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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

]P]

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