ATRIDOX- doxycycline hyclate kit

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

थमां उपलब्ध:

Den-Mat Holdings, LLC

INN (इंटरनेशनल नाम):

DOXYCYCLINE HYCLATE

रचना:

DOXYCYCLINE ANHYDROUS 50 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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.

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

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