natgillin/translations-raw huggingface dataset:
I tilfælde af overdosering bør der tages de sædvanlige forholdsregler, f. eks. fjernelse af ikke - absorberet materiale fra gastrointestinalkanalen samt instituering af understøttende behandling, hvis dette er påkrævet.
In the event of overdose, it is reasonable to employ the usual supportive measures, e. g., remove unabsorbed material from the GI tract, employ clinical monitoring, and institute supportive therapy, if required.
Antiinflammatoriske og antirheumatiske lægemidler, non- steriod, coxiber, ATC- kode:
Anti-inflammatory and antirheumatic products, non-steroids, coxibs, ATC Code:
Etoricoxib er inden for det kliniske dosisområde en oral, aktiv, selektiv cyclo- oxygenase- 2 (COX- 2) hæmmer.
Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor within the clinical dose range.
I alle kliniske, farmakologiske undersøgelser forårsagede ARCOXIA i doser op til 150 mg dagligt, dosisafhængig hæmning af COX- 2 uden hæmning af COX- 1.
Across clinical pharmacology studies ,< ARCOXIA > produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily.
21 Cyclooxygenase er ansvarlig for dannelsen af prostaglandiner.
Cyclooxygenase is responsible for generation of prostaglandins.
Der er identificeret to isoformer, COX - 1 og COX- 2.
Two isoforms, COX-1 and COX-2, have been identified.
COX- 2 er isoformen af det enzym, som induceres af proinflammatoriske stimuli, og som man mener hovedsageligt har ansvaret for syntesen af prostanoide mediatorer for smerte, inflammation og feber.
COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
COX- 2 er identificeret i væv omkring gastriske ulcera hos mennesker, men dets relevans ved heling af ulcera er ikke fastslået.
COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Virkning
19 Efficacy
MEDAL- programmet var et prospektivt designet kardiovaskulært Safety Outcomes Program med poolede data fra tre randomiserede, dobbeltblindede aktive komparatorkontrollerede undersøgelser, MEDAL, EDGE II og EDGE.
Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) Program The MEDAL Program was a prospectively designed Cardiovascular (CV) Safety Outcomes Program of pooled data from three randomized, double-blind active comparator controlled trials, the MEDAL study, EDGE II and EDGE.
MEDAL- undersøgelsen var en endpoint- drevet kardiovaskulær outcome- undersøgelse med 17. 804 OA og 5. 700 RA- patienter, der blev behandlet med etoricoxib 60 mg (OA) eller 90 mg (OA og RA) eller diclofenac 150 mg dagligt i en gennemsnitlig periode på 20, 3 måneder (maks.
The MEDAL Study, was an endpoint driven CV Outcomes study in 17,804 OA and 5,700 RA patients treated with etoricoxib 60 (OA) or 90 mg (OA and RA) or diclofenac 150 mg daily for a mean period of 20.3 months (maximum of 42.3 months, median 21.3 months).
EDGE - og EDGE II- undersøgelserne sammenlignede den gastrointestinale tolerance over for etoricoxib mod diclofenac.
The EDGE and EDGE II studies compared the gastrointestinal tolerability of etoricoxib versus diclofenac.
16, 6 måneder, median 11, 4 måneder).
The EDGE study included 7111 OA patients treated with a dose of etoricoxib 90 mg daily (1.5 times the dose recommended for OA) or diclofenac 150 mg daily for a mean period of 9.1 months (maximum 16.6 months, median 11.4 months).
EDGE II undersøgelsen inkluderede 4086 RA- patienter, der blev behandlet med etoricoxib 90 mg dagligt eller diclofenac 150 mg dagligt i en gennemsnitlig periode på 19, 2 måneder (maks.
The EDGE II study included 4086 RA patients treated with etoricoxib 90 mg daily or diclofenac 150 mg daily for a mean period of 19.2 months (maximum 33.1 months, median 24 months).
33, 1 måneder, median 24 måneder).
In the pooled MEDAL Program, 34,701 patients with OA or RA were treated for a mean duration of 17.9 months (maximum 42.3 months, median 16.3 months) with approximately 12,800 patients receiving treatment for more than 24 months.
Patienter med nylig myokardieinfarkt i anamnesen, patienter der havde fået koronar bypass- operation eller fået foretaget perkutan koronarintervention inden for 6 måneder før inklusion, blev ekskluderet.
Patients with a recent history of myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention within 6 months preceding enrollment were excluded.
