natgillin/translations-raw huggingface dataset:
Hepatotoksicitet ACE- hæmmere er i yderst sjældne tilfælde blevet associeret med et syndrom, der starter med cholestatisk gulsot eller hepatitis og progredierer til fulminant nekrose og (sommetider) død.
Hepatotoxicity Very rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant necrosis and (sometimes) death.
Patienter, der får Lisonorm- tabletter, og som udvikler gulsot eller markant forhøjede leverenzymværdier, bør have seponeret Lisonorm og få passende medicinsk opfølgning.
Patients receiving Lisonorm tablets who develop jaundice or marked elevations of hepatic enzymes should discontinue Lisonorm and receive appropriate medical follow-up.
Nedsat leverfunktion Halveringstiden for amlodipin er forlænget hos patienter med nedsat leverfunktion.
Hepatic impairment The half-life of amlodipine is prolonged in patients with impaired liver function.
Hæmatologisk toksicitet Der er i yderst sjældne tilfælde indberettet neutropeni, agranulocytose, trombocytopeni og anæmi hos patienter, der fik ACE- hæmmere (se punkt 4. 8).
Haematological toxicity Very rarely, neutropenia, agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors (see section 4.8).
Hos patienter med normal nyrefunktion og uden andre komplicerende faktorer, forekommer der sjældent neutropeni.
In patients with normal renal function and no other complicating
Neutropeni og agranulocytose er reversible efter seponering af ACE- hæmmeren.
Neutropenia and agranulocytosis are reversible after discontinuation of the ACE inhibitor.
11 monitorering af leykocyttal, og patienterne bør instrueres om at rapportere eventuelle tegn på infektion.
If Lisonorm is used in such patients, periodic monitoring of white blood cell counts is advised and patients should be instructed to report any sign of infection.
Hoste Hoste indberettes hyppigt ved brug af ACE- hæmmere.
Cough Commonly, cough has been reported with the use of ACE inhibitors.
Typisk er hosten ikke- produktiv og ophører efter seponering af behandlingen.
Characteristically, the cough is non- productive, persistent and resolves after discontinuation of therapy.
ACE- hæmmer- induceret hoste bør betragtes som en del af den differentiale diagnosticering af hoste.
ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
Kirurgiske indgreb/ generel anæstesi Hos patienter, der gennemgår større kirurgiske indgreb, eller som er under anæstesi med midler, der fremkalder hypotension, kan lisinopril blokere angiotensin II- dannelse sekundært til den kompensatoriske renin- frigørelse.
Surgery/ general anaesthesia In patients undergoing major surgery or during anaesthesia with agents that produce hypotension, lisinopril may block angiotensin II formation secondary to compensatory renin release.
Ældre Hvis den fremskredne alder er associeret med nedsat nyrefunktion, skal de gældende anvisninger om dosisjusteringer af Lisonorm til patienter med nedsat nyrefunktion følges (se punkt 4. 2).
Elderly When advanced age is associated with decrease in renal function Lisonorm dose adjustments for patients with renal impairment apply (see section 4.2).
Forhøjede kaliumserumniveauer er observeret hos nogle af de patienter, der blev behandlet med ACE - hæmmere.
Hyperkalaemia Elevations in potassium serum levels have been observed in some patients treated with ACE inhibitors.
De patientgrupper, der er udsat for risiko for udvikling af hyperkalæmi, omfatter: patienter med nedsat nyrefunktion, patienter med diabetes mellitus, akut hjertedekompensation, dehydrering, metabolisk acidose og patienter, der er under samtidig behandling med kaliumbesparende diuretika, kaliumtilskud eller kaliumholdige saltsubstituttionsmidler eller lægemidler associeret med forhøjelser af kaliumserumniveauerne (f. eks. heparin).
Patients at risk for the development of hyperkalaemia include those with renal impairment, diabetes mellitus, acute cardiac decompensation, dehydration, metabolic acidosis, or concomitant use of potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes, or any medicinal products associated with increases in potassium serum levels (e. g. heparin).
Hvis der er behov for samtidig anvendelse af ovennævnte stoffer, anbefales regelmæssig monitorering af kaliumserumniveauerne (se punkt 4. 5).
