INN monograph
Gramicidin
Therapeutic agent (verify pharmacological class) · POM
Source-linked · Updated 03 Aug 2026 · Source: FDA drug label via OpenFDA/DailyMed; Local active-ingredient clinical extract; Professional class pharmacology (Therapeutic agent (verify pharmacological class))
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- 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. ).
Point of care
Dosing
Adult
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
Paediatric
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Renal
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Safety
Drug interactions
- Professional use: confirm indication, dose, duration, monitoring and patient counselling points against current Kenya STG / EML and the product SmPC.
- Document allergy status and key interactions.
Safety
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.
Use
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.
Pharmacology
Mode of action
Mechanism is agent-specific.
Full mechanism text
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.
ADME
Pharmacokinetics & PD
| Onset | Product-specific |
|---|---|
| Duration | Product-specific |
| Route | OPHTHALMIC |
Full PK/PD text
CLINICAL PHARMACOLOGY A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and gramicidin. Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code. Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane. Gramicidin is bactericidal for a variety of gram-positive organisms. It increases the permeability of the bacterial cell membrane to inorganic cations by forming a network of channels through the normal lipid bilayer of the membrane. Microbiology: Neomycin sulfate, polymyxin B sulfate, and gramicidin together are considered active against the following microorganisms: Staphylococcus aureus , streptococci, including Streptococcus pneumoniae , Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa . The product does not provide adequate coverage against Serratia marcescens .
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| No brands linked yet. | |||
Special populations
Pregnancy & lactation
Pregnancy
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.
Lactation
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.
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: FDA drug label via OpenFDA/DailyMed; Local active-ingredient clinical extract; Professional class pharmacology (Therapeutic agent (verify pharmacological class))
Clinical review date not recorded.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.