Country: Canada
Language: English
Source: Health Canada
NITROGLYCERIN
USPHARMA LTD
C01DA02
GLYCERYL TRINITRATE
0.2MG
PATCH (EXTENDED RELEASE)
NITROGLYCERIN 0.2MG
TRANSDERMAL
30X10CM SQ
Ethical
NITRATES AND NITRITES
Active ingredient group (AIG) number: 0103615026; AHFS:
APPROVED
2011-02-11
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION NITRO-DUR ® 0.2 NITRO-DUR ® 0.4 NITRO-DUR ® 0.6 NITRO-DUR ® 0.8 Nitroglycerin Transdermal Sy stem NITRO-DUR 0.2 (Rated release in vivo 0.2 mg/hour, 10 cm 2 ) NITRO-DUR 0.4 (Rated release in vivo 0.4 mg/hour, 20 cm 2 ) NITRO-DUR 0.6 (Rated release in vivo 0.6 mg/hour, 30 cm 2 ) NITRO-DUR 0.8 (Rated release in vivo 0.8 mg/hour, 40 cm 2 ) Antianginal A gent DIN Owner: USPHARMA LTD. 13900 NW 57th Court Miami Lakes, FL 33014, USA Imported by: DR. REDDY'S LABORATORIES CANADA INC. 5580 Explorer Drive, Suite 204, Mississauga, ON L4W 4Y1 CANADA Date of Revision: March 26, 2019 Submission Control No: 223266 _NITRO-DUR (Nitroglycerin Transdermal System) _ _Page 1 of 27_ _NITRO-DUR (Nitroglycerin Transdermal System)_ _Page 2 _ _of26_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFOR M ATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS....................................................................................................6 DRUG INTERACTIONS ....................................................................................................7 DOSAGE AND ADMINISTRATION ................................................................................7 OVERDOSAGE ..................................................................................................................8 ACTION AND CLINICAL PHARMACOLOGY ..............................................................9 STORAGE AND STAB IL I T Y ............................................................................................9 SPECI Read the complete document