Doxirobe Gel (Canada)

This page contains information on Doxirobe Gel for veterinary use.
The information provided typically includes the following:
  • Doxirobe Gel Indications
  • Warnings and cautions for Doxirobe Gel
  • Direction and dosage information for Doxirobe Gel

Doxirobe Gel

This treatment applies to the following species:
Manufacturer: Zoetis

doxycycline hyclate gel

Description

Doxirobe Gel is provided in a two 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 as medicinal ingredient 44 mg doxycycline (as doxycycline hyclate). Once mixed, the product is a flowable solution (approximately 0.5 mL) of doxycycline hyclate equivalent to 8.8% doxycycline activity (w/w). The product 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.

Clinical Pharmacology

Doxycycline is a semi-synthetic tetracycline derivative. Consistent with the tetracycline class of antibiotics, it has a wide range of antimicrobial activity. Upon contact with the aqueous environment (gingival crevicular fluid), the polymer will coagulate, resulting in the formation of a solid, pliable delivery system within the treated periodontal pocket(s). Doxycycline is released into the gingival crevicular fluid for a local effect on the microorganisms present, particularly gram-negative anaerobic bacteria involved in periodontal disease.

In a clinical trial, the highest plasma doxycycline concentration (0.7 µg/mL) was observed at 6 hours after treatment administration (2 - 4 affected teeth in each of 6 dogs). Plasma doxycycline concentrations observed at 12 hours were at or below the limit of quantitation (0.1 - 0.4 µg/mL). Doxycycline was not detected in plasma samples taken at 24 hours after treatment administration or any time point thereafter. All detectable concentrations of doxycycline were well below levels associated with systemic activity or toxicity.

Doxirobe Gel Indications

For the treatment and control of periodontal disease in dogs caused by susceptible strains of canine periodontal pathogens.

Use of this product as directed should result in attachment level gains, periodontal pocket depth reductions, local antimicrobial effect and improved gingival health. Noticeable improvements in these parameters should be evident within 2 - 4 weeks following treatment.

Periodontal pocket probing depths ≥ 4 mm are evidence of disease that may be responsive to treatment with Doxirobe Gel. 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 (exposure of > 75% of the length of the tooth root or excessive mobility of the tooth).

Dosage and Administration

Apply subgingivally to periodontal pocket(s) of affected teeth. 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.

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.

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.

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.

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 greater. Ensure that the pockets are filled approximately to the gingival margin.

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.

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.

The long-term prognosis for a periodontally diseased tooth is dependent on many factors including, but not limited to, diet, occlusion, systemic health, local immune response, level of home-care and maintenance therapy. These factors must all be evaluated in determining if a tooth is a candidate for periodontal treatment versus extraction. Clients should be advised to suspend brushing treated teeth for approximately 2 weeks following application.

Contraindications

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 or lactating bitches.

Warning

Individuals with a sensitivity to the tetracycline group of antibiotics should wear gloves, mask and safety goggles when mixing and handling this product and should avoid contact with the saliva of treated animals for two weeks following treatment.

KEEP OUT OF REACH OF CHILDREN.

Doxirobe Gel Caution

The use of the product in breeding dogs has not been evaluated.

Storage

Store at a temperature between 2° and 8°C.

PRESENTATION: Doxirobe Gel is available as a 3 unit carton (containing 1 additional cannula).

® Registered trade-mark of Pfizer Enterprises S.A.R.L.; Pfizer Canada Inc., licensee.

Pfizer Animal Health, Pfizer Canada Inc., Kirkland QC H9J 2M5

DIN 02244793

804 861 000

04283 Rev. 1 8/06

NAC No.: 11982823

ZOETIS CANADA
16,740 TRANS-CANADA HIGHWAY, KIRKLAND, QC, H9H 4M7
Order Desk:   800-663-8888
Technical Services Canada:   800-461-0917
Technical Services USA:   800-366-5288
Website:   www.zoetis.ca
Every effort has been made to ensure the accuracy of the Doxirobe Gel information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-12-03

(web4)