If concomitant use of the abovementioned substances is needed, regular monitoring of potassium serum levels is recommended (see section 4.5).
Interaktioner relateret til lisinopril Stoffer, der påvirker kaliumniveauerne:
Interactions related to lisinopril Substances affecting potassium levels:
Kaliumbesparende diuretika (f. eks. spironolakton, amilorid og triamteren), kaliumtilskud eller kaliumholdige saltsubstitutionsmidler og andre stoffer, der kan øge kaliumniveauerne (f. eks. heparin), kan medføre hyperkalæmi i kombination med ACE- hæmmere, specielt hos patienter med nedsat nyrefunktion og andre præeksisterende tilstande (se punkt 4. 4).
Potassium-sparing diuretics (e. g. spironolactone, amiloride, and triamterene), potassium supplements, or potassium-containing salt substitutes and other substances that may increase potassium levels (e. g. heparin) can lead to hyperkalaemia in combination with ACE inhibitors, particularly in patients with renal impairment and other pre-existing conditions (see section 4.4).
Hvis der tilføjes et diuretikun til behandlingen af en patient, der får Lisonorm, er den antihypertensive effekt i reglen additiv (se punkt 4. 4).
When a diuretic is added to the therapy of a patient receiving Lisonorm the antihypertensive effect is usually additive (see section 4.4).
Andre antihypertensiva:
Other antihypertensives:
Samtidig anvendelse af disse midler kan øge de hypotensive virkninger af Lisonorm.
Concomitant use of these agents may increase the hypotensive effects of Lisonorm.
Tricykliske antidepressiva/ antipsykotika/ anæstetika/ narkotika:
Tricyclic antidepressants/ antipsychotics/ anaesthetics/ narcotics:
Anvendelse samtidigt med ACE - hæmmere kan medføre yderligere nedsættelse af blodtrykket (se punkt 4. 4).
Concomitant use with ACE inhibitors may result in further reduction of blood pressure (see section 4.4).
Alkohol øger den hypotensive effekt.
13 Alcohol enhances the hypotensive effect.
Allopurinol, procainamid, cytostatika eller immunsuppressiva (systemiske corticosteroider) kan medføre øget risiko for leukopeni ved samtidig administration af ACE- hæmmere.
Allopurinol, procainamide, cytostatics or immunosuppressive agents (systemic corticosteroids) may lead to an increased risk of leukopenia when administered concomitantly with ACE inhibitors.
Antacida reducerer biotilgængeligheden af de samtidig brugte ACE- hæmmere.
Antacids decrease the bioavailability of the concomitant use of ACE inhibitors.
Epidemiologiske undersøgelser har tydet på, at samtidig administration af ACE - hæmmere og antidiabetika (insuliner, orale hypoglykæmiske midler) kan medføre øget blodglucosesænkende virkning med risiko for hypoglykæmi.
Epidemiological studies have suggested that concomitant administration of ACE inhibitors and antidiabetic medicinal products (insulins, oral hypoglycaemic agents) may cause an increased blood glucose lowering effect with risk of hypoglycaemia.
Non- steroide antiinflammatoriske stoffer (NSAID' er):
Non-steroidal anti-inflammatory drugs (NSAIDs):
Kronisk administration af NSAID' er, herunder højdosis acetylsalicylsyre ≥ 3 g/ dag, kan reducere den antihypertensive virkning af en ACE- hæmmer.
Chronic administration of NSAIDs, including high-dosed acetylsalicylic acid ≥ 3 g/ day, may reduce the antihypertensive effect of an ACE inhibitor.
NSAID' er og ACE- hæmmere har en additiv effekt på forhøjelsen af serumkalium og kan medføre en nedsættelse af nyrefunktionen.
NSAIDs and ACE inhibitors exert an additive effect on the increase in serum potassium and may result in a deterioration of renal function.
Lithium- udskillelsen kan være nedsat ved samtidig anvendelse af ACE- hæmmer, og derfor bør serumlithiumniveauerne monitoreres.
Lithium elimination may be reduced during concomitant use of ACE inhibitor and therefore, serum lithium levels should be monitored.
