Doxycycline

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This page reprints a manufacturer label. Everything below in quotation marks is copied from Doxirobe® Gel, published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.

This page reprints the FDA label for Doxirobe® Gel by Zoetis Inc, a doxycycline product labelled for dogs. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed.

The label

Product: Doxirobe® Gel. Manufacturer: Zoetis Inc. FDA Structured Product Label set id 95d81bde-9044-4192-8820-9f6d88614128. Label effective 2023-07-07. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

DOXIROBE Gel is indicated for the treatment and control of periodontal disease in dogs. Periodontal pocket probing depths ≥ 4 mm are evidence of disease that may be responsive to treatment with DOXIROBE Gel. In clinical trials, use of the product resulted in attachment level gains, periodontal pocket depth reductions and improved gingival health. Noticeable improvements in these parameters should be evident within 2-4 weeks following treatment. The response in individual animals is dependent on the severity of the condition and rigor of adjunctive therapy. This product is not intended for use in oronasal fistulas, periapical abscesses, or severely compromised teeth.

Dosage and Administration

Teeth should be cleaned and scaled prior to application of the product. If required, root planing and debridement of affected sites should be performed. The product is applied with the animal under sedation or anesthesia. Use as many units as required to fill the periodontal pockets of affected teeth. Picture 1 Each pouch contains 2 syringes and a blunt cannula. Syringe A contains the polymer delivery system and Syringe B contains doxycycline. Lock the syringes together. Picture 2 Beginning with Syringe A, use the plungers of Syringes A and B to exchange the material between the syringes approximately 100 times to achieve a consistent mixture. Picture 3 Fully deliver the mixture into Syringe A, separate the syringes, and lock the supplied blunt cannula onto Syringe A. The cannula may be bent to the desired angle. Picture 4 Gently place the cannula 1-2 mm below the gingival margin of an affected tooth. Express a small amount of the mixture into each periodontal pocket 4 mm or deeper. Ensure that the pockets are filled approximately to the gingival margin. Picture 5 The formulation will begin to solidify immediately upon application; however, lavage with a few drops of water or saline will facilitate the process. Allow approximately 30-60 seconds for the polymer to harden before beginning to press it into the pocket Picture 6 The exposed surface of the product may be pressed into the pocket with the edge of a wax spatula or the back of a curette. Pressure may be applied to the gingival margin to avoid dislodging the polymer inadvertently. As the product is biodegradable, removal at a subsequent visit is not required. Treatment and control of periodontal disease requires a comprehensive program of routine scaling and cleaning, home care and dental hygiene (e.g., brushing, rinses or the use of chewing devices) in addition to application of this product. Severe cases may require surgical intervention. Reconstituted product not used on the day of mixing should be stored in the resealable foil pouch at room temperature (15-25°C or 59-77°F) and used within 3 days of reconstitution. Ten additional exchanges between syringes should be performed if reconstituted product has been stored. Picture 1 Picture 2 Picture 3 Picture 4 Picture 5 Picture 6

Precautions

Do not use in dogs less than 1 year of age as the use of tetracyclines during tooth development has been associated with permanent discoloration of the teeth. Do not use in pregnant bitches. The use of the product in breeding dogs has not been evaluated. Clients should be advised to suspend brushing treated teeth for approximately 2 weeks following treatment.

Description

DOXIROBE Gel is provided in a 2-syringe system requiring mixing prior to use. Syringe A contains the polymer delivery system (N-methyl-2-pyrrolidone and poly (DL-lactide)) and Syringe B contains the active ingredient (doxycycline). 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. The product is non-irritating and biodegradable.

Storage

Store at controlled room temperature 15° to 30°C (59° to 86°F).

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming doxycycline as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.

Dogs: 3,870 reports

Reactions most often coded in dogs, 3,870 reports
VeDDRA reaction termReports
Lack of efficacy (endoparasite) - heartworm1,194
Vomiting569
Lethargy (see also Central nervous system depression in 'Neurological')423
Other abnormal test result NOS314
Death by euthanasia286
Anorexia279
Elevated alanine aminotransferase (ALT)268
Diarrhoea253
Lack of efficacy - NOS237
Cough225
Death212
Leucocytosis NOS210
Fever201
Abnormal radiograph finding200
Weight loss197

Outcome as recorded by the reporter: Ongoing 1,887; Outcome Unknown 851; Recovered/Normal 527; Euthanized 280; Died 228; Recovered with Sequela 25.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Sources

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