INDOPRIL 2 perindopril erbumine 2mg tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

perindopril erbumine, Quantity: 2 mg

Dostupné s:

Arrotex Pharmaceuticals Pty Ltd

INN (Mezinárodní Name):

Perindopril erbumine

Léková forma:

Tablet, uncoated

Složení:

Excipient Ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose; silica dimethyl silylate

Podání:

Oral

Jednotky v balení:

30 tablets

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

INDOPRIL 2 is indicated for: The treatment of hypertension.The treatment of heart failure. In such patients it is recommended that INDOPRIL 2 be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of perindopril tablets have not been demonstrated for New York Heart Association Category IV patients); and Patients with established coronary artery disease (See Clinical Trials) who are stable on concomitant therapy and have no heart failure, to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

Přehled produktů:

Visual Identification: White to off-white, round, biconvex tablets, plain on one side and debossed with '2' on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Stav Autorizace:

Licence status A

Datum autorizace:

2007-10-03

Informace pro uživatele

INDOPRIL- Consumer Medicine Information
Page 1 of 5
INDOPRIL
_perindopril _ _ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers
some common
questions about
INDOPRIL. 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 taking
INDOPRIL 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 INDOPRIL IS
USED FOR
INDOPRIL is available
only with a doctor's
prescription.
INDOPRIL lowers high
blood pressure, a
condition which doctors
call hypertension.
Everyone has blood
pressure. This pressure
helps get your blood all
around the body. Your
blood pressure may be
different at different
times of the day,
depending on how busy
or worried you are. You
have high blood
pressure when your
blood pressure stays
higher than is needed,
even when you are calm
or relaxed.
There are usually no
symptoms of high blood
pressure. The only way
of knowing that you
have it is to have your
blood pressure checked
on a regular basis. If
high blood pressure is
not treated it can lead to
serious health problems.
You may feel fine and
have no symptoms, but
eventually it can cause
stroke, heart disease
and kidney failure.
INDOPRIL helps lower
your blood pressure.
You may be prescribed
INDOPRIL for heart
failure. Heart failure
means that the heart
muscle cannot pump
blood strongly enough to
supply all the blood
needed throughout the
body. Heart failure is not
the same as heart attack
and does not mean that
the heart stops working.
Some people develop
heart failure after having
had a heart attack.
However there are also
other causes of heart
failure.
Heart failure may start
off with no symptoms,
but as the condition
progresses, you may
feel short of breath or
may get tired easily after
light physical activity
such as walkin

Charakteristika produktu

_ _
INDOPRIL-Product Information
Page 1 of 14
PRODUCT INFORMATION
INDOPRIL 2, INDOPRIL 4 AND INDOPRIL 8 TABLETS
NAME OF MEDICINE
INDOPRIL tablets (Perindopril erbumine 2 mg, 4 mg and 8 mg tablets)
DESCRIPTION
Perindopril erbumine is chemically described as tert-butylammonium
(2S, 3aS, 7aS) 1 - N
[ (
S)
-
1- ethoxycarbonyl butyl]-L- alanyl) perhydroindole-2 – carboxylate.
Perindopril is a dipeptide
monoacid
monoester
with
a
perhydroindole
group
and
no
sulphydryl
radical.
Perindopril
erbumine is a white powder, readily soluble in purified water, 95%
ethanol and chloroform.
Perindopril erbumine has five asymmetric centres. The drug is
synthesised stereoselectively so
that it is a single enantiomer (all S stereochemistry).
CAS Registry Number: 107133-36-8
Molecular formula:
C
19
H
32
N
2
O
5,
C
4
H
11
N
_ _
Chemical structure:
_ _
Excipients: Lactose, microcrystalline cellulose, magnesium stearate
and silica dimethyl silylate.
PHARMACOLOGY
MECHANISM OF ACTION
Perindopril
(prodrug),
following
hydrolysis
to
perindoprilat,
inhibits
angiotensin
converting
enzyme (ACE) both in vitro and in vivo. It is thought that ACE
inhibitors reduce blood pressure
by inhibiting the enzyme which catalyses the conversion of angiotensin
I to angiotensin II.
Decreased plasma angiotensin II leads to increased plasma renin
activity and a decrease in
aldosterone. In addition to its effects on circulating ACE,
perindopril binds to and inhibits tissue
converting enzyme, predominantly in the kidney and vascular wall. The
contribution of this
mechanism to the overall antihypertensive effect of perindopril is
unknown. Animal studies have
demonstrated reversal of vascular hypertrophy and an improvement in
the ratio of elastin to
collagen in the vessel wall. Studies in man have demonstrated an
improvement in the visco-
elastic properties of large vessels and in compliance. Studies in
animals and humans suggest
that specific and competitive suppression of the
renin-angiotensin-aldosterone system is the
main mechanism by which blood pressure is redu