Country: Canada
Language: English
Source: Health Canada
DROSPIRENONE; ETHINYL ESTRADIOL
GLENMARK PHARMACEUTICALS CANADA INC.
G03AA12
DROSPIRENONE AND ESTROGEN
3MG; 0.02MG
TABLET
DROSPIRENONE 3MG; ETHINYL ESTRADIOL 0.02MG
ORAL
28
Prescription
CONTRACEPTIVES
Active ingredient group (AIG) number: 0250430002; AHFS:
APPROVED
2020-09-01
_____________________________________________________________________________________________ _Pr_ _Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg / 0.02 mg_ _Page 1 of 67_ 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 _____________________________________________________________________________________________ _Pr_ _Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg / 0.02 mg_ _Page 2 of 67_ 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 .............. Read the complete document