Der var ingen signifikant forskel mellem etoricoxib og diclofenac i forekomsten af kardiovaskulære trombotiske hændelser.
20 There was no significant difference between etoricoxib and diclofenac in the rate of cardiovascular thrombotic events.
Incidensen af bivirkninger i EDGE og EDGE II samt incidensen af bivirkninger, der blev anset for alvorlige eller som resulterede i afbrydelse af deltagelse i MEDAL- undersøgelsen, var højere for etoricoxib end for diclofenac.
The incidence of adverse experiences in EDGE and EDGE II and of adverse experiences considered serious or resulting in discontinuation in the MEDAL study was higher with etoricoxib than diclofenac.
Hyppighed for bekræftede thrombotiske kardiovaskulære hændelser (Poolet MEDAL - program)
Rates of Confirmed Thrombotic CV Events (Pooled MEDAL Program)
Etoricoxib (N=16819) 25836 patientår
25836 Patient- Years
Diclofenac (N=16483) 24766 patientår
24766 Patient- Years
Sammenligning mellem behandling
Comparison
Hyppighed † (95% KI)
Rate† (95% CI)
Relativ Risiko (95% KI)
Relative Risk (95% CI)
Bekræftede trombotiske kardiovaskulære alvorlige hændelser Per- protocol Intent- to- treat
Confirmed Thrombotic Cardiovascular Serious Adverse Events
1, 24 (1, 11; 1, 38) 1, 25 (1, 14; 1, 36)
1.30 (1.17, 1.45) 1.19 (1.08, 1.30)
1, 30 (1, 17; 1, 45) 0, 95 (0, 81; 1, 11) 1, 19 (1, 08; 1, 30) 1, 05 (0, 93; 1, 19)
0.95 (0.81, 1.11) 1.05 (0.93, 1.19)
Bekræftede kardielle hændelser Per- protocol Intent- to- treat
0.71 (0.61, 0.82) 0.69 (0.61, 0.78)
0, 71 (0, 61; 0, 82) 0, 69 (0, 61; 0, 78)
0.78 (0.68, 0.90) 0.70 (0.62, 0.79)
0, 78 (0, 68; 0, 90) 0, 90 (0, 74; 1, 10) 0, 70 (0. 62; 0, 79) 0, 99 (0, 84; 1, 17)
0.90 (0.74, 1.10) 0.99 (0.84, 1.17)
Bekræftede cerebrovaskulære hændelser Per- protocol Intent- to- treat
0.34 (0.28, 0.42) 0.33 (0.28, 0.39)
0, 34 (0, 28; 0, 42) 0, 33 (0, 28; 0, 39)
0.32 (0.25, 0.40) 0.29 (0.24, 0.35)
0, 32 (0, 25; 0, 40) 1, 08 (0, 80; 1, 46) 0, 29 (0, 24; 0, 35) 1, 12 (0, 87; 1, 44)
1.08 (0.80, 1.46) 1.12 (0.87, 1.44)
Bekræftede perifere vaskulære hændelser Per- protocol Intent- to- treat †
Per-protocol Intent-to-treat †
0, 20 (0, 15; 0, 27) 0, 24 (0. 20; 0, 30)
0.20 (0.15, 0.27) 0.24 (0.20, 0.30)
0, 22 (0, 17; 0, 29) 0, 92 (0, 63; 1, 35) 0, 23 (0, 18; 0, 28) 1, 08 (0, 81; 1, 44)
0.22 (0.17, 0.29) 0.23 (0.18, 0.28)
Hændelser pr.
0.92 (0.63, 1.35) 1.08 (0.81, 1.44)
100 patientår; KI=Konfidensinterval N=samlet antal patienter inkluderet i per- protocol- populationen
Events per 100 Patient-Years; CI=confidence interval N=total number of patients included in Per-protocol population
Patienter, som tog < 75% af studiemedicinen eller tog NSAID, der ikke hørte til undersøgelsen > 10% af tiden).
Per-protocol: all events on study therapy or within 14 days of discontinuation (excluded: patients who took< 75% of their study medication or took non-study NSAIDs > 10% of the time).
Alle bekræftede hændelser op til slutningen af undersøgelsen (inklusive patienter, der potentielt blev eksponeret for indgreb, der ikke hørte til undersøgelsen, efter ophør med studiemedicinen).
Intent-to-treat: all confirmed events up to the end of the trial (included patients potentially exposed to non-study interventions following discontinuation of study medication).
