Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 19

HOS-086286 · Präparat HOS-083284

Calcium channel antagonists Amlodipine, diltiazem, nifedipine Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of calcium channel antagonists. Careful monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with ritonavir.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): calcium (HOS-085615) amlodipine (HOS-086287) diltiazem (HOS-086288) nifedipine (HOS-086289)

Wechselwirkungen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 51

HOS-086463 · Präparat HOS-083284

Calcium channel antagonists Amlodipine, diltiazem, nifedipine Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of calcium channel antagonists. Careful monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with ritonavir.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): calcium (HOS-085615) amlodipine (HOS-086287) diltiazem (HOS-086288) nifedipine (HOS-086289)

Wechselwirkungen · Viagra

VIAGRA 25 mg film-coated tablets VIAGRA 50 mg film-coated tablets VIAGRA 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-088805 · Präparat HOS-083727

Pooling of the following classes of antihypertensive medicinal products: diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrally-acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking sildenafil compared to placebo treatment. 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. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. 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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): placebo (HOS-088378) amlodipine (HOS-086287) angiotensin II (HOS-085480) calcium (HOS-085615)

Wechselwirkungen · Viagra

VIAGRA 50 mg orodispersible tablets · Abschnitt 4.5 · PDF-Seite 21

HOS-088859 · Präparat HOS-083727

Pooling of the following classes of antihypertensive medicinal products: diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrally-acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking sildenafil compared to placebo treatment. 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. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. 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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): angiotensin II (HOS-085480) calcium (HOS-085615) placebo (HOS-088378) amlodipine (HOS-086287)

Wechselwirkungen · Viagra

VIAGRA 50 mg orodispersible films · Abschnitt 4.5 · PDF-Seite 35

HOS-088910 · Präparat HOS-083727

Pooling of the following classes of antihypertensive medicinal products: diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrally-acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the adverse events profile in patients taking sildenafil compared to placebo treatment. 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. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. 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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): angiotensin II (HOS-085480) calcium (HOS-085615) placebo (HOS-088378) amlodipine (HOS-086287)

Wechselwirkungen · Cialis

CIALIS 2.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-111258 · Präparat HOS-093485

In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive medicinal products was examined. Major classes of antihypertensive medicinal products were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers). Tadalafil (10 mg except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes. In another clinical pharmacology study tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives. In subjects taking multiple antihypertensives, the ambulatory-blood-pressure changes appeared to relate to the degree of blood-pressure control. In this regard, study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen in healthy subjects. In study subjects whose blood pressure was not controlled, the reduction was greater although this reduction was not associated with hypotensive symptoms in the majority of subjects. In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of alpha blockers -see above-) is, in general, minor and not likely to be clinically relevant. Analysis of phase 3 clinical trial data showed no difference in

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): calcium (HOS-085615) amlodipine (HOS-086287) enalapril (HOS-085479) metoprolol (HOS-090094) angiotensin II (HOS-085480)

Wechselwirkungen · Cialis

CIALIS 5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 21

HOS-111303 · Präparat HOS-093485

In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive medicinal products was examined. Major classes of antihypertensive medicinal products were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers). Tadalafil (10 mg except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes. In another clinical pharmacology study tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives. In subjects taking multiple antihypertensives, the ambulatory-blood-pressure changes appeared to relate to the degree of blood-pressure control. In this regard, study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen in healthy subjects. In study subjects whose blood pressure was not controlled, the reduction was greater although this reduction was not associated with hypotensive symptoms in the majority of subjects. In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of alpha blockers -see above-) is, in general, minor and not likely to be clinically relevant. Analysis of phase 3 clinical trial data showed no difference in adverse events in patients taking tadalafil with or without antihypertensive medicinal products. However, appropriate clinical advice should be given to patients regarding a possible decrease in blood pressure when they are treated with antihypertensive medicinal products.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): calcium (HOS-085615) amlodipine (HOS-086287) enalapril (HOS-085479) metoprolol (HOS-090094) angiotensin II (HOS-085480)

Wechselwirkungen · Cialis

CIALIS 10 mg film-coated tablets CIALIS 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 35

HOS-111342 · Präparat HOS-093485

In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive medicinal products was examined. Major classes of antihypertensive medicinal products were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers). Tadalafil (10 mg except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes. In another clinical pharmacology study tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives. In subjects taking multiple antihypertensives, the ambulatory-blood-pressure changes appeared to relate to the degree of blood-pressure control. In this regard, study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen in healthy subjects. In study subjects whose blood pressure was not controlled, the reduction was greater although this reduction was not associated with hypotensive symptoms in the majority of subjects. In

