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Atridox

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Atridox

Indications
Dosage
How Supplied

INDICATIONS

ATRIDOX (doxycycline hyclate) ® is indicated for use in the treatment of chronic adult periodontitis for a gain in clinical attachment, reduction in probing depth, and reduction in bleeding on probing.

DOSAGE AND ADMINISTRATION

ATRIDOX (doxycycline hyclate) ® is a variable dose product dependent on the size, shape, and number of pockets being treated.

Preparation for Use

1. If refrigerated, remove the product from refrigeration at least 15 minutes prior to mixing.

2. Couple Syringe A (liquid delivery system) and Syringe B (drug powder).

Couple Syringe A and Syringe B - Illustration

3. Inject the liquid contents of Syringe A (indicated by red stripe) into Syringe B (doxycycline powder) and then push the contents back into Syringe A. This entire operation is one mixing cycle.

4. Complete 100 mixing cycles at a pace of one cycle per second using brisk strokes.

If immediate use is desired, skip to step 7.

5. If necessary, the coupled syringes can be stored at room temperature for a maximum of three days. Some of the Atridox (doxycycline hyclate) systems are packaged in resealable pouches that can be used for this purpose. If the Atridox (doxycycline hyclate) system is packaged in a try, use an airtight container.

Coupled syringes can be stored at room temperature - Illustration

6. After storage, perform an additional ten mixing cycles just prior to use.

Continue with immediate use instructions.

7. The contents will be in Syringe A (indicated by red stripe). Hold the coupled syringes vertically with Syringe A at the bottom. Pull back on the Syringe A plunger and allow the contents to flow down the barrel for several seconds.

8. Uncouple the two syringes and attach one of the provided cannulae to Syringe A.

Uncouple the two syringes and attach one of the provided cannulae to Syringe A - Illustration

Product is now ready for application.

Product Administration

ATRIDOX (doxycycline hyclate) ® does not require local anesthesia for placement. Bend the cannula to resemble a periodontal probe and explore the periodontal pocket in a manner similar to periodontal probing. Keeping the cannula tip near the base of the pocket, express the product into the pocket until the formulation reaches the top of the gingival margin. Withdraw the cannula tip from the pocket. In order to separate the tip from the formulation, turn the tip of the cannula towards the tooth, press the tip against the tooth surface, and pinch the string of formulation from the tip of the cannula. Variations on this technique may be needed to achieve separation between ATRIDOX (doxycycline hyclate) ® and cannula.

If desired, using an appropriate dental instrument, ATRIDOX (doxycycline hyclate) ® may be packed into the pocket. Dipping the edge of the instrument in water before packing will help keep ATRIDOX (doxycycline hyclate) ® from sticking to the instrument, and will help speed coagulation of ATRIDOX (doxycycline hyclate) ®. A few drops of water dripped onto the surface of ATRIDOX (doxycycline hyclate) ® once in the pocket will also aid in coagulation. If necessary, add more ATRIDOX (doxycycline hyclate) ® as described above and pack it into the pocket until the pocket is full.

Cover the pockets containing ATRIDOX (doxycycline hyclate) ® with either Coe-Pak™ periodontal dressing or a cyanoacrylate dental adhesive.

Application of ATRIDOX (doxycycline hyclate) ® may be repeated four months after initial treatment.

HOW SUPPLIED

The final blended product is 500 mg of formulation containing 50 mg of doxycycline hyclate (doxycycline hyclate, 10%).

ATRIDOX (doxycycline hyclate) ® is available as a tray or pouch containing a doxycycline hyclate syringe (50 mg), an ATRIGEL® Delivery System syringe (450 mg), and a blunt cannula. The pouched product is available in a box of six (NDC 63646-191-00) a box of two (NDC63646-191-02), or a professional sample pouch (NDC 63646-191-01). The trayed product is available in a box of six (NDC 63646-191-05), a box of four (NDC 63646-191-04), or a professional sample box of two (NDC 63646-191-03).

Each ATRIDOX (doxycycline hyclate) ® syringe system is intended for use in only one patient. Do not use if packaging has been previously opened or damaged.

Storage Conditions

Store at 2° - 30°C (36° - 86°F).

Manufactured by TOLMAR Inc. Fort Collins, CO 80526. Distributed by Zila Therapeutics, Inc. Rev. 02/11.

Last reviewed on RxList: 4/11/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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