BOSENTAN ASTRON Bosentan (as monohydrate) 62.5 mg film-coated tablets bottle pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

bosentan monohydrate, Quantity: 64.54 mg (Equivalent: bosentan, Qty 62.5 mg)

Beschikbaar vanaf:

Accord Healthcare Pty Ltd

INN (Algemene Internationale Benaming):

bosentan monohydrate

farmaceutische vorm:

Tablet, film coated

Samenstelling:

Excipient Ingredients: povidone; purified water; maize starch; pregelatinised maize starch; sodium starch glycollate type A; magnesium stearate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red

Toedieningsweg:

Oral

Eenheden in pakket:

500 tablets in HDPE bottle, 60 tablets in HDPE bottle, 100 tablets in HDPE bottle

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Bosentan Astron is indicated for the treatment of ? idiopathic pulmonary arterial hypertension ? familial pulmonary arterial hypertension ? pulmonary arterial hypertension associated with scleroderma or ? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger?s physiology,in patients with WHO functional Class II, III or IV symptoms.

Product samenvatting:

Visual Identification: Orange-white, round, biconvex, film-coated tablets, debossed with IB1 on one side and plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorisatie-status:

Licence status A

Autorisatie datum:

2016-03-22

Bijsluiter

BOSENTAN ASTRON
CONSUMER MEDICINE INFORMATION
Version: 2.0
‐2016‐ Page 1 of 5
BOSENTAN ASTRON
(BOSENTAN FILM‐COATED TABLETS 62.5 MG AND 125 MG)
_Bosentan monohydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Bosentan Astron.
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 Bosentan Astron
against the benefits this
medicine is expected to have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING BOSENTAN ASTRON
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it
again.
WHAT BOSENTAN ASTRON IS
USED FOR
Bosentan Astron is used for
the treatment of high blood
pressure in the blood vessels
between the heart and the
lungs. This condition is called
pulmonary arterial
hypertension.
This medicine acts to reduce
abnormally high blood
pressure by widening these
blood vessels. It belongs to
the class of medicines known
as endothelin receptor
antagonists.
Your doctor however, may
prescribe Bosentan Astron
for another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY IT
HAS BEEN PRESCRIBED FOR YOU.
This medicine is only
available with a doctor's
prescription.
BEFORE YOU TAKE BOSENTAN
ASTRON
_WHEN YOU MUST NOT TAKE _
_BOSENTAN ASTRON _
DO NOT TAKE THIS MEDICINE IF
YOU ARE:
•
PREGNANT OR INTEND TO
BECOME PREGNANT. YOU
MUST STOP TAKING THE
MEDICINE AT LEAST 3 MONTHS
BEFORE TRYING TO BECOME
PREGNANT. It is known that
this medicine causes harm
to the developing baby if
you take it during
pregnancy and in the three
months before becoming
pregnant.
•
BREAST‐FEEDING: Tell your
doctor immediately if you
are breast‐feeding. You are
advised to stop breast‐
feeding if this medicine is
prescribed for you because
it is not known if this drug
passes into the milk
in
women who are taking this
medicine.
•
Being treated with
cyclosporine A (a medicine
used after a tr

Productkenmerken

Bosentan Astron (Bosentan Film-coated Tablets 62.5 mg and 125 mg)
Version 2.0
-2016-
Page 1 of 27
PRODUCT INFORMATION
Bosentan Astron
(bosentan film-coated tablets 62.5 mg and 125 mg)
BOSENTAN ASTRON may cause birth defects and is contraindicated in
pregnancy.
See CONTRAINDICATIONS and PRECAUTIONS.
Rare cases of hepatic cirrhosis and hepatic failure have been reported
in patients using
bosentan. See PRECAUTIONS
NAME OF THE MEDICINE
Bosentan Astron (bosentan film-coated tablets 62.5 mg and 125 mg).
Active: bosentan (as monohydrate)
The
chemical
name
of
bosentan
monohydrate
is
benzenesulphonamide,
4-(1,1-
dimethylethyl)-N-[6-(2hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2’-bipyrimidin]-4-yl]-,
monohydrate.
The structural formula is:
The molecular formula is:
C
27
H
29
N
5
O
6
S
Anhydrous
molecular weight: 551.62
C
27
H
29
N
5
O
6
S.H
2
O
Monohydrate
molecular weight: 569.63
CAS 147536-97-8 (anhydrous substance)
Bosentan is the first of a new drug class, an endothelin receptor
antagonist.
Bosentan Astron (bosentan) belongs to a class of highly substituted
pyrimidine derivatives,
with no chiral centres.
DESCRIPTION
Bosentan monohydrate, a white to off-white powder, is practically
insoluble at low pH (0.1
mg/100 mL at pH 1.1 and 4.0; 0.2 mg/100 mL at pH 5.0). Solubility
increases at higher pH
values (43 mg/100 mL at pH 7.5). In the solid state, bosentan
monohydrate is very stable, is
not hygroscopic and shows no light sensitivity.
Bosentan Astron (Bosentan Film-coated Tablets 62.5 mg and 125 mg)
Version 2.0
-2016-
Page 2 of 27
Inactive:
maize
starch,
pregelatinised
maize
starch,
sodium
starch
glycollate
type
A,
povidone, magnesium stearate, hypromellose, glycerol triacetate,
purified talc, titanium
dioxide, iron oxide yellow and iron oxide red.
PHARMACOLOGY
Pharmacodynamic Properties
The neurohormone endothelin-1 (ET-1) is a potent vasoconstrictor. ET-1
concentrations are
elevated
in
plasma
and
lung
tissue
of
patients
with
pulmonary
arterial
hypertension,
suggesting a pathogenic role for ET-1 in this disease.
Bosentan is