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): calcium (HOS-085615) amlodipine (HOS-086287) enalapril (HOS-085479) metoprolol (HOS-090094) angiotensin II (HOS-085480)

Wechselwirkungen · Procoralan

Procoralan 5 mg film-coated tablets Procoralan 7.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7–8

HOS-113863 · Präparat HOS-093985

Other concomitant use Specific interaction studies have shown no clinically significant effect of the following medicinal products on pharmacokinetics and pharmacodynamics of ivabradine: proton pump inhibitors (omeprazole, lansoprazole), sildenafil, HMG CoA reductase inhibitors (simvastatin), dihydropyridine calcium channel blockers (amlodipine, lacidipine), digoxin and warfarin. In addition there was no 7 clinically significant effect of ivabradine on the pharmacokinetics of simvastatin, amlodipine, lacidipine, on the pharmacokinetics and pharmacodynamics of digoxin, warfarin and on the pharmacodynamics of aspirin. In pivotal phase III clinical trials the following medicinal products were routinely combined with ivabradine with no evidence of safety concerns: angiotensin converting enzyme inhibitors, angiotensin II antagonists, beta-blockers, diuretics, anti-aldosterone agents, short and long acting nitrates, HMG CoA reductase inhibitors, fibrates, proton pump inhibitors, oral antidiabetics, aspirin and other anti- platelet medicinal products.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): aspirin (HOS-111273) aldosterone (HOS-086926) omeprazole (HOS-085912) lansoprazole (HOS-085166) sildenafil (HOS-086162) simvastatin (HOS-086158) calcium (HOS-085615) amlodipine (HOS-086287) lacidipine (HOS-113865) digoxin (HOS-086172) warfarin (HOS-085950)

Wechselwirkungen · Corlentor

Corlentor 5 mg film-coated tablets Corlentor 7.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7–8

HOS-113899 · Präparat HOS-093993

Other concomitant use Specific interaction studies have shown no clinically significant effect of the following medicinal products on pharmacokinetics and pharmacodynamics of ivabradine: proton pump inhibitors (omeprazole, lansoprazole), sildenafil, HMG CoA reductase inhibitors (simvastatin), dihydropyridine 7 calcium channel blockers (amlodipine, lacidipine), digoxin and warfarin. In addition there was no clinically significant effect of ivabradine on the pharmacokinetics of simvastatin, amlodipine, lacidipine, on the pharmacokinetics and pharmacodynamics of digoxin, warfarin and on the pharmacodynamics of aspirin. In pivotal phase III clinical trials the following medicinal products were routinely combined with ivabradine with no evidence of safety concerns: angiotensin converting enzyme inhibitors, angiotensin II antagonists, beta-blockers, diuretics, anti-aldosterone agents, short and long acting nitrates, HMG CoA reductase inhibitors, fibrates, proton pump inhibitors, oral antidiabetics, aspirin and other anti- platelet medicinal products.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): omeprazole (HOS-085912) lansoprazole (HOS-085166) sildenafil (HOS-086162) simvastatin (HOS-086158) calcium (HOS-085615) amlodipine (HOS-086287) lacidipine (HOS-113865) digoxin (HOS-086172) warfarin (HOS-085950) aspirin (HOS-111273) aldosterone (HOS-086926)

Wechselwirkungen · Revatio

Revatio 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-114952 · Präparat HOS-094193

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. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): amlodipine (HOS-086287)

Wechselwirkungen · Revatio

Revatio 0.8 mg/ml solution for injection · Abschnitt 4.5 · PDF-Seite 28

HOS-115015 · Präparat HOS-094193

In a specific interaction study, where oral sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): amlodipine (HOS-086287)

Wechselwirkungen · Revatio

Revatio 10 mg/ml powder for oral suspension · Abschnitt 4.5 · PDF-Seite 46

HOS-115073 · Präparat HOS-094193

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. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): amlodipine (HOS-086287)

