PROVIRON mesterolone 25 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mesterolone, Quantity: 25 mg

Available from:

Bayer Australia Ltd

INN (International Name):

Mesterolone

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: propyl hydroxybenzoate; lactose monohydrate; povidone; magnesium stearate; methyl hydroxybenzoate; maize starch

Administration route:

Oral

Units in package:

50 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hypogonadism - Androgen replacement for male hypogonadism, where there is androgen deficiency confirmed by clinical and biochemical testing (see 'Precautions' and 'Dosage and Administration').

Product summary:

Visual Identification: round white scored tablets marked with "AX" inside a hexagon; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-06-20

Patient Information leaflet

PROVIRON
®
CMI
1
PROVIRON
®
(PRO·VAI·RON)
_mesterolone _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Proviron.
It does not contain all of 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 Proviron
against the benefits they expect it
will 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 PROVIRON IS
USED FOR
Proviron is used to replace
testosterone in men with
hypogonadism. Male hypogonadism
is a condition when the body does
not produce enough testosterone.
Testosterone is a natural male
hormone, known as an androgen,
which controls normal sexual
development in men.
Testosterone is essential for the
development and maintenance of
the male reproductive organs as
well as other male characteristics,
such as hair growth, deep voice,
sexual drive, muscle mass and body
fat distribution.
Proviron is for use in male patients
only.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU USE
PROVIRON
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PROVIRON IF YOU HAVE
AN ALLERGY TO:
• mesterolone, the active ingredient
in Proviron
• any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue
or other parts of the body
• rash, itching or hives on the skin.
DO NOT TAKE PROVIRON IF YOU HAVE:

prostate cancer

previous or existing liver
tumours

male breast cancer

high blood calcium levels
DO NOT USE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK
AND BLISTER.
The expiry date is printed on the
carton and on each blister after
“EXP” (e.g.

Summary of Product characteristics

PRODUCT INFORMATION
PROVIRON
®
NAME OF THE MEDICINE
Mesterolone is a white to yellowish crystalline powder and is
practically insoluble
in water.
The chemical name for mesterolone is 17 beta-Hydroxy-1 alpha-methyl-5
alpha-
androstan-3-one and has the following structural formula:
O
CH
3
CH
3
OH
H
H
H
CH
3
H
Molecular formula
C
20
H
32
O
2
Molecular weight
304.47
Melting point
205 - 211
°
C
CAS Number
001424-00-6
DESCRIPTION
Proviron is a hormonal preparation and contains 25 mg mesterolone.
Each small white tablet contains mesterolone 25 mg and the excipients:
lactose,
starch-maize, povidone, methyl hydroxybenzoate, propyl hydroxybenzoate
and
magnesium stearate.
PHARMACOLOGY
PHARMACODYNAMICS
1
Mesterolone (Proviron) has androgenic properties. Early studies
suggested oral
mesterolone did not usually suppress gonadotrophins or endogenous
testosterone production. A later single dose study suggests there may
be a
central suppression effect at doses of 75-100 mg daily.
PHARMACOKINETICS
Following oral ingestion mesterolone is rapidly absorbed. In a study
in 18 men
the intake of Proviron 25 mg generated maximum serum drug levels of
3.1 ± 1.1
ng/mL after 1.6 ± 0.6 hours. Thereafter, drug levels in serum
decrease with a
terminal half-life of 12 - 13 hours. Mesterolone is bound to serum
proteins by 98
%. Binding to albumin accounts for 40 % and binding to SHBG (sex
hormone
binding globulin) to 58 %.
Mesterolone is rapidly metabolised. The metabolic clearance rate from
serum
accounts for 4.4 ± 1.6 mL·min
-1
·kg
-1
. Renal excretion of unchanged drug has not
been detected. In a study of C14 labelled mesterolone in two men, up
to 2% of
mesterolone was excreted as the conjugated form in the urine. The main
metabolite has been identified as 1
α
-methyl-androsterone, which - in conjugated
form - accounts for 55 - 70 % of renally excreted metabolites. The
ratio of
conjugated main metabolite glucuronide to sulfate detected in urine
was about
12:1. As a further metabolite 1
α
-methyl-5
α
-androstane-3
α
,17
β
-diol has b