Levitra

Levitra

Lub npe: vardenafil hydrochloride hmoov
Daim ntawv noj tshuaj: ntsiav tshuaj, zaj duab xis coated
Hoob tshuaj: Cov neeg ua haujlwm tsis muaj zog

Tshuaj kho los ntawm Varixcare.cz. Hloov kho zaum kawg thaum Lub Kaum Hli 22, 2020.



Ntawm Nplooj Ntawv no
Nthuav dav

Indications thiab Siv rau Levitra

Levitra® ibtau qhia rau kev kho mob erectile kawg.



Levitra Dosage thiab Kev Tswj

Cov Ntaub Ntawv Dav Dav

Rau cov neeg mob feem ntau, kev pom zoo pib koob tshuaj Levitra yog 10 mg, noj qhov ncauj, raws li xav tau, kwv yees li 60 feeb ua ntej kev sib deev. Cov koob tshuaj tuaj yeem nce mus rau qhov siab tshaj plaws pom zoo ntawm 20 mg lossis txo mus rau 5 mg raws li kev ua tau zoo thiab cov kev mob tshwm sim. Qhov siab tshaj plaws pom zoo koob tshuaj yog ib zaug ib hnub. Kev txhawb kev sib deev yog xav tau los teb rau kev kho mob.

Siv nrog Zaub Mov

Levitra tuaj yeem noj nrog lossis tsis muaj zaub mov noj.



Siv Hauv Cov Pej Xeem Tshwj Xeeb

Geriatrics:Thawj koob tshuaj ntawm 5 mg Levitra yuav tsum raug txiav txim siab rau cov neeg mob ≧ 65 xyoos[saib Siv Hauv Cov Pej Xeem Tshwj Xeeb ( 8.5 )].

Hepatic tsis zoo:Rau cov neeg mob uas muaj lub cev tsis zoo me me (Child-Pugh B), pib txhaj tshuaj ntawm 5 mg Levitra raug pom zoo. Qhov siab tshaj plaws nyob rau hauv cov neeg mob uas muaj lub siab ua haujlwm tsis zoo yuav tsum tsis pub ntau tshaj 10 mg.

Tsis txhob siv Levitra rau cov neeg mob uas muaj lub cev tsis zoo (Child-Pugh C)[saib Cov Lus Ceeb Toom thiab Ceev faj ( 5.8 ), Siv Hauv Cov Pej Xeem Tshwj Xeeb ( 8.6 ) thiab Clinical Pharmacology ( 12.3 )].



Lub raum tsis zoo:Tsis txhob siv Levitra rau cov neeg mob ntawm lub raum lim ntshav[saib Cov Lus Ceeb Toom thiab Ceev faj ( 5.9 ), Siv Hauv Cov Pej Xeem Tshwj Xeeb ( 8.7 ) thiab Clinical Pharmacology ( 12.3 )].

Cov tshuaj sib xyaw ua ke

Nitrates:Kev siv ua ke nrog nitrates thiab nitric oxide pub nyob rau hauv ib daim ntawv twg yog contraindicated[saib Contraindications ( 4.1 )].

Guanylate Cyclase (GC) Stimulators, xws li riociguat: Kev siv ua ke tsis raug cai[saib Contraindications ( 4.2 )].

CYP3A4 Inhibitors:Qhov ntau npaum li cas ntawm Levitra yuav xav tau kev hloov pauv hauv cov neeg mob uas tau txais CYP3A4 muaj zog inhibitors xws li ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, thiab clarithromycin zoo li hauv lwm tus neeg mob tau txais CYP3A4 inhibitors me me xws li erythromycin[saib yeeb tshuaj yeeb tshuaj ( 7.2 )].Txog ritonavir, ib koob tshuaj 2.5 mg Levitra yuav tsum tsis pub ntau tshaj hauv 72 teev. Txog indinavir, saquinavir, atazanavir, ketoconazole 400 mg txhua hnub, itraconazole 400 mg txhua hnub, thiab clarithromycin, ib koob 2.5 mg Levitra yuav tsum tsis pub dhau 24 teev. Txog ketoconazole 200 mg txhua hnub, itraconazole 200 mg txhua hnub, thiab erythromycin, ib koob ntawm 5 mg Levitra yuav tsum tsis pub dhau 24 teev.

ntsuab tshuaj 48 11 txoj kev tus nqi

Alpha-Blockers:Hauv cov neeg mob uas ruaj khov ntawm kev kho alpha-blocker, phosphodiesterase type 5 (PDE5) inhibitors yuav tsum tau pib ntawm qhov qis tshaj pom zoo pib koob tshuaj. Kev kho mob ua ke yuav tsum tau pib tsuas yog tus neeg mob ruaj khov ntawm nws txoj kev kho alpha-blocker. Kev nce qib hauv qib alpha-blocker tuaj yeem cuam tshuam nrog kev txo qis ntshav siab ntxiv hauv cov neeg mob noj phosphodiesterase (PDE5) inhibitor suav nrog vardenafil. Hauv cov neeg mob uas ruaj khov ntawm kev kho alpha-blocker, Levitra yuav tsum tau pib ntawm koob tshuaj 5 mg (2.5 mg thaum siv ua ke nrog qee yam CYP3A4 inhibitors).[Saib Cov Lus Ceeb Toom thiab Ceev faj ( 5.6 )thiabKev Sib Tham Tshuaj ( 7.1 ).]

Lub sijhawm sib nrug ntawm kev siv tshuaj yuav tsum tau txiav txim siab thaum Levitra tau sau tseg ua ke nrog kev kho alpha-blocker[saib Clinical Pharmacology ( 12.2 )].

Hom Tshuaj thiab Lub Zog

Levitra tau tsim ua txiv kab ntxwv, puag ncig, zaj duab xis-coated ntsiav tshuaj nrog BAYER hla debossed ntawm ib sab thiab 5, 10 thiab 20 ntawm lwm sab sib xws rau 5 mg, 10 mg, thiab 20 mg ntawm vardenafil, feem.

Contraindications

Nitrates

Kev tswj hwm ntawm Levitra nrog nitrates (tsis tu ncua thiab/lossis sib quas ntus) thiab cov neeg pub nitric oxide tau txwv[saib Clinical Pharmacology ( 12.2 )]. Zoo ib yam nrog kev cuam tshuam ntawm PDE5 inhibition ntawm nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, suav nrog Levitra, tuaj yeem ua rau lub zog hypotensive ntawm nitrates. Lub sijhawm tsim nyog ncua sijhawm tom qab noj Levitra rau kev tswj hwm kev nyab xeeb ntawm nitrates lossis nitric oxide pub dawb tsis tau txiav txim siab.

Guanylate Cyclase (GC) Stimulators

Tsis txhob siv Levitra hauv cov neeg mob uas tab tom siv GC kev txhawb nqa, xws li riociguat. PDE5 inhibitors, suav nrog Levitra tuaj yeem txhawb lub zog hypotensive ntawm GC stimulators.

Ceeb Toom thiab Ceev faj

Kev tshuaj xyuas qhov ua haujlwm tsis tau erectile yuav tsum suav nrog kev tshuaj xyuas mob, txiav txim siab qhov muaj peev xwm ua rau lub hauv paus thiab kev txheeb xyuas qhov tsim nyog kho.

Ua ntej yuav sau ntawv Levitra, nws yog ib qho tseem ceeb uas yuav tsum nco ntsoov cov hauv qab no:

Teeb meem plawv

dav dav

Cov kws kho mob yuav tsum txiav txim siab txog kab mob plawv ntawm lawv cov neeg mob, vim tias muaj qib kev pheej hmoo mob plawv cuam tshuam nrog kev sib deev. Yog li ntawd, kev kho mob rau erectile kawg, suav nrog Levitra, yuav tsum tsis txhob siv rau cov txiv neej uas tsis muaj kev sib deev ua haujlwm vim tias lawv cov kab mob plawv pib.

Tsis muaj kev tswj hwm cov ntaub ntawv kho mob ntawm kev nyab xeeb lossis ua tau zoo ntawm vardenafil hauv cov neeg mob hauv qab no; thiab yog li nws siv tsis pom zoo kom txog thaum muaj cov ntaub ntawv ntxiv: tsis ruaj khov angina; hypotension (so systolic ntshav siab ntawm 170/110 mmHg); keeb kwm tsis ntev los no ntawm kev mob hlab ntsha tawg, ua rau lub plawv dhia tsis txaus, lossis myocardial infarction (tsis pub dhau 6 lub hlis dhau los); mob plawv tsis zoo.

Sab laug Ventricular Outflow Obstruction

Cov neeg mob uas muaj sab laug ventricular txhaws txhaws, (piv txwv li, aortic stenosis thiab idiopathic hypertrophic subaortic stenosis) tuaj yeem nkag siab rau qhov ua ntawm vasodilators suav nrog PDE5 inhibitors.

Ntshav Siab Teeb Meem

Levitra muaj cov kab mob vasodilatory uas ua rau txo qis hauv cov ntshav siab hauv cov neeg ua haujlwm pab dawb (txhais tau tias txo qis tshaj 7 mmHg systolic thiab 8 mmHg diastolic)[saib Clinical Pharmacology ( 12.2 )]. Thaum qhov no ib txwm xav tias yuav muaj qhov tshwm sim me me hauv cov neeg mob feem ntau, ua ntej yuav sau ntawv Levitra, cov kws kho mob yuav tsum ua tib zoo txiav txim siab seb lawv cov neeg mob uas muaj kab mob hauv lub plawv puas tuaj yeem cuam tshuam tsis zoo los ntawm cov txiaj ntsig vasodilatory.

Muaj peev xwm rau kev cuam tshuam nrog Tshuaj nrog Muaj Peev Xwm lossis Nruab Nrab CYP3A4 Inhibitors

Kev tswj hwm ua ke nrog CYP3A4 muaj zog tiv thaiv kab mob (xws li ritonavir, indinavir, ketoconazole) lossis qib nruab nrab CYP3A4 inhibitors (xws li erythromycin) nce ntshav ntau ntawm vardenafil. Kev hloov kho tshuaj yog tsim nyog thaum Levitra raug tswj hwm nrog qee yam CYP3A4 inhibitors[saib Dosage thiab Administration ( 2.4 ), Kev Sib Tham Tshuaj ( 7.2 )].

Cov ntaub ntawv hais txog kev nyab xeeb mus sij hawm ntev tsis muaj nyob ntawm kev tswj hwm ua ke ntawm vardenafil nrog cov tshuaj tiv thaiv kab mob HIV.

Kev pheej hmoo ntawm Priapism

Muaj cov ntawv ceeb toom tsis ntev ntawm kev kho erections ntau dua 4 teev thiab priapism (mob hnyav dua ntau dua 6 teev nyob rau lub sijhawm) rau chav kawm ntawm cov tebchaw no, suav nrog vardenafil. Yog tias kev txhim kho txuas ntxiv ntev dua 4 teev, tus neeg mob yuav tsum nrhiav kev pab kho mob tam sim. Yog tias priapism tsis kho tam sim ntawd, cov ntaub so ntswg puas thiab ua rau lub zog tsis muaj peev xwm ua tau.

Levitra yuav tsum tau siv nrog ceev faj los ntawm cov neeg mob uas lub cev hloov pauv ntawm qhov chaw mos (xws li kev nruj, cavernosal fibrosis, lossis Peyronie tus kab mob) lossis los ntawm cov neeg mob uas muaj cov xwm txheej uas tuaj yeem ua rau lawv mob ntshav qab zib (xws li mob qog noj ntshav ntawm tes, ntau yam myeloma, lossis mob qog noj ntshav) ).

Teeb meem ntawm Qhov Muag

Cov kws kho mob yuav tsum qhia cov neeg mob kom tsis txhob siv tag nrho cov tshuaj phosphodiesterase type 5 (PDE5) inhibitors, suav nrog Levitra, thiab nrhiav kev kho mob thaum muaj qhov muag tsis pom sai sai hauv ib lossis ob lub qhov muag. Cov xwm txheej zoo li no tuaj yeem yog ib qho cim ntawm tsis-arteritic anterior ischemic optic neuropathy (NAION), qhov xwm txheej tsis tshua muaj thiab ua rau tsis pom kev, suav nrog tsis pom kev tas mus li, uas tau tshaj tawm tsis tshua muaj kev lag luam tom ntej nrog kev siv tag nrho PDE5 inhibitors. Raws li cov ntaub ntawv luam tawm, qhov xwm txheej txhua xyoo ntawm NAION yog 2.5 - 11.8 tus neeg rau 100,000 tus txiv neej hnub nyoog ≧ 50.

Ib qho kev soj ntsuam qhov teeb meem-kev tshawb fawb soj ntsuam kev pheej hmoo ntawm NAION thaum siv PDE5 inhibitor, raws li chav kawm, tshwm sim tam sim ua ntej NAION pib (tsis pub dhau 5 ib nrab neej), piv rau PDE5 inhibitor siv nyob rau lub sijhawm ua ntej. Cov txiaj ntsig tau qhia kwv yees kwv yees li 2-npaug kev pheej hmoo ntawm NAION, nrog kev kwv yees kev pheej hmoo ntawm 2.15 (95% CI 1.06, 4.34). Txoj kev tshawb fawb zoo sib xws tau tshaj tawm cov txiaj ntsig zoo ib yam, nrog kev kwv yees kev pheej hmoo ntawm 2.27 (95% CI 0.99, 5.20). Lwm yam kev pheej hmoo rau NAION, xws li muaj cov neeg coob coob pom qhov muag pom, tuaj yeem ua rau muaj tshwm sim ntawm NAION hauv cov kev tshawb fawb no.

Tsis yog cov ntawv tshaj tawm tom khw muag khoom tsis tshua muaj, lossis koom nrog PDE5 inhibitor siv thiab NAION hauv kev soj ntsuam kev tshawb fawb, ua pov thawj kev sib raug zoo ntawm PDE5 inhibitor siv thiab NAION[saib Cov Kev Tsis Zoo (6.2)].

Cov kws kho mob yuav tsum txiav txim siab seb lawv cov neeg mob nrog rau NAION qhov xwm txheej txaus ntshai tuaj yeem cuam tshuam tsis zoo los ntawm kev siv PDE5 inhibitors. Cov tib neeg uas twb tau ntsib NAION muaj qhov pheej hmoo pheej hmoo ntawm NAION rov tshwm sim. Yog li ntawd, PDE5 inhibitors, suav nrog Levitra, yuav tsum tau siv nrog ceev faj hauv cov neeg mob no thiab tsuas yog thaum qhov kev cia siab tau txais txiaj ntsig ntau dua qhov txaus ntshai. Cov tib neeg uas muaj cov neeg kho qhov muag pom tau tias tseem muaj kev pheej hmoo ntau rau NAION piv rau cov pej xeem, txawm li cas los xij, pov thawj tsis txaus los txhawb kev tshuaj xyuas ntawm cov neeg siv yav tom ntej ntawm PDE5 inhibitors, suav nrog Levitra, rau qhov xwm txheej tsis zoo no.

Levitra tsis tau raug tshuaj xyuas hauv cov neeg mob uas paub tias muaj keeb kwm keeb kwm tsis zoo ntawm lub paj hlwb, suav nrog retinitis pigmentosa, yog li nws tsis siv rau thaum cov ntaub ntawv muaj nyob hauv cov neeg mob no.

Tsis hnov ​​lus li cas

Cov kws kho mob yuav tsum qhia cov neeg mob kom tsis txhob siv tag nrho PDE5 inhibitors, suav nrog Levitra, thiab nrhiav kev kho mob tam sim thaum muaj kev poob qis lossis tsis hnov ​​lus. Cov xwm txheej no, uas tuaj yeem suav nrog tinnitus thiab kiv taub hau, tau tshaj tawm hauv kev sib koom ua ke ib ntus kom tau txais PDE5 inhibitors, suav nrog vardenafil. Nws tsis tuaj yeem txiav txim siab seb cov xwm txheej no cuam tshuam ncaj qha rau kev siv PDE5 inhibitors lossis lwm yam[saib Cov Kev Tsis Zoo ( 6.2 )].