Wechselwirkungen · Prezista

PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 19–20

HOS-116394 · Präparat HOS-094447

19 ANTIPSYCHOTICS/NEUROLEPTICS Quetiapine Not studied. Boosted PREZISTA is Concomitant administration of expected to increase these antipsychotic boosted PREZISTA and quetiapine plasma concentrations. is contraindicated as it may (CYP3A inhibition) increase quetiapine-related toxicity. Increased concentrations of quetiapine may lead to coma (see section 4.3). Perphenazine Not studied. Boosted PREZISTA is A dose decrease may be needed for Risperidone expected to increase these antipsychotic these drugs when co-administered Thioridazine plasma concentrations. with boosted PREZISTA. (CYP3A, CYP2D6 and/or P-gp Lurasidone inhibition) Concomitant administration of Pimozide boosted PREZISTA and Sertindole lurasidone, pimozide or sertindole is contraindicated (see section 4.3). β-BLOCKERS Carvedilol Not studied. Boosted PREZISTA is Clinical monitoring is Metoprolol expected to increase these β-blocker recommended when Timolol plasma concentrations. co-administering boosted (CYP2D6 inhibition) PREZISTA with β-blockers. A lower dose of the β-blocker should be considered. CALCIUM CHANNEL BLOCKERS Amlodipine Not studied. Boosted PREZISTA can be Clinical monitoring of therapeutic Diltiazem expected to increase the plasma and adverse effects is Felodipine concentrations of calcium channel recommended when these Nicardipine blockers. medicines are concomitantly Nifedipine (CYP3A and/or CYP2D6 inhibition) administered with boosted Verapamil PREZISTA. CORTICOSTEROIDS Corticosteroids primarily Fluticasone: in a clinical study where Concomitant use of boosted metabolised by CYP3A ritonavir 100 mg capsules twice daily PREZISTA and corticosteroids (all (including were co-administered with 50 g routes of administration) that are betamethasone, intranasal fluticasone propionate (4 times metabolised by CYP3A may budesonide, fluticasone, daily) for 7 days in healthy subjects, increase the risk of development of mometasone, prednisone, fluticasone propionate plasma systemic corticosteroid effects, triamcinolone) concentrations increased significantly, including Cushing’s syndrome and whereas the intrinsic cortisol levels adrenal suppression. decreased by approximately 86% (90% CI 82-89%). Greater effects may be Co-administration with CYP3A- expected when fluticasone is inhaled. metabolised corticosteroids is not Systemic corticosteroid effects including recommended unless the potential Cushing’s syndrome and adrenal benefit to the patient outweighs the suppression have been reported in risk, in which case patients should patients receiving ritonavir and inhaled or be monitored for systemic intranasally administered fluticasone. The corticosteroid effects. effects of high fluticasone systemic exposure on ritonavir plasma levels are Alternative corticosteroids which unknown. are less dependent on CYP3A metabolism e.g. beclomethasone Other corticosteroids: interaction not should be considered, particularly studied. Plasma concentrations of these for long term use. medicinal products may be increased when co-administered with boosted PREZISTA, resulting in reduced serum cortisol concentrations. Dexamethasone Not studied. Dexamethasone may Systemic dexamethasone should (systemic) decrease plasma concentrations of be used with caution when darunavir. combined with boosted (CYP3A induction) PREZISTA.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): felodipine (HOS-108908) quetiapine (HOS-086150) lead (HOS-085592) perphenazine (HOS-116395) risperidone (HOS-086280) thioridazine (HOS-086281) lurasidone (HOS-086148) pimozide (HOS-085600) sertindole (HOS-085601) carvedilol (HOS-115322) metoprolol (HOS-090094) timolol (HOS-090571) calcium (HOS-085615) amlodipine (HOS-086287) diltiazem (HOS-086288) nicardipine (HOS-090619) nifedipine (HOS-086289) verapamil (HOS-090602) fluticasone (HOS-108914) ritonavir (HOS-084521) betamethasone (HOS-090066) fluticasone propionate (HOS-086331) budesonide (HOS-086332) mometasone (HOS-114048) prednisone (HOS-084526) triamcinolone (HOS-086333) beclomethasone (HOS-086334) dexamethasone (HOS-084535)

Wechselwirkungen · Prezista

PREZISTA 75 mg film-coated tablets PREZISTA 150 mg film-coated tablets PREZISTA 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 61–62

