Puroxan (Doxofylline 400mg) Tablet

Država: Malezija

Jezik: engleski

Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivni sastojci:

Doxofylline

Dostupno od:

EURODRUG LABORATORIES (M) SDN. BHD.

INN (International ime):

Doxofylline

Jedinice u paketu:

100 Tablets; 20 Tablets

Proizveden od:

ABC Farmaceutici SPA

Uputa o lijeku

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PUROXAN
® TABLET
_Doxofylline 400mg Tablet) _
_ _
1
WHAT IS IN THIS LEAFLET
1. What PUROXAN Tablet is
used for
2. How PUROXAN Tablet
works
3.
Before you use
PUROXAN
Tablet
4.
How to use PUROXAN
Tablet
5. While you are using it
6. Side effects
7. Storage and Disposal of
PUROXAN
Tablet
8.
Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT
PUROXAN
TABLETIS
USED FOR AND HOW IT WORKS
-
PUROXAN
Tablet contains
Doxofylline
as
the
active
ingredient.
-
PUROXAN
Tablet
is
indicated for the treatment
of
bronchial
asthma
and
Chronic
Obstructive
Pulmonary Disease (COPD)
associated
with
bronchospasm.
Doxofylline is a bronchodilator
structurally
classified
as
a
xanthine derivative. Doxofylline
directly
relaxes
the
smooth
muscle of the bronchial airways
and
pulmonary
blood
vessels,
thus
acting
mainly
as
a
bronchodilator
and
smooth
muscle
relaxant.
At
high
concentrations,
doxofylline
is
also able to inhibit the cellular
release of histamine
BEFORE
YOU
USE
PUROXAN
TABLET
_ _
_When you must not use it:_
•
if you are allergic or
hypersensitive to the
active substance or any
of the other ingredients
of PUROXAN
Tablet
•
if you are breast feeding
_ _
_ _
_Before you start to use it_
Always
tell
your
doctor
or
pharmacist if you are taking or
have
recently
taken
any
other
medicines, including medicines
obtained without a prescription.
_Taking other medicines _
Doxofylline
should
not
be
administered together with other
xanthine
derivatives,
including
beverages and foods containing
excessive amounts of caffeine.
Please
tell
your
doctor
or
pharmacist
if
you
are
taking
other
drugs
like
erythromycin,
troleandomycin, lincomycin and
other
antibiotics
of
the
same
group,
allopurinol,
cimetidine,
propanolol, ephedrine and anti-
flu vaccine. In this case you may
require
lower
dose
of
Doxofylline. Similarly if you are
taking
phenytoin
or
other
anticonvulsants and if you are
smoking you may require higher
doses of Doxofylline.
HOW TO USE PUROXAN TABLET
Al

Svojstava lijeka

PRESCRIPTION DRUG ONLY
INTERNATIONAL NON-PROPRIETARY NAME
Doxofylline
PRODUCT DESCRIPTION
Each tablet contains Doxofylline - 400 mg
Description: White, round, scored tablets with smooth surface.
THERAPEUTIC PROPERTIES
Doxofylline is a bronchodilator structurally classified as a xanthine
derivative.
Doxofylline directly relaxes the smooth muscle of the bronchial
airways and pulmonary blood vessels, thus acting mainly
as a bronchodilator and smooth muscle relaxant.
PHARMACODYNAMICS
Doxofylline is a novel bronchodilator structurally classified as a
xanthine derivative.
Doxofylline directly relaxes the smooth muscle of the bronchial
airways and pulmonary blood vessels, thus acting mainly
as a bronchodilator and smooth muscle relaxant.
Doxofylline did not antagonise adenosine A1, A2B and A3 receptors;
there was only a modest inhibition at the highest
tested concentration (10
4
M) against A2A receptors. This may explain the improved tolerability
profile of doxofylline in
comparison with other xanthine based medicines.
Doxofylline does not inhibit any of the PDE enzyme subtypes, except a
modest inhibition at the highest tested concentra-
tion (10
4
M) against PDE2A1.
PDE3 inhibitors are known to cause vasodilation and cardiac effects.
The lack of effect of doxofylline on PDEs may help
explain its improved tolerability profile on the cardiovascular
system.
Doxofylline does not exert any significant inhibitory effect against
any of the 11 HDAC enzymes.
Doxofylline significantly inhibited the migration of neutrophils and
the release of IL-6 and TNF-α into the lung lumen,
demonstrating the anti-inflammatory action of doxofylline.
PHARMACOKINETICS
The half-life of Doxofylline is greater than six hours; so as to allow
effective constant plasma levels with a t.i.d. dose
regimen. Single dose pharmacokinetic studies in man after oral and
intravenous administration defined distribution and
absorption of the drug.
After i.v. administration of 100 mg to 5 healthy volunteers,
distribution of Doxofylline in plasma followed a bi-comp