Country: Canada
Language: English
Source: Health Canada
LOSARTAN POTASSIUM
BIOMED PHARMA
C09CA01
LOSARTAN
50MG
TABLET
LOSARTAN POTASSIUM 50MG
ORAL
100
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0127971003; AHFS:
CANCELLED POST MARKET
2022-07-19
_Bio-LOSARTAN _ _Page 1 of 36_ PRODUCT MONOGRAPH PR BIO-LOSARTAN Losartan Potassium Tablets 25, 50 and 100 mg (House Standard) Angiotensin II Receptor Antagonist BIOMED PHARMA DATE OF PREPARATION: 100-5950, Ch. de la Côte de Liesse September 14, 2015 Mont-Royal Qc, H4T 1E2 Control # 186979 _Bio-LOSARTAN _ _Page 2 of 36_ 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 ................................................................................................................ 7 DRUG INTERACTIONS ................................................................................................................ 9 DOSAGE AND ADMINISTRATION .......................................................................................... 11 OVERDOSAGE ............................................................................................................................ 13 ACTION AND CLINICAL PHARMACOLOGY ........................................................................ 13 STORAGE AND STABILITY ...................................................................................................... 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................................... 16 PART II: SCIENTIFIC INFORMATION ..................................................................................... 17 PHARMACEUTICAL INFORMATION ...................................................................................... 17 CLINICAL Read the complete document