Amlodipine

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Amlodipine besilate 13.869mg Equivalent to 10 mg amlodipine anhydrous base;  

제공처:

Dr Reddy's New Zealand Limited

INN (International Name):

Amlodipine besilate 13.869 mg (Equivalent to 10 mg amlodipine anhydrous base)

복용량:

10 mg

약제 형태:

Tablet

구성:

Active: Amlodipine besilate 13.869mg Equivalent to 10 mg amlodipine anhydrous base   Excipient: Magnesium stearate Microcrystalline cellulose

패키지 단위:

Blister pack, Alu/Triplex Film x 28 Tablets, 28 tablets

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

Dr Reddy's Laboratories Limited

제품 요약:

Package - Contents - Shelf Life: Blister pack, Alu/Triplex Film x 28 Tablets - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, Alu/PVC coated with PVdC x 28 Tablets - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, Alu/Triplex Film x 30 Tablets - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, Alu/PVC coated with PVdC x 30 Tablets - 30 tablets - 24 months from date of manufacture stored at or below 25°C

승인 날짜:

2007-03-05

제품 특성 요약

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