Megace

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Megestrol acetate 160mg;  

זמין מ:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (שם בינלאומי):

Megestrol acetate 160 mg

כמות:

160 mg

טופס פרצבטיות:

Tablet

הרכב:

Active: Megestrol acetate 160mg   Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Sodium starch glycolate

יחידות באריזה:

Blister pack, Aluminium/PVC, 30 tablets

סיווג:

Prescription

סוג מרשם:

Prescription

תוצרת:

Pharmacia & Upjohn Company LLC

leaflet_short:

Package - Contents - Shelf Life: Blister pack, Aluminium/PVC - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, glass, - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

תאריך אישור:

1982-09-09

עלון מידע

MEGACE* TABLETS 
1 
NEW ZEALAND CONSUMER MEDICINE INFORMATION 
MEGACE* TABLETS 
_Megestrol acetate _

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 
MEGACE 
_WHEN YOU MUST NOT TAKE _
_MEGACE _
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 MEGACE IF THE 
PACKAGING SHOWS SIGNS OF 
TAMPERING. 
IF YOU ARE NOT SURE WHETHER YOU 
SHOULD START TAKING MEGACE, 
TALK TO YOUR DOCTOR OR 
PHARMACIST. 
_BEFORE YOU START TO TAKE _
_MEGACE _
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, ES

מאפייני מוצר

  
1 
NEW ZEALAND DATA SHEET 
MEGACE 
_MEGESTROL ACETATE 160MG TABLETS _
PRESENTATION 
MEGACE 160MG TABLETS are off-white, oval, biconvex tablets with a
bisect. 
Inactive ingredients are lactose, microcrystalline cellulose, sodium
starch 
glycolate, magnesium stearate, silicon dioxide (colloidal) and
povidone. 
USES 
_ACTIONS _
Mechanism of Action 

The anti-tumour action of megestrol acetate on carcinoma of the breast
is 
unclear.  However, it is known to compete for progesterone, androgen
and 
glucocorticoid receptors and effect pituitary functions.

_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 the dose. 

Excretion 

2 
Approximately 66% of an administered dose is excreted in the urine
and 
approximately 20% in the faeces. 

Respiratory excretion and fat storage may account for the fraction of
an 
administered dose not found in urine or faeces. 

Clinical Implications of Pharmacokinetic Data 

As megestrol acetate is primarily excreted in the urine and has a
reasonably 
long half-life, a potential for accumulation does exist.
 However, because 
megestrol acetate is relatively non-toxic, there are no
recommendations at 
present for routine dosage adjustment. 

INDICATIONS 
MEGACE (MEGESTROL ACETATE) is indicated for the palliative treatment
of