Country: Canada
Language: English
Source: Health Canada
PRAVASTATIN SODIUM
PHARMASCIENCE INC
C10AA03
PRAVASTATIN
20MG
TABLET
PRAVASTATIN SODIUM 20MG
ORAL
10/100/500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0122563002; AHFS:
APPROVED
2003-07-21
PRODUCT MONOGRAPH PR PMS-PRAVASTATIN Pravastatin Sodium Tablets, USP 10 mg, 20 mg and 40 mg LIPID METABOLISM REGULATOR PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 www.pharmascience.com DATE OF REVISION: July 6, 2020 SUBMISSION CONTROL NO: 239593 _pms-PRAVASTATIN Product Monograph _ _Page 2 of 38_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................5 WARNINGS AND PRECAUTIONS ..................................................................................5 ADVERSE REACTIONS ..................................................................................................11 DRUG INTERACTIONS ..................................................................................................15 DOSAGE AND ADMINISTRATION ..............................................................................17 OVERDOSAGE ................................................................................................................18 ACTION AND CLINICAL PHARMACOLOGY ............................................................19 STORAGE AND STABILITY ..........................................................................................21 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................21 PART II: SCIENTIFIC INFORMATION ...............................................................................22 PHARMACEUTICAL INFORMATION ..........................................................................22 CLINICAL TRIALS ..........................................................................................................23 DETAILED PHARMACOLOGY ......................... Read the complete document