natgillin/translations-raw huggingface dataset:
I en særlig interaktions - undersøgelse, hvor sildenafil (100 mg) blev givet sammen med amlodipin til hypertensive patienter, sås en ekstra reduktion i systolisk blodtryk i liggende stilling på 8 mmHg.
In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg.
5. 1).
These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers (see section 5.1).
Sildenafil (100 mg) påvirker ikke steady state farmakokinetikken af HIV- proteasehæmmerne saquinavir og rinatovir, som begge er CYP3A4- substrater.
Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.
I reproduktionsforsøg på rotter og kaniner ses ingen relevante bivirkninger efter oral indgift af sildenafil.
No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil.
Da der er rapporteret svimmelhed og ændret syn i kliniske undersøgelser med sildenafil, bør patienter være opmærksomme på, hvordan de reagerer på VIAGRA, inden de kører bil eller betjener maskiner.
As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to VIAGRA, before driving or operating machinery.
VIAGRAs sikkerhedsprofil er baseret på 8. 691 patienter, der er behandlet med de anbefalede doser i 67 placebo- kontrollerede kliniske undersøgelser.
The safety profile of VIAGRA is based on 8691 patients who received the recommended dosing regimen in 67 placebo-controlled clinical studies.
De hyppigst rapporterede bivirkninger i kliniske undersøgelser hos sildenafilbehandlede patienter var hovedpine, rødmen, dyspepsi, synsforandringer, næsetilstopning, svimmelhed og synsfarveforvrængning.
The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, visual disorders, nasal congestion, dizziness and visual colour distortion.
I bivirkningsovervågningen efter markedsføringen er der indsamlet bivirkninger i en periode på mere end 9 år.
6 Adverse reactions from post-marketing surveillance has been gathered covering an estimated period > 9 years.
(≥1/ 10), almindelig (≥1/ 100 og < 1/ 10), ikke almindelig (≥1/ 1000 og < 1/ 100), sjælden (≥1/ 10. 000 og < 1/ 1000).
In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000).
Derudover er frekvensen af medicinsk vigtige bivirkninger rapporteret efter markedsføring angivet som ikke kendt.
In addition, the frequency of medically important adverse reactions reported from post-marketing experience is included as not known.
Medicinsk vigtige bivirkninger, som er rapporteret i kontrollerede kliniske undersøgelser med en hyppighed større end placebo samt medicinsk vigtige bivirkninger rapporteret gennem overvågning efter markedsføring.
Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post- marketing surveillance
Meget almindelig Almindelig Ikke almindelig Sjælden Ikke kendt Øjne
Very common Common Uncommon Rare Not known Eye disorders
Hovedpine Svimmelhed Søvnighed, hypæstesi Cerebrovaskulær hændelse, synkope Transitorisk cerebral iskæmi, krampeanfald, tilbagevendende krampeanfald
Headache Dizziness Somnolence, Hypoaesthesia Cerebrovascular accident, Syncope Transient ischaemic attack, Seizure, Seizure recurrence
Øjenlidelser, synsfarveforvrængning Sygdom i conjunctiva, øjensygdomme, tåreflådforstyrrelser, andre øjenlidelser
Visual disorders, Visual colour distortion Conjunctival disorders, Eye Disorders, Lacrimation Disorders, Other Eye Disorders
Ikke kendt Øre og labyrint
Not known Ear and labyrinth disorders
Non- arteritis anterior iskæmisk opticusneuropati (NAION), vaskulær okklusion i retina, synsfeltdefekt
Non-arteritic anterior ischaemic optic neuropathy (NAION), Retinal vascular occlusion, Visual field defect
Ikke almindelig Sjælden Vaskulære sygdomme
Uncommon Rare Vascular disorders
Vertigo, tinnitus Døvhed *
Vertigo, Tinnitus Deafness*
Rødmen Hypertension, hypotension
