Amlodipine

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Amlodipine besilate 13.888mg equivalent to 10 mg Amlodipine

Disponible depuis:

Norton Healthcare Limited (NZ)

DCI (Dénomination commune internationale):

Amlodipine besilate 13.888 mg (equivalent to 10 mg Amlodipine)

Dosage:

10 mg

forme pharmaceutique:

Tablet

Composition:

Active: Amlodipine besilate 13.888mg equivalent to 10 mg Amlodipine Excipient: Calcium hydrogen phosphate Magnesium stearate Microcrystalline cellulose Sodium starch glycolate

Unités en paquet:

Blister pack, Aluminium / PVC / PVdC, 30 tablets, 30 tablets

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Dr Reddy's Laboratories Limited

Descriptif du produit:

Package - Contents - Shelf Life: Blister pack, Aluminium / PVC / PVdC, 30 tablets - 30 tablets - 5 years from date of manufacture stored at or below 25°C

Date de l'autorisation:

2008-06-13

Résumé des caractéristiques du produit

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