DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP 28
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-02-2014
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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; 0.03MG
Pharmaceutical form:
TABLET
Composition:
DROSPIRENONE 3MG; ETHINYL ESTRADIOL 0.03MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
CONTRACEPTIVES
Product summary:
Active ingredient group (AIG) number: 0250430001; AHFS:
Authorization status:
APPROVED
Authorization date:
2016-08-12
Summary of Product characteristics
_Drospirenone and Ethinyl Estradiol Tablets USP, 3.0 mg/0.03 mg
Product Monograph _
_Page 1 of 59_
PRODUCT MONOGRAPH
PR
DROSPIRENONE AND ETHINYL ESTRADIOL
TABLETS USP (21-DAY REGIMEN)
PR
DROSPIRENONE AND ETHINYL ESTRADIOL
TABLETS USP (28-DAY REGIMEN)
3.0 mg drospirenone and 0.03 mg ethinyl estradiol
Oral Contraceptive
Acne Therapy
Glenmark Generics Canada Inc.
Date of Preperation:
500 King St W, 3
rd
Floor
February 21, 2014
Toronto, ON, M5V 1L9
SUBMISSION CONTROL NUMBER:
162356
_ _
_Drospirenone and Ethinyl Estradiol Tablets USP, 3.0 mg/0.03 mg
Product Monograph _
_Page 2 of 59_
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
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................25
OVERDOSAGE
................................................................................................................28
ACTION AND CLINICAL PHARMACOLOGY
............................................................28
STORAGE AND STABILITY
..........................................................................................32
SPECIAL HANDLING INSTRUCTIONS
.......................................................................32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................32
PART II: SCIENTIFIC INFORMATION
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