Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.3 · PDF-Seite 5

HOS-086159 · Präparat HOS-083284

Microsomal Lomitapide Increased plasma concentrations of lomitapide triglyceride transfer (see section 4.5). protein (MTTP) inhibitor PDE5 inhibitors Avanafil Increased plasma concentrations of avanafil (see section 4.4. and 4.5). Sildenafil Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only. Increased plasma concentrations of sildenafil. Thereby, increasing the potential for sildenafil- associated adverse events (which include hypotension and syncope). See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction. Vardenafil Increased plasma concentrations of vardenafil (see section 4.4. and 4.5). Sedatives/hypnotics Clorazepate, diazepam, Increased plasma concentrations of clorazepate, estazolam, flurazepam, diazepam, estazolam, flurazepam, oral oral midazolam and midazolam and triazolam. Thereby, increasing triazolam the risk of extreme sedation and respiratory depression from these agents. (For caution on parenterally administered midazolam, 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): estazolam (HOS-086165) lomitapide (HOS-086160) clorazepate (HOS-086164) diazepam (HOS-085904) avanafil (HOS-086161) sildenafil (HOS-086162) triazolam (HOS-086168) flurazepam (HOS-086166) midazolam (HOS-086167) vardenafil (HOS-086163)

Gegenanzeigen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 37

HOS-086390 · Präparat HOS-083284

Microsomal Lomitapide Increased plasma concentrations of lomitapide triglyceride transfer (see section 4.5). protein (MTTP) inhibitor PDE5 inhibitor Avanafil Increased plasma concentrations of avanafil (see section 4.4. and 4.5). Sildenafil Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only. Increased plasma concentrations of sildenafil. Thereby, increasing the potential for sildenafil- associated adverse events (which include hypotension and syncope). See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction. Vardenafil Increased plasma concentrations of vardenafil (see section 4.4. and 4.5). Sedatives/hypnotics Clorazepate, diazepam, Increased plasma concentrations of clorazepate, estazolam, flurazepam, diazepam, estazolam, flurazepam, oral oral midazolam and midazolam and triazolam. Thereby, increasing triazolam the risk of extreme sedation and respiratory depression from these agents. (For caution on parenterally administered midazolam, see section 4.5.). Ritonavir medicinal product level decreased Herbal Preparation St. John’s Wort Herbal preparations containing St John’s wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of ritonavir (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): estazolam (HOS-086165) lomitapide (HOS-086160) clorazepate (HOS-086164) diazepam (HOS-085904) avanafil (HOS-086161) sildenafil (HOS-086162) triazolam (HOS-086168) flurazepam (HOS-086166) midazolam (HOS-086167) vardenafil (HOS-086163)

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 21

HOS-086318 · Präparat HOS-083284

Vardenafil 5, single dose 600 q12h ↑ 49-fold ↑ 13-fold Concomitant use of vardenafil with ritonavir 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): vardenafil (HOS-086163)

Wechselwirkungen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 53

HOS-086480 · Präparat HOS-083284

When tadalafil is used concurrently with ritonavir in patients with pulmonary arterial hypertension, refer to the tadalafil SmPC. Vardenafil 5, single dose 600 q12h ↑ 49-fold ↑ 13-fold Concomitant use of vardenafil with ritonavir 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): tadalafil (HOS-086316) vardenafil (HOS-086163)

Gegenanzeigen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.3 · PDF-Seite 6

