DOM-IRBESARTAN-HCTZ TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Tilgjengelig fra:

DOMINION PHARMACAL

ATC-kode:

C09DA04

INN (International Name):

IRBESARTAN AND DIURETICS

Dosering :

150MG; 12.5MG

Legemiddelform:

TABLET

Sammensetning:

IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0240086001; AHFS:

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2019-02-07

Preparatomtale

PRODUCT MONOGRAPH
P R
DOM-IRBES ARTAN-HCT Z
(Irbesartan/Hydrochlorothiazide, In-House) tablets
150 mg/12.5 mg, 300 mg/12.5 mg and 300 mg/25 mg
Angiotensin II AT1 Receptor Blocker / Diuretic
DOMINION PHARMACAL.
6111 Royalmount Ave. Suite 100 Date of Preparation:
Montreal, Quebec August 23, 2011
H4P 2T4
CANADA
Submission Control No: 149242
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
3
SUMMARY PRODUCT INFORMATION
3
INDICATIONS AND CLINICAL USE
3
CONTRAINDICATIONS
3
WARNINGS AND PRECAUTIONS
4
ADVERSE REACTIONS
8
DOSAGE AND ADMINISTRATION
15
OVERDOSAGE
17
ACTION AND CLINICAL PHARMACOLOGY
17
STORAGE AND STABILITY
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
21
PART II: SCIENTIFIC INFORMATION
23
PHARMACEUTICAL INFORMATION
23
CLINICAL TRIALS
23
DETAILED PHARMACOLOGY
27
TOXICOLOGY
29
REFERENCES
35
PART III: CONSUMER INFORMATION
36
ABOUT THIS MEDICATION
36
WARNINGS AND PRECAUTIONS
36
INTERACTIONS WITH THIS MEDICATION
37
PROPER USE OF THIS MEDICATION
37
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
37
HOW TO STORE IT
38
MORE INFORMATION
38
3
PR DOM-IRBESARTAN-HYDROCHLOROTHIAZIDE
(irbesa
rt
an/hydrochlorothiazide)
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
CLINICALLY RELEVANT NON MEDICINAL INGREDIENTS
Oral
Tablet /
150mg/12.5 mg
300 mg/12.5 mg
300 mg/25 mg
_For a complete listing, see Dosage Forms, _
_Composition and Packaging section _
INDICATIONS AND CLINICAL USE
Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE
is
indicated
for
the
treatment
of
essential
hypertension
in
patients
for
whom
combination
therapy
is
appropriate
(see
DOSAGE
AND
ADMINISTRATION).
Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE is also indicated as initial
therapy in patients with
severe essential hypertension (Sitting DBP
≥
110 mmHg) for whom the benefit of a prompt blood
pressure reduction exceeds the risk of initiating combination therapy
in these patients (see CLINICAL
TRIALS and DOSAGE AND ADMINISTRATION).
Dom-IRBESARTAN-HYDROCHLOROTHIAZIDE is not indicated as initial therapy
in patients wit