Alpha-Blockers

Ceev faj yog qhia thaum PDE5 inhibitors koom nrog alpha-blockers. PDE5 inhibitors, suav nrog Levitra, thiab alpha-adrenergic thaiv cov neeg sawv cev yog ob leeg vasodilators nrog ntshav siab txo qis. Thaum vasodilators tau siv ua ke, cov txiaj ntsig ntxiv ntawm cov ntshav siab tuaj yeem xav tau. Hauv qee tus neeg mob, kev siv ua ke ntawm ob chav tshuaj no tuaj yeem txo cov ntshav siab ua rau cov tsos mob hypotension (piv txwv li, tsaus muag)[saib yeeb tshuaj yeeb tshuaj ( 7.1 ) thiab Clinical Pharmacology ( 12.2 )]. Kev txiav txim siab yuav tsum muab rau cov hauv qab no:

Cov neeg mob yuav tsum ruaj khov ntawm kev kho alpha-blocker ua ntej pib ua PDE5 inhibitor. Cov neeg mob uas pom hemodynamic tsis ruaj khov ntawm kev kho alpha-blocker ib leeg yog qhov pheej hmoo pheej hmoo ntawm cov tsos mob hypotension nrog kev siv ua ke ntawm PDE5 inhibitors.
Hauv cov neeg mob uas ruaj khov ntawm kev kho alpha-blocker, PDE5 inhibitors yuav tsum tau pib ntawm qhov qis tshaj pom zoo pib koob tshuaj[saib Dosage thiab Administration ( 2.4 )].
Hauv cov neeg mob no twb tau txhaj tshuaj zoo ntawm PDE5 inhibitor, kev kho alpha-blocker yuav tsum tau pib ntawm qhov qis tshaj. Kev nce qib alpha-blocker ib qib tuaj yeem cuam tshuam nrog kev txo qis ntshav siab ntxiv hauv cov neeg mob noj PDE5 inhibitor.
Kev nyab xeeb ntawm kev siv ua ke ntawm PDE5 inhibitors thiab alpha-blockers tuaj yeem cuam tshuam los ntawm lwm qhov kev hloov pauv, suav nrog kev txo qis hauv lub cev thiab lwm yam tshuaj tiv thaiv ntshav siab.

Kev xeeb tub los yog Tau Txais QT Ntev

Hauv kev tshawb fawb ntawm cov txiaj ntsig ntawm Levitra ntawm QT luv hauv 59 tus txiv neej noj qab haus huv[saib Clinical Pharmacology ( 12.2 )], kho (10 mg) thiab supratherapeutic (80 mg) koob tshuaj ntawm vardenafil thiab kev tswj hwm nquag moxifloxacin (400 mg) ua rau nce zoo ib yam hauv QTcncua sijhawm. Kev tshawb fawb tom qab kev txheeb xyuas cov txiaj ntsig ntawm kev sib xyaw Levitra nrog lwm cov tshuaj sib piv QT cov txiaj ntsig tau qhia tias muaj txiaj ntsig QT ntxiv thaum piv nrog cov tshuaj ib leeg[saib Clinical Pharmacology ( 12.2 )]. Cov kev soj ntsuam no yuav tsum tau txiav txim siab hauv kev txiav txim siab kho mob thaum sau ntawv Levitra rau cov neeg mob uas paub keeb kwm ntawm QT ncua ntev lossis cov neeg mob uas tau noj tshuaj paub kom ncua QT ncua.

Cov neeg mob noj Class 1A (piv txwv li. Quinidine, procainamide) lossis Chav III (piv txwv li, amiodarone, sotalol) cov tshuaj tiv thaiv kab mob ntshav qab zib lossis cov uas muaj QT ncua sijhawm ntev, yuav tsum zam kev siv Levitra.

Hepatic tsis zoo

Kev hloov kho tshuaj yog qhov tsim nyog rau cov neeg mob uas muaj kab mob siab tsis zoo (Child-Pugh B). Tsis txhob siv Levitra hauv cov neeg mob uas muaj mob hnyav (Child-Pugh C).[Saib Dosage thiab Administration ( 2.3 ) Clinical Pharmacology ( 12.3 )] thiab Siv Hauv Cov Pej Xeem Tshwj Xeeb ( 8.6 ).]

Lub raum tsis zoo

Tsis txhob siv Levitra hauv cov neeg mob ntawm lub raum lim dej, vim tias vardenafil tsis tau tshuaj xyuas hauv cov neeg no[saib Dosage thiab Administration ( 2.3 ) thiab Siv Hauv Cov Pej Xeem Tshwj Xeeb ( 8.7 )].

Ua ke nrog Lwm Yam Kev Kho Erectile Dysfunction

Kev nyab xeeb thiab ua tau zoo ntawm Levitra siv ua ke nrog lwm yam kev kho rau kev ua haujlwm tsis muaj zog tsis tau kawm. Yog li, kev siv cov kev sib txuas ua ke no tsis pom zoo.

Teeb meem los ntshav

Hauv tib neeg, vardenafil ib leeg hauv koob tshuaj txog 20 mg tsis ua rau lub sijhawm los ntshav. Tsis muaj pov thawj kho mob ntawm ib qho tshuaj ntxiv rau lub sijhawm los ntshav thaum siv vardenafil nrog tshuaj aspirin. Levitra tsis tau muab rau cov neeg mob uas muaj ntshav tsis txaus lossis ua rau lub plab ua haujlwm hnyav. Yog li Levitra yuav tsum tau muab rau cov neeg mob no tom qab ua tib zoo tshuaj xyuas qhov kev pheej hmoo.

Kab Mob Sib Kis

Kev siv Levitra tsis muaj kev tiv thaiv kab mob sib kis los ntawm kev sib deev. Kev sab laj ntawm cov neeg mob txog kev tiv thaiv tsim nyog yuav tsum tiv thaiv kab mob sib kis, suav nrog Human Immunodeficiency Virus (HIV), yuav tsum tau txiav txim siab.

Cov Teeb Meem Tsis Zoo

Cov teeb meem tsis zoo hauv qab no nrog kev siv Levitra (vardenafil) tau tham txog lwm qhov hauv daim ntawv lo:

1
Teeb meem plawv[saib Contraindications ( 4.1 ) thiab Ceeb Toom thiab Ceev faj ( 5.1 )]
2.
Priapism[saib Cov Lus Ceeb Toom thiab Ceev faj ( 5.3 )]
3
Los Ntawm Qhov Muag[saib Cov Lus Ceeb Toom thiab Ceev faj ( 5.4 )]
Plaub.
Tsis hnov ​​lus li cas[saib Cov Lus Ceeb Toom thiab Ceev faj ( 5.5 )]
5.
QT Kev Ncua Sijhawm[saib Cov Lus Ceeb Toom thiab Ceev faj ( 5.7 )]

Kev Kawm Kho Mob

Vim tias kev sim tshuaj tau ua nyob hauv ntau qhov xwm txheej sib txawv, cov txiaj ntsig tsis zoo tshwm sim hauv kev sim tshuaj ntawm cov tshuaj tsis tuaj yeem sib piv ncaj qha rau tus nqi hauv kev sim tshuaj ntawm lwm cov tshuaj thiab yuav tsis cuam tshuam txog cov txiaj ntsig tau pom hauv kev coj ua.

Levitra tau ua rau ntau dua 4430 tus txiv neej (hnub nyoog nruab nrab 56, thaj tsam 18-89 xyoo; 81% Dawb, 6% Dub, 2% Neeg Esxias, 2% Neeg Hispanic thiab 9% Lwm Tus) thaum tswj hwm thiab tswj tsis tau tshuaj kho mob thoob ntiaj teb. Tshaj 2200 tus neeg mob tau kho rau 6 lub hlis lossis ntev dua thiab 880 tus neeg mob tau kho yam tsawg 1 xyoos.

Hauv kev sim tshuaj ntsuam xyuas cov tshuaj placebo, qhov kev txiav tawm vim muaj cov xwm txheej tsis zoo yog 3.4% rau Levitra piv rau 1.1% rau cov placebo.

Thaum Levitra tau ua raws li kev pom zoo hauv kev sim tshuaj-tshuaj kho mob, cov kev tsis zoo hauv qab no tau tshaj tawm (saib Cov Lus 1).

Rooj 1: Cov Lus Qhia Tsis Zoo Tshaj Tawm los ntawm ≧ 2% ntawm Cov Neeg Mob Kho nrog Levitra thiab nquag siv tshuaj ntau dua li cov placebo hauv kev kho thiab hloov pauv tau * Dose Randomized, Tswj Kev sim ntawm 5 mg, 10 mg, lossis 20 mg Vardenafil
Teeb meem tsis haum Feem pua ​​ntawm Cov Neeg Mob Qhia Txog Cov Tshuaj
Cov placebo
N = 1199 Nws
Levitra
N = 2203 ib
*
Kev kawm tshuaj txhaj tau yooj yim pib txhua tus neeg mob ntawm Levitra 10 mg thiab tso cai txo qis rau hauv 5 mg lossis nce ntxiv rau 20 mg raws li kev phiv thiab ua tau zoo.
& rab riam;
Txhua qhov xwm txheej tau teev tseg hauv cov lus saum toj no tau suav tias yog kev phiv tshuaj tshwj xeeb tshwj tsis yog raug xwm txheej.

Mob taub hau

4%

kaum tsib%

Yaug

1%

kaum ib%

Rhinitis

3%

9%

Dyspepsia

1%

4%

Kev raug mob & rab riam;

2%

3%

Mob sinusitis

1%

3%

Mob khaub thuas

2%

3%

Kiv taub hau

1%

2%

Nce Creatine Kinase

1%

2%

Xeev siab

1%

2%

Mob nraub qaum tau tshaj tawm hauv 2.0% ntawm cov neeg mob kho nrog Levitra thiab 1.7% ntawm cov neeg mob ntawm cov placebo.

Kev sim tshuaj-tswj cov tshuaj placebo qhia pom qhov ua rau muaj qhov tshwm sim ntawm qee qhov kev phiv tshuaj (mob taub hau, yaug, ua tsis taus pa, xeev siab, thiab mob rhinitis) ntau dua 5 mg, 10 mg, thiab 20 mg koob tshuaj Levitra.

Txhua Vardenafil Studies:Levitra zaj duab xis-coated ntsiav tshuaj thiab vardenafil qhov ncauj disintegrating ntsiav tshuaj tau muab rau ntau dua 17,000 tus txiv neej (txhais hnub nyoog 54.5, thaj tsam 18-89 xyoo; 70% Dawb, 5% Dub, 13% Neeg Esxias, 4% Neeg Hispanic thiab 8% Lwm Yam) thaum tswj hwm thiab tsis muaj kev tswj hwm kev sim tshuaj thoob ntiaj teb. Cov neeg mob kho rau 6 lub hlis lossis ntev dua yog 3357, thiab 1350 tus neeg mob tau kho yam tsawg 1 xyoos.

Hauv qhov kev sim tshuaj-tswj cov kev sim tshuaj rau Levitra zaj duab xis-coated ntsiav tshuaj thiab vardenafil qhov ncauj ua rau cov ntsiav tshuaj tawg, qhov kev txiav tawm vim yog cov xwm txheej tsis zoo yog 1.9% rau vardenafil piv rau 0.8% rau cov placebo.

Tshooj lus hauv qab no txheeb xyuas ntxiv, tsis tshua muaj tshwm sim tsis zoo tshwm sim (<2%) reported during the clinical development of Levitra film-coated tablets and vardenafil orally disintegrating tablets. Excluded from this list are those adverse reactions that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug:

Lub cev tag nrho:ua xua ua xua thiab angioedema, tsis xis nyob, tsis haum tshuaj, mob hauv siab

Hnov:tinnitus, vertigo

Lub plawv:palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension

Plab:xeev siab, mob plab thiab mob plab, lub qhov ncauj qhuav, raws plab, kab mob gastroesophageal reflux, gastritis, ntuav, nce hauv transaminases

Cov leeg musculoskeletal:nce hauv creatine phosphokinase (CPK), nce cov leeg nqaij thiab cramping, myalgia

Nervous:paresthesia thiab dysesthesia, tsaug zog, pw tsis tsaug zog, syncope, amnesia, qaug dab peg

Ua pa:dyspnea, qhov ntswg congestion

Cov tawv nqaij thiab cov ntawv ntxiv:erythema, ua pob

Kev kho qhov muag:qhov muag tsis pom kev, qhov muag tsis pom kev, qhov muag tsis pom xim, qhov muag mob thiab qhov muag tsis pom, photophobia, nce hauv siab hauv siab, kab mob sib kis

Cov kab mob urogenital:nce hauv erection, priapism

Kev Tshaj Tawm Tom Qab Muag

Cov kev tsis zoo hauv qab no tau raug txheeb xyuas thaum pom zoo siv Levitra. Vim tias cov tshuaj tiv thaiv no tau tshaj tawm los ntawm cov pejxeem ntawm qhov tsis paub meej, nws ib txwm tsis tuaj yeem kwv yees lawv zaus lossis tsim kom muaj kev sib raug zoo nrog rau cov tshuaj.

Kev kho qhov muag:Tsis-arteritic anterior ischemic optic neuropathy (NAION), ua rau tsis pom kev suav nrog qhov tsis pom kev tas mus li, tau tshaj tawm tsis tshua muaj kev lag luam tom ntej nrog kev siv PDE5 inhibitors, suav nrog vardenafil. Feem ntau, tab sis tsis yog txhua tus, ntawm cov neeg mob no muaj lub hauv paus anatomic lossis vascular muaj feem cuam tshuam rau kev txhim kho ntawm NAION, suav nrog tab sis tsis tas yuav txwv rau: khob tsawg rau qhov sib piv (cov neeg coob coob), hnub nyoog tshaj 50 xyoo, mob ntshav qab zib, mob ntshav siab, kab mob hauv lub plawv, hyperlipidemia thiab haus luam yeeb[saib Cov Lus Ceeb Toom thiab Ceev faj ( 5.4 ) thiab Cov Lus Qhia Txog Tus Neeg Mob ( 17 )].

Qhov muag tsis pom kev suav nrog qhov muag tsis pom (ib ntus lossis tas mus li), xws li qhov muag tsis pom kev, qhov muag pom qhov muag, thiab txo qhov muag pom kev, kuj tau tshaj tawm tsis tshua muaj nyob hauv kev muag khoom tom ntej. Nws tsis tuaj yeem txiav txim siab seb cov xwm txheej no cuam tshuam ncaj qha rau kev siv vardenafil.

Neurologic:Kev qaug dab peg, qaug dab peg rov tshwm sim thiab ua rau lub ntiaj teb tsis nco qab tau raug tshaj tawm tom qab ua lag luam hauv kev sib raug zoo nrog vardenafil.

Otology:Cov xwm txheej ntawm kev poob qis lossis tsis hnov ​​lus tau tshaj tawm tomqab muag khoom hauv lub sijhawm luv nrog kev siv PDE5 inhibitors, suav nrog vardenafil. Qee qhov xwm txheej, kev kho mob thiab lwm yam tau tshaj tawm uas tej zaum kuj tseem ua lub luag haujlwm hauv cov xwm txheej tsis zoo. Hauv ntau qhov xwm txheej, kev tshuaj xyuas cov ntaub ntawv raug txwv. Nws tsis tuaj yeem txiav txim siab seb cov xwm txheej tau tshaj tawm no cuam tshuam ncaj qha rau kev siv vardenafil, rau tus neeg mob qhov kev pheej hmoo ntawm kev hnov ​​lus tsis hnov ​​lus, ua ke ntawm cov xwm txheej no, lossis rau lwm yam[saib Cov Lus Qhia Txog Tus Neeg Mob ( 17 )].

Kev Sib Tham Tshuaj

Muaj peev xwm rau Pharmacodynamic Sib cuam tshuam nrog Levitra

Nitrates:Kev siv ua ke ntawm Levitra thiab nitrates thiab cov neeg pub dawb nitric oxide yog contraindicated. Ntshav siab txo qis cov txiaj ntsig ntawm sublingual nitrates (0.4 mg) noj 1 thiab 4 teev tom qab vardenafil thiab nce hauv lub plawv thaum noj ntawm 1, 4 thiab 8 teev tom qab vardenafil tau muaj zog los ntawm 20 mg ntawm Levitra hauv cov neeg muaj hnub nyoog nruab nrab noj qab haus huv . Cov teebmeem no tsis tau pom thaum Levitra 20 mg tau noj 24 teev ua ntej nitroglycerin (NTG). Kev muaj peev xwm ntawm cov tshuaj hypotensive ntawm nitrates rau cov neeg mob uas mob plawv ischemic tsis tau tshuaj xyuas, thiab kev siv ua ke ntawm Levitra thiab nitrates yog contraindicated[saib Contraindications ( 4.1 ) thiab Clinical Pharmacology ( 12.2 ).

