Country: Canada
Language: English
Source: Health Canada
DROSPIRENONE; ETHINYL ESTRADIOL
MYLAN PHARMACEUTICALS ULC
G03AA12
DROSPIRENONE AND ESTROGEN
3MG; 0.03MG
TABLET
DROSPIRENONE 3MG; ETHINYL ESTRADIOL 0.03MG
ORAL
21
Prescription
PROGESTOGENS AND ESTROGENS, FIXED COMBINATIONS
Active ingredient group (AIG) number: 0250430001; AHFS:
APPROVED
2018-01-04
_Drospirenone and Ethinyl Estradiol Tablets 21 / 28 Product Monograph _ _ _ Page 1 of 60 PRODUCT MONOGRAPH PR DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS 21 PR DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS 28 Drospirenone and Ethinyl Estradiol Tablets, In-House Standard 3 mg drospirenone and 0.03 mg ethinyl estradiol tablets Oral Contraceptive Acne Therapy Mylan Pharmaceuticals ULC Date of Revision: 85 Advance Road April 13, 2023 Etobicoke, ON M8Z 2S6 Submission Control No.: 272789 _Drospirenone and Ethinyl Estradiol Tablets 21 / 28 Product Monograph _ _ _ Page 2 of 60 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 ......................................................................................................... 15 DRUG INTERACTIONS ......................................................................................................... 19 DOSAGE AND ADMINISTRATION ..................................................................................... 25 OVERDOSAGE ........................................................................................................................ 29 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 29 STORAGE AND STABILITY ................................................................................................. 33 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 33 DOSAGE FORMS, COMPOSITION AND PACKAGING . Read the complete document