FOSAMAX TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALENDRONIC ACID (ALENDRONATE SODIUM)

Available from:

MERCK CANADA INC

ATC code:

M05BA04

INN (International Name):

ALENDRONIC ACID

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

ALENDRONIC ACID (ALENDRONATE SODIUM) 5MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

BONE RESORPTION INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0150323004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-07-30

Summary of Product characteristics

_ _
_Product Monograph – FOSAMAX_
_®_
_ _
_Page 1 of 50_
PRODUCT MONOGRAPH
FOSAMAX
®
alendronate sodium tablets
5 MG, 10 MG, 40 MG AND 70 MG ALENDRONATE
alendronate sodium oral solution
70 MG/75 ML ALENDRONATE
Bone Metabolism Regulator
MERCK FROSST CANADA LTD.
16711 Trans Canada Highway
Kirkland QC H9H 3L1
Canada
www.merckfrosst.com
DATE OF REVISION:
SEPTEMBER 10, 2010
SUBMISSION CONTROL NO: 139605
FOSAMAX
®
is a Registered Trademark of Merck Sharp & Dohme Corp., a subsidiary
of
MERCK & CO., INC.
Used
under license.
_ _
_Product Monograph – FOSAMAX_
_®_
_ _
_Page 2 of 50_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS....................................................................................................7
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND
ADMINISTRATION..............................................................................15
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................16
STORAGE AND
STABILITY..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL
INFORMATION