natgillin/translations-raw huggingface dataset:
Pelzont anvendes som supplement til diæt og motion hos patienter med dyslipidæmi (unormalt højt fedtindhold i blodet), især "kombineret blandet dyslipidæmi" og "primær hyperkolesterolæmi".
Pelzont is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘ combined mixed dyslipidaemia’ and ‘ primary hypercholesterolaemia’.
Patienter med kombineret blandet dyslipidæmi har et højt blodindhold af det "dårlige" LDL- kolesterol og triglycerider (en type fedt) og et lavt indhold af det "gode" HDL- kolesterol.
Patients with combined mixed dyslipidaemia have high blood levels of ‘ bad’ LDL cholesterol and triglycerides (a type of fat), and low levels of ‘ good’ HDL cholesterol.
Det blev først
It was first used as a medicine to modify blood fat levels in the mid-1950s, but its use has been limited because of its side effects, particularly flushing (reddening of the skin).
Reproduction is authorised provided the source is acknowledged. anvendt som et lægemiddel til at ændre fedtindholdet i blodet i midten af 1950' erne, men brugen har været begrænset på grund af stoffets bivirkninger, navnlig flushing (rødmen af huden).
Reproduction is authorised provided the source is acknowledged.
Flushing fremkaldt af nikotinsyre menes at opstå som følge af frigivelsen af et stof kaldet "prostaglandin D2" (PGD2) fra hudcellerne, hvilket udvider blodkarrene i huden.
Flushing due to nicotinic acid is thought to occur because of the release of a substance called ‘ prostaglandin D2’ (PGD2) from cells in the skin, which dilates (widens) the blood vessels in the skin.
I Pelzont- tabletter er der laropiprant i et af lagene, mens det andet lag indeholder nikotinsyre.
In Pelzont tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid.
Når patienten tager tabletten, frigives laropiprant først til blodbanen og blokerer PGD2- receptorerne.
When the patient takes the tablet, laropiprant is released first into the bloodstream and blocks the PGD2 receptors.
Den første undersøgelse, der omfattede i alt 1 613 patienter, sammenlignede virkningen af Pelzont med virkningen af nikotinsyre alene eller med placebo (uvirksom behandling) med hensyn til sænkning af indholdet af LDL- kolesterol.
The first study compared the effectiveness of Pelzont with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
Denne undersøgelse så også nærmere på flushing - symptomerne ved hjælp af et specielt udformet spørgeskema.
This study also looked at the symptoms of flushing using a specially designed questionnaire.
Det primære mål for virkningen var ændringen i blodets indhold af LDL- kolesterol efter 12 uger.
The main measure of effectiveness was the change in the blood levels of LDL cholesterol after 12 weeks.
Flushing blev målt ved hjælp af spørgeskemaet om flushing- symptomer.
Flushing was measured using the flushing symptom questionnaire.
Pelzont var effektivt til at sænke blodets indhold af LDL- kolesterol.
Pelzont was effective in reducing the blood levels of LDL cholesterol.
I den første undersøgelse blev indholdet af LDL- kolesterol reduceret med 19% hos patienter, der fik Pelzont, sammenlignet med 1% hos dem, der fik placebo.
In the first study, LDL cholesterol levels were reduced by 19% in patients taking Pelzont, compared with 1% in those taking placebo.
Den anden undersøgelse viste, at indholdet af LDL- kolesterol blev yderligere sænket, når Pelzont blev givet sammen med simvastatin (48% reduktion) sammenlignet med Pelzont alene (17% reduktion) eller simvastatin alene (37% reduktion).
The second study showed that the LDL cholesterol levels were further reduced when Pelzont was taken with simvastatin (48% reduction), compared with Pelzont alone (17% reduction) or simvastatin alone (37% reduction).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Pelzont er større end risiciene ved behandling af dyslipidæmi, især hos patienter med kombineret blandet dyslipidæmi og patienter med primær hyperkolesterolæmi.
