ATRIDOX GEL (CONTROLLED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-06-2021
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Active ingredient:
DOXYCYCLINE (DOXYCYCLINE HYCLATE)
Available from:
DEN-MAT HOLDINGS, LLC
ATC code:
A01AB22
INN (International Name):
DOXYCYCLINE
Dosage:
8.8%
Pharmaceutical form:
GEL (CONTROLLED-RELEASE)
Composition:
DOXYCYCLINE (DOXYCYCLINE HYCLATE) 8.8%
Administration route:
SUBGINGIVAL
Units in package:
250ML
Prescription type:
Prescription
Therapeutic area:
ANTIBACTERIALS
Product summary:
Active ingredient group (AIG) number: 0105569007; AHFS:
Authorization status:
APPROVED
Authorization date:
2000-07-05
Summary of Product characteristics
PM-001 ATRIDOX
®
_Product Monograph_
Page 1 of 27
ECR#27139
Rev Date: 23 June 2021
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATRIDOX
® CONTROLLED-RELEASE DOXYCYCLINE GEL
8.8% w/w Doxycycline (as Hyclate)
in DOXYGEL™ Delivery System
Antimicrobial Agent for Periodontitis
Manufactured by:
Den-Mat Holdings, LLC
Date of Initial Approval:
1017 W. Central Ave.
July 5, 2000
Lompoc, CA 93436
U.S.A.
Imported by:
Date of Revision:
Radiant Global Logistics
June 28, 2021
3520 Laird Rd., unit 4
Mississauga, Ontario,
Canada L5L 5Z7
Distributed by:
Henry Schein
345 Townline Rd
Niagara on the Lake,
ON, L0S 1J0, CA
Submission Control No: 242758
PM-001 ATRIDOX
®
_Product Monograph_
Page 2 of 27
ECR#27139
Rev Date: 23 June 2021
RECENT MAJOR LABEL CHANGES
Not Applicable
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS................................................................................................................
4
1.1
Pediatrics............................................................................................................
4
1.2
Geriatrics
............................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.1
Dosing Considerations
........................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
..................................................... 5
4.3
Administration
.....................................................................................................
5
4.4
Reconstitution
.......................................................................
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