1利压膜衣锭10公丝
10
Zanidip F.C. Tablet 10mg
(Lercanidipine Hydrochloride)
p023293 Zanidip F.C. Tablet 10mg
C t Lercanidipine 9.4mg (10mg Lercanidipine HCL)
r Lactose monohydrate?A microcrystalline cellulose?A sodium starch glycolate?A povidone K30?A magnesium stearate?C
t hypromellose?A talc?A titanium dioxide (E171)?A macrogol 6000?A ferric oxide (E172)?C
A g
k q v C
q C f A A (10mg)?A e15A; p n i w O p W[20mg (2)?C
]b A P A q i A i?Y W[C
Y A u w A P Zanidip A U C n A pβ-blocker (atenolol), (hydrochlorothiazide)?ACE inhibitor (captopril enalapril)C]q20 – 30mg q P u
k A P A A q A A W[C
- H
g O q A l w S O V C
-
]18 H U w i A e C
- x w
x w l S O V A w i e q A p W[20mg N C
Zanidip Y x w C(creatinine clearance < 10mg/min)
T
Dihydropyridine s L C
Lercanidipine T U C p : ￥M i k(°D w) left ventricular outflow tract obstruction w v R?I w w?h A Y x
o?w C K P Zanidip M cyclosporin ?C A￥ Lercanidipine A i P c A C
N
Zanidip w u f g s(sick sinus syndrome)aw S O N C
g O s?S v T A?(LV dysfunction)¤w N C Y
u dihydropyridine w?e f w?D W[C M Zanidip A f
H N C CYP 3A4( inducers)|p (e.g. phenytoin, carbamazepine)?M rifampicin?A i C Lercanidipine A i Lercanidipine C K M CYP 3A4( inhibitors) C
C q (30mg)?A g w v T C
Lercanidipine w O CYP 3A4N A]CYP 3A4A i P Lercanidipine N M C
s Lercanidipine P CYP 3A4A Ketoconazole W[Lercanidipine
( the enantiomer of S-Lercanidipine -?u n[ AUC] M C max O W[15M8 )?A]
K ZANIDIP P CYP 3A4(ketoconazole A itraconazole ?A ritonavir,?A erythromycin?A troleandomycin)|
C
Lercanidipine M Cyclosporin o W[C H s
Lercanidipine 3 p,|A Cyclosporin?A M Lercanidipine S W[A O Cyclosporin -?u n[ AUC]?W[F27 % ?C M|,-Y O Lercanidipine M Cyclosporin A h Lercanidipine
W[T A Cyclosporin-?u n[ AUC]?W[27 %?A]K
Lercanidipine M Cyclosporin?C
M Dihydropyridines A Lercanidipine c N O P A]c
Lercanidipine i v M C W[C]K Lercanidipine M c A C
b s:|20mg Lercanidipine M Midazolam A Lercanidipine l W[40% A O l t C( tmax 1.75p 3 ¤p) A Midazolam v T C
Zanidip M g CYP 3A4N A p terfenadine, astemizole, cyclosporin ; class III antiarrhythmic drugs(amiodarone, quinidine)?A S O N C
C A800mg Cimetidine Lercanidipine A Y q h S O N A]
Lercanidipine i v P i W[C
Zanidip P Metoprolol A]β-blocker D n x A Metoprolol i v A O Lercanidipine i v C50￠H C o i O]Oβ-blocker x y U A i o P
b o C Lercanidipine Pβ-blocker O w A O i n q C
Zanidip P CYP 3A4p (e.g. phenytoin, carbamazepine)?M rifampicin A]i
C A W[W v C
A?t(?-methyldigoxin)¤w A A20mg Lercanidipine A L O W
F b d s:￥Digoxin A e A20mg Lercanidipine A Digoxin
W[33%?A Digoxin-?u n[ AUC] M M v h S v T C Digoxin v
w A K W Digoxin r T C
20mg Lercanidipine M 40mg Simvastatin ?A Lercanidipine-?u n[ AUC]¨S
A O Simvastatin M Simvastatin N(β-hydroxyacid)a-?u n[ AUC]?h O W[
56%?M28%?C o p s C
W Lercanidipine A U A Simvastatin C
s P Fluoxetine ( CYP2D6 ?M CYP3A4)a(￥65)?A Lercanidipine O M Fluoxetine C
H d s A Lercanidipine M Warfarin?A Warfarin O C
Zanidip P ACE inhibitor O w C
s K A]i W[i C
h P
L P?P L A O L v T C M A S Lercanidipine h P
A L Dihydropyridine P L A Zanidip h A i h w
(°D w)?C]Lercanidipine A i A]i A C
P
v T w O A]i t w z h(¨u)?A
N C
k
H Zanidip v n A[A]A: P??L
t Y h t w z C T P O o v C1% ]A: h z D
A p?R W k h M m h l P h C C h o b f C
b[A p L dihydropyridine o i W H A i i
M x transaminase i f W[ ; ¨[P Zanidip H C
Lercanidipine v T M C Y Dihydropyridine o?f h?h C?