Samlet antal randomiserede patienter, n = 17. 412 på etoricoxib og 17. 289 på diclofenac.
Total number of patients randomised, n= 17412 on etoricoxib and 17289 on diclofenac.
23 Kardiovaskulær mortalitet og samlet mortalitet var den samme i etoricoxib - og diclofenac - behandlingsgrupperne.
CV mortality, as well as overall mortality, was similar between the etoricoxib and diclofenac treatment groups.
50% af de patienter, der var inkluderet i MEDAL- undersøgelsen, havde ved baseline hypertension i anamnesen.
Approximately 50% of patients enrolled in the MEDAL study had a history of hypertension at baseline.
Incidensen af bivirkninger med venstresidigt hjertesvigt (seponering og alvorlige hændelser) forekom med samme hyppighed for etoricoxib 60 mg sammenlignet med diclofenac 150 mg, men var højere for etoricoxib 90 mg sammenlignet med diclofenac 150 mg (statistisk signifikant for etoricoxib 90 mg versus diclofenac 150 mg i MEDAL- OA- kohorten).
21 diclofenac 150 mg but was higher for etoricoxib 90 mg compared to diclofenac 150 mg (statistically significant for 90 mg etoricoxib vs.
Incidensen af bekræftede bivirkninger med venstresidigt hjertesvigt (hændelser, som var alvorlige og resulterede i hospitalsindlæggelse eller besøg på en skadestue) var ikke- signifikant højere med etoricoxib end diclofenac 150 mg; denne effekt var dosisafhængig.
150 mg diclofenac in MEDAL OA cohort).
Incidensen af seponering på grund af ødemrelaterede bivirkninger var højere for etoricoxib end diclofenac 150 mg; denne effekt var dosisafhængig (statistisk signifikant for etoricoxib 90 mg, men ikke for etoricoxib 60 mg).
The incidence of confirmed congestive heart failure adverse events (events that were serious and resulted in hospitalisation or a visit to an emergency department) was non-significantly higher with etoricoxib than diclofenac 150 mg, and this effect was dose-dependent.
De kardiorenale resultater for EDGE og EDGE II var i overensstemmelse med de resultater, der er beskrevet for MEDAL- undersøgelsen.
The cardiorenal results for EDGE and EDGE II were consistent with those described for the MEDAL Study.
Der blev observeret større hyppighed af seponering med etoricoxib 90 mg end med etoricoxib 60 mg.
In the individual MEDAL Program studies, for etoricoxib (60 mg or 90 mg), the absolute incidence of discontinuation in any treatment group was up to 2.6% for hypertension, up to 1.9% for edema, and up to 1.1% for congestive heart failure, with higher rates of discontinuation observed with etoricoxib 90 mg than etoricoxib 60 mg.
MEDAL – Gastrointestinale toleranceresultater:
MEDAL Program Gastrointestinal Tolerability Results:
Der blev observeret en signifikant lavere hyppighed af seponering for kliniske GI- hændelser (bl. a. dyspepsi, abdominalsmerter, mavesår) med etoricoxib sammenlignet med diclofenac inden for hver af de tre komponentundersøgelser i MEDAL- programmet.
A significantly lower rate of discontinuations of treatment for any clinical (e. g., dyspepsia, abdominal pain, ulcer) GI adverse event was observed with etoricoxib compared with diclofenac within each of the three component studies of the MEDAL Program.
Hyppigheden af seponering på grund af kliniske GI- hændelser pr. hundrede patientår i løbet af hele undersøgelsesperioden var:
The rates of discontinuations due to adverse clinical GI events per hundred patient-years over the entire period of study were as follows:
3, 23 for etoricoxib og 4, 96 for diclofenac i MEDAL- undersøgelsen; 9, 12 for etoricoxib og 12, 28 for diclofenac i EDGE- undersøgelsen; og 3, 71 for etoricoxib og 4, 81 for diclofenac i EDGE II- undersøgelsen.
3.23 for etoricoxib and 4.96 for diclofenac in the MEDAL Study; 9.12 with etoricoxib and 12.28 with diclofenac in the EDGE study; and 3.71 with etoricoxib and 4.81 with diclofenac in the EDGE II study.
MEDAL – Gastrointestinale sikkerhedsresultater:
MEDAL Program Gastrointestinal Safety Results:
Samlet blev de øvre GI- hændelser defineret som perforation, mavesår og blødning.
Overall upper GI events were defined as perforations, ulcers and bleeds.