HOS-116527 · Präparat HOS-094447

61  Perphenazine Not studied. PREZISTA is expected to A dose decrease may be needed for Risperidone increase these antipsychotic plasma these drugs when co-administered Thioridazine concentrations. with PREZISTA co-administered (CYP3A, CYP2D6 and/or P-gp with low dose ritonavir. inhibition) Lurasidone Concomitant administration of Pimozide PREZISTA with low dose Sertindole ritonavir and lurasidone, pimozide or sertindole is contraindicated (see section 4.3). β-BLOCKERS Carvedilol Not studied. PREZISTA is expected to Clinical monitoring is Metoprolol increase these β-blocker plasma recommended when Timolol concentrations. co-administering PREZISTA with (CYP2D6 inhibition) β-blockers. A lower dose of the β-blocker should be considered. CALCIUM CHANNEL BLOCKERS Amlodipine Not studied. PREZISTA co-administered Clinical monitoring of therapeutic Diltiazem with low dose ritonavir can be expected and adverse effects is Felodipine to increase the plasma concentrations of recommended when these Nicardipine calcium channel blockers. medicines are concomitantly Nifedipine (CYP3A and/or CYP2D6 inhibition) administered with PREZISTA with Verapamil low dose ritonavir. CORTICOSTEROIDS Corticosteroids primarily Fluticasone: in a clinical study where Concomitant use of PREZISTA metabolised by CYP3A ritonavir 100 mg capsules twice daily with low dose ritonavir and (including were co-administered with 50 g corticosteroids (all routes of betamethasone, intranasal fluticasone propionate (4 times administration) that are budesonide, fluticasone, daily) for 7 days in healthy subjects, metabolised by CYP3A may mometasone, prednisone, fluticasone propionate plasma increase the risk of development of triamcinolone) concentrations increased significantly, systemic corticosteroid effects, whereas the intrinsic cortisol levels including Cushing’s syndrome and decreased by approximately 86% (90% adrenal suppression. CI 82-89%). Greater effects may be expected when fluticasone is inhaled. Co-administration with CYP3A- Systemic corticosteroid effects including metabolised corticosteroids is not Cushing’s syndrome and adrenal recommended unless the potential suppression have been reported in benefit to the patient outweighs the patients receiving ritonavir and inhaled or risk, in which case patients should intranasally administered fluticasone. The be monitored for systemic effects of high fluticasone systemic corticosteroid effects. exposure on ritonavir plasma levels are unknown. Alternative corticosteroids which are less dependent on CYP3A Other corticosteroids: interaction not metabolism e.g. beclomethasone studied. Plasma concentrations of these should be considered, particularly medicinal products may be increased for long term use. when co-administered with PREZISTA with low dose ritonavir, resulting in reduced serum cortisol concentrations. Dexamethasone Not studied. Dexamethasone may Systemic dexamethasone should (systemic) decrease plasma concentrations of be used with caution when darunavir. combined with PREZISTA (CYP3A induction) co-administered with low dose ritonavir.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): timolol (HOS-090571) calcium (HOS-085615) amlodipine (HOS-086287) diltiazem (HOS-086288) felodipine (HOS-108908) nicardipine (HOS-090619) nifedipine (HOS-086289) verapamil (HOS-090602) perphenazine (HOS-116395) risperidone (HOS-086280) thioridazine (HOS-086281) ritonavir (HOS-084521) lurasidone (HOS-086148) pimozide (HOS-085600) sertindole (HOS-085601) carvedilol (HOS-115322) metoprolol (HOS-090094) fluticasone (HOS-108914) betamethasone (HOS-090066) fluticasone propionate (HOS-086331) budesonide (HOS-086332) mometasone (HOS-114048) prednisone (HOS-084526) triamcinolone (HOS-086333) beclomethasone (HOS-086334) dexamethasone (HOS-084535)

