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 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Coly-Mycin S is a fixed-dose otic suspension combining two aminoglycoside antibiotics (colistin sulfate and neomycin sulfate), a corticosteroid (hydrocortisone acetate), and a surfactant (thonzonium bromide) for topical ear treatment. It treats superficial bacterial infections of the external auditory canal caused by susceptible gram-positive and gram-negative organisms including Pseudomonas aeruginosa and Staphylococcus aureus. The antibiotics disrupt bacterial cell membranes and inhibit protein synthesis while the corticosteroid controls inflammation and pruritus.
LOE Approaching
This legacy product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential workforce rationalization and transition planning on the brand team.
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.