Atridox
Loading...Atridox Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD TO THE AGE OF EIGHT YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH. This adverse reaction is more common during long-term use of the drugs, but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, OR IN PREGNANT WOMEN, UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy, the patient should be apprised of the potential hazard to the fetus.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking doxycycline or other tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ATRIDOX® 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.
History
There is currently no drug history available for this drug.
Other Information
The ATRIDOX® product* is a subgingival controlled-release product composed of a two syringe mixing system. Syringe A contains 450 mg of the ATRIGEL® Delivery System, which is a bioabsorbable, flowable polymeric formulation composed of 36.7% poly(DL-lactide) (PLA) dissolved in 63.3% N-methyl-2-pyrrolidone (NMP). Syringe B contains 50 mg of doxycycline hyclate which is equivalent to 42.5 mg doxycycline. The constituted product is a pale yellow to yellow viscous liquid with a concentration of 10% of doxycycline hyclate. Upon contact with the crevicular fluid, the liquid product solidifies and then allows for controlled release of drug for a period of 7 days.
*ATRIDOX® is a registered trademark of TOLMAR Inc. ATRIGEL® is a registered trademark of TOLMAR Therapeutics, Inc.
Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline.
The structural formula of doxycycline hyclate is:
Empirical Formula: (C22H24N2O8•HCI)2•C2H6O•H2O
Sources
Atridox Manufacturers
-
Tolmar Inc.
![Atridox (Doxycycline Hyclate) Kit [Tolmar Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Atridox | Tolmar Inc.
ATRIDOX® is a variable dose product dependent on the size, shape, and number of pockets being treated.
Preparation for Use If refrigerated, remove the product from refrigeration at least 15 minutes prior to mixing. Couple Syringe A (liquid delivery system) and Syringe B (drug powder). 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. Complete 100 mixing cycles at a pace of one cycle per second using brisk strokes.If immediate use is desired, skip to step 7.
If necessary, the coupled syringes can be stored at room temperature for a maximum of three days. Some of the ATRIDOX® systems are packaged in resealable pouches that can be used for this purpose. If the ATRIDOX® system is packaged in a tray, use an airtight container.
After storage, perform an additional ten mixing cycles just prior to use.Continue with immediate use instructions.
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. Uncouple the two syringes and attach one of the provided cannulae to Syringe A.Product is now ready for application.
Product AdministrationATRIDOX® 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® and cannula.
If desired, using an appropriate dental instrument, ATRIDOX® may be packed into the pocket. Dipping the edge of the instrument in water before packing will help keep ATRIDOX® from sticking to the instrument, and will help speed coagulation of ATRIDOX®. A few drops of water dripped onto the surface of ATRIDOX® once in the pocket will also aid in coagulation. If necessary, add more ATRIDOX® as described above and pack it into the pocket until the pocket is full.
Cover the pockets containing ATRIDOX® with either Coe-Pak™ periodontal dressing or a cyanoacrylate dental adhesive.
Application of ATRIDOX® may be repeated four months after initial treatment.
Login To Your Free Account