Flushing Hypertension, Hypotension
Ikke almindelig Sjælden Ikke kendt Luftveje, thorax og mediastinum
Uncommon Rare Not known
Palpitationer, takykardi Myokardieinfarkt, atrieflimren Ventrikulær arytmi, ustabil angina, pludselig hjertedød
Palpitations, Tachycardia Myocardial infarction, Atrial fibrillation Ventricular arrhythmia, Unstable angina, Sudden cardiac death
Almindelig Sjælden Mave- tarmkanalen
Respiratory, thoracic and mediastinal disorders Common Rare Gastrointestinal disorders
Næsetilstopning Epistaxis
Nasal congestion Epistaxis
Almindelig Ikke almindelig Hud og subkutane væv
Common Uncommon
Dyspepsi Opkastning, kvalme, mundtørhed
Dyspepsia Vomiting, Nausea, Dry mouth
Ikke almindelig Knogler, led, muskler og bindevæv
Skin, subcutaneous and soft tissue disorders Uncommon
Ikke almindelig Det reproduktive system og mammae
Musculoskeletal and connective tissue disorders Uncommon Reproductive system and breast disorders
Not known
Not known
Priapisme, forlænget erektion
Priapism, Prolonged erection
Almene symptomer og reaktioner på administrationsstedet Ikke almindelig
7
Brystsmerter, træthed
System Organ Class
Undersøgelser
Adverse Reactions
Ikke almindelig
Chest pain, Fatigue
* Øre og labyrint:
* Ear disorders:
Pludselig døvhed.
Sudden
I et lille antal post- marketing forsøg og kliniske forsøg med alle PDE- hæmmere, herunder sildenafil, er der set pludselig nedsættelse eller tab af hørelse.
number of post-marketing and clinical trials cases with the use of all PDE5 inhibitors, including sildenafil.
Stoffer anvendt ved erektil dysfunktion.
Drugs used in erectile dysfunction.
ATC kode GO4B E03
G04B E03.
Sildenafil er en oral behandling af erektil dysfunktion, som genopretter nedsat erektil funktion ved at øge blodtilstrømningen til penis på en naturlig måde ved seksuel stimulation.
In the natural setting, i. e. with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis.
Når NO/ cGMP - vejen er aktiveret, som det sker ved seksuel stimulation, fører sildenafils hæmning af PDE5 til øgede cGMP- niveauer i corpus cavernosum.
When the NO/ cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by sildenafil results in increased corpus cavernosum levels of cGMP.
In vitro undersøgelser har vist, at sildenafil er selektiv for PDE5, som er involveret i erektionsprocessen.
Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process.
Ved den maksimale anbefalede dosis er der en over 80- gange større selektivitet over for PDE1 og mere end 700- gange over for PDE2, 3, 4, 7, 8, 9, 10 og 11.
At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE2, 3, 4, 7, 8, 9, 10 and 11.
2 kliniske undersøgelser var specielt udarbejdet med henblik på at bestemme den tidsramme efter indtagelse, indenfor hvilken sildenafil kunne producere en erektion efter seksuel stimulation.
Two clinical studies were specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation.
I en penis- pletysmografiundersøgelse (RigiScan) hos fastende patienter var den gennemsnitlige tid til indsættende effekt for dem, som fik erektioner med 60% stivhed (nok til gennemførelse af samleje) 25 minutter (fra 12- 37 minutter), når de fik sildenafil.
8 rigidity (sufficient for sexual intercourse) was 25 minutes (range 12-37 minutes) on sildenafil.
I en anden RigiScan- undersøgelse var sildenafil stadig i stand til at give erektion efter seksuel stimulation 4- 5 timer efter dosisindtagelsen.
In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation 4-5 hours post-dose.
Det gennemsnitlige maksimale fald i systolisk blodtryk i liggende stilling efter 100 mg sildenafil oralt var 8, 4 mmHg.
The mean maximum decreases in supine systolic blood pressure following 100 mg oral dosing of sildenafil was 8.4 mmHg.
