LISINOPRIL TABLETS

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

LISINOPRIL (LISINOPRIL DIHYDRATE)

Boleh didapati daripada:

RANBAXY PHARMACEUTICALS CANADA INC.

Kod ATC:

C09AA03

INN (Nama Antarabangsa):

LISINOPRIL

Dos:

5MG

Borang farmaseutikal:

TABLET

Komposisi:

LISINOPRIL (LISINOPRIL DIHYDRATE) 5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0121550003; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2009-08-20

Ciri produk

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_Page 1 of 41_
PRODUCT MONOGRAPH
PR
LISINOPRIL TABLETS
(LISINOPRIL)
5 mg, 10 mg and 20 mg of lisinopril as lisinopril dihydrate
USP
Angiotensin Converting Enzyme Inhibitor
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd East, Suite 200
Mississauga, Ontario
L4W 0A5
Date of Preparation:
August 17, 2009
Submission Control No: 131981
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_Page 2 of 41_
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.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND
ADMINISTRATION.............................................................................
18
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND
STABILITY.........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 24
PART II: SCIENTIFIC INFORMATION
..............................................................................
25
PHARMACEUTICAL
INFORMATION.........................................................................
25
CLINICAL
TRIALS.........................................................................................................
26
DETAILED
PHARMACOLOGY