Atridox

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.

• Atrix Laboratories, Inc.

• Collagenex Pharmaceuticals, Inc.

• TOLMAR Inc.

Oral/Injectable:

Serious side effects have been reported with doxycycline including:

• Hypersensitivity reaction:  An allergic reaction is possible with doxycycline.  Tell your doctor if you are allergic to doxycycline (Doryx and Oracea), minocycline (Solodyn), or other tetracycline antibiotics.  Tell your doctor if you are allergic to sulfites and will be taking the syrup form of doxycycline.  Symptoms of an allergic reaction include:
  • hives
  • difficulty breathing or swallowing
  • rash
  • itching
  • fatigue
  • confusion
• Photosensitivity/Phototoxicity:  Doxycycline may increase your sensitivity to sunlight, ultraviolet light from tanning beds, and sunburns. Avoid prolonged exposure to sunlight and wear protective clothing.
• Tooth discoloration during childhood development:  Tetracycline antibiotics including doxycycline can discolor the tooth enamel of children under the age of 8 and of fetuses in the last half of pregnancy.
• Decreased effectiveness of oral contraceptives (birth control): Talk to your doctor about methods to prevent pregnancy while taking doxycycline.
• Overgrowth of bacteria resistant to doxycycline. This can lead to severe infections if not identified and addressed upon occurrence. 

If you are taking doxycycline to prevent malaria, you should know:

• that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria.
• to avoid being bitten by mosquitoes by using personal protective measures that help avoid contact with mosquitoes, especially from dusk to dawn (e.g., staying in well-screened areas, using mosquito nets, covering the body with clothing, and using an effective insect repellent).
• taking doxycycline to prevent malaria:
  •  should begin 1 to 2 days before travel to the malarious area.
  •  should be continued daily while in the malarious area and after leaving the malarious area.
  •  should be continued for 4 further weeks to avoid development of malaria after returning from an endemic area.
  •  should not exceed 4 months.

Before taking doxycycline, tell your doctor about all your medical conditions. Especially tell your doctor if you:

• have had an allergic reaction to doxycycline (Doryx and Oracea), or other tetracycline antibiotics such as minocycline (Solodyn)
• take anticoagulants (blood thinners), carbamazepine (Tegretol), phenytoin (Dilantin), vitamins, oral contraceptives, or antacids
• have kidney or liver disease
• have diabetes
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are breastfeeding or plan to breastfeed.  The active ingredient in doxycycline is excreted in human breast milk. The effect of doxycycline on the nursing infant is not known, although it may affect bone and tooth development.

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

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.

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

Atridox® is available in a tray containing a doxycycline hyclate syringe (50 mg), an ATRIGEL® Delivery System syringe (450 mg), and a blunt cannula. The trayed product is available in a professional sample box of two (NDC 59883-100-02) or a box of six (NDC 59883-100-06).

Each Atridox® syringe system is intended for use in only one patient. Do not use if packaging has been previously opened or damaged.

Storage and Handling

Store at 2° - 30°C (36° - 86°F).

Rx Only

1.     Stratton CW, Lorian V. Mechanisms of action for antimicrobial agents: general principles and mechanisms for selected classes of 
        antibiotics. Antibiotics in Laboratory Medicine, 4th edition, Williams and Wilkins, Baltimore, MD, 1996.

2.     Slots J, Rams TE. Antibiotics in periodontal therapy: advantages and disadvantages. J Clin Periodontol 1990; 17:479-493.

Manufactured by TOLMAR Inc.
Fort Collins, CO 80526
Distributed by Den-Mat Holdings, LLC
1017 W. Central Ave., Lompoc, CA 93436

Part Number: 44406 Rev. 7 10/16

Atridox®
(doxycycline hyclate) 10%
in the ATRIGEL® Delivery System
for controlled release in
subgingival application

To Order Call: 1-800-433-6628
www.denmat.com

• Dental Medications
• Gum Disease
• Gum Problems