Accolate

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

Zafirlukast

Pakuotės lapelis

ACCOLATE(R)
1
ACCOLATE(R)
_Zafirlukast_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Accolate.  It does not contain all the
information that is known about
Accolate.
It does not take the place of talking
to your doctor or pharmacist. 
All medicines have risks and
benefits.  Your doctor will have
weighed the risks of you taking
Accolate against the benefits 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 ACCOLATE IS FOR
Accolate belongs to a group of
medicines called leukotriene
antagonists.  This means that it
reduces the effects of leukotrienes,
which are substances in the lung that
can cause asthma.
Accolate is used to prevent your
asthma from getting worse as well as
controlling the symptoms of your
asthma.  Accolate is not used to treat
sudden attacks of asthma.  It is a
medicine to be taken regularly.
YOUR DOCTOR WILL HAVE EXPLAINED
WHY YOU ARE BEING TREATED WITH
ACCOLATE AND TOLD YOU WHAT DOSE TO
TAKE. 
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY.
They may differ from the
information contained in this leaflet. 
ASK YOUR DOCTOR IF YOU WANT MORE
INFORMATION.
Your doctor may have prescribed
Accolate for another reason. 
There is no evidence that Accolate is
addictive. 
This medicine is available only with
a doctor's prescription. 
BEFORE YOU USE
ACCOLATE
_WHEN YOU MUST NOT USE IT_
DO NOT TAKE ACCOLATE IF YOU HAVE AN
ALLERGY TO: 
*
ZAFIRLUKAST OR 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 ACCOLATE IF YOU ARE
PREGNANT UNLESS YOUR DOCTOR�

Prekės savybės

Accolate
®
 Product Information 
1(11) 
ACCOLATE PRODUCT INFORMATION 

NAME OF THE DRUG 

Zafirlukast (INN, BAN, USAN) 

Chemical Name :-
4-(5-cyclopentyloxycarbonylamino-1-methylindol-3-ylmethyl)-3-
methoxy-N-o-tolylsulfonylbenzamide (IUPAC) 

Structural Formula :-
CAS Number :- 107753-78-6 

DESCRIPTION 

Zafirlukast a fine, white/off-white to pale yellow amorphous powder,
is practically 
insoluble in water.  It has an average pKa of 5.5 and log P of
approximately 2.3 in 
octanol/water.  Zafirlukast is slightly hygroscopic. 

ACCOLATE 20mg is a white, round, biconvex film-coated tablet
containing 20mg of 
zafirlukast.  It also includes croscarmellose sodium, lactose,
cellulose - 
microcrystalline, povidone, magnesium stearate, hypromellose and
titanium dioxide 
as inactive ingredients. 

PHARMACOLOGY 

Leukotriene (LT) production and receptor occupation has been
implicated in the 
pathophysiology of asthma.  Effects include smooth muscle
contraction, airway 
oedema and altered cell activity associated with the inflammatory
process, including 
eosinophil influx to the lung.  These effects contribute to and
correlate with the signs 
and symptoms of asthma.  ACCOLATE acts as an anti-inflammatory
agent, reducing 
the effect of these pro-inflammatory mediators. 

ACCOLATE is a competitive, highly selective and potent oral peptide
leukotriene 
receptor antagonist of LTC
4
, LTD
4
 and LTE
4
, components of slow reacting substance 
of anaphylaxis.  _In vitro _studies have shown that ACCOLATE
antagonises the 
contractile activity of all three peptide leukotrienes (leukotriene C
4
, D
4
, and E
4
) in 
human conducting airway smooth muscle to the same extent.  Animal
studies have 
shown ACCOLATE to be effective in preventing peptide
leukotriene-induced 
increases in vascular permeability, which give rise to oedema in the
airways, and to 
inhibit peptide leukotriene-induced influx of eosinophils into
airways. 
Accolate
®
 Product Info