Clinical medicine profile
Gramicidin/Neomycin/ Polymixin B eye drops
Therapeutic agent (verify pharmacological class)
- Route
- OPHTHALMIC
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- [Gramicidin] Hypersensitivity to the active substance or excipients.
- Additional absolute contraindications are indication- and product-specific — consult SmPC. [Neomycin] Use on rosacea acne, peri-oral dermatitis, scabies, leg ulcers, tuberculous, untreated viral, bacterial or fungal infections, reaction to smallpox vaccination, first three months of pregnancy, continous prophylactic use. [Polymixin B eye] Hypersensitivity to the active substance or excipients.
- Additional absolute contraindications are indication- and product-specific — consult SmPC.
Precautions
- WARNINGS NOT FOR INJECTION INTO THE EYE.
- This product should never be directly introduced into the anterior chamber of the eye or injected subconjunctivally.
- Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization.
- A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known.
- The manifestations of sensitization to topical antibiotics are usually itching, reddening and edema of the conjunctiva and eyelid.
- A sensitization reaction may manifest simply as a failure to heal.
- During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed.
- Symptoms usually subside quickly on withdrawing the medication.
- Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS : Error! Hyperlink reference not valid. ).
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
DOSAGE AND ADMINISTRATION Instill one or two drops into the affected eye every 4 hours for 7 to 10 days. In severe infections, dosage may be increased to as much as two drops every hour. donot
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Use, effects & interactions
Indications
- INDICATIONS AND USAGE Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria.
- Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
Adverse effects
- ADVERSE REACTIONS Adverse reactions have occurred with the anti-infective components of this product.
- The exact incidence is not known.
- Reactions occurring most often are allergic reactions including itching, swelling, and conjunctival erythema (see WARNINGS ).
- More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.
- Local irritation on instillation has also been reported.
- To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug interactions
Open multi-drug checker ↗- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Gramicidin, Neomycin / Gramicidin / Nystatin / Triamcinolone Acetonide.
- Confirm combination SmPC for exact dosing.
Mechanism & disposition
Mechanism is agent-specific.
Read complete mechanism
Mechanism is agent-specific. At receptor, enzyme, ion channel, transporter or microbial target level, the drug alters a physiological or pathological pathway to produce its therapeutic effect. Confirm precise molecular mechanism in current SmPC / pharmacology reference for this INN before high-stakes decisions.
Product-specific
Product-specific
OPHTHALMIC
Pregnancy, lactation & diet
Pregnancy: Teratogenic Effects Adequate animal reproductive studies have not been conducted with neomycin, polymyxin B, or gramicidin. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed.
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| No reviewed brand listings are linked yet. | |||
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.