Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.3 · PDF-Seite 4

HOS-086138 · Präparat HOS-083284

Concomitant medicinal product levels increased or decreased 1-Adrenoreceptor Alfuzosin Increased plasma concentrations of alfuzosin Antagonist which may lead to severe hypotension (see section 4.5). Analgesics Pethidine, Increased plasma concentrations of propoxyphene norpethidine and propoxyphene. Thereby, increasing the risk of serious respiratory depression or haematologic abnormalities, or other serious adverse effects from these agents. Antianginal Ranolazine Increased plasma concentrations of ranolazine which may increase the potential for serious and/or life-threatening reactions (see section 4.5). Anticancer Neratinib Increased plasma concentrations of neratinib which may increase the potential for serious and/or life-threatening reactions including hepatotoxicity (see section 4.5). Venetoclax Increased plasma concentrations of venetoclax. Increased risk of tumor lysis syndrome at the dose initiation and during the dose-titration phase (see section 4.5). Antiarrhythmics Amiodarone, bepridil, Increased plasma concentrations of amiodarone, dronedarone, bepridil, dronedarone, encainide, flecanide, encainide, flecanide, propafenone, quinidine. Thereby, increasing the propafenone, quinidine risk of arrhythmias or other serious adverse reactions from these agents. Antibiotic Fusidic Acid Increased plasma concentrations of fusidic acid and ritonavir. Anti-gout Colchicine Potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment (see sections 4.4 and 4.5). Antihistamines Astemizole, Increased plasma concentrations of astemizole terfenadine and terfenadine. Thereby, increasing the risk of serious arrhythmias from these agents. Antipsychotics/ Lurasidone Increased plasma concentrations of lurasidone Neuroleptics which may increase the potential for serious and/or life-threatening reactions (see section 4.5). Clozapine, pimozide Increased plasma concentrations of clozapine and pimozide. Thereby, increasing the risk of serious haematologic abnormalities, or other serious adverse effects from these agents. Quetiapine Increased plasma concentrations of quetiapine which may lead to coma. The concomitant administration with quetiapine is contraindicated (see section 4.5).

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): propoxyphene (HOS-086140) quetiapine (HOS-086150) encainide (HOS-086145) alfuzosin (HOS-086139) propafenone (HOS-084530) dronedarone (HOS-086144) fusidic acid (HOS-086146) bepridil (HOS-085612) quinidine (HOS-085593) neratinib (HOS-086142) venetoclax (HOS-086143) lead (HOS-085592) pimozide (HOS-085600) colchicine (HOS-086147) astemizole (HOS-085608) clozapine (HOS-086149) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ranolazine (HOS-086141)

Gegenanzeigen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 35–36

HOS-086388 · Präparat HOS-083284

35 Analgesics Pethidine, Increased plasma concentrations of propoxyphene norpethidine and propoxyphene. Thereby, increasing the risk of serious respiratory depression or haematologic abnormalities, or other serious adverse effects from these agents. Antianginal Ranolazine Increased plasma concentrations of ranolazine which may increase the potential for serious and/or life-threatening reactions (see section 4.5). Anticancer Neratinib Increased plasma concentrations of neratinib which may increase the potential for serious and/or life-threatening reactions including hepatotoxicity (see section 4.5). Venetoclax Increased plasma concentrations of venetoclax. Increased risk of tumor lysis syndrome at the dose initiation and during the dose-titration phase (see section 4.5). Antiarrhythmics Amiodarone, bepridil, Increased plasma concentrations of amiodarone, dronedarone, bepridil, dronedarone, encainide, flecainide, encainide, flecainide, propafenone, quinidine. Thereby, increasing propafenone, quinidine the risk of arrhythmias or other serious adverse effects from these agents. Antibiotic Fusidic Acid Increased plasma concentrations of fusidic acid and ritonavir. Antihistamines Astemizole, Increased plasma concentrations of astemizole terfenadine and terfenadine. Thereby, increasing the risk of serious arrhythmias from these agents. Anti-gout Colchicine Potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment (see sections 4.4 and 4.5). Antipsychotics/ Lurasidone Increased plasma concentrations of lurasidone Neuroleptics which may increase the potential for serious and/or life-threatening reactions (see section 4.5). Clozapine, pimozide Increased plasma concentrations of clozapine and pimozide. Thereby, increasing the risk of serious haematologic abnormalities, or other serious adverse effects from these agents. Quetiapine Increased plasma concentrations of quetiapine which may lead to coma. The concomitant administration with quetiapine is contraindicated (see section 4.5). Ergot Derivatives Dihydroergotamine, Increased plasma concentrations of ergot ergonovine, derivatives leading to acute ergot toxicity, ergotamine, including vasospasm and ischaemia. methylergonovine GI motility agent Cisapride Increased plasma concentrations of cisapride. Thereby, increasing the risk of serious arrhythmias from this agent. Lipid-modifying agents

