CORTISPORIN TC (COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE AND HYDROCORTISONE ACETATE) SUSPENSION [ENDO USA, INC.]
Dec 08, 2025
- Route
- topical
- Form
- Not reported
- Holder
- Endo USA, Inc.
- Scope
- Combination label
Product
Colistin
ATLPD0000022
Scientific evidence profile for the product as a whole, its reviewed components, PK exposure, clinical context, safety context, and source lineage.
- ADMETatlas IDATLPD0000022
- Product typeMulti-component product
- Measured materialWhole product
- Reviewed components1
- Product routenot established
- PK summaries0
- Trial references46
- Matched label records2
Product evidence profile
Product identity and molecular form, PK exposure evidence, safety context, clinical and label context, interpretation boundaries, and reproducibility exits available for this product.
Profile overview
4 of 6 profile areas have current evidence, product context, or reviewed identity linkage.
AvailableNo current evidence
Reviewed components
1
Measured material: whole product
PK summaries
0
1 cited source records
Product-linked records
48
46 context · 2 identity support
Product-label scope
2 matches
2 matched records
Profile areas
A compact route into product identity and molecular form, exposure evidence, context lanes, interpretation boundaries, and reproducible access.
Available
Molecular identity & structure
What components make up this product, and which structures are resolved?
ATLPD0000022
1 reviewed components · whole-product evidence
Empty
Pharmacology
What is the drug used for and how does it act?
—
not curated
Available
Pharmacokinetics
Are there curated exposure / PK summaries or cited observations?
1
1 cited observations · no grouped summary
Empty
Safety & immunogenicity
What safety, postmarketing, and immune-recognition signals surround the product?
0
AE, immune & nonclinical context
Available
Clinical & regulatory
What trial and product-label context is attached to this product?
46 trials
46 trials · 2 matched label records
Available
Provenance, scope & access
How is the evidence scoped, traced, cited, and reopened?
Trace
scope · lineage · access
One. Molecular identity & structure
What the product is, how its complete molecular form is defined, and which chemical or structural representations support that identity.
Identity
Scientific product record
Colistin
ATLPD0000022This record describes a multi-component product. Measurements remain attached to the whole product unless a source explicitly reports an individual component.
Product type
Multi-component product
1 reviewed component
Product context
46 curated anchors
0 label context · 46 trial
Identity fields
- Product name
- Colistin
- ADMETatlas product ID
- ATLPD0000022
- Aliases / marketed names
- No additional aliases
Identity anchors
These anchors support product-level lookup and context attachment. They are identity evidence, not ADMET endpoint measurements.
Product composition
1 reviewed component
Whole-product measurements are not assigned to an individual component.
Matched label records
2
Label/formulation matches; routes remain scoped to the source records.
Trial references
46
Clinical-trial context attached through product identity.
Name-normalization matches
not available
Review status: —.
Drug classification (ATC)
ATC classification © WHO Collaborating Centre for Drug Statistics Methodology; used unmodified for non-commercial research.
Label formulation evidence
Matched label records
2
direct and combination-label matches
Routes
topical
source-stated in these records, not a product-wide route
Forms
form not parsed
single parsed form
Veterinary labels
0
none explicitly identified
CORTISPORIN-TC (COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE, AND HYDROCORTISONE ACETATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]
Jan 11, 2011
- Route
- topical
- Form
- Not reported
- Holder
- Physicians Total Care, Inc.
- Scope
- Combination label
| Label / formulation | Route | Form | Holder | Context | Reference |
|---|---|---|---|---|---|
CORTISPORIN TC (COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE AND HYDROCORTISONE ACETATE) SUSPENSION [ENDO USA, INC.] Dec 08, 2025 | topical | — | Endo USA, Inc. | Combination label | DailyMed record |
CORTISPORIN-TC (COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE, AND HYDROCORTISONE ACETATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] Jan 11, 2011 | topical | — | Physicians Total Care, Inc. | Combination label | DailyMed record |
Multi-component product
Scientific scope
Multi-component product
Measurements on this profile describe the whole product as tested. Reviewed components explain its composition, but they do not inherit the product's endpoint values.
Measured material
Whole product
endpoint values stay at product level
Reviewed components
1
source-supported relationships
Source references
2
component-supporting sources
Product composition
Multi-component product
Component structure not fully resolved. The component relationships below are supported by sources, while exact canonical structures remain unavailable for one or more components.
Component structures
Not yet resolved
All 1 component structures remain unresolved
Stoichiometry
Not reported
No component ratio is inferred
Component relationships
Active colistin homologue family
Component family
Active homologue family
Component structure not fully resolved
Stoichiometry: Not reported
Source references
Whole-product evidence retained
Product context and measurements remain assigned to the whole product. Specific component identities are shown only where supported by a source.
Interpretation boundary
Whole-product measurements and context are not assigned to an individual component unless the source identifies that component as the measured material.