Interaktioner relateret til amlodipin CYP3A4- hæmmere:
Interactions related to amlodipine CYP3A4 inhibitors:
En undersøgelse på ældre patienter har vist, at diltiazem hæmmer metaboliseringen af amlodipin, sandsynligvis via CYP3A4 (plasmakoncentrationen øges med cirka 50%, og effekten af amlodipin øges).
A study in elderly patients has shown that diltiazem inhibits the metabolism of amlodipine, probably via CYP3A4 (plasma concentration increases by approximately 50% and the effect of amlodipine is increased).
Muligheden for, at mere potente hæmmere af CYP3A4 dvs. ketoconazol, itraconazol, ritonavir) kan øge plasmakoncentrationen af amlodipin i større omfang end diltiazem kan ikke udelukkes.
The possibility that more potent inhibitors of CYP3A4 (i. e. ketoconazole, itraconazole, ritonavir) may increase the plasma concentration of amlodipine to a greater extent than diltiazem cannot be excluded.
Samtidig administration af antikonvulsiva (f. eks. carbamazepin, phenobarbital, phenytoin, fosphenytoin, primidon), rifampicin, helsekostpræparater, der indeholder prikbladet perikum) kan medføre reducerede plasmakoncentrationer af amlodipin.
John’ s wort/ Hypericum perforatum) may lead to reduced plasma concentrations of amlodipine.
Ved monoterapi er amlodipin blevet sikkert administreret sammen med thiaziddiuretika, betablokkere, ACE- hæmmere, langtidsvirkende nitrater, sublingval nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, antacida (aluminiumhydroxidgel, magnesiumhydroxid, simeticon), cimetidin, non- steroide anti- inflammatoriske lægemidler, antibiotika og orale hypoglykæmiske lægemidler.
In monotherapy, amlodipine has been safely administered with thiazide diuretics, beta blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, anti- acid medicines (aluminium hydroxide gel, magnesium hydroxide, simeticone), cimetidine, non-steroidal anti- inflammatory medicines, antibiotics and oral hypoglycaemic medicines.
Graviditet Anvendelse af ACE- hæmmere kan ikke anbefales i første trimester af graviditeten, og de er kontra - indicerede i andet og tredje trimester.
Pregnancy The use of ACE inhibitors is not recommended during the first trimester of pregnancy and they are contra- indicated in the second and third trimester.
Det kan dog ikke udelukkes, at der er en let forøget risiko.
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Eksponering for behandling med ACE- hæmmere under andet og tredje trimester vides at inducere human føtotoksicitet (nedsat nyrefunktion, oligohydramnion, forsinket kranieossifikation) og neonatal toksicitet (nyresvigt, hypotension, hyperkalæmi).
ACE inhibitors therapy exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Selv om visse dihydropyridinpræparater er teratogene på dyr, giver data fra rotter og kaniner for amlodipin ingen evidens for en teratogen virkning (se punkt 5. 3).
14 Although some dihydropyridine compounds have been found to be teratogenic in animals, data in the rat and rabbit for amlodipine provide no evidence for a teratogenic effect (see section 5.3).
Følgelig er Lisonorm kontraindiceret under graviditet (se punkt 4. 3).
Consequently, Lisonorm is contraindicated in pregnancy (see section 4.3).
Hos patienter, der planlægger graviditet, skal Lisonorm udskiftes med en alternativ anti- hypertensiv behandling, der har en påvist sikkerhedsprofil til brug under graviditet.
Patients planning pregnancy Lisonorm should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Lisonorm frarådes til ammende mødre, idet lisinopril kan udskilles i modermælk (se punkt 4. 3).
Lactation Lisonorm is not recommended for breast-feeding mothers, as lisinopril may be excreted in human milk (see section 4.3).
Bivirkningerne var overensstemmende med det, der tidligere er rapporteret med amlodipin og/ eller lisinopril.
Adverse reactions were consistent with those reported previously with amlodipine and/ or lisinopril.
Bivirkningerne var i reglen milde, forbigående og berettigede sjældent seponering af behandlingen med Lisonorm.
Adverse reactions were usually mild, transient and rarely warranted the discontinuation of treatment with Lisonorm.
De mest almindelige bivirkninger ved kombinationen var hovedpine (8%), hoste (5%) og svimmelhed (3%).
