TRANDOLAPRIL- LUPIN CAPSULES trandolapril 2 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

trandolapril, Quantity: 2 mg

Available from:

Lupin Australia Pty Limited

INN (International Name):

Trandolapril

Pharmaceutical form:

Capsule

Composition:

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

Administration route:

Oral

Units in package:

28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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].

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2008-06-13

Patient Information leaflet

CONSUMER MEDICINE
INFORMATION
TRANDOLAPRIL-GENERIC
HEALTH CAPSULES
TRANDOLAPRIL
(Generic Health Pty Ltd)
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions
about Trandolapril Generic Health Capsules.
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 Generic Health Capsules 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 GENERIC HEALTH
CAPSULES IS USED FOR
Trandolapril Generic Health Capsules 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 Generic Health
Capsules helps to lower your blood pressure.
Trandolapril Generic Health Capsules 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
Generic Health Capsules for another reason.
Ask your doctor if you have any questions
about why Trandolapril Generic Health
Capsules has been prescribed for you.
_Consumer Medicine Information _
_Trandolapril Generic Health Capsules _
_ _
Page 2 of 11
Trandolapril Generic Health Capsules is only
available with a doctor's prescription.
T

Summary of Product characteristics

PRODUCT INFORMATION
TRANDOLAPRIL-GENERIC HEALTH CAPSULES
(LUPIN AUSTRALIA PTY. LTD)
NAME OF THE MEDICINE
Trandolapril.
DESCRIPTION
The chemical name is
(2_S_,3a_R_,7a_S_)-1-[(2_S_)-2-[[(1_S_)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]propanoyl]octahydro-1_H_-
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.
Trandolapril Generic Health 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 (CAS 87679-37-6) 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 Generic Health 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).
_Trandolapril Generic Health Capsules _
_ _
Page 2 of 18
PHARMACOLOGY:
_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 an
antihypertensive effect.
Angiotensin
conver