Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Den-Mat Holdings, LLC
DOXYCYCLINE HYCLATE
DOXYCYCLINE ANHYDROUS 50 mg
ORAL
PRESCRIPTION DRUG
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. ATRIDOX® should not be used in patients who are hypersensitive to doxycycline or any other drug in the tetracycline class.
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. Store at 2° - 30°C (36° - 86°F). Rx Only
New Drug Application
ATRIDOX- DOXYCYCLINE HYCLATE DEN-MAT HOLDINGS, LLC ---------- ATRIDOX (DOXYCYCLINE HYCLATE) 10% in the ATRIGEL Delivery System for controlled release in subgingival application DESCRIPTION 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: (C H N O •HCI) •C H O•H O CLINICAL PHARMACOLOGY MICROBIOLOGY Doxycycline is a broad-spectrum semisynthetic tetracycline. Doxycycline is bacteriostatic, inhibiting bacterial protein synthesis due to disruption of transfer RNA and messenger RNA at ribosomal sites. _In_ _vitro_ testing has shown that _Porphyromonas gingivalis, Prevotella intermedia, Campylobacter rectus, _and _Fusobacterium nucleatum, _which are associated with periodontal disease, are susceptible to doxycycline at concentrations ≤ 6.0 _µ_g/mL. A single-center, single-blind, randomized, clinical study in 45 subjects with periodontal disease demonstrated that a single treatment with ATRIDOX resulted in the reduction in the numbers of _P. gingivalis, P. intermedia, C. rectus, F. nucleatum, Bacteroides forsythus,_ and _E. corrodens _in subgingival plaque samples. Levels of aerobic and anaerobic bacteria were also reduced after treatment with A Citiți documentul complet