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): propoxyphene (HOS-086140) quetiapine (HOS-086150) encainide (HOS-086145) methylergonovine (HOS-086155) propafenone (HOS-084530) dronedarone (HOS-086144) cisapride (HOS-085610) fusidic acid (HOS-086146) flecainide (HOS-086203) bepridil (HOS-085612) quinidine (HOS-085593) neratinib (HOS-086142) venetoclax (HOS-086143) lead (HOS-085592) pimozide (HOS-085600) colchicine (HOS-086147) astemizole (HOS-085608) clozapine (HOS-086149) ergotamine (HOS-086154) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ranolazine (HOS-086141) ergonovine (HOS-086153) dihydroergotamine (HOS-086152)

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 13

HOS-086201 · Präparat HOS-083284

Antianginal Ranolazine Due to CYP3A inhibition by ritonavir, concentrations of ranolazine are expected to increase. The concomitant administration with ranolazine is contraindicated (see section 4.3).

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): ranolazine (HOS-086141)

Wechselwirkungen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 45

HOS-086411 · Präparat HOS-083284

Antianginal Ranolazine Due to CYP3A inhibition by ritonavir, concentrations of ranolazine are expected to increase. The concomitant administration with ranolazine is contraindicated (see section 4.3).

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): ranolazine (HOS-086141)

Gegenanzeigen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.3 · PDF-Seite 5

HOS-108791 · Präparat HOS-093083

Concomitant medicinal product levels increased Alpha1-adrenoreceptor Alfuzosin Increased plasma concentrations of antagonist alfuzosin which may lead to severe hypotension. The concomitant administration with alfuzosin is contraindicated (see section 4.5). Antianginal Ranolazine Increased plasma concentrations of ranolazine which may increase the potential for serious and/or life- threatening reactions (see section 4.5). Antiarrhythmics Amiodarone, dronedarone Increased plasma concentrations of amiodarone and dronedarone. Thereby, increasing the risk of arrhythmias or other serious adverse reactions (see section 4.5). Antibiotic Fusidic Acid Increased plasma concentrations of fusidic acid. The concomitant administration with fusidic acid is contraindicated in dermatological infections (see section 4.5). Anticancer Neratinib Increased plasma concentrations of neratinib which may increase the potential for serious and/or life-threatening reactions (see section 4.5). Venetoclax Increased plasma concentrations of venetoclax. Increased risk of tumor lysis syndrome at the dose initiation and during the ramp-up phase (see section 4.5). Anti-gout Colchicine Increased plasma concentrations of colchicine. Potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment (see sections 4.4 and 4.5). Antihistamines Astemizole, terfenadine Increased plasma concentrations of astemizole and terfenadine. Thereby, increasing the risk of serious arrhythmias from these agents (see section 4.5). Antipsychotics/ Lurasidone Increased plasma concentrations of Neuroleptics lurasidone which may increase the potential for serious and/or life- threatening reactions (see section 4.5). Pimozide Increased plasma concentrations of pimozide. Thereby, increasing the risk of serious haematologic abnormalities, or other serious adverse effects from this agent (see section 4.5).