Alpha-Blockers:Ceev faj yog qhia thaum PDE5 inhibitors koom nrog alpha-blockers. PDE5 inhibitors, suav nrog Levitra thiab alpha-adrenergic thaiv cov neeg sawv cev yog ob leeg vasodilators nrog ntshav-siab-txo cov teebmeem. Thaum vasodilators tau siv ua ke, cov txiaj ntsig ntxiv ntawm cov ntshav siab tuaj yeem xav tau. Kev tshawb fawb tshuaj kho mob tau ua tiav nrog kev sib koom ua ke ntawm vardenafil nrog alfuzosin, terazosin lossis tamsulosin.[Saib Dosage thiab Administration ( 2.4 ), Ceeb Toom thiab Ceev faj ( 5.6 ), thiab Clinical Pharmacology ( 12.2 ).]

Antihypertensives: cov tsos mobLevitra tuaj yeem ntxiv rau cov ntshav siab txo qis los ntawm cov tshuaj tiv thaiv kab mob siab. Hauv kev tshawb fawb tshuaj kho mob ntawm cov neeg mob erectile kawg, ib koob ntawm vardenafil 20 mg ua rau lub siab poob qis tshaj ntawm cov ntshav siab ntawm 7 mmHg systolic thiab 8 mmHg diastolic (piv rau cov placebo), nrog los ntawm qhov nruab nrab siab tshaj plaws ntawm lub plawv dhia ntawm 4 neeg ntaus ib feeb. Qhov siab tshaj plaws hauv cov ntshav tau tshwm sim ntawm 1 txog 4 teev tom qab noj tshuaj. Ua raws ntau qhov kev txhaj tshuaj rau 31 hnub, cov lus teb ntshav siab zoo ib yam tau pom nyob rau Hnub 31 ib yam li Hnub 1.

Cawv:Levitra (20 mg) tsis ua rau muaj kev cuam tshuam hypotensive ntawm cawv thaum lub sijhawm 4-teev kev soj ntsuam hauv cov neeg pab dawb noj qab haus huv thaum siv cawv (0.5 g/kg lub cev hnyav, kwv yees li 40 mL ntawm cawv cawv hauv 70 kg tus neeg). Cawv thiab vardenafil qib ntshav tsis tau hloov pauv thaum siv ib txhij.

Cov nyhuv ntawm Lwm Yam Tshuaj ntawm Vardenafil

Kev tshawb fawb hauv vitro

Cov kev tshawb fawb hauv tib neeg lub siab microsomes tau qhia tias vardenafil tau hloov pauv feem ntau los ntawm cytochrome P450 (CYP) isoforms 3A4/5, thiab mus rau qib qis dua los ntawm CYP2C9. Yog li, cov tshuaj tiv thaiv ntawm cov enzymes no xav kom txo vardenafil tshem tawm[saib Dosage thiab Administration ( 2.4 ) thiab Ceeb Toom thiab Ceev faj ( 5.2 )].

Hauv kev kawm vivo

Muaj zog CYP3A4 inhibitors

Ketoconazole (200 mg ib hnub ib hnub) ua rau nce 10-npaug hauv vardenafil AUC thiab nce 4-npaug nce siab tshaj plaws (C)max max ua) thaum koom nrog Levitra (5 mg) hauv cov neeg ua haujlwm pab dawb noj qab haus huv. 5-mg Levitra koob tshuaj yuav tsum tsis pub dhau 24-teev sijhawm thaum siv ua ke nrog 200 mg ib zaug ib hnub ketoconazole. Txij li cov koob tshuaj ketoconazole ntau dua (400 mg txhua hnub) tuaj yeem ua rau nce siab hauv C.max max uathiab AUC, ib koob tshuaj 2.5 mg ntawm Levitra yuav tsum tsis pub dhau 24 teev nyob rau lub sijhawm siv nrog ketoconazole 400 mg txhua hnub.[Saib Dosage thiab Administration ( 2.4 ) thiab Ceeb Toom thiab Ceev faj ( 5 ).]

Indinavir (800 mg td) sib koom ua ke nrog Levitra 10 mg ua rau muaj 16-npaug nce ntawm vardenafil AUC, nce 7 zaug hauv vardenafil Cmax max uathiab 2-npaug nce hauv vardenafil ib nrab-lub neej. Nws tau pom zoo kom tsis pub ntau tshaj 2.5 mg Levitra ib zaug hauv 24-teev sijhawm thaum siv ua ke nrog indinavir.[Saib Dosage thiab Administration ( 2.4 ) thiab Ceeb Toom thiab Ceev faj ( 5.2 ).]

Ritonavir (600 mg bd) sib koom ua ke nrog Levitra 5 mg ua rau 49-npaug nce ntawm vardenafil AUC thiab nce 13-vardenafil Cmax max ua. Kev sib cuam tshuam yog qhov tshwm sim ntawm kev thaiv cov metabolism hauv vardenafil los ntawm ritonavir, tus tiv thaiv kab mob HIV tiv thaiv kab mob thiab CYP3A4 inhibitor muaj zog heev, uas tseem tiv thaiv CYP2C9. Ritonavir ua rau muaj kev ncua ntev ib nrab ntawm vardenafil mus rau 26 teev. Thiaj li, nws tau pom zoo kom tsis pub ntau tshaj 2.5 mg Levitra koob tshuaj hauv 72-teev sijhawm thaum siv ua ke nrog ritonavir.[Saib Dosage thiab Administration ( 2.4 ) thiab Ceeb Toom thiab Ceev faj ( 5.2 ).].

Nruab nrab CYP3A4 inhibitors

Erythromycin (500 mg t.d.) ua rau 4-npaug nce hauv vardenafil AUC thiab nce 3-npaug hauv Cmax max uathaum ua ke nrog Levitra 5 mg hauv kev noj qab haus huv tuaj pab dawb. Nws tau pom zoo kom tsis pub dhau 5 mg koob tshuaj Levitra hauv 24-teev sijhawm thaum siv ua ke nrog erythromycin.[Saib Dosage thiab Administration ( 2.4 ) thiab Ceeb Toom thiab Ceev faj ( 5 ).]

Txawm hais tias kev sib cuam tshuam tshwj xeeb tsis tau kawm, lwm yam CYP3A4 inhibitors, suav nrog kua txiv kab ntxwv qaub yuav ua rau vardenafil raug ntau.

Lwm Yam Kev Sib Tham Tshuaj

Tsis muaj kev sib cuam tshuam ntawm pharmacokinetic tau pom ntawm vardenafil thiab cov tshuaj hauv qab no: glyburide, warfarin, digoxin, antacid raws li magnesium-aluminium hydroxide, thiab ranitidine. Hauv kev tshawb fawb warfarin, vardenafil tsis muaj kev cuam tshuam rau lub sijhawm prothrombin lossis lwm yam tshuaj pharmacodynamic.

Cimetidine (400 mg bd) tsis muaj kev cuam tshuam rau vardenafil bioavailability (AUC) thiab siab tshaj concentration (C)max max ua) ntawm vardenafil thaum koom nrog 20 mg Levitra hauv cov neeg ua haujlwm pab dawb noj qab haus huv.

Teeb meem ntawm Vardenafil rau Lwm Yam Tshuaj

Kev tshawb fawb hauv vitro

Vardenafil thiab nws cov metabolites tsis muaj kev cuam tshuam rau CYP1A2, 2A6, thiab 2E1 (Ki> 100 micromolar). Tsis muaj zog tiv thaiv kev cuam tshuam rau lwm isoforms (CYP2C8, 2C9, 2C19, 2D6, 3A4) tau pom, tab sis Ki cov txiaj ntsig tau dhau ntawm cov ntshav ntau ntau ua tiav tom qab noj tshuaj. Kev ua kom muaj zog tshaj plaws tau pom rau vardenafil metabolite M1, uas muaj Ki ntawm 1.4 micromolar mus rau CYP3A4, uas yog kwv yees li 20 npaug siab dua M1 Cmax qhov muaj txiaj ntsig tom qab 80 mg vardenafil koob tshuaj.

Hauv kev kawm vivo

Nifedipine:Vardenafil 20 mg, thaum ua ke nrog kev tso tawm qeeb nifedipine 30 mg lossis 60 mg ib hnub ib zaug, tsis cuam tshuam rau AUC lossis Cmax max uantawm nifedipine, tshuaj uas tau hloov pauv ntawm CYP3A4. Nifedipine tsis hloov pauv qib ntshav ntawm Levitra thaum noj ua ke. Hauv cov neeg mob no uas tau tswj hwm ntshav siab nrog nifedipine, Levitra 20 mg ua rau txhais tau tias ntxiv supine systolic/diastolic ntshav siab txo ntawm 6/5 mmHg piv rau cov placebo.

Ritonavir thiab Indinavir:Thaum ua thawj coj ntawm 5 mg ntawm Levitra nrog 600 mg BID ritonavir, Cmax max uathiab AUC ntawm ritonavir tau raug txo los ntawm kwv yees li 20%. Thaum tswj hwm 10 mg ntawm Levitra nrog 800 mg TID indinavir, Cmax max uathiab AUC ntawm indinavir tau raug txo los ntawm 40% thiab 30%, feem.

Tshuaj Aspirin:Levitra (10 mg thiab 20 mg) tsis muaj zog ntxiv rau lub sijhawm los ntshav los ntawm tshuaj aspirin (ob lub tshuaj 81 mg).

Lwm yam kev sib tshuam:Levitra tsis muaj kev cuam tshuam rau cov tshuaj pharmacodynamics ntawm glyburide (piam thaj thiab insulin ntau ntau) thiab warfarin (lub sijhawm prothrombin lossis lwm yam tshuaj pharmacodynamic tsis).

Siv HAUV TSEV NEEG POPULATIONS

Cev xeeb tub

Cev xeeb tub qeb B

Levitra tsis qhia rau siv rau poj niam. Tsis muaj kev tshawb fawb txog Levitra siv rau poj niam cev xeeb tub. Tsis muaj pov thawj ntawm qhov muaj peev xwm tshwj xeeb rau teratogenicity, embryotoxicity lossis fetotoxicity tau pom hauv nas thiab luav uas tau txais vardenafil txog li 18 mg/kg/hnub thaum lub sijhawm tsim khoom. Qhov koob tshuaj no yog kwv yees li 100 npaug (nas) thiab 29 npaug (luav) ntau dua li AUC qhov tseem ceeb rau vardenafil tsis muaj qhov txwv thiab nws cov metabolite loj hauv tib neeg muab qhov siab tshaj plaws qhia rau tib neeg (MRHD) ntawm 20 mg.

Hauv kev kawm ua ntej thiab tom qab yug menyuam, NOAEL (tsis pom muaj qib tsis zoo) rau niam lub cev tsis zoo yog 8 mg/kg/hnub. Kev txhim kho lub cev ntawm cov menyuam yaus thaum tsis muaj kev cuam tshuam los ntawm niam tau pom tom qab niam tau txais 1 thiab 8 mg/kg tej zaum vim yog vasodilatation thiab/lossis tso tshuaj rau hauv mis. Tus naj npawb ntawm cov menyuam yaus uas yug los rau nas tau nthuav tawm ua ntej thiab tom qab yug menyuam tau txo qis ntawm 60 mg/kg/hnub. Raws li cov txiaj ntsig ntawm kev kawm ua ntej thiab tom qab yug menyuam, kev txhim kho NOAEL tsawg dua 1 mg/kg/hnub. Raws li kev nthuav tawm ntshav hauv cov nas kawm kev txhim kho kev mob toxicity, 1 mg/kg/hnub hauv cov menyuam yaus cev xeeb tub tau kwv yees los tsim tag nrho AUC qhov tseem ceeb rau vardenafil tsis txwv thiab nws cov metabolite loj piv rau tib neeg AUC ntawm MRHD ntawm 20 mg.

Niam laus

Levitra tsis qhia rau siv rau poj niam. Nws tsis paub yog tias vardenafil raug tso tawm hauv tib neeg lub mis niam.

Vardenafil tau zais rau hauv cov mis nyuj ntawm cov nas lactating ntawm cov concentration kwv yees li 10-npaug ntau dua li pom hauv cov ntshav. Tom qab txhaj tshuaj ib zaug ntawm 3 mg/kg, 3.3% ntawm cov tshuaj tau muab tso rau hauv cov mis hauv 24 teev.

Kev Siv Menyuam Yaus

Levitra tsis qhia rau siv hauv cov neeg mob menyuam yaus. Kev nyab xeeb thiab ua tau zoo tseem tsis tau tsim nyob hauv cov neeg no.

Kev siv Geriatric

Cov txiv neej laus dua 65 xyoos thiab laus dua muaj vardenafil ntshav ntau dua li cov txiv neej hluas (18 - 45 xyoos), txhais tau tias Cmax thiab AUC yog 34% thiab 52% siab dua, feem. Theem 3 kev sim tshuaj suav nrog ntau dua 834 tus neeg mob laus, thiab tsis muaj qhov sib txawv hauv kev nyab xeeb lossis ua haujlwm tau zoo ntawm Levitra 5, 10, lossis 20 mg tau sau tseg thaum cov neeg mob laus no piv rau cov neeg mob yau. Txawm li cas los xij, vim tias muaj vardenafil ntau ntxiv hauv cov neeg laus, pib txhaj tshuaj ntawm 5 mg Levitra yuav tsum tau txiav txim siab hauv cov neeg mob ≧ 65 xyoos[saib Clinical Pharmacology ( 12.3 )].

Hepatic tsis zoo

Kev hloov kho tshuaj yog qhov tsim nyog rau cov neeg mob uas muaj kab mob siab tsis zoo.

Tsis txhob siv Levitra rau cov neeg mob uas muaj lub cev tsis zoo (Child-Pugh C). Vardenafil tsis tau tshuaj xyuas hauv cov neeg mob no.

Thawj koob tshuaj ntawm 5 mg tau pom zoo hauv cov neeg mob uas muaj lub cev tsis zoo (Child-Pugh B) thiab qhov siab tshaj plaws yuav tsum tsis pub tshaj 10 mg. Hauv cov neeg ua haujlwm pab dawb uas muaj lub cev tsis zoo, Cmax max uathiab AUC tom qab 10 mg vardenafil koob tshuaj tau nce 130% thiab 160%, feem, piv rau kev tswj hwm kev noj qab haus huv.[Saib Cov Lus Ceeb Toom thiab Ceev faj ( 5.8 ) thiab Dosage and Administration ( 2.3 ).]

Hauv cov neeg ua haujlwm pab dawb uas muaj lub cev tsis zoo (Child-Pugh A), C.max max uathiab AUC tom qab 10 mg vardenafil koob tau nce 22% thiab 17%, feem, piv rau kev tswj hwm kev noj qab haus huv. Tsis tas yuav hloov tshuaj ntau npaum li cas hauv cov neeg mob uas muaj lub cev tsis zoo.

Lub raum tsis zoo

Tsis txhob siv Levitra hauv cov neeg mob ntawm kev lim ntshav raws li vardenafil tsis tau tshuaj xyuas hauv cov neeg mob ntawd.

Tsis tas yuav hloov kho tshuaj ntxiv rau cov neeg mob nrog kev tshem tawm creatinine (CLcr) ntawm 30-80 mL/min. Hauv cov txiv neej ua haujlwm pab dawb nrog CLcr = 50-80 ml/min, cov tshuaj pharmacokinetics ntawm vardenafil zoo ib yam li cov tau pom hauv pawg tswj hwm nrog CLcr> 80 mL/min. Hauv cov txiv neej ua haujlwm pab dawb nrog CLcr = 30-50 mL/min lossis CLcr<30 mL/min, the AUC of vardenafil was 20–30% higher compared to that observed in a control group with CLcr>80 ml/feeb[Saib Dosage thiab Administration ( 2.3 ) thiab Ceeb Toom thiab Ceev faj ( 5.9 ).]

Tshaj dhau

Qhov siab tshaj plaws ntawm Levitra uas tib neeg cov ntaub ntawv muaj yog ib qho 120 mg koob tshuaj rau cov txiv neej ua haujlwm pab dawb. Feem ntau ntawm cov ncauj lus no tau ntsib kev mob nraub qaum rov qab/myalgia thiab/lossis tsis pom kev txawv txav. Kev txhaj tshuaj ib zaug txog 80 mg vardenafil thiab ntau koob mus txog 40 mg vardenafil tau siv ib zaug ib hnub dhau 4 lub lis piam tau zam rau yam tsis ua rau muaj kev phiv loj.

