COLY-MYCIN S
LOE Approachingcolistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate
NDAOTICSUSPENSION/DROPS
Approved
May 1962
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
COLY-MYCIN S (colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate) by Pfizer is clinical pharmacology colistin sulfate is a polypeptide antibiotic which penetrates into and disrupts the bacterial cell membrane. Approved for superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics. First approved in 1962.
Drug data last refreshed 16h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COLY-MYCIN S is a fixed-dose combination otic suspension containing colistin sulfate (polypeptide antibiotic), neomycin sulfate (aminoglycoside antibiotic), thonzonium bromide (surface-active agent), and hydrocortisone acetate (corticosteroid) for topical ear treatment. It treats superficial bacterial infections of the external auditory canal caused by susceptible organisms including Staphylococcus aureus, Pseudomonas aeruginosa, and Enterobacteriaceae. The combination delivers dual antimicrobial activity plus anti-inflammatory and anti-pruritic effects to manage infection and associated symptoms.
LOE Approaching
This legacy otic antibiotic is approaching loss of exclusivity in a mature, low-growth market with modest commercial team investment and primarily maintenance-focused sales infrastructure.
Mechanism of Action
CLINICAL PHARMACOLOGY Colistin sulfate is a polypeptide antibiotic which penetrates into and disrupts the bacterial cell membrane. Neomycin sulfate is an aminoglycoside antibiotic which inhibits protein synthesis, disrupting the normal cycle of ribosomal function. Hydrocortisone acetate is a…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.