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): alfuzosin (HOS-086139) dronedarone (HOS-086144) fusidic acid (HOS-086146) neratinib (HOS-086142) venetoclax (HOS-086143) lead (HOS-085592) pimozide (HOS-085600) colchicine (HOS-086147) astemizole (HOS-085608) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ranolazine (HOS-086141)

Gegenanzeigen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 42

HOS-108987 · Präparat HOS-093083

Concomitant medicinal product levels increased Alpha1- Alfuzosin Increased plasma concentrations of adrenoreceptor alfuzosin which may lead to severe antagonist hypotension. The concomitant administration with alfuzosin is contraindicated (see section 4.5). Antianginal Ranolazine Increased plasma concentrations of ranolazine which may increase the potential for serious and/or life- threatening reactions (see section 4.5). Antiarrhythmics Amiodarone, dronedarone Increased plasma concentrations of amiodarone and dronedarone. Thereby, increasing the risk of arrhythmias or other serious adverse reactions (see section 4.5). Antibiotic Fusidic Acid Increased plasma concentrations of fusidic acid. The concomitant administration with fusidic acid is contraindicated in dermatological infections (see section 4.5). Anticancer Neratinib Increased plasma concentrations of neratinib which may increase the potential for serious and/or life-threatening reactions (see section 4.5). Venetoclax Increased plasma concentrations of venetoclax. Increased risk of tumor lysis syndrome at the dose initiation and during the ramp-up phase (see section 4.5). Anti-gout Colchicine Increased plasma concentrations of colchicine. Potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment (see sections 4.4 and 4.5).

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): alfuzosin (HOS-086139) dronedarone (HOS-086144) fusidic acid (HOS-086146) neratinib (HOS-086142) venetoclax (HOS-086143) lead (HOS-085592) colchicine (HOS-086147) amiodarone (HOS-085596) ranolazine (HOS-086141)

Gegenanzeigen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 77

HOS-109061 · Präparat HOS-093083

Concomitant medicinal product levels increased Alpha1-adrenoreceptor Alfuzosin Increased plasma concentrations of antagonist alfuzosin which may lead to severe hypotension. The concomitant administration with alfuzosin is contraindicated (see section 4.5). Antianginal Ranolazine Increased plasma concentrations of ranolazine which may increase the potential for serious and/or life- threatening reactions (see section 4.5). Antiarrhythmics Amiodarone, dronedarone Increased plasma concentrations of amiodarone and dronedarone. Thereby, increasing the risk of arrhythmias or other serious adverse reactions (see section 4.5). Antibiotic Fusidic Acid Increased plasma concentrations of fusidic acid. The concomitant administration with fusidic acid is contraindicated in dermatological infections (see section 4.5). Anticancer Neratinib Increased plasma concentrations of neratinib which may increase the potential for serious and/or life-threatening reactions (see section 4.5).

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): alfuzosin (HOS-086139) dronedarone (HOS-086144) fusidic acid (HOS-086146) neratinib (HOS-086142) lead (HOS-085592) amiodarone (HOS-085596) ranolazine (HOS-086141)

Wechselwirkungen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.5 · PDF-Seite 12–13