Thaum 40 mg ntawm vardenafil tau siv ob zaug ib hnub, cov tsos mob ntawm mob nraub qaum tau pom. Tsis tau txheeb xyuas cov leeg nqaij lossis lub paj hlwb.

Nyob rau hauv cov ntaub ntawv ntawm overdose, tus qauv txhawb nqa kev ntsuas yuav tsum tau ua raws li qhov xav tau. Kev lim ntshav hauv lub raum tsis xav kom nrawm dua kev tshem tawm vim tias vardenafil tau khi ntau rau cov ntshav ntshav thiab tsis raug tshem tawm hauv cov zis.

Kev piav qhia Levitra

Levitra (vardenafil hydrochloride) tau hais lus rau kev kho mob erectile kawg. Qhov no monohydrochloride ntsev ntawm vardenafil yog xaiv cov tshuaj tiv thaiv ntawm cyclic guanosine monophosphate (cGMP) -specific phosphodiesterase type 5 (PDE5).

Vardenafil HCl raug xaiv ua tshuaj raws li piperazine, 1-[[3- (1,4-dihydro-5-methyl-4-oxo-7-propylimidazo] [5,1-f] [1,2,4] triazin-2-yl) -4-ethoxyphenyl] sulfonyl] -4-ethyl-, monohydrochloride thiab muaj cov qauv hauv qab no:

Vardenafil HCl yog ze li tsis muaj xim, muaj cov khoom hnyav nrog lub cev hnyav ntawm 579.1 g/mol thiab qhov sib tov ntawm 0.11 mg/mL hauv dej.

Levitra tau tsim ua txiv kab ntxwv, puag ncig, zaj duab xis-coated ntsiav tshuaj nrog BAYER hla debossed ntawm ib sab thiab 5, 10, thiab 20 ntawm lwm sab sib xws rau 5 mg, 10 mg, thiab 20 mg ntawm vardenafil, feem. Ntxiv rau cov khoom xyaw nquag, vardenafil HCl, txhua lub ntsiav tshuaj muaj microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, daj ferric oxide, thiab liab ferric oxide.

Levitra - Clinical Pharmacology

Mechanism of Action

Kev ua kom cov qau yog txheej txheem hemodynamic pib los ntawm kev so ntawm cov leeg du hauv lub corpus cavernosum thiab nws cov hlab ntsha txuam nrog. Thaum lub sijhawm txhawb kev sib deev, nitric oxide raug tso tawm los ntawm cov hlab ntsha kawg thiab cov hlab ntshav endothelial hauv lub corpus cavernosum. Nitric oxide ua kom cov enzyme guanylate cyclase ua rau muaj kev sib xyaw ua ke ntawm cyclic guanosine monophosphate (cGMP) hauv cov leeg nqaij ntawm cov leeg nqaij ntawm corpus cavernosum. Lub cGMP tig ua rau cov leeg nqaij so, tso ntshav ntxiv rau hauv qhov chaw mos, ua rau muaj kev txhim kho. Cov ntaub so ntswg ntawm cGMP raug tswj los ntawm ob qho tib si tus nqi ntawm kev sib xyaw thiab kev puas tsuaj ntawm phosphodiesterases (PDEs). PDE ntau tshaj plaws hauv tib neeg lub cev cavernosum yog cGMP-tshwj xeeb phosphodiesterase type 5 (PDE5); yog li ntawd, kev txwv ntawm PDE5 txhim kho kev ua haujlwm erectile los ntawm kev nce tus nqi ntawm cGMP. Vim tias kev txhawb kev sib deev yuav tsum tau pib ua qhov tso tawm hauv zos ntawm nitric oxide, kev txwv ntawm PDE5 tsis muaj kev cuam tshuam thaum tsis muaj kev txhawb nqa kev sib deev.

Hauv vitrocov kev tshawb fawb tau qhia tias vardenafil yog tus xaiv inhibitor ntawm PDE5. Qhov cuam tshuam ntawm vardenafil yog xaiv ntau dua ntawm PDE5 dua li lwm qhov paub phosphodiesterases (> 15-ntu txheeb ze rau PDE6,> 130-ntu txheeb ze rau PDE1,> 300-ntu txheeb ze rau PDE11, thiab> 1,000-quav txheeb ze rau PDE2, 3 4, 7, 8, 9, thiab 10).

Pharmacodynamics

Los Ntawm Ntshav Siab

Hauv kev tshawb fawb tshuaj kho mob ntawm cov neeg mob erectile kawg, ib koob ntawm vardenafil 20 mg ua rau lub siab poob qis tshaj ntawm cov ntshav siab ntawm 7 mmHg systolic thiab 8 mmHg diastolic (piv rau cov placebo), nrog los ntawm qhov nruab nrab siab tshaj plaws ntawm lub plawv dhia ntawm 4 neeg ntaus ib feeb. Qhov siab tshaj plaws hauv cov ntshav tau tshwm sim ntawm 1 txog 4 teev tom qab noj tshuaj. Ua raws ntau qhov kev txhaj tshuaj rau 31 hnub, cov lus teb ntshav siab zoo ib yam tau pom nyob rau Hnub 31 zoo li Hnub 1. Vardenafil tuaj yeem ntxiv rau cov ntshav siab txo qis los ntawm cov tshuaj tiv thaiv kev tiv thaiv ntshav siab[saib yeeb tshuaj yeeb tshuaj ( 7 )].

Teeb meem ntawm Ntshav Siab thiab Lub Plawv Tus Nqi Thaum Levitra Ua Ke nrog Nitrates

Ib txoj kev tshawb fawb tau tshawb nrhiav qhov ntsuas ntshav siab thiab lub plawv teb rau 0.4 mg nitroglycerin (NTG) sublingually tau tshuaj xyuas hauv 18 yam kev noj qab haus huv tom qab kho nrog Levitra 20 mg ntawm ntau lub sijhawm ua ntej NTG kev tswj hwm. Levitra 20 mg ua rau muaj sij hawm ntxiv ntsig txog txo ntshav siab thiab nce hauv lub plawv hauv kev koom nrog NTG cov thawj coj. Kev ntsuas ntshav siab tau pom thaum Levitra 20 mg tau txhaj tshuaj 1 lossis 4 teev ua ntej NTG thiab lub plawv dhia cuam tshuam tau pom thaum 20 mg tau txhaj tshuaj 1, 4, lossis 8 teev ua ntej NTG. Ntshav siab ntxiv thiab hloov pauv lub plawv tsis pom thaum Levitra 20 mg tau txhaj 24 teev ua ntej NTG. (Saib daim duab 1.)

Daim duab 1: Cov qhab-nees rho tawm qhov kwv yees kwv yees (nrog 90% CI) ntawm qhov siab tshaj plaws ntshav siab thiab lub plawv dhia cuam tshuam ntawm kev noj tshuaj ua ntej nrog vardenafil 20 mg ntawm 24, 8, 4, thiab 1 teev ua ntej 0.4 mg NTG sublingually

Vim tias qhov xwm txheej ntawm cov neeg mob xav tau kev kho mob nitrate tau cia siab tias yuav ua rau muaj kev pheej hmoo ntawm hypotension, kev siv vardenafil los ntawm cov neeg mob ntawm kev kho nitrate lossis ntawm nitric oxide donors yog contraindicated[saib Contraindications ( 4.1 )].

Ntshav Siab Teeb Meem Hauv Cov Neeg Mob ntawm Kev Kho Kom Ruaj Alpha-Blocker

Peb txoj kev tshawb fawb tshuaj kho mob tau ua hauv cov neeg mob uas muaj benign prostatic hyperplasia (BPH) ntawm kev kho kom ruaj khov-alpha-blocker kho, suav nrog alfuzosin, tamsulosin lossis terazosin.

Kawm 1:Txoj kev tshawb no tau tsim los ntsuas qhov txiaj ntsig ntawm 5 mg vardenafil piv rau cov placebo thaum muab rau cov neeg mob BPH ntawm kev kho mob alpha-blocker ntev nyob hauv ob pawg sib cais: tamsulosin 0.4 mg txhua hnub (cohort 1, n = 21) thiab terazosin 5 lossis 10 mg txhua hnub (pawg 2, n = 21). Kev tsim qauv yog kev xaiv ua ob, dig muag, hla kev kawm nrog plaub qhov kev kho mob: vardenafil 5 mg lossis cov tshuaj placebo tau siv ib txhij nrog alpha-blocker thiab vardenafil 5 mg lossis placebo muab 6 teev tom qab alpha-blocker. Ntshav siab thiab mem tes tau ntsuas dua li 6 teev ua haujlwm tom qab siv vardenafil. Rau cov ntshav siab (BP) cov txiaj ntsigsaib Table 2. Ib tus neeg mob tom qab kho tas li nrog 5 mg vardenafil thiab 10 mg terazosin nthuav tawm cov tsos mob hypotension nrog cov ntshav siab txog 80/60 mmHg tshwm sim ib teev tom qab kev tswj hwm thiab tom qab mob taub hau me ntsis thiab mob taub hau me ntsis ntev li 6 teev. Rau vardenafil thiab cov placebo, tsib thiab ob tus neeg mob, feem, tau ntsib kev txo qis hauv kev nce ntshav systolic ntshav siab (SBP) ntawm> 30 mmHg tom qab kev tswj hwm terazosin ib txhij. Hypotension tsis tau pom thaum vardenafil 5 mg thiab terazosin tau siv 6 teev sib nrug. Tom qab kev tswj hwm ua ke ntawm vardenafil 5 mg thiab tamsulosin, ob tus neeg mob tau sawv SBP ntawm<85 mmHg. A decrease in standing SBP of>30 mmHg tau pom hauv ob tus neeg mob ntawm tamsulosin tau txais vardenafil ib txhij thiab hauv ib tus neeg mob tau txais kev kho mob ua ke nrog cov placebo. Thaum tamsulosin thiab vardenafil 5 mg tau sib cais los ntawm 6 teev, ob tus neeg mob tau sawv SBP<85 mmHg and one patient had a decrease in SBP of>30 mmHg. Tsis muaj cov xwm txheej tsis zoo cuam tshuam nrog hypotension qhia thaum kawm. Tsis muaj cov xwm txheej ntawm syncope.

Table 2: Txhais tau tias (95% CI) qhov hloov pauv ntau tshaj los ntawm qhov pib hauv systolic ntshav siab (mmHg) tom qab vardenafil 5 mg hauv BPH cov neeg mob ntawm kev ruaj khov alpha-blocker kho (Kawm 1)
Alpha-Thaiv Ib txhij siv Vardenafil 5 mg
thiab Alpha-Blocker,
Cov placebo-rho tawm
Kev siv Vardenafil 5 mg
thiab Alpha-Blocker
Sib cais los ntawm 6 Teev,
Cov placebo-rho tawm

Terazosin
5 lossis 10 mg txhua hnub

Sawv ntsug SBP

-3 (-6.7, 0.1)

-4 (-7.4, -0.5)

Supine swb se

-4 (-6.7, -0.5)

-4 (-7.1, -0.7)

Tamsulosin
0.4 mg ib hnub twg

Sawv ntsug SBP
Supine swb se

-6 (-9.9, -2.1)
-4 (-7, -0.8)

-4 (-8.3, -0.5)
-5 (-7.9, -1.7)

Ntshav siab ntshav siab (sawv SBP) hauv cov txiv neej normotensive ruaj khov ntawm tamsulosin 0.4 mg tom qab kev tswj hwm ib txhij ntawm vardenafil 5 mg lossis cov placebo, lossis tom qab kev tswj hwm ntawm vardenafil 5 mg lossis cov placebo sib cais los ntawm 6 teev tau qhia hauv daim duab 2. Ntshav siab cuam tshuam ( sawv SBP) hauv cov txiv neej normotensive ruaj khov koob tshuaj terazosin (5 lossis 10 mg) tom qab kev tswj hwm vardenafil 5 mg lossis placebo, lossis tom qab kev tswj hwm ntawm vardenafil 5 mg lossis cov placebo sib cais los ntawm 6 teev, tau qhia hauv daim duab 3.

Daim duab 2: Txhais qhov hloov pauv ntawm lub hauv paus ntawm kev sawv systolic ntshav siab (mmHg) ntau dua 6 teev sib nrug tom qab ua ke lossis 6 teev sib cais kev tswj hwm ntawm vardenafil 5 mg lossis cov placebo nrog cov tshuaj ruaj khov tamsulosin 0.4 mg hauv cov neeg mob BPH ntau (Kawm 1)

Daim duab 3: Txhais qhov hloov pauv ntawm lub hauv paus ntawm kev sawv siab systolic ntshav siab (mmHg) ntau dua 6 teev sib nrug tom qab ua ke lossis 6 teev sib cais kev tswj hwm ntawm vardenafil 5 mg lossis cov placebo nrog cov tshuaj ruaj khov terazosin (5 lossis 10 mg) hauv cov neeg mob BPH ntau (Kawm 1)

Kawm 2:Txoj kev tshawb no tau tsim los ntsuas qhov txiaj ntsig ntawm 10 mg vardenafil (theem 1) thiab 20 mg vardenafil (theem 2) piv rau cov placebo, thaum tswj hwm rau ib pawg ntawm BPH cov neeg mob (n = 23) ntawm kev kho mob ruaj khov nrog tamsulosin 0.4 mg lossis 0.8 mg ib hnub rau tsawg kawg plaub lub lis piam. Kev tsim qauv yog kev xaiv ua, dig muag ob npaug, ob-lub sijhawm kawm hla kev kawm. Vardenafil lossis placebo tau muab ib txhij nrog tamsulosin. Ntshav siab thiab mem tes tau ntsuas dua li 6 teev ua haujlwm tom qab siv vardenafil. Rau cov txiaj ntsig BPsaib Rooj 3. Ib tus neeg mob tau ntsib kev txo qis los ntawm lub hauv paus sawv SBP ntawm> 30 mmHg tom qab vardenafil 10 mg. Tsis muaj lwm qhov xwm txheej ntawm qhov ntsuas ntshav siab dhau (sawv SBP 30 mmHg). Peb tus neeg mob qhia kiv taub hau tom qab vardenafil 20 mg. Tsis muaj cov xwm txheej ntawm syncope.

Table 3: Txhais tau tias (95% CI) qhov hloov pauv ntau tshaj los ntawm qhov pib hauv systolic ntshav siab (mmHg) tom qab vardenafil 10 thiab 20 mg hauv BPH cov neeg mob ntawm kev ruaj khov alpha-blocker kho nrog tamsulosin 0.4 lossis 0.8 mg txhua hnub (Kawm 2)
Vardenafil 10 mg
Cov placebo-rho tawm
Vardenafil 20 mg
Cov placebo-rho tawm

Sawv ntsug SBP

-4 (-6.8, -0.3)

-4 (-6.8, -1.4)

Supine swb se

-5 (-8.2, -0.8)

-4 (-6.3, -1.8)

Ntshav siab ntshav siab (sawv SBP) hauv cov txiv neej normotensive ruaj khov ntawm tamsulosin 0.4 mg tom qab kev tswj hwm ib txhij ntawm vardenafil 10 mg, vardenafil 20 mg lossis cov placebo tau qhia hauv daim duab 4.

Daim duab 4: Kev hloov pauv ntawm lub hauv paus ntawm kev sawv systolic ntshav siab (mmHg) ntau dua 6 teev sib nrug tom qab kev tswj hwm ib txhij ntawm vardenafil 10 mg (Theem 1), vardenafil 20 mg (Theem 2), lossis cov placebo nrog cov tshuaj ruaj khov tamsulosin 0.4 mg hauv normotensive BPH cov neeg mob (Kawm 2)

Kawm 3:Txoj kev tshawb no tau tsim los txhawm rau ntsuas qhov tshwm sim ntawm kev txhaj tshuaj ib zaug ntawm 5 mg vardenafil (theem 1) thiab 10 mg vardenafil (theem 2) piv rau cov placebo, thaum muab rau ib pawg ntawm BPH cov neeg mob (n = 24) ntawm kev kho mob ruaj khov nrog alfuzosin 10 mg ib hnub rau tsawg kawg plaub lub lis piam. Kev tsim qauv yog qhov kev xaiv ua, dig muag ob npaug, 3-lub sij hawm hla kev kawm. Vardenafil lossis cov placebo tau siv 4 teev tom qab kev tswj hwm ntawm alfuzosin. Ntshav siab thiab mem tes tau ntsuas ntau dua 10 teev nyob rau ib ntus tom qab siv vardenafil lossis cov placebo. Txog BP cov txiaj ntsig pom ntawm Rooj 4.