The Committee for Medicinal Products for Human Use (CHMP) decided that Pelzont’ s benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Den 3. juli 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Pelzont to Merck Sharp & Dohme Ltd. on 3 July 2008.
2/ 3 Dette sammendrag blev sidst ajourført i 05- 2008.
This summary was last updated in 05-2008.
Pelzont 1. 000 mg/ 20 mg tabletter med modificeret udløsning.
Pelzont 1000 mg/ 20 mg modified-release tablets.
Hver tablet med modificeret udløsning indeholder 1. 000 mg nicotinsyre og 20 mg laropiprant.
Each modified-release tablet contains 1000 mg of nicotinic acid and 20 mg of laropiprant.
Hver tablet med modificeret udløsning indeholder 128, 4 mg lactosemonohydrat.
Excipient Each modified-release tablet contains 128.4 mg of lactose monohydrate.
Kapselformet, hvid/ off- white tablet mærket med "552" på den ene side.
Capsule-shaped, white to off-white tablet, with “ 552 ” debossed on one side.
Pelzont er indiceret til behandling af dyslipidæmi, især hos patienter med kombineret dyslipidæmi (karakteriseret ved forhøjede koncentrationer af LDL- kolesterol og triglycerider samt lavt HDL - kolesterol) og hos patienter med primær hyperkolesterolæmi (heterozygot familiær og non- familiær).
Pelzont is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).
Pelzont bør anvendes sammen med HMG- CoA reduktasehæmmere (statiner), når den kolesterolsænkende effekt af monoterapi med HMG- CoA- reduktasehæmmere er utilstrækkelig.
Pelzont should be used in patients in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate.
Pelzont kan anvendes som monoterapi hos patienter, hvor HMG- CoA- reduktasehæmmere anses for at være utilstrækkelige eller ikke tåles.
It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated.
Diæt og anden ikke- farmakologisk behandling (f. eks. motion, vægtreduktion) bør fortsætte under behandlingen med Pelzont.
Diet and other non-pharmacological treatments (e. g. exercise, weight reduction) should be continued during therapy with Pelzont.
Startdosis er én tablet med modificeret udløsning (1. 000 mg nicotinsyre/ 20 mg laropiprant) én gang dagligt.
Posology The starting dose is one modified-release tablet (1000 mg nicotinic acid/ 20 mg laropiprant) once a day.
Efter fire uger bør dosis øges til en vedligeholdelsesdosis på 2. 000 mg/ 40 mg, der tages som to tabletter med modificeret udløsning (1. 000 mg/ 20 mg hver) én gang dagligt.
After four weeks, it is recommended that patients be advanced to the maintenance dose of 2000 mg/ 40 mg taken as two modified-release tablets (1000 mg/ 20 mg each) once daily.
Daglige doser over 2. 000 mg/ 40 mg er ikke undersøgt og bør derfor ikke anvendes.
Daily doses greater than 2000 mg/ 40 mg have not been studied and therefore are not recommended.
Hvis patienten har undladt at tage Pelzont i 7 eller flere på hinanden følgende dage, kan behandlingen genoptages med 1. 000 mg/ 20 mg i en uge, før dosis øges til vedligeholdelsesdosis på 2. 000 mg/ 40 mg.
If Pelzont is missed for 7 or more consecutive days, therapy should be resumed at the 1000 mg/ 20 mg dose for 1 week, before advancing to the maintenance dose of 2000 mg/ 40 mg.
Patienter, som skifter fra 2. 000 mg eller mere af et nicotinsyredepotpræparat, kan starte behandling med Pelzont med en dosis på 2. 000 mg/ 40 mg.
2 Those patients switching from 2000 mg or more of prolonged-release nicotinic acid can initiate Pelzont at the 2000 mg/ 40 mg dose.
Patienter, der skifter fra < 2. 000 mg af et nicotinsyredepotpræparat, bør starte behandling med en startdosis på 1. 000 mg/ 20 mg og gå over til en vedligeholdelsesdosis på 2. 000 mg/ 40 mg efter fire uger.