Den tilsvarende forandring i diastolisk blodtryk i liggende stilling var 5, 5 mmHg.
The corresponding change in supine diastolic blood pressure was 5.5 mmHg.
Disse blodtryksfald svarer til sildenafils vasodilatatoriske virkning, sandsynligvis som følge af øgede cGMP- niveauer i den glatte muskulatur i karrene.
These decreases in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle.
I en klinisk undersøgelse af de hæmodynamiske virkninger efter en enkelt oral dosis på 100 mg sildenafil hos 14 patienter med alvorlig koronararteriesygdom (CAD) (> 70% stenoser i mindst 1
In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (> 70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline.
I en dobbelt- blind, placebo- kontrolleret motionsstressundersøgelse, hvori 144 patienter med erektil dysfunktion og stabil angina tog deres sædvanlige medicin mod angina pectoris (undtaget nitrater), blev der ikke set klinisk relevante forskelle i tiden indtil angina blev en begrænsende faktor for sildenafil sammenlignet med placebo.
No clinical relevant differences were demonstrated in time to limiting angina for sildenafil when compared with placebo in a double blind, placebo controlled exercise stress trial in 144 patients with erectile dysfunction and chronic stable angina, who were taking on a regular basis anti-anginal medications (except nitrates).
Lette og forbigående forskelle i evnen til at skelne farver (blå/ grøn) er set hos nogle individer ved hjælp af Farnsworth- Munsell 100 nuance test 1 time efter en dosis på 100 mg dog uden synlig effekt 2 timer efter indtagelse.
Mild and transient differences in colour discrimination (blue/ green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
I en mindre, placebo- kontrolleret undersøgelse hos patienter med dokumenteret tidlig aldersrelateret makuløs degenerering (n=9) viste sildenafil (100 mg enkeltdosis) ingen signifikante ændringer i udførte visuelle test (visuel skarphed, Amsler- kort, farvesskelnen ved simuleret trafiklys, Humphrey perimeter og fotostress).
In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).
Der var ingen effekt på spermiemotilitet eller – morfologi efter indgift af en enkelt oral dosis sildenafil 100 mg hos raske forsøgspersoner.
There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers.
Yderligere oplysninger om kliniske undersøgelser I kliniske undersøgelser blev sildenafil givet til mere end 8. 000 patienter mellem 19 og 87 år.
Further information on clinical trials In clinical trials sildenafil was administered to more than 8000 patients aged 19-87.
Ældre (19, 9%), patienter med hypertension (30, 9%), diabetes mellitus (20, 3%), iskæmisk hjertesygdom (5, 8%), hyperlipidæmi (19, 8%), rygmarvsskade (0, 6%), depression (5, 2%), transuretral resektion af prostata (TURP) (3, 7%), radikal prostatektomi (3, 3%).
The following patient groups were represented: elderly (19.9%), patients with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%).
4. 3).
The following groups were not well represented or excluded from clinical trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or hepatic impairment and patients with certain cardiovascular conditions (see section 4.3).
Psykogen erektil dysfunktion (84%), blandet erektil dysfunktion (77%), organisk erektil dysfunktion (68%), ældre (67%), diabetes mellitus (59%), iskæmisk hjertesygdom (69%), hypertension (68%), TURP (61%), radikal prostatektomi (43%), rygmarvsskade (83%), depression (75%).
Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%).
Maksimale plasmakoncentrationer nås inden for 30- 120 minutter (gennemsnitlig 60 minutter) efter oral indgift i fastende tilstand.
Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Oral indgift af sildenafil øger AUC og Cmax proportionalt med dosis over det anbefalede dosisområde (25- 100 mg).
After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range (25-100 mg).
Efter en enkelt oral dosis på 100 mg er den gennemsnitlige maksimale totale plasmakoncentration af sildenafil ca.
After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/ ml (CV 40%).
