DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-04-2021
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Active ingredient:
DROSPIRENONE; ETHINYL ESTRADIOL
Available from:
GLENMARK PHARMACEUTICALS CANADA INC.
ATC code:
G03AA12
INN (International Name):
DROSPIRENONE AND ESTROGEN
Dosage:
3MG; 0.02MG
Pharmaceutical form:
TABLET
Composition:
DROSPIRENONE 3MG; ETHINYL ESTRADIOL 0.02MG
Administration route:
ORAL
Units in package:
28
Prescription type:
Prescription
Therapeutic area:
CONTRACEPTIVES
Product summary:
Active ingredient group (AIG) number: 0250430002; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-09-01
Summary of Product characteristics
_____________________________________________________________________________________________
_Pr_
_Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg / 0.02 mg_
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PRODUCT MONOGRAPH
PR
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP
3 mg drospirenone and 0.02 mg ethinyl estradiol tablets
Oral Contraceptive
Acne Therapy
Submission Control Number: 245894
Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Ave. West, Suite 407
Concord, Ontario
L4K 4M2
Date of Revision:
April 09, 2021
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_Pr_
_Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg / 0.02 mg_
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
ADVERSE REACTIONS
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
18
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 27
STORAGE AND STABILITY
.........................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 32
PART II: SCIENTIFIC INFORMATION
..............
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