MEGACE megestrol acetate 160mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

megestrol acetate

Available from:

Aspen Pharma Pty Ltd

Authorization status:

Registered

Patient Information leaflet

MEGACE- Consumer Medicine Information
Page 1 of 2
MEGACE
_megestrol acetate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Megace. It does not
contain all of the available
information. It does not take the
place of talking with your doctor or
pharmacist.
You should read this leaflet carefully
before starting Megace.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THE LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MEGACE IS USED
FOR
Megace contains megestrol acetate a
synthetic steroid which is similar to
the naturally occurring hormone
progesterone. Megestrol acetate
competes with naturally occurring
hormones for receptor sites in breast
tissue, in this way preventing the
naturally occurring hormones from
stimulating breast cancer cells.
Megace is used to treat the symptoms
of breast cancer.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
YOU MUST NOT TAKE MEGACE IF YOU
HAVE AN ALLERGY TO MEGESTROL
ACETATE OR TO ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
YOU MUST NOT TAKE MEGACE AS A TEST
TO SEE IF YOU ARE PREGNANT.
DO NOT TAKE MEGACE AFTER THE
EXPIRY DATE PRINTED ON THE PACK.
If you take this medicine after the
expiry date has passed, it may not
work as well.
DO NOT TAKE THIS MEDICINE IF THE
PACKAGING SHOWS SIGNS OF
TAMPERING.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING IT, TALK TO YOUR
DOCTOR OR PHARMACIST.
_BEFORE YOU START TO TAKE IT _
YOU MUST TELL YOUR DOCTOR IF:
*
you are or may be pregnant; your
doctor will discuss the possible
risks and benefits of taking
Megace during pregnancy.
*
you are breast feeding; your
doctor will discuss the possible
risks and benefits of taking
Megace during breastfeeding.
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY MEDICAL CONDITIONS,
ESPECIALLY THE FOLLOWING:
*
diabetes
*
swelling and clotting in a vein
IF YOU HAVE NOT TOLD YOUR DOCTOR
ABOUT ANY OF THE ABOVE, TELL THEM
BEFORE YOU START TO TAKE MEGACE.
_TAKING OTHER MEDICINES _
TELL Y

Summary of Product characteristics

MEGACE- Product Information
Page 1 of 6
PRODUCT INFORMATION
MEGACE
®
(MEGESTROL ACETATE)
TABLETS
DESCRIPTION
MEGACE (megestrol acetate). Megestrol acetate is a white, crystalline
solid chemically
described as 17
α
-acetoxy-6-methylpregna-4,6-diene-3,20-dione. Megestrol acetate is
chemically related to progesterone. It differs by the addition of a
17-acetoxy group, a
double bond at position 6 and the presence of a methyl group.
Megestrol acetate is
practically insoluble in water. Soluble in alcohol (1 in 55),
chloroform (1 in 8.0), ether (1
in 130), acetone and benzyl alcohol. slightly soluble in fixed oils.
Structural formula:
Molecular weight:
384.5
Molecular formula:
C
24
H
32
O
4
MEGACE tablets contain 160 mg micronised megestrol acetate per tablet.
MEGACE tablets contain the following inactive ingredients: lactose,
sodium starch
glycolate, magnesium stearate, silicon dioxide, microcrystalline
cellulose and povidone.
PHARMACOLOGY
Megestrol acetate exhibits classical progestational activity. It
possesses little or no
oestrogenic, androgenic or adrenocorticoid action.
The anti-neoplastic action of MEGACE (megestrol acetate) on carcinoma
of the breast
is unclear. However, it is known to compete for progesterone, androgen
and
glucocorticoid receptors, and affect pituitary functions.
MEGACE- Product Information
Page 2 of 6
PHARMACOKINETICS
ABSORPTION
Estimates of plasma levels of megestrol acetate are dependent on the
measurement
method used. Peak plasma concentrations occur 2 to 3 hours after a
single oral dose
160mg tablets
.
DISTRIBUTION
Similar peak plasma concentrations (90-110ng/mL) occur after the
administration of one
160mg tablet or four 40mg tablets given over 24 hours. The extent of
absorption
(AUC) was also not different between the two dosage forms. The plasma
half-life was
33 to 38 hours.
METABOLISM
The metabolites are three glucuronide conjugates with hydroxylation
occurring at either
the 2-alpha, or the 6-methyl position or at both positions. Other
metabolites occur but
account for only 5 to 8% of