MEPROGEST TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

MEDROXYPROGESTERONE ACETATE

Dostępny od:

PFIZER CANADA ULC

Kod ATC:

G03DA02

INN (International Nazwa):

MEDROXYPROGESTERONE

Dawkowanie:

2.5MG

Forma farmaceutyczna:

TABLET

Skład:

MEDROXYPROGESTERONE ACETATE 2.5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/500/1000

Typ recepty:

Prescription

Dziedzina terapeutyczna:

PROGESTINS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0106339004; AHFS:

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2019-11-06

Charakterystyka produktu

_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