NU-MEDROXY TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

MEDROXYPROGESTERONE ACETATE

Disponible depuis:

NU-PHARM INC

Code ATC:

G03DA02

DCI (Dénomination commune internationale):

MEDROXYPROGESTERONE

Dosage:

2.5MG

forme pharmaceutique:

TABLET

Composition:

MEDROXYPROGESTERONE ACETATE 2.5MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PROGESTINS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED (UNRETURNED ANNUAL)

Date de l'autorisation:

2018-03-28

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
NU-MEDROXY
MEDROXYPROGESTERONE ACETATE TABLETS USP
2.5 AND 5 MG
PROGESTIN
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL ST, UNITS 1 & 2
APRIL 20, 2004
RICHMOND HILL ON
L4B 1E4
CONTROL#: 091035
1
PRODUCT
MONOGRAPH
NU-MEDROXY
Medroxyprogesterone Acetate Tablets USP
2.5 and 5 mg
THERAPEUTIC 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.
•
Estrogens with or without progestins should be prescribed for THE
SHORTEST PERIOD possible.
ACTIONS AND CLINICAL PHARMACOLOGY
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), medroxyprogesterone acetate transforms a
proliferative
endometrium into a secretory endometrium.
2
Pharmacokinetics
Medroxyprogesterone acetate has an apparent half-life of about 30
hours. It is rapidly absorbed
from the gastrointestinal tract and metabolized in the liver to
several progestin metabolites. The
major drug-related material found in circulation following oral
administration has been
characterized as both free and glucuronide-conjugated metabolites of
medroxyprogesterone
acetate.
Medroxyprogesterone acetate is primarily eliminated via fecal
excretion, to which biliary secretion
may contribute. Approximately 44% of an oral dose is eliminated
through urinary excretion in the
form of metabolites.
The only metabolite of medroxyprogeste