HOS-108863 · Präparat HOS-093083

12  CYP3A4 inhibition by concomitantly administered with lopinavir/ritonavir. Kaletra. Antianginal Ranolazine Due to CYP3A inhibition by The concomitant administration of lopinavir/ritonavir, concentrations Kaletra and ranolazine is of ranolazine are expected to contraindicated (see section 4.3). increase. Antiarrhythmics Amiodarone, Dronedarone Amiodarone, Dronedarone: Concomitant administration of Concentrations may be increased Kaletra and amiodarone or due to CYP3A4 inhibition by dronedarone is contraindicated (see lopinavir/ritonavir. section 4.3) as the risk of arrhythmias or other serious adverse reactions may be increased. Digoxin Digoxin: Caution is warranted and Plasma concentrations may be therapeutic drug monitoring of increased due to P-glycoprotein digoxin concentrations, if inhibition by lopinavir/ritonavir. available, is recommended in case The increased digoxin level may of co-administration of Kaletra and lessen over time as P-gp digoxin. Particular caution should induction develops. be used when prescribing Kaletra in patients taking digoxin as the acute inhibitory effect of ritonavir on P-gp is expected to significantly increase digoxin levels. Initiation of digoxin in patients already taking Kaletra is likely to result in lower than expected increases of digoxin concentrations. Bepridil, Systemic Bepridil, Systemic Lidocaine, Caution is warranted and Lidocaine, and Quinidine Quinidine: therapeutic drug concentration Concentrations may be increased monitoring is recommended when when co-administered with available. lopinavir/ritonavir. Antibiotics Clarithromycin Clarithromycin: For patients with renal impairment Moderate increases in (CrCL < 30 ml/min) dose reduction clarithromycin AUC are expected of clarithromycin should be due to CYP3A inhibition by considered (see section 4.4). lopinavir/ritonavir. Caution should be exercised in administering clarithromycin with Kaletra to patients with impaired hepatic or renal function. Anticancer agents and kinase inhibitors Abemaciclib Serum concentrations may be Co-administration of abemaciclib increased due to CYP3A and Kaletra should be avoided. If inhibition by ritonavir. this co-administration is judged unavoidable, refer to the abemaciclib SmPC for dosage adjustment recommendations. Monitor for ADRs related to abemaciclib. Apalutamide Apalutamide is a moderate to Decreased exposure of Kaletra may strong CYP3A4 inducer and this result in potential loss of may lead to a decreased exposure virological response. of lopinavir/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): dronedarone (HOS-086144) abemaciclib (HOS-086209) lidocaine (HOS-108866) apalutamide (HOS-086212) bepridil (HOS-085612) quinidine (HOS-085593) digoxin (HOS-086172) lead (HOS-085592) clarithromycin (HOS-084517) amiodarone (HOS-085596) ranolazine (HOS-086141)

Wechselwirkungen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 48–49

HOS-109005 · Präparat HOS-093083

48 (Lopinavir/ritonavir resulted in a higher incidence of 400/100 mg BID) gastrointestinal adverse events and elevations in triglycerides with the or combination regimen without increases in virological efficacy, Fosamprenavir when compared with standard doses (1400 mg BID) of fosamprenavir/ritonavir. Concomitant administration of these (Lopinavir/ritonavir medicinal products is not 533/133 mg BID) recommended. Kaletra must not be administered once daily in combination with amprenavir. Tipranavir/ritonavir Lopinavir: Concomitant administration of these (500/100 mg BID) AUC: ↓ 55% medicinal products is not Cmin: ↓ 70% recommended. Cmax: ↓ 47% Acid reducing agents Omeprazole (40 mg Omeprazole: ↔ No dose adjustment necessary QD) Lopinavir: ↔ Ranitidine (150 mg Ranitidine: ↔ No dose adjustment necessary single dose) Alpha1 adrenoreceptor antagonist Alfuzosin Alfuzosin: Concomitant administration of Due to CYP3A inhibition by Kaletra and alfuzosin is contra- lopinavir/ritonavir, concentrations indicated (see section 4.3) as of alfuzosin are expected to alfuzosin-related toxicity, including increase. hypotension, may be increased. Analgesics Fentanyl Fentanyl: Careful monitoring of adverse effects Increased risk of side-effects (notably respiratory depression but (respiratory depression, sedation) also sedation) is recommended when due to higher plasma fentanyl is concomitantly concentrations because of administered with Kaletra. CYP3A4 inhibition by lopinavir/ritonavir. Antianginal Ranolazine Due to CYP3A inhibition by The concomitant administration of lopinavir/ritonavir, concentrations Kaletra and ranolazine is of ranolazine are expected to contraindicated (see section 4.3). increase.

