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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: Merck Sharp & Dohme Corp.
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis ). Species commonly shown: Both, Dog.
POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa , and Enterococcus faecalis ).
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Top reported reactions (openFDA): Deafness, Partial deafness, Drug administration duration too long, Underdose, Lack of efficacy - NOS, Overdose.
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Used for:
POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase positive staphylococci, Pseudomonas aerug...
Dosing note:
Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.
What to watch for:
When to call the vet:
Regulatory restrictions are shown in Vet View.
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Orbiflox/Momet/Posaco Eardrops; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 28 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.
Unsteady walking (ataxia) (1 reports), Injection site pain (1 reports), Injection site oedema (1 reports), Injection site mass NOS (1 reports), Injection site inflammation (1 reports)
Digestive (1), Skin & allergy (1), Neurologic (1), Behavior (1)
Dog (21 reports), Cat (11 reports)
Domestic Shorthair (3), Persian (1), ['Retriever - Labrador', 'Dog (unknown)'] (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Orbiflox/Momet/Posaco Eardrops fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
wobbly/unsteady walking, Injection site pain, Injection site oedema
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: April 22, 2026, 10:06 AM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2025-12-29 · MSK · MSK
Received 2025-12-08 · MSK · MSK
Received 2025-12-03 · MSK · MSK
Received 2025-11-18 · MSK · MSK
Received 2025-10-16 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Neurologic | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 |
Species coverage: Dog (21) Cat (11)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Neurologic | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Skin & allergy | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 |
The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.
Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.
Full source previews and metadata remain in the veterinary/professional layer.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
SPL · Structured Product Label
FOI · FOI
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 0061-0089-01 | 0061 | - | |
| 0061-0089-02 | 0061 | - | |
| 0061-0089-03 | 0061 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
Posatex® Otic Suspension
RX
Mometasone Furoate Monohydrate Orbifloxacin posaconazole
Topical Suspension
• Otic
|
Intervet, Inc. | NADA 141-266 | Approved | Mar 23, 2020 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
FDA page: Open in Animal Drugs @ FDA
POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa , and Enterococcus faecalis ).
Source: FDA Animal Drugs @ FDA • Reference
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Skin & allergy.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Cat, Persian, Male, 12.5 year, 4.4 kilogram • Drug: MSK, Liquid, Oral • Reactions: Intentional misuse, Lack of efficacy - NOS, Death by euthanasia, Gait abnormality, Lumbar pain • Outcome: Euthanized
Dog, ['Retriever - Labrador', 'Dog (unknown)'], Female, 11 year • Drug: MSK, Liquid, Oral • Reactions: Vocalisation, Injection site pain, Increased skin sensitivity, Injection site inflammation, Injection site reddening… • Outcome: Ongoing
Cat, Domestic Shorthair, Male, 5 year, 5.897 kilogram • Drug: MSK, Ophthalmic • Reactions: Weight loss, Decreased appetite, Vomiting • Outcome: Ongoing
Cat, Domestic Shorthair, Female, 9 year, 3.83 kilogram • Drug: MSK, Unknown • Reactions: Not eating, Less social, Reluctant to move, Hiding, Not drinking • Outcome: Recovered/Normal
Cat, Domestic Shorthair, Female, 10 year, 2.54 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Lack of efficacy - NOS, Non-regenerative anaemia • Outcome: Ongoing
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.