Patients switching from less than 2000 mg of prolonged-release nicotinic acid should initiate therapy at the starting dose of 1000 mg/ 20 mg and advance to the 2000 mg/ 40 mg maintenance dose after four weeks.
Patienter, der skifter fra nicotinsyre med umiddelbar udløsning til Pelzont, bør starte behandling med 1. 000 mg/ 20 mg og overgå til en vedligeholdelsesdosis på 2. 000 mg/ 40 mg efter fire uger.
For patients switching from immediate-release nicotinic acid to Pelzont, therapy should be initiated at the 1000 mg/ 20 mg dose and advanced to the 2000 mg/ 40 mg maintenance dose after four weeks.
Indgivelsesmåde Tabletterne bør tages sammen med mad, om aftenen eller ved sengetid.
Method of administration The tablets should be taken whole, with food, in the evening or at bedtime.
For at bevare egenskaberne vedrørende den modificerede udløsning, må tabletterne ikke deles, brydes, knuses eller tygges, før de
To preserve the modified-release properties, the tablets must not be split, broken, crushed, or chewed before swallowing.
For at reducere risikoen for flushing bør alkohol eller varme drikke undgås samtidig med indtagelse af lægemidlet.
To reduce the possibility of flushing, alcohol or hot drinks should be avoided at the time of ingestion of the medicinal product.
Ældre Dosisjustering er ikke nødvendig hos ældre patienter.
Use in the elderly No dose adjustment is required for elderly patients.
Pædiatriske patienter Pelzont bør ikke anvendes til pædiatriske patienter p. g. a. manglende dokumentation for sikkerhed og virkning.
Therefore, treatment is not recommended in this age group.
Patienter med lever - eller nyreinsufficiens Anvendelse af Pelzont er ikke undersøgt hos patienter med lever - eller nyreinsufficiens.
Use in patients with hepatic or renal insufficiency Use of Pelzont in patients with hepatic or renal insufficiency has not been studied.
4. 3, 4. 4 og 5. 2).
It should be used with caution in patients with renal insufficiency, because nicotinic acid and its metabolites are primarily excreted by the kidneys (see sections 4.3, 4.4 and 5.2).
Samtidig behandling Acetylsalicylsyre giver ikke yderligere reduktion af flushing, ud over den der opnås ved Pelzont.
Concomitant therapy Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Pelzont.
5. 1).
Therefore, treatment with acetylsalicylic acid to alleviate flushing symptoms is not necessary (see section 5.1).
4. 5).
Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Pelzont be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant (see section 4.5).
• Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne. • Signifikant eller uforklarlig leverinsufficiens. • Aktivt ulcus pepticum. • Arteriel blødning.
• Hypersensitivity to the active substances or to any of the excipients. • Significant or unexplained hepatic dysfunction. • Active peptic ulcer disease. • Arterial bleeding.
Leverpåvirkning Skift fra nicotinsyre med umiddelbar udløsning (krystallinsk) til Pelzont er ikke undersøgt.
Hepatic effects Switching from immediate-release (crystalline) nicotinic acid to Pelzont has not been studied.
Der er dog set tilfælde af svær levertoksicitet, herunder fulminant levernekrose, hos patienter, som har skiftet fra nicotinsyre med umiddelbar udløsning til langtidsvirkende nicotinsyre- præparater i tilsvarende doser.
However, cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in
Patienter, der skifter fra nicotinsyre med umiddelbar udløsning til Pelzont, bør derfor starte med 1. 000 mg/ 20 mg.
Therefore, patients switching from immediate-release nicotinic acid to Pelzont should be initiated at the 1000 mg/ 20 mg dose.
Pelzont bør anvendes med forsigtighed hos patienter, som indtager væsentlige mængder alkohol og/ eller har leversygdom i anamnesen.