Rooj 4: Txhais tau tias (95% CI) qhov hloov pauv ntau tshaj los ntawm qhov pib hauv systolic ntshav siab (mmHg) tom qab vardenafil 5 thiab 10 mg hauv BPH cov neeg mob ntawm kev ruaj khov alpha-blocker kho nrog alfuzosin 10 mg txhua hnub (Kawm 3)
Vardenafil 5 mg
Cov placebo-rho tawm
Vardenafil 10 mg
Cov placebo-rho tawm

Sawv ntsug SBP

-2 (-5.8, 1.2)

-5 (-8.8, -1.6)

Supine swb se

-1 (-4.1, 2.1)

-6 (-9.4, -2.8)

Ib tus neeg mob tau ntsib kev txo qis los ntawm lub hauv paus sawv ntawm systolic ntshav siab> 30 mm Hg tom qab tswj hwm vardenafil 5 mg zaj duab xis-coated ntsiav tshuaj thiab vardenafil 10 mg zaj duab xis-coated ntsiav tshuaj. Tsis muaj cov xwm txheej sawv ntawm cov ntshav siab systolic<85 mm Hg were observed during this study. Four patients, one dosed with placebo, two dosed with vardenafil 5 mg film-coated tablets and one dosed with vardenafil 10 mg film-coated tablets, reported dizziness. Blood pressure effects (standing SBP) in normotensive men on a stable dose of alfuzosin 10 mg following administration of vardenafil 5 mg, vardenafil 10 mg, or placebo separated by 4 hours, are shown in Figure 5.

Daim duab 5: Kev hloov pauv ntawm lub hauv paus ntawm kev sawv systolic ntshav siab (mmHg) dhau 6 teev sib nrug tom qab 4 teev sib cais kev tswj hwm ntawm vardenafil 5 mg (theem 1), vardenafil 10 mg (theem 2) lossis cov placebo nrog cov tshuaj ruaj khov alfuzosin 10 mg hauv BPH cov neeg mob (Kawm 3)

Ntshav siab cuam tshuam rau cov txiv neej normotensive tom qab yuam titration nrog alpha-blockers:

Ob qhov randomized, ob qhov muag tsis pom, tshuaj kho tshuaj kho mob tshuaj tshawb fawb tshawb fawb nrog kev noj qab haus huv normotensive tuaj pab dawb (hnub nyoog ntau, 45-74 xyoo) tau ua tom qab yuam titration ntawm alpha-blocker terazosin rau 10 mg txhua hnub dhau 14 hnub (n = 29), thiab tom qab pib ntawm tamsulosin 0.4 mg txhua hnub rau tsib hnub (n = 24). Tsis muaj cov xwm txheej tsis zoo cuam tshuam nrog hypotension hauv ob txoj kev tshawb fawb. Cov tsos mob ntawm hypotension yog qhov ua rau tshem tawm hauv 2 yam tau txais terazosin thiab hauv 4 yam tau txais tamsulosin. Cov xwm txheej ntawm qhov ntsuas ntshav siab dhau (txhais tau tias sawv SBP<85 mmHg and/or a decrease from baseline of standing SBP>30 mmHg) tau pom hauv 9/24 cov ntsiab lus tau txais tamsulosin thiab 19/29 tau txais terazosin. Qhov xwm txheej ntawm cov ncauj lus nrog sawv SBP<85 mmHg given vardenafil and terazosin to achieve simultaneous Tmax max uacoj mus rau qhov kev txiav tawm ntxov ntawm caj npab ntawm txoj kev kawm. Hauv feem ntau (7/8) ntawm cov ncauj lus no, piv txwv ntawm sawv SBP<85 mmHg were not associated with symptoms. Among subjects treated with terazosin, outlier values were observed more frequently when vardenafil and terazosin were given to achieve simultaneous Tmax max uatshaj li thaum txhaj tshuaj tau muab cais cais T.max max uamus 6h. Muaj 3 kis ntawm kiv taub hau tau pom nrog kev tswj hwm terazosin thiab vardenafil. Xya yam kev kawm paub kiv taub hau feem ntau tshwm sim nrog ua ke T.max max uakev tswj hwm tamsulosin. Tsis muaj cov xwm txheej ntawm syncope.

Table 5: Txhais tau tias (95% CI) qhov hloov pauv ntau tshaj hauv lub hauv paus systolic ntshav siab (mmHg) tom qab vardenafil 10 thiab 20 mg hauv cov neeg pab dawb noj qab haus huv ntawm kev kho alpha-blocker txhua hnub
Kev siv Vardenafil thiab Alpha-Blocker Sib cais los ntawm 6 teev Ib txhij siv Vardenafil thiab Alpha-Blocker
Alpha-Thaiv Vardenafil
10 mg
Cov placebo-rho tawm
Vardenafil
20 mg / os
Cov placebo-rho tawm
Vardenafil
10 mg
Cov placebo-rho tawm
Vardenafil
20 mg / os
Cov placebo-rho tawm
*
Vim yog qhov piv txwv me me, kev ntseeg siab ib ntus yuav tsis yog qhov ntsuas raug rau cov ntaub ntawv no. Cov txiaj ntsig no sawv cev rau qhov sib txawv rau qhov sib txawv.

Terazosin
10 mg txhua hnub

Sawv ntsug SBP

-7 (-10, -3)

-11 (-14, -7)

-23 (-31, 16) *

-14 (-33, 11) *

Supine swb se

-5 (-8, -2)

-7 (-11, -4)

-7 (-25, 19) *

-7 (-31, 22) *

Tamsulosin
0.4 mg ib hnub twg

Sawv ntsug SBP

-4 (-8, -1)

-8 (-11, -4)

-8 (-14, -2)

-8 (-14, -1)

Supine swb se

-4 (-8, 0)

-7 (-11, -3)

-5 (-9, -2)

-3 (-7, 0)

Daim duab 6: Txhais qhov hloov pauv ntawm lub hauv paus ntawm kev sawv systolic ntshav siab (mmHg) ntau dua 6 teev sib nrug tom qab ua ke lossis 6 teev sib cais kev tswj hwm ntawm vardenafil 10 mg, vardenafil 20 mg lossis cov placebo nrog terazosin (10 mg) hauv cov neeg pab dawb noj qab haus huv

Daim duab 7: Txhais qhov hloov pauv ntawm lub hauv paus ntawm kev sawv systolic ntshav siab (mmHg) ntau dua 6 teev sib nrug tom qab ua ke lossis 6 teev cais kev tswj hwm ntawm vardenafil 10 mg, vardenafil 20 mg lossis cov placebo nrog tamsulosin (0.4 mg) hauv cov neeg ua haujlwm pab dawb noj qab haus huv

Teeb meem ntawm Cardiac Electrophysiology

Cov nyhuv ntawm 10 mg thiab 80 mg vardenafil ntawm QT ncua sijhawm tau tshuaj xyuas hauv ib zaug, ob-qhov muag tsis pom, tsis siv neeg, cov placebo- thiab nquag tswj hwm (moxifloxacin 400 mg) kev tshawb fawb crossover hauv 59 tus txiv neej noj qab nyob zoo (81% Dawb, 12%) Dub, 7% Neeg Mev) hnub nyoog 45-60 xyoo. QT ncua sijhawm tau ntsuas ntawm ib teev tom qab txhaj tshuaj vim tias lub sijhawm no kwv yees kwv yees nruab nrab lub sijhawm ntawm qhov siab tshaj ntawm vardenafil. Qhov koob tshuaj 80 mg ntawm Levitra (plaub zaug qhov koob tshuaj pom zoo tshaj plaws) tau xaiv vim tias qhov koob tshuaj no ua rau cov ntshav ntau ntau suav nrog cov uas tau pom thaum koom ua ke nrog kev txhaj tshuaj tsawg ntawm Levitra (5 mg) thiab 600 mg BID ntawm ritonavir. Ntawm CYP3A4 inhibitors uas tau kawm, ritonavir ua rau muaj kev cuam tshuam tseem ceeb tshaj plaws ntawm kev siv yeeb tshuaj nrog vardenafil. Cov lus 6 suav nrog cov txiaj ntsig ntawm QT tsis raug kho thiab txhais tau tias raug kho QT luv (QTc) nrog cov txheej txheem sib txawv ntawm kev kho (Fridericia thiab ib txoj kab kev kho tus kheej) ntawm ib teev tom qab txhaj tshuaj. Tsis muaj ib txoj hauv kev kho kom paub tias siv tau ntau dua li lwm qhov. Hauv txoj kev tshawb fawb no, qhov nruab nrab nce hauv plawv dhia nrog 10 mg koob tshuaj Levitra piv rau cov placebo yog 5 zaug/feeb thiab nrog 80 mg koob tshuaj Levitra qhov nruab nrab nce yog 6 zaug/feeb.

Table 6: Txhais QT thiab QTc hloov pauv hauv msec (90% CI) los ntawm qhov txheeb ze piv rau cov placebo ntawm 1 teev tom qab txhaj tshuaj nrog cov txheej txheem sib txawv los kho qhov cuam tshuam ntawm lub plawv dhia.
Phooj ywg / Dose QT Tsis tau kho dua
(msec)
QIB Fridericia
Kho
(msec)
QT tus kheej
Kho
(msec)
*
Kev tswj hwm nquag (tshuaj paub ua kom ntev QT)

Vardenafil 10 mg

-2
(-4, 0)

8
(6, 9)

4
(3, 6)

Vardenafil 80 mg

-2
(-4, 0)

10
(8, 11)

6
(4, 7)

Moxifloxacina 400 mg *

3
(kaum tsib)

8
(6, 9)

7
(5, 8)

Kev kho tshuaj thiab siv tshuaj kho mob vardenafil thiab kev tswj hwm ua haujlwm moxifloxacin ua rau nce zoo ib yam hauv QTcncua sijhawm. Txoj kev tshawb fawb no, txawm li cas los xij, tsis tau tsim los ua qhov sib piv ncaj qha ntawm cov tshuaj lossis qib koob tshuaj. Qhov cuam tshuam ntawm chaw kho mob ntawm cov QT noctsis paub hloov[saib Cov Lus Ceeb Toom thiab Ceev faj ( 5 )].

Hauv kev tshawb fawb cais kev tshaj tawm tom ntej ntawm 44 tus neeg pab dawb noj qab haus huv, txhaj ib koob ntawm 10 mg Levitra ua rau cov placebo-rho tawm cov ntsiab lus hloov pauv los ntawm QTcF (Fridericia kho) ntawm 5 msec (90% CI: 2,8). Ib zaug ntawm cov tshuaj gatifloxacin 400mg ua rau cov placebo-rho tawm txhais tau tias hloov pauv los ntawm cov hauv paus QTcF ntawm 4 msec (90% CI: 1,7). Thaum Levitra 10mg thiab gatifloxacin 400 mg tau koom ua ke, lub ntsiab lus QTcF hloov pauv los ntawm lub hauv paus tau ntxiv thaum piv rau ib yam tshuaj ib leeg thiab tsim lub ntsiab lus QTcF hloov ntawm 9 msec los ntawm lub hauv paus (90% CI: 6,11). Qhov kev soj ntsuam cuam tshuam ntawm cov kev hloov pauv QT no tsis paub[saib Cov Lus Ceeb Toom thiab Ceev faj ( 5.7 )].

Cov teebmeem ntawm Kev Treadmill Test hauv Cov Neeg Mob Nrog Kab Mob Coronary Artery (CAD):

Hauv ob qhov kev sim ywj pheej uas ntsuas 10 mg (n = 41) thiab 20 mg (n = 39) vardenafil, ntsig txog, vardenafil tsis hloov pauv tag nrho lub sijhawm ua si qoj ib ce piv rau cov placebo. Cov neeg mob suav nrog cov txiv neej hnub nyoog 40-80 xyoo nrog kev ua haujlwm ruaj khov ua rau mob angina tau sau tseg los ntawm tsawg kawg ib qho ntawm cov hauv qab no: 1) yav dhau los keeb kwm ntawm kev mob myocardial infarction (MI), mob hlab ntsha hlab ntshav hla txoj hlab ntshav (CABG), percutaneous transluminal coronary angioplasty (PTCA) ), lossis stenting (tsis pub dhau 6 lub hlis); 2) zoo coronary angiogram qhia tsawg kawg 60% nqaim ntawm txoj kab uas hla ntawm tsawg kawg ib lub plawv loj loj; lossis 3) qhov kev xav zoo echocardiogram lossis kev nyuab siab nuclear perfusion kawm.

Cov txiaj ntsig ntawm cov kev tshawb fawb no tau qhia tias Levitra tsis hloov pauv tag nrho lub sijhawm ua haujlwm qoj ib ce piv rau cov placebo (10 mg Levitra vs. placebo: 433 ± 109 thiab 426 ± 105 vib nas this, feem; 20 mg Levitra vs. placebo: 414 ± 114 thiab 411 ±) 124 vib nas this, feem). Lub sijhawm tag nrho rau angina tsis tau hloov pauv los ntawm Levitra thaum piv rau cov placebo (10 mg Levitra vs. placebo: 291 ± 123 thiab 292 ± 110 vib nas this; 20 mg Levitra vs. placebo: 354 ± 137 thiab 347 ± 143 vib nas this, feem). Tag nrho lub sijhawm rau 1 mm lossis ntau dua ST-ntu kev nyuaj siab zoo ib yam li cov placebo hauv ob qho 10 mg thiab 20 mg Levitra pawg (10 mg Levitra vs. placebo: 380 ± 108 thiab 334 ± 108 vib nas this; 20 mg Levitra vs. placebo) : 364 ± 101 thiab 366 ± 105 vib nas this, feem)

Los Ntawm Qhov Muag

Kev txhaj tshuaj ib zaug ntawm qhov ncauj ntawm phosphodiesterase inhibitors tau qhia txog kev siv tshuaj tsis tu ncua txog kev puas tsuaj ntawm kev ntxub ntxaug xim (xiav/ntsuab) siv Farnsworth-Munsell 100-hue kuaj thiab txo qis hauv electroretinogram (ERG) b-wave amplitude, nrog cov txiaj ntsig siab tshaj nyob ze lub sijhawm ntawm qhov siab qib ntshav. Cov kev tshawb pom no zoo ib yam nrog kev txwv ntawm PDE6 hauv pas nrig thiab lub khob hliav qab, uas koom nrog hauv kev xa duab hauv lub qhov muag. Cov kev tshawb pom tau pom tseeb tshaj plaws ib teev tom qab kev tswj hwm, txo qis tab sis tseem muaj 6 teev tom qab kev tswj hwm. Hauv kev kawm tshuaj ib zaug hauv 25 tus txiv neej ib txwm, Levitra 40 mg, ob zaug ntau tshaj qhov pom zoo txhua hnub, tsis hloov pauv qhov pom kev pom, lub siab hauv lub qhov muag, pob nyiaj siv nyiaj thiab pom teeb pom kev.

Hauv lwm qhov ob-qhov muag tsis pom, cov tshuaj placebo tswj kev sim tshuaj, tsawg kawg 15 koob ntawm 20 mg vardenafil tau siv ntau dua 8 lub lis piam piv rau cov placebo rau 52 tus txiv neej. Peb caug-ob (32) txiv neej (62%) ntawm cov neeg mob ua tiav qhov kev sim. Retinal function tau ntsuas los ntawm ERG thiab FM-100 kuaj 2, 6 thiab 24 teev tom qab txhaj tshuaj. Kev sim tau tsim los txhawm rau txheeb xyuas kev hloov pauv ntawm lub qog ua haujlwm uas yuav tshwm sim hauv ntau dua 10% ntawm cov neeg mob. Vardenafil tsis tau tsim kho mob tseem ceeb ERG lossis FM-100 cuam tshuam rau cov txiv neej noj qab haus huv piv rau cov placebo. Ob tus neeg mob ntawm vardenafil hauv kev sim qhia txog ntu ntu ntawm cyanopsia ncua (cov khoom zoo li xiav).

