No

Antibiotic, Tetracycline Derivative

Dental: Treatment of periodontitis associated with presence of Actinobacillus actinomycetemcomitans (AA)

Atridox™ gel is indicated for the treatment of adult periodontitis for a gain in clinical attachment, reduction in probing depth, and reduction in bleeding on probing

D

Hypersensitivity to doxycycline, tetracycline or any component; children <8 years of age; severe hepatic dysfunction

Do not use during pregnancy - use of tetracyclines during tooth development may cause permanent discoloration of the teeth and enamel hypoplasia; prolonged use may result in superinfection, including oral or vaginal candidiasis; photosensitivity reaction may occur with this drug; avoid prolonged exposure to sunlight or tanning equipment

>10%: Discoloration of teeth in children

<1%: Gastrointestinal: Nausea, diarrhea

Rare adverse effects of tetracyclines: Glossitis, vomiting, dysphagia, hepatotoxicity, esophageal ulceration (if capsule forms are taken before lying down), rash, anaphylaxis, exfoliative dermatitis, photosensitivity, exacerbations of SLE, hemolytic anemia, neutropenia and thrombocytopenia

Doxycycline periodontal gel (Atridox™): The adverse effects reported in clinical trials were similar in incidence between doxycycline-containing product and vehicle alone. In addition, these effects were comparable to standard therapies including scaling and root planing or oral hygiene. Events associated with application reported with an incidence >1% included: gum discomfort (18.1%), toothache (14.3%), periodontal abscess (9.9%), tooth sensitivity (7.7%), broken tooth (5.1%), tooth mobility (2%), endodontic abscess (1.5%) and jaw pain (1.1%). Systemic adverse events included headache (27.3%), muscle aches (6.6%), diarrhea (3.3%), upset stomach (3.6%), and nausea (1.8%). Although there is no known relationship between doxycycline and hypertension, unspecified essential hypertension was noted in 1.6% of the doxycycline gel group, as compared to 0.2% in the vehicle group. Allergic reactions to the vehicle were also reported in two patients.

Iron and bismuth subsalicylate may decrease doxycycline bioavailability; barbiturates, phenytoin, and carbamazepine decrease doxycycline's half-life; increased effect of warfarin. Concurrent use of tetracycline may render oral contraceptives less effective. Concurrent use of tetracycline and Penthrane® has been reported to result in fatal renal toxicity.

Dental gel: Store at 2°C to 8°C (36°F to 46°F); after mixing, coupled syringes may be stored for a maximum of 3 days at room temperature

Inhibits protein synthesis by binding with the 30S and possibly the 50S ribosomal subunit(s) of susceptible bacteria; may also cause alterations in the cytoplasmic membrane

Systemic absorption from dental subgingival gel may occur, but is limited by the slow rate of dissolution from this formulation over 7 days.

Adults: Subgingival application: Dose depends on size, shape and number of pockets treated. Contains 50 mg doxycycline per 500 mg of formulation in each final blended syringe product. Application may be repeated four months after initial treatment.

May be taken with food, milk, or water

Atridox™ subgingival controlled-release product: The delivery system consists of 2 separate syringes in a single pouch. Syringe A contains 450 mg of a bioabsorbable polymer gel; syringe B contains doxycycline hyclate 50 mg. To prepare for instillation, couple syringe A to syringe B. Inject contents of syringe A (purple stripe) into syringe B, then push contents back into syringe A. Repeat this mixing cycle at a rate of one cycle per second for 100 cycles. If syringes are stored prior to use (a maximum of 3 days), repeat mixing cycle 10 times before use. After appropriate mixing, contents should be in syringe A. Holding syringes vertically, with syringe A at the bottom, pull back on the syringe A plunger, allowing contents to flow down barrel for several seconds. Uncouple syringes and attach enclosed blunt cannula to syringe A. Local anesthesia is not required for placement. Cannula tip may be bent to resemble periodontal probe and used to explore pocket. Express product from syringe until pocket is filled. To separate tip from formulation, turn tip towards the tooth and press against tooth surface to achieve separation. An appropriate dental instrument may be used to pack gel into the pocket. Pockets may be covered with either Coe-pak™ or Octyldent™ dental adhesive.

No information available to require special precautions

Mechanical oral hygiene procedures (ie, toothbrushing, flossing) should be avoided in any treated area for 7 days

Avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline. Doxycycline may decrease the efficacy of birth control pills.

Gel, for subgingival application (Atridox™): 50 mg in each 500 mg of blended formulation; 2-syringe system contains doxycycline syringe (50 mg) and delivery system syringe (450 mg) along with a blunt cannula