Amlodipine
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
07-02-2012
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Active ingredient:
Amlodipine besilate 6.935mg equivalent to 5 mg Amlodipine;
Available from:
Ipca Pharma (NZ) Pty Limited
INN (International Name):
Amlodipine besilate 6.935 mg (equivalent to 5 mg Amlodipine)
Dosage:
5 mg
Pharmaceutical form:
Tablet
Composition:
Active: Amlodipine besilate 6.935mg equivalent to 5 mg Amlodipine Excipient: Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Magnesium stearate Microcrystalline cellulose Sodium starch glycolate
Units in package:
Blister pack, PVC/PVDC, 28 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Glochem Industries Limited
Therapeutic indications:
Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme inhibitor.
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC - 56 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC - 84 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 250 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 500 tablets - 24 months from date of manufacture stored at or below 25°C
Authorization date:
2006-06-01
Summary of Product characteristics
1
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Vasorex
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amlodipine besilate 2.5 mg, 5 mg and 10 mg tablets
3 PHARMACEUTICAL FORM
Vasorex 2.5 mg tablets are white to off white, round with “C”
debossed on one side and
“126” on the other side. Alternatively, they are debossed on one
side with “3235” and
“WPI” on the other side. Each tablet contains amlodipine besilate
equivalent to 2.5 mg of
amlodipine.
Vasorex 5 mg tablets are white to off white, round with “C”
debossed on one side and
“127” on the other side. Alternatively, they are debossed on one
side with “3236” and
“WPI” on the other side. Each tablet contains amlodipine besilate
equivalent to 5 mg
amlodipine.
Vasorex 10 mg tablets are white to off white, round with “C”
debossed on one side and
“128” on the other side. Alternatively, they are debossed on one
side with “3237” and
“WPI” on the other side. Each tablet contains amlodipine besilate
equivalent to 10 mg
amlodipine.
Do not halve the tablet as dose equivalence when the tablet is divided
has not been
established.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Vasorex is indicated for the first line treatment of hypertension and
can be used as the
sole agent to control blood pressure in the majority of patients.
Patients not adequately
controlled on a single antihypertensive agent may benefit from the
addition of amlodipine,
which has been used in combination with a thiazide diuretic, beta
adrenoceptor blocking
agent, or an angiotensin-converting enzyme inhibitor.
Vasorex is indicated for the first line treatment of myocardial
ischaemia, whether due to
fixed obstruction (stable angina) and/or vasospasm/vasoconstriction
(Prinzmetal's or
variant angina) of coronary vasculature.
Vasorex
may
be
used
where
the
clinical
presentation
suggests
a
possible
vasospastic/vasoconstrictive component but where
vasospasm/vasoconstriction has not
been confirmed. Vasorex may be used alone as monotherapy, or in
combination with other
anti
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