Multi-component product
Component structure not fully resolved. The product is described by its reviewed composition and is not reduced to one peptide structure.
Two. Pharmacology: indication & mechanism
What the drug is used for and how it acts, based on curated therapeutic indications and mechanism-of-action evidence for the product identity.
Indication & mechanism of action
No curated mechanism-of-action or indication evidence is attached to this product in the current release.
Three. Pharmacokinetics & exposure
1 cited PK observation with direct measurement trace.
Source-reported PK evidence
PK evidence
Source-reported exposure properties
Cited values describe the multi-component product as tested.
Observed properties
1
source-reported endpoints
Observations
1
cited measurements
Measured material
Whole product
scientific subject of the value
Observed PK properties
1
PPB
Cited measurement trace1 observation
1-1 / 1
PPB
≈50 %
- Context
- human · plasma
- Measured material
- Whole product
- Evidence role
- Source-reported observation
- Reference
- Reference
Reported statement: Clinical review reports active colistin is approximately 50% bound to human plasma.
| PK property | Value | Context | Reference | Measured material | Evidence role | Reported statement |
|---|---|---|---|---|---|---|
| PPB | ≈50 % | human · plasma | Reference | Whole product | Source-reported observation | Clinical review reports active colistin is approximately 50% bound to human plasma. |
1–1 / 1
How PK values are grouped
Source observations remain at their reported endpoint and context. Whole-product values stay attached to the complete product.
Four. Safety & immunogenicity
Regulatory safety warnings, postmarketing and nonclinical safety context, and immune-recognition context. These describe available signals, not incidence rates or causality.
Safety & immunogenicity
Postmarketing safety
0
report entries
Immune recognition
0
assay entries
Nonclinical safety
0
context entries
Product context landscape shows 0 of 3 lanes with current signal support for this product.
LaneCountCurrent signalBoundary
Postmarketing safety
No report context attached
0
report entries
No postmarketing safety report context attached.
Serious: 0 (0%)Reactions: 0Countries: 0
Spontaneous reports are safety-surveillance context only. They do not establish incidence, comparative risk, or causality.External search
Immune recognition
No immune-assay context attached
0
assay entries
No immune-recognition assay context attached.
Positive: 0Negative: 0MHC classes: 0
Immune-assay entries show epitope or MHC recognition assay context. They are not clinical immunogenicity incidence.Context entries
Nonclinical safety
No nonclinical safety context attached
0
context entries
No nonclinical safety context attached.
Label refs: 0Reviewed refs: 0Species: 0
Nonclinical safety entries retain animal, toxicology, or label context and are not normalized human safety endpoints.Context entries
The source-level context signal index is deferred from the initial product profile. Use the context-lane links above or the structured product profile below to inspect all 46 retained context signal entries.
Interpretation boundary Product-context signals are retained for interpretation and traceability. They are not incidence rates, causal safety findings, or normalized peptide endpoint measurements.
Five. Clinical & regulatory evidence
Clinical-trial context and structured product-label references attached by product identity.
Clinical & regulatory evidence
Human study context
46
trial signals
Regulatory label
0
label contexts
Product context landscape shows 1 of 2 lanes with current signal support for this product.
LaneCountCurrent signalBoundary
Human study context
Study registry context attached
46
trial signals
NCT07512596: Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria
Strong NCTs: 28Exact match: 19Has results: 5
Study registry references provide trial context. Phase, status, and posted-results metadata are not endpoint evidence by themselves.Registry search
Regulatory label
Supporting label context
0
label contexts
No structured label reference attached.
Label refs: 0Reviewed AE: 0Immunogenicity: 0
Product-label entries are regulatory product-label context unless an entry is separately promoted by endpoint-specific policy.Label search
The source-level context signal index is deferred from the initial product profile. Use the context-lane links above or the structured product profile below to inspect all 46 retained context signal entries.
Interpretation boundary Product-context signals are retained for interpretation and traceability. They are not incidence rates, causal safety findings, or normalized peptide endpoint measurements.
Six. Provenance, scope & access
How to read, trace, cite, and reopen this profile: evidence scope, reference lineage, and reproducible data access.
Evidence scope
How to read this profile
Evidence roles stay separate before interpretation
Endpoint summaries, product-context lanes, identity links, and source references answer different questions. This boundary keeps the page useful without converting context into stronger claims than the current review layer supports.
Endpoint comparison
Traceable within endpoint context
Compare PK results only when endpoint and experimental context are compatible.
Product-context reading
Context available, not endpoint truth
Label, trial, safety, immune, and nonclinical records remain contextual unless separately extracted as an endpoint.
Context propagation
Whole-product evidence only
Components do not inherit product measurements.
Detailed interpretation and provenance guidance
Scientific interpretation details
SurfaceEvidence roleSupportsDoes not supportRelated evidence
Curated endpoint evidence
Evidence role
Comparable measurement layer
Supports
Endpoint-level interpretation when context fields match.
