QUINAPRIL-GA quinapril 5mg (as hydrochloride) tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

quinapril hydrochloride, Quantity: 5.416 mg (Equivalent: quinapril, Qty 5 mg)

Available from:

Medis Pharma Pty Ltd

INN (International Name):

quinapril hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; crospovidone; povidone; calcium sulfate dihydrate; magnesium carbonate hydrate; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

HYPERTENSION: Quinapril hydrochloride tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Sufficient data have not been provided to support the use of quinapril tablets in renovascular hypertension. CONGESTIVE HEART FAILURE: Quinapril hydrochloride tablets are indicated as an adjunctive treatment of mild to moderate congestive heart failure when given concomitantly with a diuretic and/or cardiac glycoside.

Product summary:

Visual Identification: Yellow coloured, oval shaped, film coated tablets debossed with '5' on one side and scoreline on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-10-23

Patient Information leaflet

QUINAPRIL-GA
_quinapril (as hydrochloride) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Quinapril-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 Quinapril-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 your Quinapril-
GA. You may need to read it again.
WHAT QUINAPRIL-GA IS USED FOR
Quinapril-GA tablets are used to
lower high blood pressure
(hypertension). It is also used to
treat heart failure.
_HYPERTENSION_
Everyone has blood pressure. This
pressure helps get your blood all
around your body. Your blood
pressure may be different at
different times of the day, depending
on how busy or worried you are.
You have hypertension (high blood
pressure) when your blood pressure
stays higher than is needed, even
when you are calm and relaxed.
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,
including stroke, heart disease and
kidney failure.
_HEART FAILURE_
Heart failure means that the heart
muscle is weak and 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. Heart failure
may start off with no symptoms, but
as the condition progresses,
patients may feel short of breath or
may get tired easily after light
physical activity such as walking.
Some patients may wake up short
of breath at night. Fluid may collect
in different parts of the body, often
first noticed as swollen ankles and
feet.
_HOW QUINAPRIL-GA WORKS_
Quinapril-GA works by widening
your blood vessels, which reduces
pressure in

Summary of Product characteristics

QUINAPRIL-GA TABLETS
Product information
Quinapril-GA PI V2 120720
Page 1 of 17
NAME OF THE MEDICINE
Quinapril hydrochloride
Quinapril tablets contain the hydrochloride salt of quinapril the
ethyl ester of a nonsulfhydryl,
angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.
Quinapril hydrochloride (CAS no. 82586-55-8) is chemically described
as 3-Isoquinolinecarboxylic
acid,
2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-
monohydrochloride,
[3S-[2[R*(R*)],3R*]]
or
(S)-2-[(S)-N-
[(S)-1-Carboxy-3-phenylpropyl]
alanyl]-
1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, 1-ethyl ester,
monohydrochloride. It is chemically
and pharmacologically related to enalapril.
Its empirical formula is C
25
H
30
N
2
O
5
•HCl
Molecular weight: 475.0
CAS no. 82586-55-8
DESCRIPTION
Quinapril hydrochloride is a white to off-white amorphous powder that
is freely soluble in aqueous
solvents. The drug molecule contains three chiral centres but is
present as the pure S-S-S-
stereoisomer.
Quinapril-GA tablets also contain heavy magnesium carbonate, calcium
sulfate dihydrate, colloidal
anhydrous silica, crospovidone, povidone, magnesium stearate,
polyvinyl alcohol, titanium dioxide,
talc, lecithin, iron oxide yellow, and xanthan gum.
PHARMACOLOGY
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS:
Quinapril is deesterified to the principal metabolite, quinaprilat,
which is an inhibitor of ACE activity
in human subjects and animals. ACE is a peptidyl dipeptidase that
catalyzes the conversion of
angiotensin I to the vasoconstrictor, angiotensin II. The effect of
quinapril in hypertension appears
to result primarily from the inhibition of circulating and tissue ACE
activity, thereby reducing
angiotensin II formation. Quinapril inhibits the elevation in blood
pressure caused by intravenously
administered
angiotensin
I,
but
has
no
effect
on
the
pressor
response
to
angiotensin
II,
noradrenaline or adrenaline. Angiotensin II also stimulates the
secretion of aldosterone from the
Product Information
Quinapril-GA PI V2