Undergruppen af samlede øvre GI- hændelser, der blev anset for komplicerede, omfattede perforation, obstruktion og kompliceret blødning; Undergruppen af øvre GI- hændelser, der blev anset for ikke- komplicerede, omfattede ukompliceret blødning og ukompliceret mavesår.
The subset of overall upper GI events considered complicated included perforations, obstructions, and complicated bleeding; the subset of upper GI events considered uncomplicated included uncomplicated bleeds and uncomplicated ulcers.
Der blev observeret en signifikant lavere hyppighed totalt af øvre GI- hændelser for etoricoxib sammenlignet med diclofenac.
A significantly lower rate of overall upper GI events was observed with etoricoxib compared to diclofenac.
For undergruppen af øvre GI- blødningshændelser (komplicerede og ukomplicerede samlet) var der ingen signifikant forskel mellem etoricoxib og diclofenac.
For the subset of upper GI hemorrhage events (complicated and uncomplicated combined), there was no significant difference between etoricoxib and diclofenac.
33% af patienterne).
The upper GI benefit for etoricoxib compared with diclofenac was not statistically significant in patients taking concomitant low-dose aspirin (approximately 33% of patients).
Hyppigheden af bekræftede komplicerede og ukomplicerede øvre GI- hændelser (perforation, mavesår og blødning (PUBs)) pr. hundrede patientår var 0, 67 (95% konfidensinterval 0, 57; 0, 77) for etoricoxib og 0, 97 (95% konfidensinterval 0, 85; 1, 10) for diclofenac, hvilket gav en relativ risiko på 0, 69 (95% konfidensinterval 0, 57, 0, 83).
The rates per hundred patient-years of confirmed complicated and uncomplicated upper GI clinical events (perforations, ulcers and bleeds (PUBs)) were 0.67 (95% CI 0.57, 0.77) with etoricoxib and 0.97 (95% CI 0.85, 1.10) with diclofenac, yielding a relative risk of 0.69 (95% CI 0.57, 0.83).
Hyppigheden af bekræftede øvre GI- hændelser hos ældre patienter blev vurderet, og den største reduktion blev observeret hos patienter ≥ 75 år (1, 35 [95% konfidensinterval 0, 94; 1, 87] versus 2, 78 [95% konfidensinterval 2, 14; 3, 56]) hændelser pr. hundrede patientår for henholdsvis etoricoxib og diclofenac.
2.78 [95% CI 2.14, 3.56] events per hundred patient-years for etoricoxib and diclofenac, respectively.
24 Hyppigheden af bekræftede kliniske hændelser i den nederste del af mave- tarmkanalen (perforation af tyndtarm eller tyktarm, obstruktion eller blødning (POBs)) var ikke signifikant forskellig for etoricoxib og diclofenac.
The rates of confirmed lower GI clinical events (small or large bowel perforation, obstruction, or hemorrhage, (POBs)) were not significantly different between etoricoxib and diclofenac.
MEDAL – Hepatiske sikkerhedsresultater Etoricoxib var associeret med signifikant lavere hyppighed af seponering på grund af leverrelaterede hændelser end diclofenac.
Etoricoxib was associated with a statistically significantly lower rate of discontinuations due to hepatic- related adverse experiences than diclofenac.
I det poolede MEDAL- program stoppede 0, 3% af de patienter, der fik etoricoxib, og 2, 7% af de patienter, der fik diclofenac på grund af leverrelaterede hændelser.
In the pooled MEDAL Program, 0.3% of patients on etoricoxib and 2.7% of patients on diclofenac discontinued due to hepatic-related adverse experiences.
Hyppigheden pr. hundrede patientår var 0, 22 for etoricoxib og 1, 84 for diclofenac (p- værdien var < 0, 001 for etoricoxib versus diclofenac).
The rate per hundred patient-years was 0.22 on etoricoxib and 1.84 for diclofenac (p-value was < 0.001 for etoricoxib vs. diclofenac).
De fleste hepatiske bivirkninger i MEDAL- programmet var dog ikke- alvorlige.
However, most hepatic adverse experiences in the MEDAL Program were non-serious.
3100 patienter behandlet med etoricoxib ≥60 mg dagligt i 12 uger eller længere.
Additional Thrombotic Cardiovascular Safety Data In clinical studies excluding the MEDAL Program Studies, approximately 3100 patients were treated with etoricoxib ≥ 60 mg daily for 12 weeks or longer.
