Periodontitis, non-severe, plaque-associated (adjunctive agent): Subgingival: Atridox subgingival controlled-release product: Dose depends on size, shape, and number of pockets treated; local anesthesia is not required for placement. Each final blended syringe product formulation contains 50 mg doxycycline hyclate per 500 mg. May be repeated 4 months after initial treatment (Ref). Use in addition to periodontal debridement (Ref).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Central nervous system: Headache (27%)
Gastrointestinal: Minor gum irritation (18%), toothache (14%; pressure sensitivity)
1% to 10%:
Cardiovascular: Hypertension (<1% to 2%)
Central nervous system: Local discomfort (sensitive teeth: 8%), sore mouth (4%; soft tissue erythema, unspecified pain), insomnia (3%), tension headache (2%)
Dermatologic: Dermatitis (1%), skin infection (1%)
Endocrine & metabolic: Premenstrual syndrome (4%)
Gastrointestinal: Periodontal abscess (10%), sore throat (6%), injury of tooth (5%), dyspepsia (4%), gingivitis (4%), diarrhea (3%), nausea (2%), periodontal abscess (2%; lesion), vomiting (2%), dental bleeding (1%)
Infection: Common cold (26%), influenza (3% to 6%) ), tooth abscess (2%; pulpitis)
Neuromuscular & skeletal: Myalgia (6%), back pain (4%), arm pain (2%), leg pain (2%), lower back pain (2%), muscle tenderness (2%), jaw pain (1%), neck pain (1%), shoulder pain (1%)
Respiratory: Sinus congestion (6%), sinus infection (5%), cough (4%), bronchitis (2%), ENT infection (2%), allergic rhinitis (1%)
Miscellaneous: Fever (1%)
<1%, postmarketing, and/or case reports: Aphthous stomatitis, enamel hypoplasia, fistula, hypersensitivity reaction, permanent dental discoloration, skin photosensitivity, tooth loss
Hypersensitivity to doxycycline, tetracycline or any component of the formulation; children <8 years of age.
Canadian labeling: Additional contraindications (not in US labeling): Children <12 years of age; pregnancy; breastfeeding.
Concerns related to adverse effects:
• Photosensitivity: May cause photosensitivity; discontinue if skin erythema occurs. Use skin protection and avoid prolonged exposure to sunlight; do not use tanning equipment.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Special populations:
• Pediatric: May cause tissue hyperpigmentation, enamel hypoplasia, or permanent tooth discoloration; use of tetracyclines should be avoided during tooth development (children <8 years of age) unless other drugs are not likely to be effective or are contraindicated.
Other warnings/precautions:
• Appropriate use: For subgingival application: This product has not been evaluated or tested in immunocompromised patients, in patients with oral candidiasis, or in conditions characterized by severe periodontal defects with little remaining periodontium. May result in overgrowth of nonsusceptible organisms, including fungi. Effects of treatment >9 months have not been evaluated. Has not been evaluated for use in regeneration of alveolar bone.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, Mouth/Throat:
Atridox: 42.5 mg/0.5 mL (0.5 mL)
May be product dependent
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, Mouth/Throat:
Atridox: 44 mg/0.5 mL (0.5 mL)
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. If refrigerated, remove the product from refrigeration at least 15 minutes prior to mixing.
To prepare for instillation, couple syringe A to syringe B. Inject contents of syringe A (red 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.
Periodontitis, non-severe, plaque-associated: Treatment of chronic adult periodontitis for a gain in clinical attachment, reduction in probing depth, and reduction in bleeding on probing (John 2017).
None known.
There are no known significant interactions.
Tetracyclines cross the placenta (Mylonas 2011). Tetracyclines accumulate in developing teeth and long tubular bones. Permanent discoloration of teeth (yellow, gray, brown) can occur following in utero exposure and is more likely to occur following long-term or repeated exposure. Serum concentrations following subgingival use are significantly less than with oral tablets. Use of this product should be avoided in pregnant patients unless other options are not likely to be effective or are contraindicated.
Refer to the Doxycycline monograph for additional information.
It is not known if doxycycline is present in breast milk following subgingival application.
Doxycycline is present in breast milk following systemic use. Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends a decision be made to discontinue breastfeeding or to discontinue the drug, considering the importance of treatment to the mother.
Refer to the Doxycycline monograph for additional information.
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
Doxycycline inhibits collagenase in vitro and has been shown to inhibit collagenase in the gingival crevicular fluid in adults with periodontitis
Systemic absorption from dental subgingival gel may occur, but is limited by the slow rate of dissolution from this formulation over 7 days.
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