APO-MEDROXY TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-08-2017
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Active ingredient:
MEDROXYPROGESTERONE ACETATE
Available from:
APOTEX INC
ATC code:
G03DA02
INN (International Name):
MEDROXYPROGESTERONE
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
MEDROXYPROGESTERONE ACETATE 10MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
PROGESTINS
Product summary:
Active ingredient group (AIG) number: 0106339006; AHFS:
Authorization status:
APPROVED
Authorization date:
2006-02-22
Summary of Product characteristics
Page 1 of 39
PRODUCT MONOGRAPH
Pr
APO-MEDROXY
(MEDROXYPROGESTERONE ACETATE TABLETS USP)
2.5 MG, 5 MG, 10 MG AND 100 MG
PROGESTIN
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Date of Revision:
M9L 1T9
July 21, 2017
CONTROL NO. 207292
Page 2 of 39
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
.......................................................................................................
13
DRUG INTERACTIONS
.......................................................................................................
15
DOSAGE AND ADMINISTRATION
...................................................................................
17
OVERDOSAGE
......................................................................................................................
19
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
19
STORAGE AND STABILITY
...............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 23
PART II: SCIENTIFIC INFORMATION
.............................................................................
24
PHARMACEUTICAL INFORMATION
...............................................................................
24
CLINICAL TRIALS
...............................................................................................................
24
DETAILED PHARMACOLOGY
.................................
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