Der var ingen mærkbar forskel i incidensen af bekræftede alvorlige thrombotiske kardiovaskulære hændelser hos patienter, der fik etoricoxib ≥60 mg, placebo eller non- naproxen NSAID.
There was no discernible difference in the rate of confirmed serious thrombotic cardiovascular events between patients receiving etoricoxib ≥ 60 mg, placebo, or non-
Incidensen af disse hændelser var imidlertid højere hos patienter, der fik etoricoxib sammenlignet med dem, der fik naproxen 500 mg 2 gange dagligt.
However, the rate of these events was higher in patients receiving etoricoxib compared with those receiving naproxen 500 mg twice daily.
Forskellen i antitrombocytaktivitet mellem COX- 1- hæmmende NSAID og selektive COX- 2- hæmmere kan være af klinisk betydning for patienter med risiko for udvikling af thromboemboliske hændelser.
The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and selective COX-2 inhibitors may be of clinical significance in patients at risk of thrombo-embolic events.
Selektive COX- 2 hæmmere reducerer dannelsen af systemiske (og dermed muligvis endotelderiveret) prostacyclin uden at påvirke thromboxan i blodpladerne.
Selective COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Supplerende gastrointestinale sikkerhedsdata I 2, 12- ugers, dobbeltblinde endoskopiundersøgelser, var den kumulative incidens af gastroduodenal ulceration signifikant lavere hos de patienter, der blev behandlet med etoricoxib 120 mg én gang dagligt, end hos de patienter, der blev behandlet med enten naproxen 500 mg 2 gange dagligt eller ibuprofen 800 mg 3 gange dagligt.
Additional Gastrointestinal Safety Data In two 12-week double-blind endoscopy studies, the cumulative incidence of gastroduodenal ulceration was significantly lower in patients treated with etoricoxib 120 mg once daily than in patients treated with either naproxen 500 mg twice daily or ibuprofen 800 mg three times daily.
Nyrefunktionsundersøgelse hos ældre En randomiseret, dobbeltblind, placebokontrolleret undersøgelse med parallelle grupper vurderede effekten af 15 dages behandling med etoricoxib (90 mg), celecoxib (200 mg to gange daglig), naproxen (500 mg to gange daglig) og placebo på natriumudskillelsen i urin, blodtryk, og andre nyrefunktionsparametre hos patienter mellem 60 og 85 år, som var på en natriumdiæt på 200 mEq/ dag.
Renal Function Study in the Elderly A randomized, double-blind, placebo-controlled, parallel-group study evaluated the effects of 15 days of treatment of etoricoxib (90 mg), celecoxib (200 mg bid), naproxen (500 mg bid) and placebo on urinary sodium excretion, blood pressure, and other renal function parameters in subjects 60 to 85 years of age on a 200-mEq/ day sodium diet.
Etoricoxib, celecoxib og naproxen havde en lignende effekt på natriumudskillelsen i urinen i løbet af de to ugers behandling.
Etoricoxib, celecoxib, and naproxen had similar effects on urinary sodium excretion over the 2 weeks of treatment.
Alle tre lægemidler viste en øgning i forhold til placebo med hensyn til det systoliske blodtryk; etoricoxib var imidlertid forbundet med en statistisk signifikant øgning ved dag 14 i sammenligning med celecoxib og naproxen (gennemsnitlig ændring fra baseline for det systoliske blodtryk var for etoricoxib 7, 7 mmHg; celecoxib 2, 4 mmHg; naproxen 3, 6 mmHg).
All active comparators showed an increase relative to placebo with respect to systolic blood pressures; however, etoricoxib was associated with a statistically significant increase at Day 14 when compared to celecoxib and naproxen (mean change from baseline for systolic blood pressure: etoricoxib 7.7 mmHg, celecoxib 2.4 mmHg, naproxen 3.6 mmHg).
Absorption Oralt administreret etoricoxib absorberes godt.
Absorption Orally administered etoricoxib is well absorbed.
100%.
The absolute bioavailability is approximately 100%.
1 time (Tmax) hos fastende voksne.
Following 120 mg once-daily dosing to steady state, the peak plasma concentration (geometric mean Cmax = 3.6 µg/ ml) was observed at approximately 1 hour (Tmax) after administration to fasted adults.
Det geometriske middelareal under kurven (AUC0- 24 timer) er 37, 8 µg t/ ml.
The geometric mean area under the curve (AUC0-24hr) was 37.8 µg• hr/ ml.
Indtagelse af et måltid (højt fedtindhold) har ikke klinisk betydning for absorptionsgraden af en etoricoxibdosis på 120 mg.