Wechselwirkungen · Prezista

PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 101–102

HOS-116617 · Präparat HOS-094447

101 ANTIPSYCHOTICS/NEUROLEPTICS Quetiapine Not studied. Boosted PREZISTA is Concomitant administration of expected to increase these antipsychotic boosted PREZISTA and quetiapine plasma concentrations. is contraindicated as it may (CYP3A inhibition) increase quetiapine-related toxicity. Increased concentrations of quetiapine may lead to coma (see section 4.3). Perphenazine Not studied. Boosted PREZISTA is A dose decrease may be needed for Risperidone expected to increase these antipsychotic these drugs when co-administered Thioridazine plasma concentrations. with boosted PREZISTA. (CYP3A, CYP2D6 and/or P-gp Lurasidone inhibition) Concomitant administration of Pimozide boosted PREZISTA and Sertindole lurasidone, pimozide or sertindole is contraindicated (see section 4.3). β-BLOCKERS Carvedilol Not studied. Boosted PREZISTA is Clinical monitoring is Metoprolol expected to increase these β-blocker recommended when Timolol plasma concentrations. co-administering boosted (CYP2D6 inhibition) PREZISTA with β-blockers. A lower dose of the β-blocker should be considered. CALCIUM CHANNEL BLOCKERS Amlodipine Not studied. Boosted PREZISTA can be Clinical monitoring of therapeutic Diltiazem expected to increase the plasma and adverse effects is Felodipine concentrations of calcium channel recommended when these Nicardipine blockers. medicines are concomitantly Nifedipine (CYP3A and/or CYP2D6 inhibition) administered with boosted Verapamil PREZISTA. CORTICOSTEROIDS Corticosteroids primarily Fluticasone: in a clinical study where Concomitant use of boosted metabolised by CYP3A ritonavir 100 mg capsules twice daily PREZISTA and corticosteroids (all (including were co-administered with 50 g routes of administration) that are betamethasone, intranasal fluticasone propionate (4 times metabolised by CYP3A may budesonide, fluticasone, daily) for 7 days in healthy subjects, increase the risk of development of mometasone, prednisone, fluticasone propionate plasma systemic corticosteroid effects, triamcinolone) concentrations increased significantly, including Cushing’s syndrome and whereas the intrinsic cortisol levels adrenal suppression. decreased by approximately 86% (90% CI 82-89%). Greater effects may be Co-administration with CYP3A- expected when fluticasone is inhaled. metabolised corticosteroids is not Systemic corticosteroid effects including recommended unless the potential Cushing’s syndrome and adrenal benefit to the patient outweighs the suppression have been reported in risk, in which case patients should patients receiving ritonavir and inhaled or be monitored for systemic intranasally administered fluticasone. The corticosteroid effects. effects of high fluticasone systemic exposure on ritonavir plasma levels are Alternative corticosteroids which unknown. are less dependent on CYP3A metabolism e.g. beclomethasone Other corticosteroids: interaction not should be considered, particularly studied. Plasma concentrations of these for long term use. medicinal products may be increased when co-administered with boosted PREZISTA, resulting in reduced serum cortisol concentrations. Dexamethasone Not studied. Dexamethasone may Systemic dexamethasone should (systemic) decrease plasma concentrations of be used with caution when darunavir. combined with boosted (CYP3A induction) PREZISTA.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): quetiapine (HOS-086150) lead (HOS-085592) perphenazine (HOS-116395) risperidone (HOS-086280) thioridazine (HOS-086281) lurasidone (HOS-086148) pimozide (HOS-085600) sertindole (HOS-085601) carvedilol (HOS-115322) metoprolol (HOS-090094) timolol (HOS-090571) calcium (HOS-085615) amlodipine (HOS-086287) diltiazem (HOS-086288) felodipine (HOS-108908) nicardipine (HOS-090619) nifedipine (HOS-086289) verapamil (HOS-090602) fluticasone (HOS-108914) ritonavir (HOS-084521) betamethasone (HOS-090066) fluticasone propionate (HOS-086331) budesonide (HOS-086332) mometasone (HOS-114048) prednisone (HOS-084526) triamcinolone (HOS-086333) beclomethasone (HOS-086334) dexamethasone (HOS-084535)

Gegenanzeigen · Exforge

Exforge 5 mg/80 mg film-coated tablets Exforge 5 mg/160 mg film-coated tablets Exforge 10 mg/160 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 4

HOS-117023 · Präparat HOS-094529

• Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1. • Severe hepatic impairment, biliary cirrhosis or cholestasis. • Concomitant use of Exforge with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1). • Second and third trimesters of pregnancy (see sections 4.4 and 4.6). • Severe hypotension. • Shock (including cardiogenic shock). • Obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis). • Haemodynamically unstable heart failure after acute myocardial infarction.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Exforge

Exforge 5 mg/80 mg film-coated tablets Exforge 5 mg/160 mg film-coated tablets Exforge 10 mg/160 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-117024 · Präparat HOS-094529

Interactions common to the combination

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Exforge

Exforge 5 mg/80 mg film-coated tablets Exforge 5 mg/160 mg film-coated tablets Exforge 10 mg/160 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-117025 · Präparat HOS-094529

No drug-drug interaction studies have been performed with Exforge and other medicinal products.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Exforge

Exforge 5 mg/80 mg film-coated tablets Exforge 5 mg/160 mg film-coated tablets Exforge 10 mg/160 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-117026 · Präparat HOS-094529

To be taken into account with concomitant use Other antihypertensive agents Commonly used antihypertensive agents (e.g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e.g. tricyclic antidepressants, alpha blockers for treatment of benign prostate hyperplasia) may increase the antihypertensive effect of the combination.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.