Da 96% af sildenafil (og dets væsentligste cirkulerende N- desmethylmetabolit) er bundet til plasmaproteiner, resulterer dette i den
Since sildenafil (and its major circulating N- desmethyl metabolite) is 96% bound to plasma proteins, this results in the mean maximum free plasma concentration for sildenafil of 18 ng/ ml (38 nM).
Hos raske forsøgspersoner, som fik sildenafil (100 mg som enkeltdosis), fandtes mindre end 0, 0002% (gennemsnitlig 188 ng) af indgivet dosis i ejakulatet 90 minutter efter indgift.
In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002% (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing.
Den væsentligste cirkulerende metabolit er resultatet af en N - demethylering af sildenafil.
The major circulating metabolite results from N-demethylation of sildenafil.
40% af sildenafils.
Plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil.
4 timer.
The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h.
Sildenafils totale kropsclearance er 41 l/ t med en deraf følgende halveringstid på 3- 5 timer.
The total body clearance of sildenafil is 41 l/ h with a resultant terminal phase half-life of 3-5 h.
Hos frivillige forsøgspersoner med let til moderat nedsat nyrefunktion (kreatininclearance = 30- 80 ml/ min) ændres farmakokinetikken ikke efter en enkelt oral dosis på 50 mg.
In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 ml/ min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
Gennemsnitlig AUC og Cmax af N- desmethylmetabolitten øges med henholdsvis 126% og 73% sammenlignet med frivillige forsøgspersoner med samme alder uden nedsat nyrefunktion.
The mean AUC and Cmax of the N-desmethyl metabolite increased 126% and 73% respectively, compared to age-matched volunteers with no renal impairment.
Hos frivillige forsøgspersoner med svært nedsat nyrefunktion (kreatininclearance < 30 ml/ min) reduceres sildenafil- clearance, hvilket fører til gennemsnitlige stigninger i AUC og Cmax på henholdsvis 100% og 88% sammenlignet med forsøgspersoner i samme alderskategori uden nedsat nyrefunktion.
In volunteers with severe renal impairment (creatinine clearance < 30 ml/ min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment.
Herudover er AUC og Cmax - værdierne for N- desmethylmetabolitten signifikant forhøjede, henholdsvis 79% og 200%.
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 79% and 200% respectively.
Leverinsufficiens:
10 Hepatic insufficiency:
Hos frivillige forsøgspersoner med let til moderat levercirrhose (Child- Pugh A og B) reduceres sildenafils clearance, hvilket giver stigninger i AUC (84%) og Cmax (47%) sammenlignet med frivillige forsøgspersoner i samme alderskategori uden leverinsufficiens.
In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh A and B) sildenafil clearance was reduced, resulting in increases in AUC (84%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment.
De præ- kliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinogenicitet og reproduktionstoksicitet.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Cellulose, mikrokrystallinsk calciumhydrogenfosfat (vandfrit) croscarmellosenatrium magnesiumstearat
Tablet core: microcrystalline cellulose calcium hydrogen phosphate (anhydrous) croscarmellose sodium magnesium stearate
Hypromellose titandioxid (E171) lactose triacetin indigotin I( E132)
Film coat: hypromellose titanium dioxide (E171) lactose triacetin indigo carmine aluminium lake (E132)
6. 5 Emballage og pakningsstørrelser
6.5 Nature and content of container
PVC/ aluminium folie blisterplader i kartoner med 2, 4, 8 eller 12 tabletter.
PVC/ Aluminium foil blisters in cartons of 2, 4, 8 or 12 tablets.
14. september 1998 Dato for seneste fornyelse:
14 September 1998 Date of last renewal:
26. august 2008
26 August 2008
VIAGRA 50 mg filmovertrukne tabletter.
VIAGRA 50 mg film-coated tablets
Hver tablet indeholder 50 mg sildenafil som citrat.
Each tablet contains 50 mg of sildenafil (as citrate) Excipient:
Hjælpestoffer: lactose.
Lactose.
