Zanidip

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

即購入

ダウンロード 製品の特徴 (SPC)
05-07-2011

有効成分:

Lercanidipine hydrochloride 10mg;  

から入手可能:

Viatris Limited

INN(国際名):

Lercanidipine hydrochloride 10 mg

投薬量:

10 mg

医薬品形態:

Film coated tablet

構図:

Active: Lercanidipine hydrochloride 10mg   Excipient: Hypromellose Iron oxide yellow Lactose monohydrate Macrogol 6000 Magnesium stearate Povidone Powdered cellulose Purified talc Sodium starch glycolate Titanium dioxide

パッケージ内のユニット:

Blister pack, opaque PVC-Al Sample pack, 7 tablets

クラス:

Prescription

処方タイプ:

Prescription

製:

Recordati Ireland Ltd

適応症:

Zanidip is indicated for the treatment of mild to moderate hypertension.

製品概要:

Package - Contents - Shelf Life: Blister pack, opaque PVC-Al Sample pack - 7 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, opaque PVC-Al - 30 tablets - 36 months from date of manufacture stored at or below 30°C

承認日:

2000-02-18

情報リーフレット

                                Zanidip 
Version 02 
30/06/2011 
Page 1 of 3 
 
ZANIDIP    
 
_Lercanidipine hydrochloride _
CONSUMER MEDICINE INFORMATION 
 
WHAT IS IN THIS LEAFLET 
 
This  leaflet  answers  some  of  the 
common  questions  about  ZANIDIP. 
It  does  not  contain  all  the  available 
information.    It  does  not  replace 
seeking  advice  from  your  doctor  or 
pharmacist.  
 
PLEASE  READ  THIS  LEAFLET  BEFORE  YOU 
START  TAKING  ZANIDIP.    If  you  are 
helping someone else take ZANIDIP, 
please  read  this  leaflet  before  you 
give the
 
first dose
. 
 
All medicines have risks and 
benefits.  Your doctor has weighed 
the risks of you taking ZANIDIP 
against the benefits this medicine is 
expected to have for you.   
 
IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 
 
KEEP THIS LEAFLET WITH THE MEDICINE.  
You may need to read it again. 
 
WHAT ZANIDIP IS USED 
FOR 
 
The name of your medicine is 
ZANIDIP, which is also known as 
lercanidipine.  ZANIDIP belongs to a 
group of medicines called calcium 
channel blockers (of the 
dihydropyridine group). 
 
ZANIDIP lowers high blood 
pressure, which doctors call 
hypertension.  It works by relaxing 
some of the blood vessels in the body 
and reducing resistance to the flow of 
blood through the blood vessels. 
 
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 on
                                
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製品の特徴

                                DATA SHEET 
ZANIDIP
®
 
 
NAME OF THE MEDICINE 
Lercanidipine hydrochloride 
CHEMICAL STRUCTURE 
Lercanidipine is a dihydropyridine derivative. It is a racemate due
to the presence of 
a chiral carbon atom at position 4 of the 1,4-dihydropyridine ring. 
 
 
 
3,5-pyridinedicarboxylic acid, 1,4- dihydro-2,
6-dimethyl-4-(3-nitrophenyl)-2-[(3,3-
diphenylpropyl)methylamino]-1,1-dimethylethyl methyl ester
hydrochloride.  
MW: 648.2 (free base: 611.7). 
CAS NUMBER  
132866-11-6 
DESCRIPTION 
Lercanidipine hydrochloride is a microcrystalline, odourless, citrine
powder, readily 
soluble in chloroform and methanol, practically insoluble in water.
Octanol:water 
partition coefficient (LogP): 6.4. 
Zanidip tablets also contain lactose, microcrystalline cellulose,
sodium starch 
glycolate, povidone and magnesium stearate. The tablets are
film-coated with the 
proprietary ingredient Opadry OY-SR-6497. 
PHARMACOLOGY 
PHARMACODYNAMICS  
Lercanidipine is a calcium antagonist of the dihydropyridine group
and selectively 
inhibits the transmembrane influx of calcium into cardiac and
vascular smooth 
muscle, with a greater effect on vascular smooth muscle than on
cardiac smooth 
muscle. The antihypertensive action is due to a direct relaxant
effect on vascular 
smooth muscle which lowers total peripheral resistance and hence
blood pressure. 
Lercanidipine has a prolonged antihypertensive activity because of
its high 
membrane partition coefficient. It is devoid of negative inotropic
effects and its 
vascular selectivity is due to its voltage-dependent calcium
antagonist activity. Since 
the vasodilatation induced by lercanidipine hydrochloride is
gradual in onset, acute 
hypotension with reflex tachycardia has rarely been observed
in hypertensive 
patients. 
As for other asymmetric, 1,4-dihydropyridines, the antihypertensive
activity of 
lercanidipine is mainly due to the (S) - enantiomer. 
_Zanidip Version _
_1 _
_Page1_
/_9_
 
No significant effects on ECG hav
                                
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