Cov teebmeem ntawm phev Mobility/Morphology

Tsis muaj kev cuam tshuam rau phev txav mus los lossis kev hloov pauv tom qab ib leeg 20 mg qhov ncauj ntawm vardenafil hauv cov neeg ua haujlwm pab dawb noj qab haus huv.

Pharmacokinetics

Cov chaw muag tshuaj pharmacokinetics ntawm vardenafil yog kwv yees li koob ib feem ntawm qhov pom zoo koob tshuaj. .

Kev nqus

Lub ntsiab lus vardenafil ntshav ntau ntau ntsuas tom qab kev tswj hwm ntawm qhov ncauj ib zaug ntawm 20 mg rau cov txiv neej noj qab haus huv tuaj yeem pab dawb tau qhia hauv daim duab 8.

Daim duab 8: Plasma Vardenafil Concentration (Mean ± SD) Nkhaus rau Ib Leeg 20 mg Levitra Dose

Vardenafil tau nqus sai nrog qhov muaj peev xwm txaus ntawm kwv yees li 15%. Qhov siab tshaj plaws pom cov ntshav ntau ntau tom qab siv 20 mg ib zaug hauv cov neeg ua haujlwm pab dawb noj qab haus huv feem ntau mus txog nruab nrab ntawm 30 feeb thiab 2 teev (nruab nrab 60 feeb) tom qab noj tshuaj hauv lub xeev yoo mov. Ob txoj kev tshawb fawb cuam tshuam txog zaub mov tau ua uas pom tias cov zaub mov muaj roj ntau ua rau txo qis hauv C.max max ualos ntawm 18%-50%.

Kev faib tawm

Lub ntsiab lus ruaj khov-lub xeev ntim ntawm kev faib khoom (Vss) rau vardenafil yog 208 L, qhia txog kev nthuav dav cov nqaij mos. Vardenafil thiab nws cov khoom tseem ceeb hloov pauv metabolite, M1, tau raug khi rau cov ntshav ntshav protein (kwv yees li 95% rau niam txiv cov tshuaj thiab M1). Qhov kev khi cov protein no yog thim rov qab thiab ywj siab ntawm tag nrho cov tshuaj ntau npaum li cas.

Ua raws li qhov ncauj ib zaug ntawm 20 mg vardenafil hauv cov neeg ua haujlwm pab dawb noj qab haus huv, lub ntsiab lus ntawm 0.00018% ntawm cov tshuaj tau txais hauv phev 1.5 teev tom qab txhaj tshuaj.

Metabolism

Vardenafil yog metabolized feem ntau los ntawm lub siab enzyme CYP3A4, nrog kev koom tes los ntawm CYP3A5 thiab CYP2C isoforms. Qhov loj circulating metabolite, M1, tshwm sim los ntawm desethylation ntawm piperazine moiety ntawm vardenafil. M1 yog raug rau cov metabolism ntxiv. Plasma concentration ntawm M1 yog kwv yees li 26% ntawm cov niam txiv sib xyaw. Cov tshuaj metabolite no qhia txog phosphodiesterase selectivity profile zoo ib yam li ntawm vardenafil thiabhauv vitroinhibitory potency rau PDE5 28% ntawm qhov ntawm vardenafil. Yog li ntawd, M1 suav txog kwv yees li 7% ntawm tag nrho cov tshuaj ua haujlwm.

Kev tshem tawm

Tag nrho lub cev tshem tawm ntawm vardenafil yog 56 L/h, thiab lub davhlau ya nyob twg ib nrab ntawm vardenafil thiab nws thawj cov tshuaj metabolite (M1) yog kwv yees li 4-5 teev. Tom qab kev tswj hwm qhov ncauj, vardenafil raug tso tawm raws li cov metabolites feem ntau hauv cov quav (kwv yees li 91-95% ntawm kev tswj hwm qhov ncauj) thiab kom tsawg dua hauv cov zis (kwv yees li 2-6% ntawm kev siv tshuaj qhov ncauj).

Pharmacokinetics hauv Cov Pej Xeem Tshwj Xeeb

Pediatrics

Levitra tsis qhia rau siv hauv cov neeg mob menyuam yaus. Vardenafil kev sim tsis tau ua hauv cov menyuam yaus.

Geriatric

Hauv kev noj qab haus huv txoj haujlwm kawm txog txiv neej laus (≧ 65 xyoo) thiab txiv neej hluas (18-45 xyoo), txhais Cmax max uathiab AUC yog 34% thiab 52% siab dua, raws li, hauv cov txiv neej laus[saib Siv Hauv Cov Pej Xeem Tshwj Xeeb ( 8.5 )].

Hepatic tsis zoo

Hauv cov neeg ua haujlwm pab dawb uas muaj lub cev tsis zoo (Child-Pugh A), C.max max uathiab AUC tom qab 10 mg vardenafil koob tau nce 22% thiab 17%, feem, piv rau kev tswj hwm kev noj qab haus huv. Hauv cov neeg tuaj yeem pab dawb nrog lub siab tsis zoo (Child-Pugh B), C.max max uathiab AUC tom qab 10 mg vardenafil koob tshuaj tau nce 130% thiab 160%, feem, piv rau kev tswj hwm kev noj qab haus huv. Vardenafil tsis tau tshuaj xyuas hauv cov neeg mob uas muaj mob hnyav (Child-Pugh C).[Saib Dosage thiab Administration ( 2.3 ), Ceeb Toom thiab Ceev faj ( 5.8 ), thiab Siv Hauv Cov Pej Xeem Tshwj Xeeb ( 8.6 ).]

Lub raum tsis zoo

Hauv txiv neej tuaj yeem pab dawb nrog CLua cr= 50-80 mL/min, cov tshuaj pharmacokinetics ntawm vardenafil zoo ib yam li cov tau pom hauv pawg tswj hwm nrog CLcr> 80 mL/min. Hauv txiv neej tuaj yeem pab dawb nrog CLua cr= 30-50 mL/min lossis CLua cr<30 mL/min renal impairment groups, the AUC of vardenafil was 20–30% higher compared to that observed in a control group with CLua cr> 80 ml/min). Vardenafil pharmacokinetics tsis tau tshuaj xyuas hauv cov neeg mob uas xav tau kev lim ntshav hauv lub raum.[Saib Dosage thiab Administration ( 2.3 ), Ceeb Toom thiab Ceev faj ( 5.9 ), thiab Siv Hauv Cov Pej Xeem Tshwj Xeeb ( 8.7 ).]

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Kev Tsis Txaus Siab ntawm Fertility

Carcinogenesis

Vardenafil tsis yog mob qog noj ntshav hauv nas thiab nas thaum siv tshuaj txhua hnub rau 24 lub hlis. Hauv cov kev tshawb fawb no nthuav tawm cov tshuaj muaj yees (AUCs) rau qhov tsis pub dawb (tsis pub dawb) vardenafil thiab nws cov metabolite loj tau kwv yees li 400- thiab 170-npaug rau cov txiv neej thiab poj niam nas, feem, thiab 21- thiab 37-npaug rau txiv neej thiab poj niam nas, feem, kev nthuav tawm pom nyob rau hauv tib neeg txiv neej muab Qhov Siab Tshaj Plaws Pom Zoo Tib Neeg Dhau (MRHD) ntawm 20 mg.

Mutagenesis

Vardenafil tsis yog mutagenic raws li ntsuas hauv ob qho tib sihauv vitrokab mob Ames assay lossis kev hloov pauv tom ntej hauv Suav hamster V79hlwb. Vardenafil tsis yog clastogenic raws li ntsuas hauv ob qho tib sihauv vitrochromosomal aberration test los yoghauv vivonas kuaj micronucleus.

Kev tsis taus ntawm Fertility

Vardenafil tsis cuam tshuam rau kev muaj menyuam hauv txiv neej thiab poj niam nas tau txhaj tshuaj txog li 100 mg/kg/hnub rau 28 hnub ua ntej sib deev hauv txiv neej, thiab rau 14 hnub ua ntej sib yuav thiab dhau hnub 7 ntawm cev xeeb tub hauv poj niam. Hauv kev sib tham 1-hli nas tshuaj lom, qhov koob tshuaj no ua rau AUC tus nqi rau vardenafil tsis pub dhau 200 npaug ntau dua li AUC hauv tib neeg ntawm MRHD ntawm 20 mg.

Kev Kho Mob

Levitra tau tshuaj xyuas hauv plaub qhov loj ob-qhov muag tsis pom, tsis siv neeg, tswj cov placebo, tsau tshuaj, tsim qauv sib luag, ntau qhov kev sim hauv 2431 tus txiv neej hnub nyoog 20-83 (hnub nyoog nruab nrab 57 xyoo; 78% Dawb, 7% Dub, 2% Neeg Esxias, 3% Neeg Mev thiab 10% Lwm Yam/Tsis Paub). Cov koob tshuaj Levitra hauv cov kev tshawb fawb no yog 5 mg, 10 mg, thiab 20 mg. Ob ntawm cov kev sim no tau ua nyob rau hauv cov pejxeem erectile kawg (ED) cov pejxeem thiab ob hauv tshwj xeeb ED pejxeem (ib tus neeg mob ntshav qab zib mellitus thiab ib tus tom qab prostatectomy cov neeg mob). Levitra tau txhaj tshuaj yam tsis suav nrog kev noj zaub mov raws li xav tau hauv cov txiv neej nrog ED, ntau tus neeg muaj ntau yam mob. Thawj qhov kawg tau ntsuas ntawm 3 lub hlis.

Thawj qhov kev ntsuas ua tau zoo hauv tag nrho plaub qhov kev sim loj yog los ntawm Erectile Function (EF) Cov qhab nia ntawm qhov kev lees paub thoob ntiaj teb Kev Tshawb Fawb Kev Ua Haujlwm Erectile (IIEF) Cov lus nug thiab ob nqe lus nug los ntawm Kev Sib Deev Sib Ntsib (SEP) cuam tshuam nrog lub peev xwm ua tiav qhov chaw mos kev nkag mus (SEP2), thiab lub peev xwm los tuav lub erection ntev txaus rau kev sib raug zoo (SEP3).

Hauv tag nrho plaub qhov kev sim ua kom muaj txiaj ntsig zoo, Levitra tau qhia txog kev kho mob muaj txiaj ntsig thiab muaj txiaj ntsig zoo ntawm kev txheeb cais hauv EF Domain, SEP2, thiab SEP3 cov qhab nia piv rau cov placebo. Lub hauv paus nruab nrab EF Cov qhab nia qhab nia hauv cov kev sim no yog 11.8 (cov qhab nias ntawm 0-30 qhov twg cov qhab nia qis sawv cev rau tus kab mob hnyav dua). Levitra (5 mg, 10 mg, thiab 20 mg) muaj txiaj ntsig zoo rau txhua pawg hnub nyoog (<45, 45 to <65, and ≧65 years) and was also effective regardless of race (White, Black, Other).

Kev sim nyob rau hauv Feem Ntau Erectile Dysfunction Population

Hauv qhov tseem ceeb ntawm North American kev sim tshuaj, 762 tus neeg mob (hnub nyoog nruab nrab 57, thaj tsam 20-83 xyoo; 79% Dawb, 13% Dub, 4% Neeg Hispanic, 2% Neeg Esxias thiab 2% Lwm Tus) tau tshuaj xyuas. Lub ntsiab lus hauv paus EF Cov qhab nia yog 13, 13, 13, 14 rau Levitra 5 mg, 10 mg, 20 mg thiab cov placebo pawg, feem. Muaj kev txhim kho tseem ceeb (p<0.0001) at 3 months with Levitra (EF Domain scores of 18, 21, 21, for the 5 mg, 10 mg, and 20 mg dose groups, respectively) compared to the placebo group (EF Domain score of 15). The European trial (total N=803) confirmed these results. The improvement in mean score was maintained at all doses at 6 months in the North American trial.

Hauv North American kev sim siab, Levitra tau txhim kho cov txiaj ntsig ntawm kev ua tiav erection txaus rau kev nkag mus (SEP2) ntawm koob ntawm 5 mg, 10 mg, thiab 20 mg piv rau cov placebo (65%, 75%, thiab 80%, feem, sib piv) rau 52% cov lus teb hauv pawg placebo ntawm 3 lub hlis; p<0.0001). The European trial confirmed these results.

Levitra tau qhia txog kev kho mob muaj txiaj ntsig thiab muaj nuj nqis tseem ceeb hauv kev suav nrog ib tus neeg mob ntawm kev saib xyuas kev txhim kho erection kom ua tiav kev sib deev (SEP3) (51% ntawm 5 mg, 64% ntawm 10 mg, thiab 65% ntawm 20 mg, feem, piv rau 32% ntawm cov placebo; p<0.0001) at 3 months in the North American trial. The European trial showed comparable efficacy. This improvement in mean score was maintained at all doses at 6 months in the North American trial.

Sim hauv Cov Neeg Mob nrog ED thiab Ntshav Qab Zib Mellitus

Levitra tau qhia txog kev kho mob muaj txiaj ntsig thiab muaj txiaj ntsig zoo ntawm kev txhim kho erectile kev ua haujlwm yav tom ntej, tsau tshuaj (10 thiab 20 mg Levitra), ob-qhov muag tsis pom, cov tshuaj placebo tswj kev sim ntawm cov neeg mob ntshav qab zib mellitus (n = 439; hnub nyoog nruab nrab 57 xyoos, ntau yam) 33-81; 80% Dawb, 9% Dub, 8% Neeg Mev, thiab 3% Lwm Yam).

Kev txhim kho tseem ceeb hauv EF Domain tau qhia hauv qhov kev tshawb fawb no (EF Cov qhab nia ntawm 17 ntawm 10 mg Levitra thiab 19 ntawm 20 mg Levitra piv rau 13 ntawm cov placebo; p<0.0001).

Levitra tau txhim kho qhov txiaj ntsig tag nrho rau ib tus neeg mob ntawm kev ua tiav kev txhim kho erection txaus rau kev nkag mus (SEP2) (61% ntawm 10 mg thiab 64% ntawm 20 mg Levitra piv rau 36% ntawm cov placebo; p<0.0001).

Levitra tau qhia txog kev kho mob muaj txiaj ntsig thiab muaj nuj nqis tseem ceeb hauv kev suav nrog ib tus neeg mob ntawm kev saib xyuas kev txhim kho erection kom ua tiav kev sib deev (SEP3) (49% ntawm 10 mg, 54% ntawm 20 mg Levitra piv rau 23% ntawm cov placebo; p<0.0001).

Kev sim hauv Cov Neeg Mob nrog ED tom qab Radical Prostatectomy

Levitra tau qhia txog kev kho mob muaj txiaj ntsig thiab muaj txiaj ntsig zoo ntawm kev txhim kho erectile kev ua haujlwm yav tom ntej, tsau tshuaj (10 thiab 20 mg Levitra), ob-qhov muag tsis pom, cov tshuaj placebo-tswj kev sim hauv cov neeg mob tom qab prostatectomy (n = 427, txhais tau tias muaj hnub nyoog 60, thaj tsam 44 -77 xyoo; 93% Dawb, 5% Dub, 2% Lwm Yam).

Kev txhim kho tseem ceeb hauv EF Domain tau qhia hauv qhov kev tshawb fawb no (EF Cov qhab nia ntawm 15 ntawm 10 mg Levitra thiab 15 ntawm 20 mg Levitra piv rau 9 ntawm cov placebo; p<0.0001).

Levitra tau txhim kho qhov txiaj ntsig tag nrho rau ib tus neeg mob ntawm kev ua tiav kev txhim kho erection txaus rau kev nkag mus (SEP2) (47% ntawm 10 mg thiab 48% ntawm 20 mg Levitra piv rau 22% ntawm cov placebo; p<0.0001).

Levitra tau qhia txog kev kho mob muaj txiaj ntsig thiab muaj nuj nqis tseem ceeb hauv kev suav nrog ib tus neeg mob ntawm kev saib xyuas kev txhim kho erection kom ua tiav kev sib deev (SEP3) (37% ntawm 10 mg, 34% ntawm 20 mg Levitra piv rau 10% ntawm cov placebo; p<0.0001).

Kev Muab/Cia thiab Ua Li Cas

Levitra (vardenafil HCl) tau tsim ua txiv kab ntxwv, zaj duab xis-coated puag ncig cov ntsiav tshuaj nrog debossed BAYER hla ntawm ib sab thiab 5, 10, thiab 20 ntawm lwm sab sib npaug rau 5 mg, 10 mg, thiab 20 mg ntawm vardenafil, feem.

