TRANDOLAPRIL- GA trandolapril 2 mg capsules blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

trandolapril, Quantity: 2 mg

Dostupné s:

Medis Pharma Pty Ltd

INN (Mezinárodní Name):

Trandolapril

Léková forma:

Capsule

Složení:

Excipient Ingredients: povidone; sodium stearylfumarate; maize starch; lactose monohydrate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; iron oxide yellow; erythrosine; Gelatin

Podání:

Oral

Jednotky v balení:

28 capsules

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Trandolapril is indicated for the treatment of hypertension. Data to support the usage of trandolapril in renovascular hypertension are, at present, not available. Trandolapril is also indicated for patients with left ventricular dysfunction post myocardial infarction [ejection fraction less than or equal to 35% or WMI (Wall Motion Index) less than or equal to 1.2].

Přehled produktů:

Visual Identification: "Size 4" Orange coloured cap imprinted with 'TR' in black ink and orange coloured body imprinted with '2' in black ink; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizace:

Licence status A

Datum autorizace:

2008-06-13

Informace pro uživatele

TRANDOLAPRIL-GA
_TRANDOLAPRIL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Trandolapril-GA.
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
Trandolapril-GA 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 TRANDOLAPRIL-GA IS
USED FOR
Trandolapril-GA is used to treat
high blood pressure, which
doctors call hypertension and
also to treat some heart
conditions.
There are usually no symptoms
of hypertension. The only way
of knowing that you have
hypertension 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 hypertension can
lead to serious health problems,
including stroke, heart disease
and kidney failure.
Trandolapril-GA helps to lower
your blood pressure.
Trandolapril-GA belongs to a
group of medicines called
Angiotensin Converting
Enzyme (ACE) inhibitors. It
works by relaxing your blood
vessels, making it easier for
blood to move around your
body. This helps lower blood
pressure and increase the
supply of blood and oxygen to
the heart.
Your doctor may prescribe
Trandolapril-GA for another
reason.
Ask your doctor if you have
any questions about why
Trandolapril-GA has been
prescribed for you.
Trandolapril-GA is only
available with a doctor's
prescription.
Trandolapril-GA is not
addictive.
Trandolapril-GA is not
recommended for use in
children as there have been no
studies of its effects in children.
BEFORE YOU TAKE
TRANDOLAPRIL-GA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TRANDOLAPRIL-GA
IF YOU HAVE HAD AN ALLERGIC
REACTION TO TRANDOLAPRIL OR TO
ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.

Charakteristika produktu

PRODUCT INFORMATION
TRANDOLAPRIL-GA CAPSULES
NAME OF THE MEDICINE
Trandolapril
The
chemical
name
is
(2S,3aR,7aS)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]
propanoyl]octahydro-1H-indole-2- carboxylic acid.
CH
3
N
N
O
O
O
CH
3
HOOC
H
H
H
Trandolapril
Molecular weight:
430.54
Molecular formula:
C
24
H
34
N
2
O
5
CAS number:
87679-37-6
DESCRIPTION
Trandolapril-GA Capsules is trandolapril, a long acting, highly
lipophilic, non-peptide, angiotensin
converting enzyme (ACE) inhibitor with a carboxyl group but without a
sulphydryl group.
Trandolapril is a colourless, crystalline substance that is soluble in
chloroform, dichloromethane
and methanol. It is practically insoluble in water and sparingly
soluble in hydrochloric acid.
Each Trandolapril-GA capsule contains 0.5 mg, 1 mg, 2 mg or 4mg of
trandolapril. Each capsule
also
contains
the
following
inactive
ingredients:
Lactose,
starch-maize,
povidone,
sodium
stearylfumarate.
In addition the 0.5mg and 2mg capsule contains the following inactive
ingredients: gelatin, titanium
dioxide (E171), erythrosine – FD & C red 3 (E127) yellow iron oxide
(E172) and black ink (SW-
9008).
The 1 mg capsule contains: gelatin, titanium dioxide (E171),
erythrosine – FD & C red 3 (E127),
yellow iron oxide (E172) red iron oxide (E172) and black ink
(SW-9008).
The 4mg capsule contains: gelatin, titanium dioxide (E171), red iron
oxide (E172) and black ink
(SW-9008 / SW-9009).
PHARMACOLOGY
Trandolapril-GA PI v2 110603
Page 1 of 17
Product Information
Page 2 of 17
MECHANISM OF ACTION
Trandolapril is an orally active angiotensin converting enzyme (ACE)
inhibitor. It is administered as
a pro-drug (trandolapril) which is rapidly converted to its
biologically active metabolite trandolaprilat:
a compound which binds tightly to, and dissociates slowly from, ACE.
There is evidence that
trandolapril itself has a marked affinity for angiotensin converting
enzyme, and may therefore have
n antihypertensive effect.
ldosterone secretion and an
crease in plasma renin activity by suppressing