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): alfuzosin (HOS-086139) amprenavir (HOS-086183) ranitidine (HOS-085660) fentanyl (HOS-086196) fosamprenavir (HOS-086182) ranolazine (HOS-086141) tipranavir (HOS-086184) omeprazole (HOS-085912)

Wechselwirkungen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 84–85

HOS-109080 · Präparat HOS-093083

84 Fentanyl Fentanyl: Careful monitoring of adverse Increased risk of side-effects effects (notably respiratory (respiratory depression, sedation) depression but also sedation) is due to higher plasma recommended when fentanyl is concentrations because of concomitantly administered with CYP3A4 inhibition by Kaletra. lopinavir/ritonavir. Antianginal Ranolazine Due to CYP3A inhibition by The concomitant administration of lopinavir/ritonavir, concentrations Kaletra and ranolazine is of ranolazine are expected to contraindicated (see section 4.3). increase. Antiarrhythmics Amiodarone, Amiodarone, Dronedarone: Concomitant administration of Dronedarone Concentrations may be increased Kaletra and amiodarone or due to CYP3A4 inhibition by dronedarone is contraindicated (see lopinavir/ritonavir. section 4.3) as the risk of arrhythmias or other serious adverse reactions may be increased. Digoxin Digoxin: Caution is warranted and Plasma concentrations may be therapeutic drug monitoring of increased due to P-glycoprotein digoxin concentrations, if available, inhibition by lopinavir/ritonavir. is recommended in case of The increased digoxin level may co-administration of Kaletra and lessen over time as P-gp digoxin. Particular caution should induction develops. be used when prescribing Kaletra in patients taking digoxin as the acute inhibitory effect of ritonavir on P-gp is expected to significantly increase digoxin levels. Initiation of digoxin in patients already taking Kaletra is likely to result in lower than expected increases of digoxin concentrations. Bepridil, Systemic Bepridil, Systemic Lidocaine, Caution is warranted and Lidocaine, and Quinidine: therapeutic drug concentration Quinidine Concentrations may be increased monitoring is recommended when when co-administered with available. lopinavir/ritonavir. Antibiotics Clarithromycin Clarithromycin: For patients with renal impairment Moderate increases in (CrCL < 30 ml/min) dose reduction clarithromycin AUC are expected of clarithromycin should be due to CYP3A inhibition by considered (see section 4.4). lopinavir/ritonavir. Caution should be exercised in administering clarithromycin with Kaletra to patients with impaired hepatic or renal function. Anticancer agents and kinase inhibitors Abemaciclib Serum concentrations may be Co-administration of abemaciclib increased due to CYP3A and Kaletra should be avoided. If inhibition by ritonavir. this co-administration is judged unavoidable, refer to the abemaciclib SmPC for dosage adjustment recommendations. Monitor for ADRs related to abemaciclib.

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): dronedarone (HOS-086144) abemaciclib (HOS-086209) lidocaine (HOS-108866) bepridil (HOS-085612) quinidine (HOS-085593) digoxin (HOS-086172) clarithromycin (HOS-084517) fentanyl (HOS-086196) amiodarone (HOS-085596) ranolazine (HOS-086141)

Gegenanzeigen · Prezista

PREZISTA 100 mg/ml oral suspension · Abschnitt 4.3 · PDF-Seite 6

HOS-116288 · Präparat HOS-094447

Darunavir boosted with either ritonavir or cobicistat inhibits the elimination of active substances that are highly dependent on CYP3A for clearance, which results in increased exposure to the co-administered medicinal product. Therefore, concomitant treatment with such medicinal products for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (applies to darunavir boosted with either ritonavir or cobicistat). These active substances include e.g.: - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine - astemizole, terfenadine - colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - elbasvir/grazoprevir - cisapride - dapoxetine - domperidone - naloxegol - lurasidone, pimozide, quetiapine, sertindole (see section 4.5) - triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5) - sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil - simvastatin, lovastatin, lomitapide (see section 4.5) - ticagrelor (see section 4.5).