The most common adverse reactions with the combination were headache (8%), cough (5%), and dizziness (3%).
I kontrollerede kliniske forsøg indberettedes følgende bivirkninger hos ≥ 1% af patienterne ved enten samtidigt administreret amlodipin plus lisinopril eller ved amlodipin og lisinopril monoterapier (se nedenstående tabel):
In controlled clinical trials, the following adverse reactions were reported in ≥ 1% of patients with either concomitantly administered amlodipine plus lisinopril or with amlodipine and lisinopril monotherapies (see Table below):
Lisinopril (n=68)
Lisinopril (n=68)
Hjertesygdomme Luftveje, thorax - og mediastinum
Cardiac disorders Respiratory, thoracic and mediastinal disorders
Palpitation Hoste
Palpitation Cough
1, 5% 5%
1.5% 5%
4, 6% 3%
4.6% 3%
Frekvenserne defineres som:
Frequencies are defined as follows:
Meget almindelig (≥ 1/ 10), Almindelig (≥ 1/ 100 til < 1/ 10), Usædvanlig (≥ 1/ 1. 000 til < 1/ 100), Sjælden (≥ 1/ 10. 000 til < 1/ 1. 000) Meget sjælden (< 1/ 10. 000), Ikke kendt (kan ikke bestemmes ud fra tilgængelige data).
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), Very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Følgende bivirkninger (ADR) er indberettet under behandling med lisinopril og amlodipin uafhængigt af hinanden:
The following adverse drug reactions (ADRs) have been reported during the treatment with lisinopril and amlodipine independently:
Knoglemarvsdepression, agranulocytose, leukopeni, neutropeni, trombocytopeni, hæmolytisk anæmi Anæmi, lymfadenopatier
Bone marrow depression, Agranulocytosis, Leucopenia, Neutropenia, Thrombocytopenia, Haemolytic anaemia Anaemia, Lymphadenopathies
Autoimmunsygdomme
Autoimmune disorders
Metabolisme - og ernæring
Metabolism and nutrition disorders
Meget sjældent Hypoglykæmi
Very rare
Hyperglykæmi
Hypoglycaemia
ADR med amlodipin
Hyperglycaemia
Usædvanligt
Uncommon
Stemningsændring, søvnforstyrrelser
Mood altered, Sleep disturbances
Svimmelhed, hovedpine
Dizziness, Headache
Somnolens, svimmelhed, hovedpine
Somnolence, Dizziness, Headache
Vertigo, paræstesi, smagsforstyrrelse
Vertigo, Paraesthesia, Taste disturbance
Synkope, tremor, smagsforvrængning, hypoæstesi, paræstesi
Syncope, Tremor, Taste perversion, Hypoaesthesia, Paraesthesia
Øre - og labyrint- lidelser
Ear and labyrinth disorders
Myokardieinfarkt (se punkt 4. 4), takykardi, palpitationer,
Myocardial infarction (see section 4.4), Tachycardia, Palpitations,
Cerebrovaskulær hændelse (se punkt 4. 4), Raynaudfænomen
Cerebrovascular accident (see section 4.4), Raynaud’ s phenomenon
Luftveje, thorax- og mediastinum
Respiratory, thoracic and mediastinal disorders
Rhinitis
Rhinitis
Dyspnø, rhinitis
System Organ Class
Bronkospasme, Allergisk alveolitis/ eosinofil pneumoni, sinusitis
Bronchospasm, Allergic alveolitis/ Eosinophilic pneumonia, Sinusitis
Mavesmerter, kvalme, fordøjelsesbesvær
Abdominal pain, Nausea, Indigestion
Pankreatitis, intestinalt angioødem
Pancreatitis, Intestinal angioedema
Leversvigt, hepatitis, cholestatisk gulsot, (se punkt 4. 4)
Hepatic failure, Hepatitis, Cholestatic jaundice, (see section 4.4)
Usædvanligt
Skin and subcutaneous tissue Uncommon disorders
Hypersensitivitet/ angioødem Alopeci, udslæt, purpura, i ansigtet, ekstremiteterne, hudmisfarvning, læber, tunge, glottis og/ eller diaforese, pruritus larynx (se punkt 4. 4), udslæt, pruritus
Hypersensitivity/ angioedem Alopecia, Rash, Purpura, a of the face, extremities, Skin discolouration, lips, tongue, glottis and/ or Diaphoresis, Pruritus larynx (see section 4.4), Rash, Pruritus
Meget sjældent Toksisk epidermal
Very rare
nekrolyse, Stevens- Johnsons angioødem, urtikaria syndrom, erythema multiforme.
