Provera

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Medroxyprogesterone acetate

Available from:

Pfizer Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

PROVERA* TABLETS
1
PROVERA* TABLETS
_Medroxyprogesterone acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROVERA.  It does
not contain all the available
information.  It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits.  Your doctor has weighed
the risks of you taking PROVERA
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PROVERA IS
USED FOR
PROVERA is a progestogen that
comes from progesterone, a natural
sex hormone.  PROVERA works in a
similar way to progesterone.
PROVERA is used to treat:
1. Endometriosis - a condition in
which tissue similar to the lining
of the uterus (womb) grows
outside the uterus, causing pain
and bleeding.  PROVERA helps
to stop the growth of this tissue.
2. Secondary amenorrhea (a lack of
menstrual periods not due to
pregnancy).  PROVERA, with or
without an oestrogen, helps to
re-establish a regular menstrual
cycle.
3. Abnormal bleeding from the
uterus, when the lining of the
uterus breaks down during the
menstrual cycle rather than at the
end, resulting in vaginal spotting
or bleeding.  PROVERA helps to
re-establish a regular menstrual
cycle.
4. Symptoms of menopause in
women with an intact uterus.
PROVERA is used together with
an oestrogen-containing medicine
to protect the lining of the uterus
while the oestrogen relieves the
symptoms.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PROVERA
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
PROVERA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PROVERA IF YOU HAVE
AN ALLERGY TO MEDROXYPROGESTERONE
ACETATE OR ANY OF THE INGREDIE

Summary of Product characteristics

PRODUCT INFORMATION 
PROVERA
®
(MEDROXYPROGESTERONE ACETATE TABLETS) 
DESCRIPTION 
Medroxyprogesterone acetate is a progestogen and a derivative of
progesterone.  It is a white to 
off-white, odourless crystalline powder, stable in air, melting
between 200 and 210°C.  It is 
freely soluble in chloroform, soluble in acetone and dioxane,
sparingly soluble in ethanol and 
methanol, slightly soluble in ether and insoluble in water.
 Medroxyprogesterone acetate is 
6
α-methyl-3,20-dioxopregn-4-en-17α-yl acetate, and its structural
formula is as follows: 

PHARMACOLOGY 
_Animal:  _Medroxyprogesterone acetate induces responses in
laboratory animals comparable to 
those caused by progesterone.  It is more potent than progesterone.
 Medroxyprogesterone 
acetate induces glandular maturation in the endometrium, maintains
pregnancy, delays 
parturition, inhibits ovulation and suppresses oestrous cycles.  It
is devoid of androgenic and 
oestrogenic activity.  In selected animal tests it has some adrenal
corticoid-like activity and in 
dogs increases serum growth hormone levels. 
_Human:  _PROVERA is a progestational agent.  When administered in
recommended doses to 
women with adequate endogenous oestrogen, it transforms proliferative
into secretory 
endometrium.  Medroxyprogesterone acetate may inhibit gonadotrophin
production, which in 
turn prevents follicular maturation and ovulation. 
Like progesterone, medroxyprogesterone acetate is thermogenic.  At
the very high dosage levels 
used in the treatment of certain cancers (500 mg daily or more),
corticoid-like activity may be 
manifest. 
Version: pfpprovt10609 
Supersedes: pfpprovt11206 
Commercial/Non-Commercial 
Page 1 of 9 
PHARMACOKINETICS 
PROVERA is an orally active progestational steroid having an apparent
half-life of about 30 
hours. 
Medroxyprogesterone acetate is rapidly absorbed after oral
administration.  There is high 
interindividual variability in serum levels after standard doses
given by eith