Pob

Lub zog

NDD Code

Fwj ntawm 30

5mg ib

0173-0829-13

10 mg

0173-0830-13

20 mg / os

0173-0831-13

Khaws ntawm 25 ° C (77 ° F); kev tso cai mus ncig rau 15-30 ° C (59-86 ° F) [saib USP Chav Tswj Xyuas Kub Kub].

Cov Lus Qhia Tus Neeg Mob

Saib FDA-pom zoo daim ntawv lo tus neeg mob (Cov Ntaub Ntawv Tus Neeg Mob)

Nitrates

Qhia rau cov neeg mob tias Levitra raug txwv tsis pub siv thiab/lossis tsis tu ncua siv cov organic nitrates. Cov neeg mob yuav tsum tau txais kev sab laj tias kev siv Levitra nrog nitrates tuaj yeem ua rau ntshav siab poob sai sai rau qib tsis nyab xeeb, ua rau kiv taub hau, syncope, lossis txawm tias plawv nres lossis mob stroke.

Guanylate Cyclase (GC) Stimulators

Qhia cov neeg mob tias Levitra yog txwv tsis pub siv rau cov neeg mob uas siv cov tshuaj guanylate cyclase stimulators, xws li riociguat.

Mob plawv

Sib tham nrog cov neeg mob qhov muaj peev xwm mob plawv ntawm kev sib deev rau cov neeg mob uas muaj kev pheej hmoo mob plawv ua ntej.

Kev siv ua ke nrog tshuaj uas txo ntshav siab

Qhia cov neeg mob tias hauv qee tus neeg mob ua ke siv PDE5 inhibitors, suav nrog Levitra, nrog alpha-blockers tuaj yeem txo cov ntshav siab ntau ua rau cov tsos mob hypotension (piv txwv li, tsaus muag). Cov neeg mob sau npe Levitra uas tab tom noj alpha-blockers yuav tsum tau pib ntawm qhov qis tshaj pom zoo pib koob tshuaj Levitra[saib Dosage thiab Administration ( 2.4 ) thiab Kev Sib Tham Tshuaj ( 7 )].Cov neeg mob yuav tsum tau qhia txog qhov tshwm sim tshwm sim ntawm cov tsos mob cuam tshuam nrog postural hypotension thiab kev tiv thaiv tsim nyog. Cov neeg mob yuav tsum tau qhia kom hu rau kws kho mob yog tias lwm yam tshuaj tiv thaiv ntshav siab lossis tshuaj tshiab uas yuav cuam tshuam nrog Levitra tau sau los ntawm lwm tus kws kho mob.

Pom zoo Thawj Coj

Tham nrog cov neeg mob txog kev siv Levitra thiab nws cov txiaj ntsig tau xav tseg. Nws yuav tsum tau piav qhia tias kev txhawb kev sib deev xav tau rau kev txhim kho kom tshwm sim tom qab noj Levitra. Levitra yuav tsum tau kwv yees li 60 feeb ua ntej kev sib deev. Cov neeg mob yuav tsum tau sab laj txog kev noj tshuaj Levitra tshwj xeeb tshaj yog hais txog qhov koob tshuaj ntau tshaj txhua hnub. Cov neeg mob yuav tsum tau qhia kom hu rau lawv tus kws kho mob rau kev hloov kho tshuaj yog tias lawv tsis txaus siab nrog qhov ua tau zoo ntawm lawv kev sib deev nrog Levitra lossis thaum muaj qhov tsis xav tau.

Priapism

Qhia rau cov neeg mob tias muaj cov ntawv ceeb toom tsis ntev ntawm kev kho erections ntau dua 4 teev thiab priapism (mob hnyav dua ntau dua 6 teev nyob rau lub sijhawm) rau Levitra thiab chav kawm ntawm cov sib txuas no. Yog tias kev txhim kho txuas ntxiv ntev dua 4 teev, tus neeg mob yuav tsum nrhiav kev pab kho mob tam sim. Yog tias priapism tsis kho tam sim ntawd, cov ntaub so ntswg puas thiab ua rau lub zog tsis muaj peev xwm ua tau.

Kev Sib Tham Tshuaj

Qhia cov neeg mob kom hu rau kws kho mob yog tias cov tshuaj tshiab uas tuaj yeem cuam tshuam nrog Levitra tau hais los ntawm lwm tus kws kho mob.

Tsis pom kev sai

Qhia cov neeg mob kom tsis txhob siv tag nrho PDE5 inhibitors, suav nrog Levitra, thiab nrhiav kev kho mob thaum muaj qhov muag tsis pom sai sai hauv ib lossis ob lub qhov muag. Qhov xwm txheej zoo li no tuaj yeem yog ib qho cim ntawm tsis-arteritic anterior ischemic optic neuropathy (NAION), ua rau tsis pom kev, suav nrog kev tsis pom kev tas mus li, uas tau tshaj tawm tsis tshua muaj kev lag luam tom ntej nrog kev siv tag nrho PDE5 inhibitors. Cov kws kho mob tseem yuav tsum tham nrog cov neeg mob kom muaj kev pheej hmoo NAION ntau ntxiv hauv cov tib neeg uas twb tau ntsib NAION hauv ib lub qhov muag lawm. Cov kws kho mob tseem yuav tsum tham nrog cov neeg mob kom muaj kev pheej hmoo ntau ntxiv ntawm NAION ntawm cov pej xeem hauv cov neeg mob uas muaj cov neeg kho qhov muag ntau, txawm tias cov pov thawj tsis txaus los txhawb kev tshuaj xyuas ntawm cov neeg siv yav tom ntej ntawm PDE5 inhibitor, suav nrog Levitra, rau qhov xwm txheej tsis zoo no[saib Cov Lus Ceeb Toom thiab Ceev faj ( 5.4 ) thiab [Cov Teeb Meem Tsis Zoo ( 6.1 )].

Tsis hnov ​​lus li cas

Qhia cov neeg mob kom tsis txhob noj PDE5 inhibitors, suav nrog Levitra, thiab nrhiav kev kho mob tam sim thaum muaj kev poob qis lossis tsis hnov ​​lus. Cov xwm txheej no, uas tuaj yeem suav nrog tinnitus thiab kiv taub hau, tau tshaj tawm hauv kev sib koom ua ke mus rau qhov tau txais PDE5 inhibitors, suav nrog Levitra. Nws tsis tuaj yeem txiav txim siab seb cov xwm txheej no cuam tshuam ncaj qha rau kev siv PDE5 inhibitors lossis lwm yam[saib Cov Kev Tsis Zoo ( 6 )].

Kab Mob Sib Kis

Qhia rau cov neeg mob tias Levitra tsis muaj kev tiv thaiv kab mob sib kis. Tham nrog cov neeg mob uas ntsuas kev tiv thaiv tsim nyog los tiv thaiv kab mob sib kis, suav nrog Human Immunodeficiency Virus (HIV), yuav tsum tau txiav txim siab.

Kev Kho Dose

Qhia cov neeg mob tias qhov pib pom zoo koob tshuaj Levitra yog 10 mg. Cov koob tshuaj tuaj yeem nce mus rau qhov siab tshaj plaws pom zoo ntawm 20 mg lossis txo mus rau 5 mg raws li qhov ua tau zoo thiab ua siab ntev. Qhov pom zoo kom noj ntau zaus yog ib ntsiav tshuaj hauv ib hnub.

FDA-pom zoo daim ntawv lo tus neeg mob

Levitra® ib(Luh-VEE-Trah)
(vardenafil HCl) Ntsiav tshuaj

Nyeem Cov Neeg Mob Cov Ntaub Ntawv txog Levitra ua ntej koj pib noj thiab rov ua dua txhua lub sijhawm koj tau txais cov nyiaj rov qab. Tej zaum yuav muaj xov xwm tshiab. Koj kuj tseem yuav pom tias nws muaj txiaj ntsig los qhia cov ntaub ntawv no nrog koj tus khub. Daim ntawv no tsis siv qhov chaw tham nrog koj tus kws kho mob. Koj thiab koj tus kws kho mob yuav tsum tham txog Levitra thaum koj pib noj nws thiab ntawm kev kuaj mob tas li. Yog koj tsis nkag siab cov ntaub ntawv, lossis muaj lus nug, nrog koj tus kws kho mob lossis kws muag tshuaj tham.

Cov ntaub ntawv tseem ceeb dab tsi koj yuav tsum paub txog Levitra?

Levitra tuaj yeem ua rau koj cov ntshav siab poob sai sai rau qib tsis nyab xeeb yog tias nws tau noj nrog lwm yam tshuaj.Nrog kev poob ntshav sai, koj tuaj yeem kiv taub hau, tsaus muag, lossis muaj lub plawv nres lossis mob hlab ntsha tawg.

Tsis txhob noj Levitra yog tias koj:

Noj cov tshuaj twg hu ua nitrates (feem ntau siv los tswj mob hauv siab, tseem hu ua angina).
Siv cov tshuaj ua si hu ua poppers xws li amyl nitrate thiab butyl nitrate.
Siv riociguat (Adempas®), cov tshuaj tiv thaiv guanulate cyclase, tshuaj uas kho tus mob ntshav siab thiab mob ntsws-thromboembolic pulmonary hypertension.

(Saib 'Leej Twg Yuav Tsis Siv Levitra?')

Qhia rau txhua tus kws kho mob uas koj noj Levitra.Yog tias koj xav tau kev kho mob xwm txheej ceev rau teeb meem plawv, nws yuav yog qhov tseem ceeb rau koj tus kws kho mob kom paub thaum twg koj tau noj Levitra zaum kawg.

Levitra yog dab tsi?

Levitra yog tshuaj noj los ntawm qhov ncauj rau kev kho mob erectile kawg (ED) rau txiv neej.

ED yog ib yam mob uas tus qau tsis tawv thiab nthuav dav thaum tus txiv neej muaj kev sib deev zoo siab, lossis thaum nws tsis tuaj yeem ua kom erection. Ib tug txiv neej uas muaj teeb meem tau txais lossis ua kom erection yuav tsum mus ntsib nws tus kws kho mob yog tias tus mob cuam tshuam rau nws. Levitra tuaj yeem pab tus txiv neej nrog ED tau thiab ua kom erection thaum nws muaj kev sib deev zoo siab.

Levitra tsis:

Kho ED
Ua kom txiv neej lub siab nyiam sib deev
Tiv thaiv tus txiv neej lossis nws tus khub los ntawm kab mob sib kis, suav nrog HIV. Tham nrog koj tus kws kho mob txog txoj hauv kev tiv thaiv kab mob sib kis.
Ua raws li txiv neej daim ntawv tswj kev yug menyuam.

Levitra tsuas yog rau cov txiv neej nrog ED. Levitra tsis yog rau poj niam lossis menyuam yaus. Levitra yuav tsum tau siv tsuas yog nyob hauv kev saib xyuas kws kho mob.

Levitra ua haujlwm li cas?

Thaum tus txiv neej tau txhawb kev sib deev, nws lub cev lub cev ua haujlwm zoo yog ua kom cov ntshav ntws mus rau nws tus qau. Qhov no ua rau muaj kev txhim kho. Levitra pab ua kom cov ntshav ntws mus rau qhov chaw mos thiab tuaj yeem pab txiv neej nrog ED tau txais thiab ua kom muaj kev txhim kho erection txaus siab rau kev sib deev. Thaum tus txiv neej tau ua tiav kev sib deev, cov ntshav ntws mus rau nws tus qau txo qis, thiab nws erection ploj mus.

Leej twg tuaj yeem nqa Levitra?

Tham nrog koj tus kws kho mob los txiav txim seb Levitra puas haum rau koj.

Levitra tau pom tias muaj txiaj ntsig zoo rau txiv neej hnub nyoog tshaj 18 xyoo uas muaj kev txhim kho erectile, suav nrog cov txiv neej uas muaj ntshav qab zib lossis leej twg tau ua tiav prostatectomy.

LEEJ TWG YUAV TSUM tsis siv Levitra?

Tsis txhob noj Levitra yog tias koj:

Siv cov tshuaj uas hu ua nitrates(SaibCov ntaub ntawv tseem ceeb dab tsi koj yuav tsum paub txog Levitra?). Nitrates feem ntau siv los kho angina. Angina yog cov tsos mob ntawm kab mob hauv lub plawv thiab tuaj yeem ua rau mob hauv koj lub hauv siab, lub puab tsaig, lossis qis koj txhais caj npab.
Cov tshuaj hu ua nitrates suav nrog nitroglycerin uas pom hauv cov ntsiav tshuaj, tshuaj tsuag, tshuaj pleev, tshuaj pleev, lossis thaj ua rau thaj. Nitrates kuj tseem tuaj yeem pom hauv lwm cov tshuaj xws li isosorbide dinitrate lossis isosorbide mononitrate. Qee cov tshuaj ua si hu ua poppers kuj muaj nitrates, xws li amyl nitrate thiab butyl nitrate. Tsis txhob siv Levitra yog tias koj siv cov tshuaj no. Nug koj tus kws kho mob lossis kws muag tshuaj yog tias koj tsis paub tseeb tias ib yam ntawm koj cov tshuaj yog nitrates.
Siv riociguat, tus tiv thaiv guanylate cyclase,ib yam tshuaj uas kho tus mob ntshav siab thiab mob throembolic pulmonary hypertension.
Tau hais los ntawm koj tus kws kho mob kom tsis txhob muaj kev sib deev vim muaj teeb meem kev noj qab haus huv.Kev sib deev tuaj yeem ua rau koj lub plawv mob hnyav, tshwj xeeb tshaj yog tias koj lub plawv twb tsis muaj zog los ntawm kev mob plawv lossis mob plawv.

YUAV UA LI CAS KOJ YUAV TSHUAJ tham nrog koj tus kws kho mob ua ntej noj Levitra?

Ua ntej noj Levitra, qhia koj tus kws kho mob txog txhua yam teeb meem kev kho mob, suav nrog yog tias koj:

Muaj teeb meem plawv xws li angina, lub plawv tsis ua haujlwm, lub plawv dhia tsis xwm yeem, lossis muaj lub plawv nres. Nug koj tus kws kho mob yog tias nws muaj kev nyab xeeb rau koj kom muaj kev sib deev.
Muaj ntshav siab lossis muaj ntshav siab uas tsis tuaj yeem tswj tau.
Muaj pulmonary hypertension.
Muaj mob stroke.
Tau qaug dab peg.
Los yog ib tus neeg hauv tsev neeg muaj mob plawv tsawg uas paub tias yog QT ncua ntev (ntev QT syndrome).
Muaj teeb meem daim siab.
Muaj teeb meem ntawm lub raum thiab xav tau kev lim ntshav.
Muaj retinitis pigmentosa, tsis tshua muaj caj ces (khiav hauv tsev neeg) kab mob qhov muag
Puas tau muaj qhov muag tsis pom kev hnyav, lossis yog tias koj muaj qhov muag mob hu ua non-arteritic anterior ischemic optic neuropathy (NAION).
Muaj mob plab.
Muaj teeb meem los ntshav.
Muaj tus cwj pwm tsis zoo lossis Peyronie tus kab mob.
Tau muaj kev txhim kho uas kav ntev dua 4 teev.
Muaj teeb meem ntawm tes ntshav xws li mob ntshav tsis txaus ntshav, ntau yam mob myeloma, lossis mob qog noj ntshav.
Muaj teeb meem hnov ​​lus.

Puas Muaj Lwm Yam Tshuaj Kho Mob Levitra?