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): sertindole (HOS-085601) ticagrelor (HOS-112065) quetiapine (HOS-086150) elbasvir (HOS-108814) alfuzosin (HOS-086139) methylergonovine (HOS-086155) dronedarone (HOS-086144) cisapride (HOS-085610) lovastatin (HOS-086157) lomitapide (HOS-086160) cobicistat (HOS-088111) bepridil (HOS-085612) simvastatin (HOS-086158) quinidine (HOS-085593) domperidone (HOS-114656) avanafil (HOS-086161) naloxegol (HOS-109428) grazoprevir (HOS-108815) ivabradine (HOS-109426) pimozide (HOS-085600) colchicine (HOS-086147) astemizole (HOS-085608) sildenafil (HOS-086162) ergotamine (HOS-086154) ritonavir (HOS-084521) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ranolazine (HOS-086141) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167)

Gegenanzeigen · Prezista

PREZISTA 75 mg film-coated tablets PREZISTA 150 mg film-coated tablets PREZISTA 600 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 49

HOS-116497 · Präparat HOS-094447

Co-administration of PREZISTA with low dose ritonavir, with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These active substances include e.g.: - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine - astemizole, terfenadine - colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - elbasvir/grazoprevir - cisapride - dapoxetine - domperidone - naloxegol - lurasidone, pimozide, quetiapine, sertindole (see section 4.5) - triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5) - sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil - simvastatin, lovastatin and lomitapide (see section 4.5) - ticagrelor (see section 4.5).

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): sertindole (HOS-085601) ticagrelor (HOS-112065) quetiapine (HOS-086150) elbasvir (HOS-108814) alfuzosin (HOS-086139) methylergonovine (HOS-086155) dronedarone (HOS-086144) cisapride (HOS-085610) lovastatin (HOS-086157) lomitapide (HOS-086160) bepridil (HOS-085612) simvastatin (HOS-086158) quinidine (HOS-085593) domperidone (HOS-114656) avanafil (HOS-086161) naloxegol (HOS-109428) grazoprevir (HOS-108815) ivabradine (HOS-109426) pimozide (HOS-085600) colchicine (HOS-086147) astemizole (HOS-085608) sildenafil (HOS-086162) ergotamine (HOS-086154) ritonavir (HOS-084521) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ranolazine (HOS-086141) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167)

Gegenanzeigen · Prezista

PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 87

HOS-116580 · Präparat HOS-094447

Darunavir boosted with either ritonavir or cobicistat inhibits the elimination of active substances that are highly dependent on CYP3A for clearance, which results in increased exposure to the co-administered medicinal product. Therefore, concomitant treatment with such medicinal products for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (applies to darunavir boosted with either ritonavir or cobicistat). These active substances include e.g.: - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine - astemizole, terfenadine - colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - elbasvir/grazoprevir - cisapride

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): elbasvir (HOS-108814) alfuzosin (HOS-086139) methylergonovine (HOS-086155) dronedarone (HOS-086144) cisapride (HOS-085610) cobicistat (HOS-088111) bepridil (HOS-085612) quinidine (HOS-085593) grazoprevir (HOS-108815) ivabradine (HOS-109426) colchicine (HOS-086147) astemizole (HOS-085608) ergotamine (HOS-086154) ritonavir (HOS-084521) amiodarone (HOS-085596) terfenadine (HOS-085607) ranolazine (HOS-086141) dihydroergotamine (HOS-086152)

