País: Canadá
Língua: inglês
Origem: Health Canada
ETHINYL ESTRADIOL; NORGESTIMATE; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL
PATRIOT A DIVISION OF JANSSEN INC
G03AB11
NORGESTIMATE AND ESTROGEN
0.025MG; 0.180MG; 0.215MG; 0.025MG; 0.250MG; 0.025MG
TABLET
ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.180MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.025MG
ORAL
21
Prescription
CONTRACEPTIVES
Active ingredient group (AIG) number: 0636783003; AHFS:
CANCELLED PRE MARKET
2017-08-03
_165473.doc _ _ _ _Page 1 of 52 _ PRODUCT MONOGRAPH PR CENTRISA ™ LO 21 AND PR CENTRISA ™ LO 28 norgestimate and ethinyl estradiol Tablets, House Std. 0.180 mg norgestimate and 0.025 mg ethinyl estradiol 0.215 mg norgestimate and 0.025 mg ethinyl estradiol 0.250 mg norgestimate and 0.025 mg ethinyl estradiol Oral Contraceptive Patriot, a Division of Janssen Inc. 19 Green Belt Drive Toronto, Ontario M3C 1L9 www.patriot-canada.ca Date of Preparation: August 19, 2013 SUBMISSION CONTROL NO.: 165473 © 2013 Patriot, a Division of Janssen Inc. All trademarks used under license. _165473.doc _ _ _ _Page 2 of 52 _ PRODUCT MONOGRAPH PR CENTRISA ™ LO 21 AND PR CENTRISA ™ LO 28 norgestimate and ethinyl estradiol Tablets, House Std. 0.180 mg norgestimate and 0.025 mg ethinyl estradiol 0.215 mg norgestimate and 0.025 mg ethinyl estradiol 0.250 mg norgestimate and 0.025 mg ethinyl estradiol PHARMACOLOGICAL CLASSIFICATION Synthetic steroidal combination oral contraceptive. CLINICAL PHARMACOLOGY ORAL CONTRACEPTION Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). Receptor binding studies, as well as studies in animals and humans, have shown that norgestimate and 17-deacetyl norgestimate (norelgestromin), the major serum metabolite, combine high progestational activity with minimal intrinsic androgenicity. Norgestimate, in combination with ethinyl estradiol, does not counteract the estrogen-induced increases in sex hormone binding globulin (SHBG), resulting in lower serum testosterone. INDICATIONS AND CLINICAL USE CENTRISA ™ LO Tablets are indicated for conception control. In an active controlled clinical trial including 1,673 subjects completing 11,003 cycles of CENTRISA ™ LO use, a total of 20 pregnancies were reported among CENTRISA ™ LO us Leia o documento completo