Doxycycline Hyclate: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Doxycycline Hyclate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Doxirobe™ Gel (NADA/ANADA 141-082)
Doxirobe™ Gel NADA 141-082, Original approval, November 19, 1997; sponsor Zoetis Inc.; species: Dogs; foi_id 616; FDA PDF
Indication
Treatment and control of periodontal disease in dogs.
Dose regimen
8.5% doxycycline (as doxycycline hyclate) flowable gel; as many units as required to fill the periodontal pockets, subgingival (topical) application into periodontal pockets of affected teeth, single administration (product forms a slow-release polymer depot), two-syringe system mixed before use
Once mixed, the product is a flowable solution of doxycycline hyclate equivalent to 8.5% doxycycline activity. The formulation is applied subgingivally to the periodontal pocket(s) of affected teeth, and doxycycline is slowly released from the polymer providing a local antimicrobial effect. Use as many units as required to fill the periodontal pockets of affected teeth.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| other | plasma doxycycline detectable only at 6 and 12 hours (dogs with four treated sites) | subgingival 5% and 10% doxycycline hyclate formulations, 6 beagles (ATS-32); total doses 13.7-22.6 mg in the dogs with detectable levels | Detectable plasma doxycycline concentrations were present in the three dogs which had four treated sites, but only at 6 and 12 hours after treatment onset (Table 5). |
| other | no plasma drug after 12 hours post-treatment | sampling at 6, 12, 24 h, daily to day 6, then days 10-28 | No drug was detected in any plasma sample after 12 hours post-treatment |
| other | gingival crevicular fluid doxycycline exceeded MIC of most periodontal pathogens | ATS-65 dose confirmation study | Gingival crevicular fluid concentrations of doxycycline exceeded the minimum inhibitory concentration of most periodontal pathogens. |
Target-animal safety
dose multiples 5% and 10% doxycycline hyclate formulations (label formulation is 10% hyclate = 8.5% doxycycline); duration 7-28 days (necropsy at day 7 or 28); animals Twelve.
Animals: Twelve adult (6.5-10 years), 7.5-16.5 kg, female Beagle dogs with naturally occurring periodontal disease.
| Finding | Quote |
|---|---|
| No tissue irritation attributable to the product (GLP study ATS-31) | This study demonstrated the lack of tissue irritation when the test articles were placed into naturally occurring periodontal pockets in the dog. |
| Gingivitis incidence comparable between 5%, 10% and saline control sites | The microscopic and macroscopic incidence of gingivitis was comparable between the 5% and 10% formulations and the control sites. |
| ATS-32: mild erythema/edema for ~3 days in treated and control sites, attributed to scaling | Mild inflammation characterized by erythema and edema was present for approximately three days after treatment in treated and control sites and was attributed to the dental scaling procedure. |
| Only one emesis observation, attributed to anesthetic recovery | Emesis was noted in the cage of one dog (treated with 5% doxycycline) at 2 and 4 hours after treatment administration. The finding was attributed to anesthetic recovery. |
Effectiveness
Dose confirmation study ATS-53 in adult female Beagles with naturally occurring periodontal disease, each dog's baseline as control, 3 teeth/dog, evaluated for 9 months after a single subgingival application; supported by ATS-65 (5 dogs, 4 months) and a vehicle-control study ATS-58 (4 dogs); n = Four; primary endpoint: Periodontal pocket depth, attachment level and bleeding on probing over time; result: Significant (p<0.001) reductions: mean pocket depth 6.10 mm at baseline to 3.43-3.93 mm, attachment level 4.93 to 2.40 mm and bleeding on probing 2.43 to 0.73 at 9 months; total bacterial counts reduced within two weeks and maintained 9 months; vehicle alone did not change pocket depth or attachment level
Animals: Four adult (7-10 years) female Beagle dogs with naturally occurring periodontal disease.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| None attributed to treatment (ATS-53 treatment sites) | No adverse reactions attributed to the treatment were observed at the treatment sites. |
Extraction notes: 1997 original approval (Heska Corporation; product later marketed as Doxirobe Gel). No dose-multiple margin-of-safety study: safety was assessed by local tissue-irritation studies with 5% and 10% formulations (ATS-32, six dogs, 28 days; ATS-31, twelve dogs, 7-28 days). Effectiveness studies are small laboratory studies (4-5 dogs) with no field trial. PK content is limited to plasma detectability and gingival crevicular fluid statements.
Reproduce: foi_structured_search(query="Doxycycline Hyclate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).