Wechselwirkungen · Prezista

PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 15

HOS-116362 · Präparat HOS-094447

Amiodarone Co-administration of boosted Bepridil PREZISTA and amiodarone, Dronedarone bepridil, dronedarone, ivabradine, Ivabradine quinidine, or ranolazine is Quinidine contraindicated (see section 4.3). Ranolazine Digoxin digoxin AUC ↑ 61% Given that digoxin has a narrow 0.4 mg single dose digoxin Cmin ND therapeutic index, it is digoxin Cmax ↑ 29% recommended that the lowest (↑ digoxin from probable inhibition of possible dose of digoxin should P-gp) initially be prescribed in case digoxin is given to patients on boosted PREZISTA therapy. The digoxin dose should be carefully titrated to obtain the desired clinical effect while assessing the overall clinical state of the subject.

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): dronedarone (HOS-086144) bepridil (HOS-085612) quinidine (HOS-085593) digoxin (HOS-086172) ivabradine (HOS-109426) amiodarone (HOS-085596) ranolazine (HOS-086141)

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 57

HOS-116517 · Präparat HOS-094447

Amiodarone PREZISTA co-administered with Bepridil low dose ritonavir and Dronedarone amiodarone, bepridil, dronedarone, Ivabradine ivabradine, quinidine, or Quinidine ranolazine is contraindicated (see Ranolazine section 4.3). Digoxin digoxin AUC ↑ 61% Given that digoxin has a narrow 0.4 mg single dose digoxin Cmin ND therapeutic index, it is digoxin Cmax ↑ 29% recommended that the lowest (↑ digoxin from probable inhibition of possible dose of digoxin should P-gp) initially be prescribed in case digoxin is given to patients on darunavir/ritonavir therapy. The digoxin dose should be carefully titrated to obtain the desired clinical effect while assessing the overall clinical state of the subject. ANTIBIOTIC Clarithromycin clarithromycin AUC ↑ 57% Caution should be exercised when 500 mg twice daily clarithromycin Cmin ↑ 174% clarithromycin is combined with clarithromycin Cmax ↑ 26% PREZISTA co-administered with # darunavir AUC ↓ 13% low dose ritonavir. # darunavir Cmin ↑ 1% # For patients with renal impairment darunavir Cmax ↓ 17% the Summary of Product 14-OH-clarithromycin concentrations Characteristics for clarithromycin were not detectable when combined with should be consulted for the PREZISTA/ritonavir. recommended dose. (↑ clarithromycin from CYP3A inhibition and possible P-gp inhibition) ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR Apixaban Not studied. Co-administration of The use of boosted PREZISTA Rivaroxaban boosted PREZISTA with these with a direct oral anticoagulant anticoagulants may increase (DOAC) that is metabolised by concentrations of the anticoagulant. CYP3A4 and transported by P-gp (CYP3A and/or P-gp inhibition) is not recommended as this may lead to an increased bleeding risk.

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): dronedarone (HOS-086144) bepridil (HOS-085612) quinidine (HOS-085593) digoxin (HOS-086172) rivaroxaban (HOS-086236) lead (HOS-085592) clarithromycin (HOS-084517) apixaban (HOS-112091) ivabradine (HOS-109426) ritonavir (HOS-084521) amiodarone (HOS-085596) ranolazine (HOS-086141)

