Country: Canada
Language: English
Source: Health Canada
DROSPIRENONE; ETHINYL ESTRADIOL
COBALT PHARMACEUTICALS COMPANY
G03AA12
DROSPIRENONE AND ESTROGEN
3MG; 0.03MG
TABLET
DROSPIRENONE 3MG; ETHINYL ESTRADIOL 0.03MG
ORAL
28 (7 HORMONE FREE)
Prescription
CONTRACEPTIVES
Active ingredient group (AIG) number: 0250430001; AHFS:
CANCELLED POST MARKET
2018-11-12
_ZARAH_ _TM_ _ Product Monograph _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 1 of 58_ PRODUCT MONOGRAPH PR ZARAH ™ 21 PR ZARAH ™ 28 (3.0 mg drospirenone and 0.030 mg ethinyl estradiol tablets) Oral Contraceptive Acne Therapy Cobalt Pharmaceuticals Company 6733 Mississauga Road, Suite 400 Mississauga, Ontario L5N 6J5 Date of Revision: July 03, 2015 Submission Control No.: 181396 _ZARAH_ _TM_ _ Product Monograph _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 2 of 58_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS ................................................................................. 4 ADVERSE REACTIONS ................................................................................................. 14 DRUG INTERACTIONS ................................................................................................. 19 DOSAGE AND ADMINISTRATION ............................................................................. 25 OVERDOSAGE ............................................................................................................... 27 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 28 STORAGE AND STABILITY ......................................................................................... 32 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 32 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 32 PART II: SCIENTIFIC INFORMATION .............................................................................. 34 PHARMACEUTICAL INFORMATION ...................... Read the complete document