Tracleer

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Bosentan 62.5mg (as monohydrate);  

Available from:

Janssen-Cilag (New Zealand) Ltd

INN (International Name):

Bosentan 62.5 mg (as monohydrate)

Dosage:

62.5 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Bosentan 62.5mg (as monohydrate)   Excipient: Ethylcellulose Glyceryl behenate Hypromellose Iron oxide red Iron oxide yellow Magnesium stearate Maize starch Povidone Purified talc Sodium starch glycolate Starch Titanium dioxide Triacetin

Units in package:

Bottle, 60 tablets - HDPE with dessicant, 60 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Divi's Laboratories Limited

Therapeutic indications:

TRACLEER® 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 Class III or IV symptoms.

Product summary:

Package - Contents - Shelf Life: Bottle, 60 tablets - HDPE with dessicant - 60 tablets - 60 months from date of manufacture stored at or below 25°C

Authorization date:

2004-02-25

Patient Information leaflet

TRACLEER®
(TRAK-LEER)
_Bosentan (BOZ-en-tan) 62.5 mg/125 mg film-_
_coated tablets _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tracleer.
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
using this medicine against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TRACLEER IS USED FOR
Tracleer (TRAK-leer) 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
Tracleer for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY IT HAS BEEN PRESCRIBED
FOR YOU.
This medicine is only available with a
doctor’s prescription.
BEFORE YOU TAKE TRACLEER
_WHEN YOU MUST NOT TAKE TRACLEER _
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. I
t
is known
that this medicine causes harm
to the developing baby if you
take it during pregnancy and in
the three months before
b
ecoming pregnant.

BREASTFEEDING: Tell your doctor
immediately if you are
breastfeeding. You are advised
to stop breastfeeding 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.
•
B
eing treated with cyclosporine
A (a medicine used after a
transplant or to treat psoriasis)
•
Being treated with
glibenclamide (a medicine used
for diabetes)
DO NOT TAKE TRACLEER IF YOU ARE ALLERGIC
TO IT

Summary of Product characteristics

NEW ZEALAND DATA SHEET
10.230907
Page 1 of 26
TRACLEER (231222) ADS
TRACLEER
®
BOSENTAN (AS MONOHYDRATE) 62.5 MG & 125 MG TABLETS WARNING: CAUSES 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 TRACLEER®. SEE PRECAUTIONS
1 PRODUCT NAME
TRACLEER
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bosentan is the first of a new drug class, an endothelin receptor
antagonist.
TRACLEER® (bosentan) belongs to a class of highly substituted
pyrimidine derivatives, with
no chiral centres.
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.
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:
C27H29N5O6S Anhydrous MW: 551.62
C27H29N5O6S.H2O Monohydrate MW: 569.64
CAS 147536-97-8 (anhydrous substance)
_Active_: Bosentan (as monohydrate)
For the full list of excipients, see Section 6.1
NEW ZEALAND DATA SHEET
10.230907
Page 2 of 26
TRACLEER (231222) ADS
3 PHARMACEUTICAL FORM
TRACLEER® bosentan (as monohydrate) 62.5 mg, film-coated, round,
biconvex, orange-
white tablets, embossed with identification marking "62.5", packaged
in white high density
polyethylene bottle and a white polypropylene cap, enclosed in an
outer carton.
TRACLEER® bosentan (as monohydrate) 125 mg, film-coated, oval,
biconvex, orange-white
tablets, embossed with identification marking "125", packaged in a
white high density
polyethylene bottle and a white polypropylene cap, enclosed in an
outer carton.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TRACLEER® is indicated for the treatment of idio