pharmacopeia
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/api/v1/drug/gramicidin

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Protein Synthesis Inhibitors.

Protein Synthesis

Indications

Sourced from openFDA
  • 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.ICD-10: H10.9

Contraindications

Sourced from openFDA
  • This product is contraindicated in those persons who have shown hypersensitivity to any of its components.contraindicated

Dosage & administration

Sourced from openFDA

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

Warnings & precautions

Sourced from openFDA

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. ).

Adverse reactions

Sourced from openFDA

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 in specific populations

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Jan 31, 1996ANDAANDA064047Bausch And Lomb Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
8 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective450%
  2. 2Macular Degeneration450%
  3. 3Anaphylactic Reaction113%
  4. 4Bronchospasm113%
  5. 5Condition Aggravated113%
  6. 6Drug Dispensing Error113%
  7. 7Dry Eye113%
  8. 8Ear Discomfort113%
  9. 9Expired Product Administered113%
  10. 10Eye Irritation113%
  11. 11Eye Pain113%
  12. 12Eye Pruritus113%
  13. 13Eye Swelling113%
  14. 14Eyelid Disorder113%
  15. 15Foreign Body Sensation In Eyes113%

Literature

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Recent PubMed references pinned to Gramicidin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Gramicidin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Gramicidin work?
Mechanism-of-action class: Protein Synthesis Inhibitors.
What is Gramicidin used for?
According to FDA labeling, Gramicidin carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Gramicidin?
Gramicidin is classified as Antibiotics, Protein Synthesis Inhibitors, Decreased Protein Synthesis.
What are the contraindications for Gramicidin?
Gramicidin labeling lists contraindications including: This product is contraindicated in those persons who have shown hypersensitivity to any of its components.. Always consult the full prescribing information and a clinician.
Note. Data for gramicidin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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