h w i]A?h W v Y W[C f[?H C
L q
Zanidip L q C p L Dihydropyridine A L q i P L i C
u?L t C p o Y C?L w M L N H A?k N U q A?L w h
i H Atropine R?g C
]Lercanidipine z A]i Lercanidipine L q f H A f w?p
n24p H W C z R v T A e S i C M A]Lercanidipine A]
Lercanidipine A q M I A z R]i L C
z S
S
Lercanidipine O Dihydropyridine t l A t l L M i?M C
O]i C P O C M b I A]
M t Y(membrane partition coefficient) A]C P]
A v T?Y O C
]Zanidip i O i A]A Zanidip f w A]C P
u?L t H O u C
p P L1?A4 - dihydropyridines A Lercanidipine D n O (S) - enantiomer?C
F s A g A i p H L Y(μi114.5±3.7 mmHg)±w i
s A H C20mg q i25W w A40%af H C C A C10mg i 25W w A56%af H i C b H P w isolated systolic hypertension s : Lercanidipine Y q172.6±5.6mmHg140.2±8.7mmHg?C
S
Zanidip 10-20mg f A l O 3.30ng/ml±2.09 (s.d.)?M7.66/±5.90 (s.d.).?A o f
A 1.5 – 3p C?M x O t s x C
Lercanidipine M v W L98%?C Y x w A]
v i W[C
W O; ]Zanidip A f w f A Zanidip?A Zanidip
i v10%?C d b p U A f A Zanidip i v N1/3?C
b I8-10p A]P M A H i F24p C
W n C
Zanidip O CYP 3A4N;|b T K L(parent drug)3o C a
N A50%￥C
H H x M microsome:|b20mg Lercanidipine a160 M40
p U A Lercanidipine ?|{?×aCYP3A4 M CYP2D6C Mó|b H§??a@￥??: Lercanidipine v T Midazolam (￥CYP 3A4N) Metoprolol (￥CYP 2D6N) C]A
b Zanidip v q U A CYP3A4N M CYP2D6N
N o C
f A Zanidip A Lercanidipine P q(?D u Y) C P10?2040mg?A[
O 1 : 3 : 8?A-?u U n(|-?u n[ AUC])a 1 : 4 : 18?A
g N v M C]i v]q W[C
Lercanidipine c; O P A(S) enantiomer
P-?u U n(|-?u n[ AUC] (S) enantiomer ?O(R)enantiomer 1.2 A b I A W(S) , (R)enantiomer O P A C
A Zanidip?A2p A Lercanidipine f A i v N W[C]A Zanidip e
C
H M x w O s O; Y w z R
w]70￠H C x w A]h b x N A
i v i W[C
e w
w z s b q U A v T D g t g t z D C
P s P q t l A g C
Lercanidipine L]r L P M I C
H Lercanidipine v v T O C
L M?P L; M A P q Lercanidipine?A o Z e l
w L o C
Y L A q (12mg/kg/day)§P Lercanidipine HCL?A o C
Lercanidipine M/?N h P n A s C
N W b r s C
e
3
S x s D
L
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Aluminium/opaque PVC blisters
7, 14, 28, 35, 50, 56, 98, 100
s y t: RECORDATI Industria Chimica e Farmaceutica S.p.A.
t §:Via Matteo Civitali, 1-20148 Milan, Italy
°: ¤q
a §: ￥x n q3687
q ?: (02) 2755-4881