Dosing with food (a high-fat meal) had no effect on the extent of absorption of etoricoxib after administration of a 120-mg dose.
Absorptionen påvirkedes, resulterende i et 36% fald i Cmax og en øgning i Tmax med 2 timer.
The rate of absorption was affected, resulting in a 36% decrease in Cmax and an increase in Tmax by 2 hours.
92% til humant plasmaprotein ved koncentrationer på 0, 05- 5 µg/ ml.
Distribution Etoricoxib is approximately 92% bound to human plasma protein over the range of concentrations of 0.05 to 5 µg/ ml.
120 liter.
The volume of distribution at steady state (Vdss) was approximately 120 l in humans.
Etoricoxib passerer placentabarrieren hos rotter og kaniner, og blod- hjernebarrieren hos rotter.
Etoricoxib crosses the placenta in rats and rabbits, and the blood-brain barrier in rats.
Metabolisme Etoricoxib metaboliseres i udstrakt grad, < 1% af dosis genfindes i urinen som moderstoffet.
Metabolism Etoricoxib is extensively metabolised with < 1% of a dose recovered in urine as the parent drug.
Den primære metaboliseringsvej for at danne 6 ’ - hydroxymethylderivatet er katalyseret af CYP- enzymer.
The major route of metabolism to form the 6’ -hydroxymethyl derivative is catalyzed by CYP enzymes.
In vitro- undersøgelser indikerer at CYP2D6, CYP2C9, CYP1A2 og CYP2C19 også kan katalysere den primære metaboliseringsvej, men deres kvantitative roller in vivo er ikke undersøgt.
In vitro studies indicate that CYP2D6, CYP2C9, CYP1A2 and CYP2C19 also can catalyse the main metabolic pathway, but their quantitative roles in vivo have not been studied.
Hovedmetabolitten er 6 ’ - carboxylsyrederivatet af etoricoxib, dannet ved yderligere oxydering af 6 ’ - hydroxymethylderivatet.
The principal metabolite is the 6’ -carboxylic acid derivative of etoricoxib formed by further oxidation of the 6’ -hydroxymethyl derivative.
Disse hovedmetabolitter viste enten ingen målelig aktivitet eller kun svag aktivitet som COX- 2 hæmmere.
These principal metabolites either demonstrate no measurable activity or are only weakly active as COX-2 inhibitors.
Ingen af disse metabolitter hæmmer COX- 1.
None of these metabolites inhibit COX-1.
Elimination Efter intravenøs administration af enkeltdosis på 25 mg radioaktivmærket etoricoxib til raske frivillige, blev 70% af radioaktiviteten genfundet i urinen og 20% i fæces, hovedsageligt i form af metabolitter.
23 Following administration of a single 25-mg radiolabeled intravenous dose of etoricoxib to healthy subjects, 70% of radioactivity was recovered in urine and 20% in faeces, mostly as metabolites.
22 timer.
Steady state concentrations of etoricoxib are reached within seven days of once daily administration of 120 mg, with an accumulation ratio of approximately 2, corresponding to a half-life of approximately 22 hours.
50 ml/ min for en intravenøs dosis på 25 mg.
The plasma clearance after a 25-mg intravenous dose is estimated to be approximately 50 ml/ min.
Farmakokinetikken hos ældre patienter (65 år og derover) svarer til den hos yngre patienter.
Pharmacokinetics in the elderly (65 years of age and older) are similar to those in the young.
Etoricoxibs farmakokinetik er sammenlignelig hos mænd og kvinder.
The pharmacokinetics of etoricoxib are similar between men and women.
16% højere middel- AUC end raske frivillige i samme regime.
Patients with mild hepatic dysfunction (Child-Pugh score 5-6) administered etoricoxib 60 mg once daily had an approximately 16% higher mean AUC as compared to healthy subjects given the same regimen.
Patienter med moderat leverdysfunktion (Child- Pugh score 7- 9), der fik etoricoxib 60 mg hver anden dag havde samme middel- AUC som raske frivillige, der fik etoricoxib 60 mg én gang dagligt; etoricoxib 30 mg én gang dagligt er ikke undersøgt i denne patientgruppe.
Patients with moderate hepatic dysfunction (Child-Pugh score 7-9) administered etoricoxib 60 mg every other day had similar mean AUC to the healthy subjects given etoricoxib 60 mg once daily; etoricoxib 30 mg once daily has not been studied in this population.