MYLAN-LOSARTAN HCTZ TABLET

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE

มีจำหน่ายจาก:

MYLAN PHARMACEUTICALS ULC

รหัส ATC:

C09DA01

INN (ชื่อสากล):

LOSARTAN AND DIURETICS

ปริมาณ:

100MG; 25MG

แบบฟอร์มเภสัชกรรม:

TABLET

องค์ประกอบ:

LOSARTAN POTASSIUM 100MG; HYDROCHLOROTHIAZIDE 25MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

100

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

สรุปสินค้า:

Active ingredient group (AIG) number: 0233168002; AHFS:

สถานะการอนุญาต:

CANCELLED POST MARKET

วันที่อนุญาต:

2018-05-10

สรุปลักษณะสินค้า

________________________________________________________________________________________________________
MYLAN-LOSARTAN HCTZ
Page 1 of 42
PRODUCT MONOGRAPH
Pr
MYLAN-LOSARTAN HCTZ
losartan potassium and hydrochlorothiazide tablets
50 mg/12.5 mg, 100 mg/12.5 mg and 100 mg/25 mg
Manufacturer’s standard
Angiotensin II Receptor Antagonist and Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
August 09, 2013
SUBMISSION CONTROL NUMBER: 166901
________________________________________________________________________________________________________
MYLAN-LOSARTAN HCTZ
Page 2 of 42
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................... 3
SUMMARY PRODUCT INFORMATION
................................................................ 3
INDICATIONS AND CLINICAL USE
......................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................
4
ADVERSE REACTIONS
.............................................................................................
8
DRUG INTERACTIONS
...........................................................................................
11
DOSAGE AND ADMINISTRATION
......................................................................
16
OVERDOSAGE
..........................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................... 18
STORAGE AND STABILITY
..................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................... 21
PART II: SCIENTIFIC INFORMATION
.............................................................. 23
PHARMACEUTICAL INFORMATION
................................................................. 2