Orbifloxacin, mometasone furoate monohydrate and posaconazole: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Orbifloxacin, mometasone furoate monohydrate and posaconazole, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Posatex® Otic Suspension (NADA/ANADA 141-266)
Posatex® Otic Suspension NADA 141-266, Original approval, February 18, 2010; sponsor Intervet, Inc.; species: Dogs; foi_id 825; FDA PDF
Indication
Treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, Enterococcus faecalis).
Dose regimen
4 drops (dogs less than 30 lbs) or 8 drops (30 lbs or more) into the ear canal, otic (topical into ear canal), once daily, 7 consecutive days; shake well before use; 4 drops delivers approx. 1.0 mg orbifloxacin, 0.1 mg mometasone furoate monohydrate, 0.1 mg posaconazole
For dogs weighing less than 30 lbs. instill 4 drops of POSATEX Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops once daily into the ear canal. Therapy should continue for 7 consecutive days.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| other | between 30 and 40% of applied dose of each of the three actives systemically absorbed over 24 days | radiolabel absorption/excretion study 00209, otic administration to 6 Beagle dogs (posaconazole at 10X formulation concentration) | Based upon the amounts of radiolabeled compounds recovered from urine and feces, between 30 and 40% of the three drug components in the applied dose were systemically absorbed over a 24-day period. |
Target-animal safety
dose multiples 0X (vehicle), 1X, 3X, 5X; duration 21 consecutive days (1X once daily; 3X and 5X = clinical dose 3 or 5 times per day); animals Forty-four (22 male, 22 female) Beagle dogs.
The purpose of the study was to evaluate the safety of POSATEX Otic Suspension, when administered as an otic preparation to dogs at doses of 0 (vehicle control), 1X the clinical dose once per day, 3X (the clinical dose 3 times per day), and 5X (the clinical dose 5 times per day) for 21 consecutive days. Test Animals: Forty-four (22 male, 22 female) Beagle dogs at least 8 months at study initiation were treated with the control or POSATEX Otic Suspension.
| Finding | Quote |
|---|---|
| Pinnal erythema in vehicle control and all treated groups, likely vehicle-related | Erythema of the ear pinnae was noted in the vehicle control and all treatment groups during the dosing period and was likely related to vehicle administration. |
| Local pain, swelling or heat in 5X dogs early in dosing | Pain, swelling or heat, lasting between 1 and 3 days, were each noted in a different 5X dog early in the dosing period. |
| Slight decrease in post-ACTH serum cortisol at 5X on Day 21 | A slight, test article-related decrease in serum cortisol levels after ACTH stimulation testing on Day 21 was noted in the 5X group. |
| Generally well tolerated | POSATEX Otic Suspension was generally well-tolerated in the test animals. |
Effectiveness
Double-masked, randomized, vehicle-controlled multi-site field study (C-00-055-00) in client-owned dogs with otitis externa with concurrent bacterial and Malassezia infection; once-daily treatment for 6-8 days, re-evaluated 2-7 days after treatment; n = 143 treated with POSATEX (122 evaluated for effectiveness) vs 48 vehicle control (38 evaluated); primary endpoint: Percent of dogs showing improvement in discomfort, ear canal erythema and ear canal swelling (0-3 scale); result: Discomfort improved in 88% vs 45%, canal erythema 81% vs 39%, canal swelling 83% vs 49% (p <= 0.0001)
POSATEX Otic Suspension 143 dogs (67 females, 76 males) 122 dogs (56 females, 66 males) Vehicle Control 48 dogs (24 females, 24 males) 38 dogs (18 females, 20 males)
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Hearing loss (transient, resolved after discontinuation) | One dog with bilateral otitis externa developed hearing loss during treatment with POSATEX Otic Suspension. |
Extraction notes: Section parsing put the effectiveness text inside general_information; quotes were taken from the raw text. Primary-variable results quote (Table 4): 'Discomfort 88% (n=118)a 45% (n=38) < 0.0001 Canal Erythema 81% (n=122) 39% (n=38) < 0.0001 Canal Swelling 83% (n=107) 49% (n=35) 0.0001'. TAS groups: control 14, 1X 14, 3X 8, 5X 8 dogs; 3X/5X were the clinical dose given 3 or 5 times daily. The absorption study (6 Beagles) used posaconazole at 10 times the intended concentration. Indication quote contains the extraction artifact 's trains' (strains). Only one adverse reaction was reported in the field study (n=143 treated).
Reproduce: foi_structured_search(query="Orbifloxacin, mometasone furoate monohydrate and posaconazole") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).