Pelzont should be used with caution in patients who consume substantial quantities of alcohol and/ or have a past history of liver disease.
4. 8).
Like other lipid-lowering therapies, nicotinic acid medicinal products have been associated with abnormal liver function tests (see section 4.8).
Leverfunktionsprøver anbefales før behandlingsstart, hver 6. - 12. uge i det første år og derefter periodisk (f. eks. halvårligt).
Liver function tests are recommended before initiation, every 6 to 12 weeks for the first year, and periodically (e. g. semi-annually) thereafter.
4. 8).
Effect on skeletal muscle Rare cases of rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (≥ 1000 mg/ day) of nicotinic acid and HMG-CoA reductase inhibitors (statins) (see section 4.8).
Læger, som overvejer kombinationsbehandling med statiner og Pelzont, bør nøje overveje de mulige fordele i forhold til risikoen og bør monitorere patienterne nøje med henblik på tegn og symptomer på muskelsmerte, - ømhed eller - svaghed, især i de første måneder af behandlingen, og når doseringen af et af lægemidlerne øges.
Physicians contemplating combined therapy with statins and Pelzont should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and when the dose of either medicinal product is increased.
Forsigtighed bør udvises hos patienter med prædisponerende faktorer for rhabdomyolyse. • Alder > 70 år. • Nyreinsufficiens. • Ukontrolleret hypothyroidisme. • Personlig eller familiær historie med arvelige muskelsygdomme. • Muskulær toksicitet i anamnesen med statin eller fibrat. • Alkoholmisbrug.
Caution should be exercised in patients with pre-disposing factors for rhabdomyolysis. • Age > 70 years • Renal impairment • Uncontrolled hypothyroidism • Personal or familial history of hereditary muscular disorders • Previous history of muscular toxicity with a statin or fibrate • Alcohol abuse.
Hvis muskelsmerter, - svaghed eller - kramper opstår, mens patienten er i behandling med Pelzont sammen med et statin, skal CK- koncentrationerne måles.
If muscle pain, weakness or cramps occur while a patient is receiving Pelzont with a statin, their CK levels should be measured.
Nyreinsufficiens Da nicotinsyre og dets metabolitter udskilles via nyrerne, bør Pelzont anvendes med forsigtighed hos patienter med nyreinsufficiens.
Renal dysfunction Because nicotinic acid and its metabolites are excreted through the kidneys, Pelzont should be used with caution in patients with renal dysfunction.
4. 8).
Effect on glucose Nicotinic acid medicinal products have been associated with increases of fasting blood glucose levels (see section 4.8).
Justering af diæt og/ eller hypoglykæmisk behandling kan være nødvendig.
Adjustment of diet and/ or hypoglycaemic therapy may be necessary.
Akut koronarsyndrom Som med andre nicotinsyrepræparater bør der udvises forsigtighed, når Pelzont anvendes til patienter med ustabil angina eller patienter i den akutte fase af myokardieinfarkt, især når disse patienter også får vasoaktive lægemidler, såsom nitrater, calciumkanalblokkere eller adrenerge blokkere.
4 Acute coronary syndrome As with other nicotinic acid medicinal products, caution should be used when Pelzont is used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive medicinal products such as nitrates, calcium channel blockers, or adrenergic blocking agents.
4. 8).
Haematologic effects As with other nicotinic acid medicinal products, Pelzont (2000 mg/ 40 mg) was associated with small reductions in platelet count (see section 4.8).
4. 8).
Effect on uric acid As with other nicotinic acid medicinal products, Pelzont (2000 mg/ 40 mg) was associated with small increases in uric acid levels (see section 4.8).
Hypofosfatæmi Som med andre nicotinsyrepræparater er Pelzont blevet forbundet med små fald i fosfor.
Hypophosphatemia As with other nicotinic acid medicinal products, Pelzont was associated with small decreases in phosphorus levels.
4. 2 og 4. 3).
