycin is a well-recognized cause of allergiccontact dermatitis; redness, rash, or worsening irritation may indicate sensitization and shouldprompt discontinuation.
• With prolonged/extensive use: skin thinning (atrophy), striae, telangiectasia,delayed wound healing, and (rarely, with substantial systemic absorption) suppression of thehypothalamic-pituitary-adrenal (HPA) axis from the corticosteroid component, and ototoxicity ornephrotoxicity from the aminoglycoside component.
• Ophthalmic use: raised intraocular pressure, posterior subcapsular cataractformation, and secondary ocular infection (including fungal) with prolonged use.
• Superinfection: overgrowth of non-susceptible organisms, including fungi, mayoccur with prolonged use.

There are no adequate and well-controlled studies of Polymix H in pregnant women. Topicalcorticosteroids and aminoglycosides can be absorbed systemically, particularly with prolonged use,application to large areas, or use on broken skin. Polymix H should be used during pregnancy only ifclearly needed and if the potential benefit justifies the potential risk to the fetus; a physicianshould always be consulted before use.

It is not known whether topical application of Polymix H results in clinically significant amountsin breast milk. Caution is advised, and a physician should be consulted before using Polymix H whilebreastfeeding, particularly if applied to the breast area or over large areas of skin.

Use Polymix H exactly as prescribed by your physician; do not stop, extend, skip doses, or sharethis medicine with others without medical advice.

• Do not use for longer than directed. Prolonged or repeated use increases the risk of bacterialresistance, fungal overgrowth, and the corticosteroid- and aminoglycoside-related toxicities describedunder Side Effects.
• Avoid application to large areas of skin, broken or denuded skin, or under occlusive (airtight)dressings, as this increases systemic absorption and the risk of ototoxicity, nephrotoxicity, andHPA-axis suppression.
• Neomycin is a common sensitizer; discontinue Polymix H and seek medical advice if increasingredness, itching, or irritation develops during treatment.
• For otic use, confirm with a physician that the eardrum is intact before starting therapy (seeContraindications).
• For ophthalmic use, prolonged use can raise intraocular pressure and cause cataracts; regularmonitoring is advised if used for more than a short course.
• Avoid contact with the eyes when using non-ophthalmic formulations.
• If no improvement occurs within a few days, or if the condition worsens, stop use and consult aphysician, as reassessment for resistant organisms, fungal infection, or an alternative diagnosis maybe needed.

Overdose with topical, otic, or ophthalmic Polymix H is uncommon because systemic absorption isnormally limited. Excessive or prolonged use over large areas, however, may increase the risk ofsystemic corticosteroid and aminoglycoside effects (see Side Effects). If accidental ingestion occurs,or if signs of significant systemic absorption (such as hearing changes, dizziness, or decreasedurine output) or a severe allergic reaction develop, seek immediate medical attention or contact apoison control center/emergency services rather than attempting to manage it at home.

Store at room temperature (below 30°C), away from light and moisture. Do not freeze. Keep the container tightly closed and out of reach of children. Shake suspension formulations well before use.

Renal impairment: although systemic absorption of Polymix H is normally minimal,patients with renal impairment may be at greater risk of aminoglycoside-related toxicity ifsubstantial absorption occurs (e.g., with prolonged use over large or broken skin areas); use withcaution and physician supervision.

Hepatic impairment: no specific dose adjustment is established; use with thesame caution as in the general population, avoiding prolonged or extensive application.

Elderly: no specific dose adjustment is generally required for topical/otic/ophthalmic use, but skin may be thinner and more prone to corticosteroid-related atrophy; use thelowest effective duration.

Children and infants: see Pediatric Uses.

Polymix H is generally intended for short-term use. Otic and ophthalmic courses are typicallylimited to about 7-10 days, and topical skin use to the shortest period needed to control infectionand inflammation, usually not exceeding 1-2 weeks. Use Polymix H exactly as prescribed by yourphysician; do not stop, extend, skip doses, or share this medicine with others without medical advice.If symptoms persist beyond the prescribed duration, consult a physician for reassessment rather thancontinuing or repeating treatment on your own.

Hydrocortisone + Neomycin Sulphate + Polymixin B is a combination product of three classes: a corticosteroid (hydrocortisone), an aminoglycoside antibiotic (neomycin sulphate), and a polypeptide antibiotic (polymyxin B).

Hydrocortisone + Neomycin Sulphate + Polymixin B acts through three complementary mechanisms:

• Hydrocortisone suppresses local inflammatory and immune responses by inducing lipocortin, whichinhibits phospholipase A2 and thereby reduces production of prostaglandins and leukotrienes, and bydecreasing capillary permeability and inflammatory cell migration.
• Neomycin sulphate inhibits bacterial protein synthesis by binding irreversibly to the 30Sribosomal subunit, causing misreading of the genetic code; it is bactericidal, primarily againstGram-negative organisms and some Gram-positive organisms such as Staphylococcus aureus.
• Polymyxin B disrupts the integrity of the bacterial outer cell membrane in susceptibleGram-negative bacteria (particularly Pseudomonas aeruginosa), leading to leakage ofintracellular contents and bacterial death.

C

The safety and efficacy of Polymix H have not been well established in young children, and its usein this age group should only be under direct physician supervision.

• Otic use: generally not recommended in children under 2 years of age unlessspecifically directed by a physician, given the difficulty of confirming an intact tympanic membranein infants.
• Ophthalmic use: should only be used in children under the guidance of anophthalmologist, with attention to the risk of increased intraocular pressure and cataract withprolonged use.
• Topical (skin) use: children, especially infants, have a higher ratio of skinsurface area to body weight, which increases the risk of systemic absorption and corticosteroid- oraminoglycoside-related side effects; use the smallest effective amount for the shortest possible time.