Blå, runde rhombeformede tabletter, mærket “ PFIZER ” på den ene side og ” VGR 50 ” på den anden side.
Blue, rounded diamond-shaped tablets, marked “ PFIZER ” on one side and “ VGR 50 ” on the other.
Anvendelse hos børn og unge:
13 Use in children and adolescents:
13 Anvendelse hos patienter, som får anden medicin:
Use in patients using other medicines:
Mange hændelser er rapporteret som opstået under eller kort tid efter samleje.
Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly
Få hændelser er rapporteret som opstået kort tid efter brugen af VIAGRA uden seksuel aktivitet.
14 after the use of VIAGRA without sexual activity.
14 Præparater til behandling af erektil dysfunktion, inklusive sildenafil, bør anvendes med forsigtighed hos patienter med anatomisk deformitet af penis (som f. eks. vinkling, kavernøs fibrose eller Peyronie’ s sygdom), eller hos patienter med lidelser, som kan prædisponere til priapisme (som f. eks. seglcelleanæmi, multipelt myelom eller leukæmi).
Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’ s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Samtidig indgift med HIV- proteasehæmmeren, ritonavir, som er en meget potent P450- hæmmer, ved steady state (500 mg 2 gange dagligt) og enkeltdosis af sildenafil (100 mg) gav en stigning i sildenafils Cmax på 300% (4 gange) og en stigning i sildenafils plasma AUC på 1. 000% (11 gange).
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
200 ng/ ml sammenlignet med ca.
At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/ ml, compared to approximately 5 ng/ ml when sildenafil was administered alone.
5 ng/ ml, når sildenafil bliver givet alene.
This is consistent with ritonavir’ s marked effects on a broad
Dette er i overensstemmelse med ritonavirs udtalte virkning på et bredt udvalg af P450 - substrater.
15 range of P450 substrates.
15 Samtidig indgift med HIV- proteasehæmmeren saquinavir, en CYP3A4- hæmmer, ved steady state (1200 mg 3 gange dagligt) og enkeltdosis sildenafil (100 mg) gav en stigning i sildenafils Cmax på 140% og en stigning i sildenafils plasma AUC på 210%.
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Ved indgift af en enkeltdosis sildenafil 100 mg sammen med erythromycin, en specifik CYP3A4 - hæmmer, i steady state (500 mg 2 gange dagligt i 5 dage) sås en 182% stigning i optagelsen af sildenafil (AUC).
When a single 100 mg dose of sildenafil was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
Skønt der ikke er foretaget specifikke interaktionsundersøgelser for alle lægemidler, viste populationsfarmakokinetiske analyser, at sildenafils farmakokinetik ikke blev påvirket ved samtidig indgift med CYP2C9- hæmmere (som tolbutamid, warfarin, fenytoin), CYP2D6- hæmmere (som selektive serotonin re- uptake hæmmere, tricykliske antidepressiva), tiazider og beslægtede diuretika, loop - og kaliumbesparende diuretika, ACE- hæmmere, calciumblokkere, beta- adrenerge receptorantagonister eller stoffer, som inducerer CYP450 metabolisme (som rifampicin, barbiturater).
Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant medication on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates).
Samtidig administration af sildenafil hos patienter, der er i alfa- blokker- behandling, kan hos få følsomme individer føre til symptomatisk hypotension.
Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals.
I 3 specifikke lægemiddel - lægemiddel interaktionsundersøgelser blev alfa- blokkeren doxazosin (4 mg og 8 mg) og sildenafil (25 mg, 50 mg eller 100 mg) anvendt samtidigt hos patienter med benign prostatahyperplasi (BPH) stabiliseret på doxazosinbehandling.
In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered
16 Der ses ingen signifikante interaktioner ved indgift af sildenafil (50 mg) sammen med tolbutamid (250 mg) eller warfarin (40 mg), som begge metaboliseres af CYP2C9.
No significant interactions were shown when sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.