Toxic Epidermal Necrolysis, Erythema multiforme, Stevens-Johnson Syndrome, Angioedema, Urticaria Erythema multiforme.
Der er indberettet et syndrom, der kan omfatte en eller flere af følgende lidelser: feber, vasculitis, myalgi, artralgi/ artritis, positiv ANA, forhøjet ESR - værdi, eosinofili og leukocytose, udslæt, fotosensitivitet eller andre dermatologiske manifestationer.
A syndrome has been reported that may include one or more of the following symptoms: fever, vasculitis, myalgia, arthralgia/ arthritis, positive ANA, elevated ESR value, eosinophilia and leucocytosis, rash, photosensitivity or other dermatological manifestations.
Muskuloskeletale og bindevævs- lidelser
Musculoskeletal and connective tissue disorders
Akut nyresvigt, uræmi
Acute renal failure, Uraemia
Meget sjældent
System Organ Class
Oliguri/ anuri
Frequency
Det reproduktive system og mammae:
ADRs with lisinopril
Usædvanligt
ADRs with amlodipine
Impotens
Very rare
Impotens, gynækomasti
Oliguria/ Anuria
Sjældent
Uncommon Rare
Gynækomasti
Impotence Gynaecomastia
Ødem, træthed
Oedema, Fatigue
Træthed, asteni
Fatigue, Asthenia
Blodurea forhøjet, serumkreatinin forhøjet, hyperkalæmi, leverenzymer forhøjet
Blood urea increased, Serum creatinine increased, Hyperkalaemia, Hepatic enzymes increased
Symptomatisk behandling (anbringelse af patienten i liggende stilling, monitorering – og om nødvendigt støtte – af hjertefunktion, blodtryk, væske - og elektrolytbalance) anbefales.
Symptomatic treatment (placing the patient in a supine position, monitoring – and when necessary, support – of cardiac function, blood pressure, fluid and electrolyte balance) is recommended.
Hvis behandling med angiotensin II- infusion er tilgængelig, kan det også tages i betragtning.
If available, treatment with angiotensin II infusion may also be considered.
Amlodipin er derimod stærkt proteinbundet, og det er derfor ikke sandsynligt, at dialyse vil være gavnligt (se punkt 4. 4.)
Amlodipine, however, is highly protein-bound and, therefore, dialysis is not likely to be of benefit (see section 4.4.)
Lisonorm er en fastdosis- kombination, der indeholder de aktive stoffer lisinopril og amlodipin.
Lisonorm is a fixed dose combination containing the active substances lisinopril and amlodipine.
Lisinopril Lisinopril er en angiotensinkonverterende enzymhæmmer (ACE- hæmmer), hvilket medfører en reduktion af angiotensin II i plasma og følgelig også af aldosteron- niveauerne og forhøjer niveauerne af vasodilatorisk bradykinin.
18 Lisinopril Lisinopril is an angiotensin converting enzyme (ACE) inhibitor, which results in reduction of plasma angiotensin II and consequently aldosterone levels and elevates those of vasodilatory bradykinin.
Virkningens varighed er 24 timer – også afhængigt af dosen.
Its duration of action is 24 hours – also depending on dose.
Pludselig seponering af lisinopril- behandling er ikke forbundet med nogen substantiel rebound- effekt (blodtryksforhøjelse).
Abrupt discontinuation of lisinopril treatment is not associated with any substantial rebound effect (blood pressure elevation).
Selv om dets primære effekt formidles via renin- angiotensin- aldosteronsystemet, er lisinopril også effektivt hos hypertensive patienter med lav plasma- renin aktivitet.
Although its primary effect is mediated by the renin-angiotensin-aldosterone system, lisinopril is also effective in hypertensive patients with low plasma renin activity.