Further As with other nicotinic acid medicinal products, patients with a history of jaundice, hepato-biliary disorder or peptic ulcer should be observed closely (see sections 4.2 and 4.3).
4 Pelzont indeholder lactose.
Excipient Pelzont contains lactose.
Patienter med arvelig galactoseintolerans, Lapp Lactase- mangel eller glucose- galactosemalabsorption bør ikke tage dette lægemiddel.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Samtidig indtagelse af alkohol eller varme drikke kan forstærke flushing- effekten og bør derfor undgås omkring tidspunktet for indtagelse af Pelzont.
Simultaneous use of alcohol or hot drinks can enhance the effects of flushing and should therefore be avoided around the time of ingestion of Pelzont.
Nicotinsyre Nicotinsyres indvirkning på andre lægemidler Antihypertensiv behandling:
Nicotinic acid Effects of nicotinic acid on other medicinal products Antihypertensive therapy:
Nicotinsyre kan forstærke virkningen af ganglieblokerende stoffer og vasoaktive lægemidler, såsom nitrater, calciumkanalblokkere og adrenerge receptorblokkere, som kan resultere i postural hypotension.
Nicotinic acid may potentiate the effects of ganglionic blocking agents and vasoactive medicinal products such as nitrates, calcium channel blockers, and adrenergic receptor blocking agents, resulting in postural hypotension.
Når simvastatin kombineredes med nicotinsyre, sås en beskeden stigning i simvastatinsyres (den aktive form af simvastatin) AUC og Cmax, som kan være uden klinisk relevans.
When simvastatin is combined with nicotinic acid, a modest increase in AUC and Cmax of simvastatin acid (the active form of simvastatin) was observed, which may be devoid of clinical relevance.
4. 4).
The pharmacokinetic interaction of Pelzont with statins has been studied only with simvastatin (see section 4.4).
Andre lægemidlers indvirkning på nicotinsyre Galdesyrebindende lægemidler:
Effects of other medicinal products on nicotinic acid Bile acid sequestrants:
Da samtidig administration af galdesyrebindende lægemidler kan reducere biotilgængeligheden af sure lægemidler, såsom nicotinsyre, anbefales det, at Pelzont administreres > 1 time før eller > 4 timer efter administration af et galdesyrebindende lægemiddel.
Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Pelzont be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant.
Kosttilskud med nicotinsyre:
5 Supplements containing nicotinic acid:
Vitaminer eller andre ernæringstilskud med (≥ 50 mg / dag) nicotinsyre (eller nicotinamid) er ikke blevet undersøgt sammen med Pelzont.
Vitamins or other nutritional supplements containing (≥ 50 mg/ day) of nicotinic acid (or nicotinamide) have not been studied with Pelzont.
Lægemiddel - / laboratorietest- interaktioner:
Medicinal product / laboratory test interactions:
I uringlucoseprøver kan nicotinsyre også give falsk positive reaktioner med opløsning af kobbersulfat (Benedicts prøve).
In urine glucose tests, nicotinic acid may also give false-positive reactions with cupric sulfate solution (Benedict’ s reagent).
Laropiprant Laropiprants indvirkning på andre lægemidler Midazolam:
Laropiprant Effects of laropiprant on other medicinal products Midazolam:
Flergangsdosering med laropiprant 40 mg påvirkede ikke midazolams farmakokinetik, der er et sensitivt CYP3A4- substrat.
Multiple doses of laropiprant 40 mg did not affect the pharmacokinetics of midazolam, a sensitive CYP3A4 substrate.
2 gange ved flergangsdosering af laropiprant.
However, the plasma concentration of a metabolite of midazolam, 1'-hydroxymidazolam, was increased approximately 2-fold with multiple doses of laropiprant.
Da l '- hydroxymidazolam er en aktiv metabolit, kan midazolams sedative virkning øges, og forsigtighed bør udvises, når laropiprant gives samtidigt med midazolam.
Because 1'-hydroxymidazolam is an active metabolite, the sedative effect of midazolam may be increased and caution should be used when laropiprant is co-administered with midazolam.
