AG-IRBESARTAN HCTZ TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Доступна з:

ANGITA PHARMA INC.

Код атс:

C09DA04

ІПН (Міжнародна Ім'я):

IRBESARTAN AND DIURETICS

Дозування:

150MG; 12.5MG

Фармацевтична форма:

TABLET

Склад:

IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

(14X2)/30/100/500

Тип рецепту:

Prescription

Терапевтична области:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2022-09-21

Характеристики продукта

_AG-Irbesartan HCTZ_
_Page 1 of 40_
PRODUCT MONOGRAPH
PR
AG-IRBESARTAN HCTZ
IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS
(House Standard)
150/12.5 mg, 300/12.5 mg and 300/25 mg
Angiotensin II AT
1
Receptor Blocker/Diuretic
DATE OF REVISION:
May 30, 2018
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3
SUBMISSION CONTROL NO.: 214618
_AG-Irbesartan HCTZ_
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
3
INDICATIONS AND CLINICAL USE
3
CONTRAINDICATIONS
4
WARNINGS AND PRECAUTIONS
4
ADVERSE REACTIONS
9
DRUG INTERACTIONS
14
DOSAGE AND ADMINISTRATION
18
OVERDOSAGE
19
ACTION AND CLINICAL PHARMACOLOGY
20
STORAGE AND STABILITY
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
23
PART II: SCIENTIFIC INFORMATION
PHARMACEUTICAL INFORMATION
25
CLINICAL TRIALS
25
DETAILED PHARMACOLOGY
29
TOXICOLOGY
29
REFERENCES
35
PART III: CONSUMER INFORMATION
36
_AG-Irbesartan HCTZ_
_Page 3 of 40_
PR
AG-IRBESARTAN HCTZ
Irbesartan and Hydrochlorothiazide Tablets
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
NON MEDICINAL INGREDIENTS
Oral
Tablet /
150/12.5 mg
300/12.5 mg
300/25 mg
AG-Irbesartan HCTZ 150/12.5 mg and
300/12.5 mg
tablets: lactose monohydrate,
microcrystalline
cellulose, starch pregelatinized,
croscarmellose
sodium, povidone, magnesium
stearate,
hypromellose, titanium dioxide, polyethylene
glycol,
iron oxide red and iron oxide yellow.
AG-Irbesartan HCTZ 300/25 mg tablets
also contain:
lactose monohydrate, microcrystalline
cellulose,
starch pregelatinized, croscarmellose
sodium,
povidone, magnesium stearate, hypromellose,
titanium dioxide, polyethylene glycol, iron oxide red
and iron oxide black.
INDICATIONS AND CLINICAL USE
Irbesartan/hydrochlorothiazide is indicated:
x
For the treatment of essential hypertension in patients for whom
combination
therapy is appropriate (see DOSAGE AND ADMINISTRATION).
x
As initial therapy in patients with severe essential hypertension
(Sitting DBP ≥ 110
mmHg) for whom th