দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
MEDROXYPROGESTERONE ACETATE
PFIZER CANADA ULC
G03DA02
MEDROXYPROGESTERONE
2.5MG
TABLET
MEDROXYPROGESTERONE ACETATE 2.5MG
ORAL
100/500/1000
Prescription
PROGESTINS
Active ingredient group (AIG) number: 0106339004; AHFS:
CANCELLED PRE MARKET
2019-11-06
_Meprogest (medroxyprogesterone acetate) Product Monograph _ _Page 1 of 31 _ PRODUCT MONOGRAPH PR MEPROGEST TM Medroxyprogesterone Acetate Tablets U.S.P. (2.5 mg, 5.0 mg and 10.0 mg Tablets) PROGESTAGEN-PROGESTATIONAL STEROID Pfizer Canada Inc. DATE OF PREPARATION: 17,300 Trans-Canada Highway September 28, 2010 Kirkland, Quebec H9J 2M5 DATE OF REVISION: Control#: 141563 © Pfizer Canada Inc. _Meprogest (medroxyprogesterone acetate) Product Monograph _ _Page 2 of 31 _ PRODUCT MONOGRAPH MEPROGEST™ (MEDROXYPROGESTERONE ACETATE) TABLETS U.S.P. PHARMACEUTICAL CLASSIFICATION PROGESTIN ACTION AND CLINICAL PHARMACOLOGY MEPROGEST™, an orally-active progestational steroid, when administered to women with adequate endogenous estrogen transforms a proliferative endometrium into a secretory endometrium. MEPROGEST™ inhibits the secretion of pituitary gonadotropin which, in turn, prevents follicular maturation and ovulation. The anti-cancer activity of MEPROGEST™ at pharmacologic doses, may be dependent on its effect on the hypopituitary/gonadal axis, estrogen receptors and the metabolism of steroids at the tissue level. BIOAVAILABILITY In a randomized cross-over study with 25 healthy post-menopausal female volunteers, the bioavailability of MEPROGEST™ 10 mg and PROVERA ® 10 mg tablets was studied following multiple oral doses in the following regimens: A) one MEPROGEST™ 10 mg tablet or B) one PROVERA ® 10 mg tablet at 0-hour on Days 1-6. Each dose was administered during a fasting period which began 10 hours before and lasted until 3 hours after the dose. Treatment phases were separated by a 16-day washout period. Blood _Meprogest (medroxyprogesterone acetate) Product Monograph _ _Page 3 of 31 _ samples were collected prior to dosing on Days 1-6, and at the following times after drug administration on Day 6: 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24 and 36 hours. The resulting plasma samples were analyzed for medroxyprogesterone using a radioimmunoassay procedure. Relevant bioavailability parameters are included সম্পূর্ণ নথি পড়ুন