Does not support
Pooled product parameters across mismatched species, units, route, dose, matrix, population, or source context.
Product-context signals
Evidence role
Clinical, label, safety, immune, and nonclinical context
Supports
Reading the product's evidence surroundings and source-backed context lanes.
Does not support
Incidence rates, causality claims, product safety ranking, or normalized ADMET endpoint values.
Product composition
Evidence role
Measured-material boundary
Supports
Describing source-supported components while retaining measurements at whole-product level.
Does not support
Transfer of a whole-product result to one component.
Reference lineage
Evidence role
Reproducibility and source trace
Supports
Checking where labels, trials, safety reports, identity links, and curated measurements came from.
Does not support
A substitute for normalized evidence, context grouping, or endpoint review.
External source references
Evidence role
Original-source reading path
Supports
Reading the source reference in its native regulatory, registry, literature, or source context.
Does not support
Bypassing ADMETatlas curation status, interpretation boundaries, or endpoint-promotion policy.
Scientific interpretation limits
Endpoint interpretation
Requires compatible endpoint and context
Whole-product boundary
Components do not inherit product measurements
Causality and incidence
Not claimed from context counts
Reference lineage
Reference role map
Source families are separated by scientific role
Label, trial, safety, immune, identity-link, and PK evidence enter the product profile through different review paths. This module keeps their roles visible so users can trace evidence without over-reading context counts.
Source material
3
active reference families
Identity review
0
source-matching traces
Evidence lanes
47
PK plus context entries
Release view
public
current product profile
Reference role matrix
Source familyEvidence roleSupportsBoundaryRelated evidence
Label material
0 label · 0 sections
Evidence role
Regulatory product-label context
Supports
Label sections, label-derived PK statements, safety wording, route, formulation, and immunogenicity context when extracted.
Boundary
Label material supports product context. It becomes endpoint evidence only through the reviewed PK or endpoint extraction path.
Trial registry context
46 references
Evidence role
Human study-registration context
Supports
Trial identity, phase/status, intervention matching, and availability of results context around the product.
Boundary
Trial registry entries are study context unless endpoint-compatible results are extracted and reviewed separately.
Postmarketing reports
0 AE context entries
Evidence role
Safety surveillance context
Supports
Signal-aware reading of reported adverse-event context around marketed products.
Boundary
Report counts do not establish causality, incidence, or comparative product safety.
Immune and nonclinical context
0 entries
Evidence role
Assay and nonclinical support context
Supports
Immune-recognition assays, nonclinical safety context, and neighboring signals that help interpret the product profile.
Boundary
These entries are not clinical incidence or endpoint truth unless a review policy promotes a specific endpoint.
Product identity records
2 RxNorm identifiers
Evidence role
Named-product identity support
Supports
Matching named and dosed product presentations to a stable medication identity.
Boundary
Identity records do not provide an endpoint value, administration outcome, or route-specific clinical result.
Identity source traces
0 traces
Evidence role
Source-matching and identity-review context
Supports
Source records used to assess product-to-peptide identity relationships and retained audit context.
Boundary
Only an exact match to the current authoritative canonical identity supports a linked identity; all other traces remain product context.
Cited PK evidence
1 entries
Evidence role
Endpoint measurement trace
Supports
Rechecking source values, units, route, dose, matrix, population, and source context for PK summaries.
Boundary
PK entries remain context-bound measurements and should not be pooled across incompatible contexts.
Traceability note
Link references and selected label entries carry direct source links. Product-context entries may instead carry source labels and curated summaries in the structured profile. Both are provenance, but only direct reference fields should be displayed as citation links.
Data access & citation
Reproducible product view
The structured profile access reopens the same product view used by this page, including molecular identity, PK evidence, product context, and reference lineage for the current public release.
Current public release
ATL product ID
ATLPD0000022
public product profile
Linked peptides
0
identity link scope
PK evidence
1
cited measurement trace
Product-linked records
48
46 context · 2 identity support
References
0
label plus link traces
Analysis-ready access
Use the product profile access for product-specific reproducibility. Use full-release downloads for catalog-scale analysis, with the current source policy and data dictionary.
Structured product profile
Scope
Current product
Contents
Machine-readable profile for molecular identity, PK evidence summaries, product context, and reference lineage.
Boundary
Uses the public ATL product ID in the URL. Non-public product identifiers remain outside the navigation label.
Programmatic access
The request returns the structured product profile used by this page. It is the current product-specific reproducibility path while product-only tabular exports remain a release follow-up.
GET /api/v1/products/ATLPD0000022
curl -sS 'https://admetatlas.scbdd.com/api/v1/products/ATLPD0000022' \
-H 'accept: application/json' \
-H 'X-Visibility: public_release'Use boundary
Use this module to reproduce the current product profile and locate full-release exports. Cross-product comparison still depends on compatible endpoint, species, route, dose, matrix, population, source, identity-link, and review context.