Arrow - Lisinopril

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Lisinopril dihydrate 10.89mg equivalent to 10 mg lisinopril;  

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Lisinopril dihydrate 10.89 mg (equivalent to 10 mg lisinopril)

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Lisinopril dihydrate 10.89mg equivalent to 10 mg lisinopril   Excipient: Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Magnesium stearate Mannitol Pregelatinised maize starch Starch

Units in package:

Blister pack, PVC/PVDC/aluminium, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Zhejiang Huahai Pharmaceutical Co Ltd

Therapeutic indications:

Lisinopril is indicated in the treatment of essential hypertension and in renovascular hypertension. It may be used alone or concomitantly with other classes of antihypertensive agents.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/aluminium - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE with PP closure and desiccant - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE with PP closure and desiccant - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2006-06-30

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
ARROW - LISINOPRIL
LISINOPRIL 5 MG, 10 MG, 20 MG TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ARROW - LISINOPRIL.
It does not contain all of the available information. It does not take
the place of
talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the
risks of
you taking ARROW - LISINOPRIL against the benefits they expect it will
have
for you.
If you have any concerns about taking this medicine, talk to your
doctor or
pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
WHAT ARROW - LISINOPRIL IS USED FOR
ARROW - LISINOPRIL Tablets are used to treat
•
high blood pressure (hypertension)
•
heart failure
•
patients who have just had a heart attack.
Lisinopril dihydrate, the active ingredient in ARROW - LISINOPRIL
Tablets,
belongs to a group of medicines called angiotensin converting enzyme
(ACE)
inhibitors.
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. You may feel fine and have no symptoms, but eventually
hypertension can cause stroke, heart disease and kidney failure.
ARROW - LISINOPRIL helps to lower your blood pressure by widening your
blood vessels.
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 a

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET.
ARROW - LISINOPRIL
Lisinopril tablets
NAME OF THE DRUG
Lisinopril dihydrate. The chemical name for lisinopril dihydrate is
N-[N-[(1S)-1-
carboxy-3-phenylpropyl]-L-lysyl]-L-proline dihydrate. Its structural
formula is:
C
21
H
31
N
3
O
5
.2H
2
O Molecular weight: 441.53 CAS No.: 83915-83-7
DESCRIPTION
Lisinopril dihydrate is a white to off-white crystalline powder that
is soluble in
water, sparingly soluble in methanol and practically insoluble in
ethanol.
Arrow
-
Lisinopril
tablets
come
in
three
strengths
and
contain
lisinopril
dihydrate equivalent to 5 mg, 10 mg or 20 mg of lisinopril. The
tablets also
contain
the
following
excipients:
mannitol,
calcium
hydrogen
phosphate,
maize starch, pregelatinised maize starch, colloidal anhydrous silica
and
magnesium stearate. The tablets are gluten free.
A
synthetic peptide derivative,
lisinopril
dihydrate
is
an
oral
long
acting
angiotensin converting enzyme inhibitor. It is a lysine analogue of
enalaprilat
(active metabolite of enalapril).
_PHARMACOLOGY _
PHARMACOLOGICAL ACTIONS
Lisinopril
is
a
peptidyl
dipeptidase
inhibitor.
It
inhibits
the
angiotensin
converting enzyme (ACE) that catalyses the conversion of angiotensin I
to the
vasoconstrictor
substance,
angiotensin
II.
Angiotensin
II
also
stimulates
aldosterone secretion by the adrenal cortex. Inhibition of ACE results
in
decreased concentrations of plasma angiotensin II which results in
decreased
vasopressor
activity
and
to
decreased
aldosterone
secretion.
The
latter
decrease may result in a small increase of serum potassium. In
hypertensive
patients with normal renal function treated with lisinopril alone for
up to 24
weeks,
the
mean
increase
in
serum
potassium
was
approximately
0.1
mmol/L; however, approximately 15% of patients had increases greater
than
2
0.5 mmol/L and approximately 6% had a decrease greater than 0.5
mmol/L. In
the same study, patients treated with lisinopril and
hydrochlorothiazide for up
to 24 weeks had a mean decrease in serum potassium of 0.1 mmol/L;
approximately 4% o