Samtidig administration af laropiprant 40 mg og midazolam øgede AUC0- ∞ og Cmax for 1 '- hydroxymidazolam, en midazolammetabolit, med henholdsvis 98% og 59%.
Co-administration of laropiprant 40 mg with midazolam increased the AUC0-∞ and Cmax of 1'-hydroxymidazolam, a midazolam metabolite, by 98% and 59%, respectively.
1 '- hydroxymidazolam metaboliseres overvejende af uridindiphosphat glucuronosyltransferaserne (UGT) 2B4 og 2B7.
1'-hydroxymidazolam is metabolised predominantly by uridine diphosphate-glucuronosyltransferases (UGT) 2B4 and 2B7.
Kliniske og in vitro- undersøgelser understøtter den konklusion, at laropiprant er en mild til moderat hæmmer af UGT2B4/ UGT2B7.
Clinical and in vitro studies support the conclusion that laropiprant is a mild to moderate inhibitor of UGT2B4/ UGT2B7.
Forsigtighed bør udvises, når Pelzont administreres sammen med lægemidler, der overvejende metaboliseres af UGT2B4 eller UGT2B7, f. eks. zidovudin.
Caution should be used when Pelzont is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Simvastatin, warfarin, perorale kontraceptiva, rosiglitazon og digoxin.
In interaction studies, laropiprant did not have clinically significant effects on the pharmacokinetics of the following medicinal products: simvastatin, warfarin, oral contraceptives, rosiglitazone and digoxin.
På basis af disse data forventes laropiprant ikke at medføre interaktion med substrater af CYP- isozymerne 3A4, 2C9, 2C8 og humant P- glycoprotein (P- gp).
Based on these data, laropiprant is not expected to cause interactions with substrates of CYP isozymes 3A4, 2C9, 2C8 and human P-glycoprotein (P-gp).
I in vitro- undersøgelser hæmmede laropiprant ikke CYP1A2, CYP2B6, CYP2C19, CYP2D6 eller CYP2E1- medierede reaktioner.
In in vitro studies, laropiprant did not inhibit CYP1A2, CYP2B6, CYP2C19, CYP2D6, or CYP2E1-mediated reactions.
Clopidogrel:
Clopidogrel:
I en klinisk undersøgelse sås ingen relevant indvirkning af laropiprant på clopidogrels hæmning af ADP- induceret blodpladeaggregation, men der var en beskeden stigning i clopidogrels
In a clinical study, there was no meaningful effect of laropiprant on the inhibition of ADP-induced platelet aggregation by clopidogrel, but there was a modest increase in the inhibition of collagen-induced platelet aggregation by clopidogrel.
5 hæmning af kollagen- induceret blodpladeaggregation.
The clinical significance of these observations is unknown.
5. 1).
In a clinical study, concomitant administration of laropiprant with acetylsalicylic acid did not have an effect on collagen-induced platelet aggregation or on bleeding time compared to treatment with acetylsalicylic acid alone (see section 5.1).
Andre lægemidlers indvirkning på laropiprant CYP3A4- hæmmer:
Effects of other medicinal products on laropiprant CYP3A4 Inhibitor:
Clarithromycin (der er en potent hæmmer af CYP3A4 og P- gp) havde ingen klinisk relevant indvirkning på laropiprants farmakokinetik.
Clarithromycin (a potent inhibitor of CYP3A4 and P-gp) did not have a clinically meaningful effect on the pharmacokinetics of laropiprant.
Laropiprant er ikke et substrat af humant P- gp, og derfor forventes andre hæmmere af CYP3A4 og/ eller P- gp heller ikke at have en klinisk relevant indvirkning på laropiprants farmakokinetik.
Laropiprant is not a substrate of human P-gp, and therefore other inhibitors of CYP3A4 and/ or P-gp are also not expected to have a clinically meaningful impact on the pharmacokinetics of laropiprant.