Wechselwirkungen · Prezista

PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 97

HOS-116608 · Präparat HOS-094447

Amiodarone Co-administration of boosted Bepridil PREZISTA and amiodarone, Dronedarone bepridil, dronedarone, ivabradine, Ivabradine quinidine, or ranolazine is Quinidine contraindicated (see section 4.3). Ranolazine Digoxin digoxin AUC ↑ 61% Given that digoxin has a narrow 0.4 mg single dose digoxin Cmin ND therapeutic index, it is digoxin Cmax ↑ 29% recommended that the lowest (↑ digoxin from probable inhibition of possible dose of digoxin should P-gp) initially be prescribed in case digoxin is given to patients on boosted PREZISTA therapy. The digoxin dose should be carefully titrated to obtain the desired clinical effect while assessing the overall clinical state of the subject. ANTIBIOTIC Clarithromycin clarithromycin AUC ↑ 57% Caution should be exercised when 500 mg twice daily clarithromycin Cmin ↑ 174% clarithromycin is combined with clarithromycin Cmax ↑ 26% boosted PREZISTA. # darunavir AUC ↓ 13% # darunavir Cmin ↑ 1% For patients with renal impairment # the Summary of Product darunavir Cmax ↓ 17% Characteristics for clarithromycin 14-OH-clarithromycin concentrations should be consulted for the were not detectable when combined with recommended dose. PREZISTA/ritonavir. (↑ clarithromycin from CYP3A inhibition and possible P-gp inhibition) ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR Apixaban Not studied. Co-administration of The use of boosted PREZISTA Rivaroxaban boosted PREZISTA with these with a direct oral anticoagulant anticoagulants may increase (DOAC) that is metabolised by concentrations of the anticoagulant. CYP3A4 and transported by P-gp (CYP3A and/or P-gp inhibition) is not recommended as this may lead to an increased bleeding risk.

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): dronedarone (HOS-086144) bepridil (HOS-085612) quinidine (HOS-085593) digoxin (HOS-086172) rivaroxaban (HOS-086236) lead (HOS-085592) clarithromycin (HOS-084517) apixaban (HOS-112091) ivabradine (HOS-109426) ritonavir (HOS-084521) amiodarone (HOS-085596) ranolazine (HOS-086141)

Gegenanzeigen · Ranexa (previously Latixa)

Ranexa 375 mg prolonged-release tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-118245 · Präparat HOS-094791

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.2 and 5.2). Moderate or severe hepatic impairment (see sections 4.2 and 5.2). Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) (see sections 4.2 and 4.5). Concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone.

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): nefazodone (HOS-084519) sotalol (HOS-085597) protease (HOS-085623) ketoconazole (HOS-084513) dofetilide (HOS-085598) quinidine (HOS-085593) creatinine (HOS-086273) voriconazole (HOS-084524) telithromycin (HOS-084523) itraconazole (HOS-084516) clarithromycin (HOS-084517) amiodarone (HOS-085596) posaconazole (HOS-085622)

Gegenanzeigen · Ranexa (previously Latixa)

Ranexa 500 mg prolonged-release tablets · Abschnitt 4.3 · PDF-Seite 15

HOS-118293 · Präparat HOS-094791

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.2 and 5.2). Moderate or severe hepatic impairment (see sections 4.2 and 5.2). Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) (see sections 4.2 and 4.5). Concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone.

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): nefazodone (HOS-084519) sotalol (HOS-085597) protease (HOS-085623) ketoconazole (HOS-084513) dofetilide (HOS-085598) quinidine (HOS-085593) creatinine (HOS-086273) voriconazole (HOS-084524) telithromycin (HOS-084523) itraconazole (HOS-084516) clarithromycin (HOS-084517) amiodarone (HOS-085596) posaconazole (HOS-085622)

Gegenanzeigen · Ranexa (previously Latixa)

Ranexa 750 mg prolonged-release tablets · Abschnitt 4.3 · PDF-Seite 27

HOS-118335 · Präparat HOS-094791

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.2 and 5.2). Moderate or severe hepatic impairment (see sections 4.2 and 5.2). Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) (see sections 4.2 and 4.5). Concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone.

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): nefazodone (HOS-084519) sotalol (HOS-085597) protease (HOS-085623) ketoconazole (HOS-084513) dofetilide (HOS-085598) quinidine (HOS-085593) creatinine (HOS-086273) voriconazole (HOS-084524) telithromycin (HOS-084523) itraconazole (HOS-084516) clarithromycin (HOS-084517) amiodarone (HOS-085596) posaconazole (HOS-085622)

Wechselwirkungen · Ranexa (previously Latixa)

Ranexa 375 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 4

HOS-118247 · Präparat HOS-094791

Effects of other medicinal products on ranolazine

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