Country: Canada
Language: English
Source: Health Canada
MEDROXYPROGESTERONE ACETATE
DOMINION PHARMACAL
G03DA02
MEDROXYPROGESTERONE
5MG
TABLET
MEDROXYPROGESTERONE ACETATE 5MG
ORAL
100/500
Prescription
PROGESTINS
Active ingredient group (AIG) number: 0106339005; AHFS:
CANCELLED POST MARKET
2016-10-25
PRODUCT MONOGRAPH PR DOM-MEDROXYPROGESTERONE (Medroxyprogesterone acetate Tablets USP) 2.5mg, 5 mg and 10 mg PROGESTIN DOMINION PHARMACAL Date of Preparation: 6111 Royalmount Avenue, Suite 100 May 05, 2003 Montreal, Quebec H4P 2T4 Date of Revision: May 10, 2004 CONTROL #: 084985 2 PRODUCT MONOGRAPH PR DOM-MEDROXYPROGESTERONE (Medroxyprogesterone acetate Tablets USP) 2.5mg, 5 mg and 10 mg PHARMACOLOGICAL CLASSIFICATION Progestin WARNING As the Women's Health Initiative (WHI) study results indicated increased risk of myocardial infarction (MI), stroke, invasive breast cancer, pulmonary emboli and deep venous thrombosis in postmenopausal women receiving treatment with combined conjugated equine estrogens and medroxyprogesterone acetate compared to those receiving placebo tablets, the following should be highly considered: · Estrogens with or without progestins SHOULD NOT be prescribed for primary or secondary prevention of cardiovascular diseases. · Estrogens with or without progestins should be prescribed at THE LOWEST EFFECTIVE DOSE for the approved indication. · Estrogen with or without progestins should be prescribed for THE SHORTEST PERIOD possible for the recognized indication. 3 ACTION AND CLINICAL PHARMACOLOGY Dom-MEDROXYPROGESTERONE (medroxyprogesterone acetate) is an orally active progestational steroid (progestin) derived from a natural source (soybeans). When administered to women with adequate levels of estrogen (endogenous or exogenous), Dom- MEDROXYPROGESTERONE transforms a proliferative endometrium into a secretory endometrium. Furthermore, the anti-cancer activity of Dom-MEDROXYPROGESTERONE at pharmacologic doses, may be dependent on its effect on the hypothalamic/ pituitary/ gonadal axis, estrogen receptors and metabolism of steroids at the tissue level. CLINICAL PHARMACOLOGY Medroxyprogesterone acetate is a progestational agent devoid of androgenic and estrogenic activity. Endocrine: In appropriate doses, medroxyprogesterone acetate suppresses the secretion of pituitary gonadotropins which in t Read the complete document