Lisinopril (Teva)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Lisinopril dihydrate 10.89mg equivalent to lisinopril 10 mg;  ;  ;  

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Lisinopril dihydrate 10.89 mg (equivalent to lisinopril 10 mg)

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Lisinopril dihydrate 10.89mg equivalent to lisinopril 10 mg       Excipient: Calcium hydrogen phosphate dihydrate Ferric oxide red (CI77491) Magnesium stearate Maize starch Mannitol

Units in package:

Blister pack, PVC/Al, 10 tablets, 10 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, PVDC/PVC/Al - 10 tablets - 36 months from date of manufacture stored at or below 25°C protect from light. protect from heat - Blister pack, PVDC/PVC/Al - 14 tablets - 36 months from date of manufacture stored at or below 25°C protect from light. protect from heat - Blister pack, PVDC/PVC/Al - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from light. protect from heat - Blister pack, PVDC/PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light. protect from heat - Blister pack, PVDC/PVC/Al - 50 tablets - 36 months from date of manufacture stored at or below 25°C protect from light. protect from heat - Blister pack, PVDC/PVC/Al - 56 tablets - 36 months from date of manufacture stored at or below 25°C protect from light. protect from heat - Blister pack, PVDC/PVC/Al - 84 tablets - 36 months from date of manufacture stored at or below 25°C protect from light. protect from heat - Blister pack, PVDC/PVC/Al - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light. protect from heat - Blister pack, PVDC/PVC/Al - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light. protect from heat

Authorization date:

2004-07-06

Summary of Product characteristics

NEW ZEALAND DATA SHEET
LISINOPRIL (TEVA)
Lisinopril Tablets 5 mg, 10 mg, 20 mg
Version 1.1
1
1.
NAME OF THE MEDICINAL PRODUCT
LISINOPRIL (Teva) 5 mg, tablet
LISINOPRIL (Teva) 10 mg, tablet
LISINOPRIL (Teva) 20 mg, tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lisinopril (Teva) tablets come in three strengths and contain
lisinopril dihydrate equivalent to
5 mg, 10 mg or 20 mg lisinopril.
3.
PHARMACEUTICAL FORM
5 MG TABLET
: A light pink coloured, circular, biconvex uncoated tablet. The
tablet has a break
line and is embossed with ‘5’ on one side and embossed with
‘BL’ on the other side.
10 MG TABLET
: A light pink coloured, circular, biconvex uncoated tablet. The
tablet is
embossed with ‘10’ on one side and embossed with ‘BL’ on the
other side.
20 MG TABLET
: A pink, circular, biconvex uncoated tablet. The tablet is embossed
with ‘20’ on
one side and embossed with ‘BL’ on the other side.
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:
C21H31N3O5.2H2O,
Molecular weight: 441.53, CAS No.: 83915-83-7
Lisinopril dihydrate is a white to off-white crystalline powder that
is soluble in water,
sparingly soluble in methanol and practically insoluble in ethanol.
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).
4.
CLINICAL PARTICULARS
4.1
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.
NEW ZEALAND DATA SHEET
LISINOPRIL (TEVA)
Lisinopril Tablets 5 mg, 10 mg, 20 mg
Version 1.1
2
Lisinopril is indicated in the management of congestive heart failure
as an adjunctive
treatment with diuretics and, where appropriate, digitalis.
Lisinopril is indicated for the treatment of haemodynamically stabl