Zanidip-Recordati tablets film-coated

国: アルメニア

言語: 英語

ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有効成分:

lercanidipine (lercanidipine hydrochloride)

から入手可能:

Recordati Industria Chimica e Farmaceutica S.p.A.

ATCコード:

C08CA13

INN（国際名）:

lercanidipine (lercanidipine hydrochloride)

投薬量:

20mg

医薬品形態:

tablets film-coated

パッケージ内のユニット:

(28/2x14/) in blister

処方タイプ:

Prescription

認証ステータス:

Registered

承認日:

2016-07-11

製品の特徴

Summary of Product Characteristics (SmPC) for
Zanidip®-Recordati
Marketing authorization number:
Trade name:
Zanidip®-Recordati
International non-patented name (INN): lercanidipine
Pharmaceutical form:
film-coated tablets
Contents
Each film-coated tablet contains:
Active component:
lercanidipine hydrochloride 10 mg or 20 mg;
Excipients:
lactose monohydrate 30 mg/60 mg, microcrystalline cellulose 39 mg/78
mg, sodium starch
glycolate 15.5 mg/31 mg, povidone K30 4.5 mg/9 mg, magnesium stearate
1 mg/2 mg;
Film coating:
for 10 mg tablets – Opadry yellow (OY-SR-6479) 3 mg (hypromellose,
talc, titanium dioxide
(E171), macrogol 6000, ferric oxide yellow (E172); for 20 mg tablets -
Opadry pink (OY-SR-6479) 6 mg
(hypromellose, talc, titanium dioxide (E171), macrogol 6000, ferric
oxide red (E172)).
Description
10 mg tablets:
round-shaped biconvex tablet with a light yellow film coating, with a
breaking line on one
side, light yellow at the fracture surface.
20 mg tablets:
round-shaped biconvex tablet with a pink to dark pink film coating,
with a breaking line on
one side, light yellow at the fracture surface.
Therapeutic category
“Slow” calcium channels blocker.
ATC code: C08CA13.
Pharmacological properties
Pharmacodynamics.
“Slow” calcium channels blocker. Lercanidipine is a racemic
mixture of right- (R) and
left- (L) rotating stereomers, a derivative of 1,4-dyhydropyridine,
which is able to selectively block the
calcium
ions
current
into
the
cells
of
blood
vessels
walls,
heart
cells
and
smooth
muscle
cells.
Lercanidipine has prolonged antihypertensive action. The therapeutic
effect is reached 5 to 7 hours after
the oral administration and is maintained during 24 hours. Due to high
selectivity for the cells of smooth
muscles of the blood vessels, there is no negative inotropic effect.
Lercanidipine is a metabolically neutral drug, and it does not have
any substantial effect on serum
lipoproteins and alipoproteins level, as well as does not change the
lipid profile in hypertension patients.
Pharmacokinetics:
_-_