HOS-108817 · Präparat HOS-093083

HMG Co-A Reductase Lovastatin, simvastatin Increased plasma concentrations of Inhibitors lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5). Microsomal Lomitapide Increased plasma concentrations of triglyceride transfer lomitapide (see section 4.5). protein (MTTP) inhibitor Phosphodiesterase Avanafil Increased plasma concentrations of (PDE5) inhibitors avanafil (see sections 4.4 and 4.5). Sildenafil Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only. Increased plasma concentrations of sildenafil. Thereby, increasing the potential for sildenafil-associated adverse events (which include hypotension and syncope). See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction. Vardenafil Increased plasma concentrations of vardenafil (see sections 4.4 and 4.5) Sedatives/hypnotics Oral midazolam, triazolam Increased plasma concentrations of oral midazolam and triazolam. Thereby, increasing the risk of extreme sedation and respiratory depression from these agents. For caution on parenterally administered midazolam, see section 4.5. Lopinavir/ritonavir medicinal product level decreased Herbal products St. John’s wort Herbal preparations containing St John’s wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of lopinavir and ritonavir (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): lovastatin (HOS-086157) lomitapide (HOS-086160) simvastatin (HOS-086158) avanafil (HOS-086161) sildenafil (HOS-086162) triazolam (HOS-086168) midazolam (HOS-086167) vardenafil (HOS-086163)

Gegenanzeigen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 43

HOS-108989 · Präparat HOS-093083

HMG Co-A Lovastatin, simvastatin Increased plasma concentrations of Reductase Inhibitors lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5). Microsomal Lomitapide Increased plasma concentrations of triglyceride transfer lomitapide (see section 4.5). protein (MTTP) inhibitor Phosphodiesterase Avanafil Increased plasma concentrations of (PDE5) inhibitors avanafil (see sections 4.4 and 4.5) Sildenafil Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only. Increased plasma concentrations of sildenafil. Thereby, increasing the potential for sildenafil-associated adverse events (which include hypotension and syncope). See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction. Vardenafil Increased plasma concentrations of vardenafil (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): lovastatin (HOS-086157) lomitapide (HOS-086160) simvastatin (HOS-086158) avanafil (HOS-086161) sildenafil (HOS-086162) vardenafil (HOS-086163)

Gegenanzeigen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 78–79

HOS-109064 · Präparat HOS-093083

78  Phosphodiesterase Avanafil Increased plasma concentrations of (PDE5) inhibitors avanafil (see sections 4.4 and 4.5) Sildenafil Contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) only. Increased plasma concentrations of sildenafil. Thereby, increasing the potential for sildenafil-associated adverse events (which include hypotension and syncope). See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction. Vardenafil Increased plasma concentrations of vardenafil (see sections 4.4 and 4.5) Sedatives/hypnotics Oral midazolam, triazolam Increased plasma concentrations of oral midazolam and triazolam. Thereby, increasing the risk of extreme sedation and respiratory depression from these agents. For caution on parenterally administered midazolam, see section 4.5. Lopinavir/ritonavir medicinal product level decreased Herbal products St. John’s wort Herbal preparations containing St John’s wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of lopinavir and ritonavir (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): avanafil (HOS-086161) sildenafil (HOS-086162) triazolam (HOS-086168) midazolam (HOS-086167) vardenafil (HOS-086163)

Wechselwirkungen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.5 · PDF-Seite 23

HOS-108921 · Präparat HOS-093083

Vardenafil Vardenafil: The use of vardenafil with Kaletra AUC: ↑ 49-fold is contraindicated (see section 4.3). Due to CYP3A inhibition by lopinavir/ritonavir. Ergot alkaloids Dihydroergotamine, Serum concentrations may be Concomitant administration of ergonovine, ergotamine, increased due to CYP3A Kaletra and ergot alkaloids are methylergonovine inhibition by lopinavir/ritonavir. contraindicated as it may lead to acute ergot toxicity, including vasospasm and ischaemia (see section 4.3). GI motility agent Cisapride Serum concentrations may be Concomitant administration of increased due to CYP3A Kaletra and cisapride is inhibition by lopinavir/ritonavir. contraindicated as it may increase the risk of serious arrhythmias from this agent (see section 4.3). HCV direct acting antivirals Elbasvir/grazoprevir Elbasvir: Concomitant administration of (50/200 mg QD) AUC: ↑ 2.71-fold elbasvir/grazoprevir with Kaletra Cmax: ↑ 1.87-fold is contraindicated (see section C24: ↑ 3.58-fold 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): elbasvir (HOS-108814) methylergonovine (HOS-086155) cisapride (HOS-085610) ergot alkaloids (HOS-108807) lead (HOS-085592) grazoprevir (HOS-108815) ergotamine (HOS-086154) ergonovine (HOS-086153) dihydroergotamine (HOS-086152) vardenafil (HOS-086163)

