البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
IRBESARTAN; HYDROCHLOROTHIAZIDE
ANGITA PHARMA INC.
C09DA04
IRBESARTAN AND DIURETICS
300MG; 12.5MG
TABLET
IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 12.5MG
ORAL
(14X2)/30/100/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0240086002; AHFS:
CANCELLED POST MARKET
2022-09-21
_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 اقرأ الوثيقة كاملة