Qhia koj tus kws kho mob txog txhua yam tshuaj koj nojsuav nrog cov ntawv yuav tshuaj thiab tsis yog tshuaj yuav tshuaj, vitamins, thiab tshuaj ntsuab ntxiv. Levitra thiab lwm yam tshuaj yuav cuam tshuam rau ib leeg. Ib txwm kuaj nrog koj tus kws kho mob ua ntej pib lossis nres ib yam tshuaj. Tshwj xeeb tshaj yog qhia rau koj tus kws kho mob yog tias koj ua raws li cov hauv qab no:

Cov tshuaj hu ua nitrates (saib Cov ntaub ntawv tseem ceeb twg koj yuav tsum paub txog Levitra?).
Ketoconazole lossis itraconazole (xws li Nizoral® iblos yog Sporanox® ib).
Ritonavir (Norvir® ib) lossis indinavir sulfate (Crixivan® ibsaquinavir (Fortavase® ibsau Invirase® ib) lossis atazanavir (Reyataz® ib).
Erythromycin lossis clarithromycin.
Cov tshuaj hu ua alpha-blockers. Cov no suav nrog Hytrin® ib(terazosin HCl), Flomax® ib(tamsulosin HCl), Cardura® ib(doxazosin mesylate), Minipress® ib(prazosin HCl), Rapaflo® (silodosin) lossis Uroxatral® ib(alfuzosin HCl). Alpha-blockers qee zaum tau qhia rau teeb meem prostate lossis ntshav siab. Hauv qee tus neeg mob siv PDE5 cov tshuaj tiv thaiv kab mob, suav nrog Levitra, nrog alpha-blockers tuaj yeem txo cov ntshav siab ua rau poob ntsej muag. Koj yuav tsum hu rau kws kho mob yog tias alpha-blockers lossis lwm yam tshuaj uas txo cov ntshav siab tau teev tseg los ntawm lwm tus kws kho mob.
Cov tshuaj uas kho lub plawv dhia txawv txav. Cov no suav nrog quinidine, procainamide, amiodarone thiab sotalol.
Lwm yam tshuaj lossis kev kho mob rau ED.

YUAV UA LI CAS KOJ YUAV TAU Levitra

Noj Levitra raws nraim li koj tus kws kho mob sau tseg.Tsis txhob noj ntau dua li Levitra ib hnub.Cov koob tshuaj yuav tsum tau noj yam tsawg 24 teev sib nrug. Qee tus txiv neej tsuas tuaj yeem noj tshuaj me me ntawm Levitra vim yog mob lossis cov tshuaj uas lawv noj. Koj tus kws kho mob yuav sau ntawv noj tshuaj uas yog rau koj.

Yog tias koj laus dua 65 xyoos lossis muaj teeb meem rau lub siab, koj tus kws kho mob yuav pib ua rau koj qis dua ntawm Levitra.
Yog tias koj muaj teeb meem prostate lossis ntshav siab, uas koj noj tshuaj hu ua alpha-blockers, koj tus kws kho mob yuav pib rau koj ntawm qis dua Levitra.
Yog tias koj tab tom noj lwm yam tshuaj uas koj tus kws kho mob tuaj yeem sau tshuaj pib qis dua thiab txwv koj rau ib koob tshuaj Levitra hauv 72 teev (3 hnub).

Noj 1 ntsiav tshuaj Levitra li 1 teev (60 feeb) ua ntej kev sib deev. Qee daim ntawv ntawm kev txhawb kev sib deev yog xav tau rau kev txhim kho kom tshwm sim nrog Levitra. Levitra tuaj yeem noj nrog lossis tsis noj mov.

Tsis txhob hloov koj koob tshuaj Levitra yam tsis tham nrog koj tus kws kho mob. Koj tus kws kho mob yuav txo koj cov tshuaj lossis nce koj cov tshuaj, nyob ntawm seb koj lub cev ua li cas rau Levitra.

Hu rau koj tus kws kho mob lossis chav kho mob xwm txheej tam sim yog tias koj yuam kev siv Levitra ntau dua li tau hais tseg.

YUAV UA LI CAS THIAJ YUAV UA LI CAS THIAJ YUAV TSHUAJ TIV THAIV Levitra?

Qhov tshwm sim tshwm sim feem ntau nrog Levitra yog mob taub hau, yaug, txhaws los yog qhov ntswg, tsis zom zaub mov, mob plab, kiv taub hau lossis mob nraub qaum. Cov kev mob tshwm sim no feem ntau ploj mus tom qab ob peb teev. Hu rau koj tus kws kho mob yog tias koj tau txais cov kev mob tshwm sim uas thab koj lossis ib qho uas yuav tsis ploj mus.

Levitra tuaj yeem ua rau tsis txaus ntseeg:

Kev txhim kho uas yuav tsis ploj mus (priapism).Yog tias koj tau txais kev txhim kho uas kav ntev dua 4 teev, nrhiav kev kho mob tam sim. Priapism yuav tsum tau kho kom sai li sai tau lossis qhov puas tsuaj tas mus li tuaj yeem tshwm sim rau koj tus qau suav nrog qhov tsis muaj peev xwm ua kom muaj erections.
Kev hloov xim pom kev,xws li pom cov xim xiav rau cov khoom lossis muaj teeb meem qhia qhov sib txawv ntawm cov xim xiav thiab ntsuab.

Hauv qhov xwm txheej tsis tshua muaj tshwm sim, txiv neej noj tshuaj PDE5 inhibitors (tshuaj kho lub qhov ncauj tsis xws luag, suav nrog Levitra) tshaj tawm sai lossis poob qhov muag ntawm ib lossis ob lub qhov muag. Nws tsis paub meej tias PDE5 inhibitors ncaj qha ua rau pom kev ploj. Yog tias koj muaj kev poob qis lossis tsis pom kev sai, tsum tsis noj PDE5 inhibitors, suav nrog Levitra, thiab hu rau kws kho mob tam sim ntawd.

Tsis hnov ​​lus lossis poob qis hauv kev hnov ​​lus, qee zaum nrog lub suab nrov hauv pob ntseg thiab kiv taub hau, tsis tshua muaj qhia hauv cov neeg noj PDE5 inhibitors, suav nrog Levitra. Nws tsis tuaj yeem txiav txim siab seb cov xwm txheej no cuam tshuam ncaj qha rau PDE5 cov tshuaj tiv thaiv kab mob, rau lwm yam kab mob lossis tshuaj noj, rau lwm yam, lossis cuam tshuam nrog lwm yam. Yog tias koj pom cov tsos mob no, tsum tsis noj Levitra thiab hu rau kws kho mob tam sim ntawd.

Cov no tsis yog txhua qhov tshwm sim ntawm Levitra. Yog xav paub ntxiv, nug koj tus kws kho mob lossis kws muag tshuaj.

Hu rau koj tus kws kho mob kom tau txais kev qhia paub txog kev phiv tshuaj. Koj tuaj yeem tshaj tawm cov kev mob tshwm sim rau FDA ntawm 1-800-FDA-1088.

YUAV UA LI CAS YUAV TSHUAJ Levitra?

Khaws Levitra ntawm chav sov ntawm 59-86 ° F (15-30 ° C).
Khaws Levitra thiab tag nrho cov tshuaj kom tsis txhob ncav cuag cov menyuam.

GENERAL INFORMATION ABOUT about Levitra

Qee zaum cov tshuaj tau sau tseg rau cov xwm txheej uas tsis yog cov uas tau piav qhia hauv daim ntawv qhia cov neeg mob. Tsis txhob siv Levitra rau qhov xwm txheej uas nws tsis tau teev tseg. Tsis txhob muab Levitra rau lwm tus neeg, txawm tias lawv muaj cov tsos mob zoo ib yam uas koj muaj. Tej zaum yuav ua mob rau lawv.

Cov ntawv no suav nrog cov ntaub ntawv tseem ceeb tshaj plaws txog Levitra. Yog tias koj xav tau xov xwm ntau ntxiv, nrog koj tus kws kho mob tham. Koj tuaj yeem nug koj tus kws kho mob lossis kws muag tshuaj kom paub cov ntaub ntawv hais txog Levitra uas tau sau rau cov kws kho mob.

Yog xav paub ntxiv koj tuaj yeem mus ntsib www.Levitra.com, lossis hu rau 1-888-825-5249.

Dab tsi yog cov khoom xyaw ntawm Levitra?

oxy 30 ntsiav tshuaj xiav

Cov khoom xyaw nquag:vardenafil hydrochloride hmoov

Cov khoom xyaw tsis haum:microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, daj ferric oxide, thiab liab ferric oxide.

Cov Ntaub Ntawv Tus Neeg Mob no tau pom zoo los ntawm Asmeskas Chaw Tswj Khoom Noj thiab Tshuaj.

Cov khoom lag luam raug hais hauv Levitra USPI

Norvir (ritonavir) yog lub cim lag luam ntawm Abbott Laboratories
Crixivan (indinavir sulfate) yog lub cim lag luam ntawm Merck & Co., Inc.
Invirase lossis Fortavase (saquinavir mesylate) yog lub cim lag luam ntawm Roche Laboratories Inc.
Reyataz (atazanavir sulfate) yog lub lag luam ntawm Bristol-Myers Squibb Company
Nizoral (ketoconazole) yog lub cim lag luam ntawm Johnson & Johnson
Sporanox (itraconazole) yog lub cim lag luam ntawm Johnson & Johnson
Hytrin (terazosin HCl) yog lub cim lag luam ntawm Abbott Laboratories
Flomax (tamsulosin HCl) yog lub cim lag luam ntawm Yamanouchi Pharmaceutical Co., Ltd.
Cardura (doxazosin mesylate) yog lub cim lag luam ntawm Pfizer Inc.
Minipress (prazosin HCl) yog lub cim lag luam ntawm Pfizer Inc.
Rapaflo (silodosin) yog lub cim lag luam ntawm Watson Pharma Inc.
Uroxatral (alfuzosin HCl) yog lub cim lag luam ntawm Sanofi-Synthelabo

Hnub Kho dua: 8/2017

Manufactured rau:

Bayer HealthCare Pharmaceuticals Inc.
Whippany, NJ 07981
Tsim nyob hauv lub teb chaws Yelemees

Faib los ntawm:
GlaxoSmithKline
Tshawb fawb daim duab peb sab
NCO 27709

Levitra yog lub npe lag luam ntawm Bayer Pharma AG thiab tau siv hauv kev tso cai los ntawm GlaxoSmithKline.

Tsuas yog Rx

© 2003 Bayer HealthCare Pharmaceuticals Inc.

Levitra 5 mg Label

83491117NDC0173-0829-13

Levitra® ib

(VARDENAFIL HCI) TABLETS
Sib npaug rau

5mg ibvardenafil

Rx tsuas yog 30 ntsiav tshuaj

Levitra 10 mg Label

83491125NDC0173-0830-13

Levitra® ib

(VARDENAFIL HCI) TABLETS
Sib npaug rau

10 mgvardenafil

Rx tsuas yog 30 ntsiav tshuaj

Levitra 20 mg Daim ntawv lo

83491133NDC0173-0831-13

Levitra® ib

(VARDENAFIL HCI) TABLETS
Sib npaug rau

20 mg / osvardenafil

Rx tsuas yog 30 ntsiav tshuaj

Levitra
vardenafil hydrochloride ntsiav tshuaj, zaj duab xis coated
Khoom Qhia
Yam Khoom HLOOV KEV POV THAWJ DRUG LABEL Yam Khoom (Qhov Chaw) NDC: 0173-0829
Txoj Kev Tswj QAUV Teem caij DEA
Cov khoom xyaw nquag/nquag muaj nuj nqis
Lub Npe Lub Npe Lub hauv paus ntawm Kev Muaj Zog Lub zog
VARDENAFIL HYDROCHLORIDE (VARDENAFIL) VARDENAFIL 5mg ib
Cov khoom xyaw tsis haum
Lub Npe Lub Npe Lub zog
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (120 .MU.M)
SILICON DIOXIDE Cov
MAGNESIUM STEARATE
HYPROMELLOSE, TSIS MUAJ TSEEB
POLYETHYLENE GLYCOL, TSIS MUAJ TSEEB
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Yam Khoom
Xim LOJ Cov qhab nia tsis muaj qhab nia
Zoo ROV Loj 6 hli
Tsw Txoj Cai Luam Tawm NYOB; 5
Muaj
Ntim
# Khoom Code Cov lus piav qhia pob
1 NDC: 0173-0829-13 30 TABLET, YOOJ YIM COATED hauv 1 lub raj mis, HLAU
Cov Lus Qhia Txog Kev Lag Luam
Qeb Qeb Naj Npawb Daim Ntawv Thov lossis Monograph Citation Hnub Pib Ua Lag Luam Hnub Kawg Ua Lag Luam
NDA NDA021400 04/23/2003 kuv 12/31/2020
Levitra
vardenafil hydrochloride ntsiav tshuaj, zaj duab xis coated
Khoom Qhia
Yam Khoom HLOOV KEV POV THAWJ DRUG LABEL Yam Khoom (Qhov Chaw) NDC: 0173-0830
Txoj Kev Tswj QAUV Teem caij DEA
Cov khoom xyaw nquag/nquag muaj nuj nqis
Lub Npe Lub Npe Lub hauv paus ntawm Kev Muaj Zog Lub zog
VARDENAFIL HYDROCHLORIDE (VARDENAFIL) VARDENAFIL 10 mg
Cov khoom xyaw tsis haum
Lub Npe Lub Npe Lub zog
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (120 .MU.M)
SILICON DIOXIDE Cov
MAGNESIUM STEARATE
HYPROMELLOSE, TSIS MUAJ TSEEB
POLYETHYLENE GLYCOL, TSIS MUAJ TSEEB
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Yam Khoom
Xim LOJ Cov qhab nia tsis muaj qhab nia
Zoo ROV Loj 7 hli
Tsw Txoj Cai Luam Tawm NEEEJ; 10
Muaj
Ntim
# Khoom Code Cov lus piav qhia pob
1 NDC: 0173-0830-13 30 TABLET, YOOJ YIM COATED hauv 1 lub raj mis, HLAU
2 NDC: 0173-0830-61 1 BLISTER PACK hauv 1 CARTON
2 2 TABLET, YOOJ YIM TSHUAJ TSHUAJ TSHIAB hauv 1 BLISTER PACK
Cov Lus Qhia Txog Kev Lag Luam
Qeb Qeb Naj Npawb Daim Ntawv Thov lossis Monograph Citation Hnub Pib Ua Lag Luam Hnub Kawg Ua Lag Luam
NDA NDA021400 08/25/2003 kuv 12/31/2021
Levitra
vardenafil hydrochloride ntsiav tshuaj, zaj duab xis coated
Khoom Qhia
Yam Khoom HLOOV KEV POV THAWJ DRUG LABEL Yam Khoom (Qhov Chaw) NDC: 0173-0831
Txoj Kev Tswj QAUV Teem caij DEA
Cov khoom xyaw nquag/nquag muaj nuj nqis
Lub Npe Lub Npe Lub hauv paus ntawm Kev Muaj Zog Lub zog
VARDENAFIL HYDROCHLORIDE (VARDENAFIL) VARDENAFIL 20 mg / os
Cov khoom xyaw tsis haum
Lub Npe Lub Npe Lub zog
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (120 .MU.M)
SILICON DIOXIDE Cov
MAGNESIUM STEARATE
HYPROMELLOSE, TSIS MUAJ TSEEB
POLYETHYLENE GLYCOL, TSIS MUAJ TSEEB
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Yam Khoom
Xim LOJ Cov qhab nia tsis muaj qhab nia
Zoo ROV Loj 8 hli
Tsw Txoj Cai Luam Tawm NEEEJ; 20
Muaj
Ntim
# Khoom Code Cov lus piav qhia pob
1 NDC: 0173-0831-13 30 TABLET, YOOJ YIM COATED hauv 1 lub raj mis, HLAU
2 NDC: 0173-0831-61 1 BLISTER PACK hauv 1 CARTON
2 2 TABLET, YOOJ YIM TSHUAJ TSHUAJ TSHIAB hauv 1 BLISTER PACK
Cov Lus Qhia Txog Kev Lag Luam
Qeb Qeb Naj Npawb Daim Ntawv Thov lossis Monograph Citation Hnub Pib Ua Lag Luam Hnub Kawg Ua Lag Luam
NDA NDA021400 08/25/2003 kuv 10/31/2021
Daim ntawv lo -GlaxoSmithKline LLC (167380711) Cov.
Sau npe -Bayer HealthCare Pharmaceuticals Inc. (005436809)
Tsim
Lub Npe Chaw nyob ID/FEI Kev ua haujlwm
Bayer UA 314947622 LUS QHIA (0173-0829, 0173-0830, 0173-0831), PACK (0173-0829, 0173-0830, 0173-0831), API Kev Tsim Kho (0173-0829, 0173-0830, 0173-0831), MANUFACTURE (0173- 0829, 0173-0830, 0173-0831), TEJ LUS QHIA SIAB (0173-0829, 0173-0830, 0173-0831), STERILIZE (0173-0829, 0173-0830, 0173-0831)
Tus tsim tawm: GlaxoSmithKline LLC

Kev Tsis Pom Zoo Kho Mob