Amlodipin Amlodipin er en calciumkanalblokker af dihydropyridine- typen.
Amlodipine Amlodipine is a dihydropyridine-type calcium channel blocker.
17 og dermed den perifere vaskulære resistens, der sænker det systemiske blodtryk.
Amlodipine reduces the tone of smooth muscle in arterioles and hence the peripheral vascular resistance which lowers systemic blood pressure.
Amlodipin udøver antianginal virkning ved dilatation af perifere arterioler samt via reduktion af det kardielle afterload uden, at det medfører refleks- takykardi, og følgelig energiforbrug og iltbehov ved kardiel muskelrelaksation.
Amlodipine exerts antianginal effect through the dilation of peripheral arterioles as well as through reduction of cardiac afterload, without resulting in reflex tachycardia, and accordingly, energy consumption and oxygen demand of cardiac muscle decrease.
Dosering af amlodipin en gang dagligt reducerer blodtrykket hos hypertensive patienter, både i liggende og stående stilling over hele 24- timers intervallet.
Once daily dosing of amlodipine reduces the blood pressure of hypertensive patients both in the supine and standing position throughout the 24-hour interval.
Den calciumkanal- blokerende aktivitet fremkalder for eksempel direkte arteriel dilatation ledsaget af natrium - og vand- retention.
Calcium channel blocking activity, for example elicits direct arterial dilation accompanied by sodium and water retention.
Kompensatorisk aktivering af renin- angiotensin- aldosteronsystemet (RAAS) er forventeligt, og derfor kan modregulatoriske mekanismer aktiveret af ACE- hæmmere bidrage til retablering af fysiologiske responser på øget indtagelse af salt.
Compensatory activation of the renin-angiotensin-aldosterone system (RAAS) should be expected and therefore, counter-regulatory mechanisms activated by ACE inhibitors may contribute to the restoration of physiological responses to increased salt intake.
Dets biotilgængelighed er 29%.
Lisinopril Following oral administration, peak plasma concentrations occur after approximately 6 hours; its bioavailability is 29%.
Den effektive halveringstid for lisinopril er 12, 6 timer.
The effective half-life of lisinopril is 12.6 hours.
Den vigtigste elimination af ikke proteinbunden fraktion er ledsaget af eliminationen af ACE- bundet lisinopril i en langsommere hastighed, og dette kan medføre forlænget antihypertensiv aktion.
The major elimination of non protein-bound fraction is accompanied by that of ACE-bound lisinopril at a slower rate, and this can result in prolonged antihypertensive action.
Eliminationen af lisinopril er forlænget ved nedsat nyrefunktion, og derfor kan en dosisreduktion være nødvendig (se punkt 4. 2).
The elimination of lisinopril is prolonged in renal impairment and therefore, dose reduction may be necessary (see section 4.2).
Amlodipin Amlodipin absorberes langsomt og næsten fuldstændigt fra mave- tarm- kanalen efter oral administration.
19 Amlodipine is slowly and almost completely absorbed from the gastrointestinal tract following oral administration.
Dets distributionsvolumen er cirka 20 l/ kg.
The bioavailability of amlodipine is 64 to 80%; its volume of distribution is approximately 20 l/ kg.
I det systemiske kredsløb er 95 til 98% af amlodipinet bundet til plasmaprotein.
In the systemic circulation 95 to 98% of amlodipine is bound to plasma protein.
Amlodipin metaboliseres i vidt omfang i leveren til inaktive metabolitter med 10% af den uændrede modersubstans, og 60% af metabolitterne udskilles via urinen.
Amlodipine is extensively metabolized by the liver to inactive metabolites with 10% of the unchanged parent compound and 60% of metabolites are excreted in the urine.
Udskillelse fra plasma er bifasisk med en endelig udskillelses- halveringstid på cirka 30- 50 timer.
Elimination from the plasma is biphasic with a terminal elimination half-life of about 30-50 hours.
Amlodipin omdannes til inaktive metabolitter i leveren primært med 10% af den uændrede modersubstans udskilt i urinen.
Amlodipine is transformed into inactive metabolites in the liver primarily, with 10% of the unchanged parent compound excreted in the urine.