Wechselwirkungen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 57–58

HOS-109017 · Präparat HOS-093083

57 Inhaled, injectable or Fluticasone propionate, 50 g Greater effects may be expected intranasal fluticasone intranasal 4 times daily: when fluticasone propionate is propionate, budesonide, Plasma concentrations ↑ inhaled. Systemic corticosteroid triamcinolone Cortisol levels ↓ 86% effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide and triamcinolone. Consequently, concomitant administration of Kaletra and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4). A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g. beclomethasone). Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may have to be performed over a longer period. Phosphodiesterase(PDE5) inhibitors Avanafil Avanafil: The use of avanafil with Kaletra is (ritonavir 600 mg BID) AUC: ↑ 13-fold contraindicated (see section 4.3). Due to CYP3A inhibition by lopinavir/ritonavir. Tadalafil Tadalafil: For the treatment of pulmonary AUC: ↑ 2-fold arterial hypertension: Due to CYP3A4 inhibition by Co-administration of Kaletra with lopinavir/ritonavir. sildenafil is contraindicated (see Sildenafil Sildenafil: section 4.3). Co-administration of AUC: ↑ 11-fold Kaletra with tadalafil is not Due to CYP3A inhibition by recommended. lopinavir/ritonavir. For erectile dysfunction: Particular caution must be used when prescribing sildenafil or tadalafil in patients receiving Kaletra with increased monitoring for adverse events including hypotension, syncope, visual changes and prolonged erection (see section 4.4). When co-administered with Kaletra, sildenafil doses must not exceed 25 mg in 48 hours and tadalafil doses must not exceed 10 mg every 72 hours. Vardenafil Vardenafil: The use of vardenafil with Kaletra is AUC: ↑ 49-fold contraindicated (see section 4.3). Due to CYP3A inhibition by 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): triamcinolone (HOS-086333) tadalafil (HOS-086316) fluticasone (HOS-108914) fluticasone propionate (HOS-086331) avanafil (HOS-086161) budesonide (HOS-086332) propionate (HOS-108915) sildenafil (HOS-086162) beclomethasone (HOS-086334) vardenafil (HOS-086163)

Wechselwirkungen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 94

HOS-109096 · Präparat HOS-093083

Vardenafil Vardenafil: The use of vardenafil with Kaletra AUC: ↑ 49-fold is contraindicated (see section 4.3). Due to CYP3A inhibition by lopinavir/ritonavir. Ergot alkaloids Dihydroergotamine, Serum concentrations may be Concomitant administration of ergonovine, ergotamine, increased due to CYP3A Kaletra and ergot alkaloids are methylergonovine inhibition by lopinavir/ritonavir. contraindicated as it may lead to acute ergot toxicity, including vasospasm and ischaemia (see section 4.3). GI motility agent Cisapride Serum concentrations may be Concomitant administration of increased due to CYP3A Kaletra and cisapride is inhibition by lopinavir/ritonavir. contraindicated as it may increase the risk of serious arrhythmias from this agent (see section 4.3). HCV direct acting antivirals Elbasvir/grazoprevir Concomitant administration of (50/200 mg QD) Elbasvir: elbasvir/grazoprevir with Kaletra is AUC: ↑ 2.71-fold contraindicated (see section 4.3). Cmax: ↑ 1.87-fold C24: ↑ 3.58-fold

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) methylergonovine (HOS-086155) cisapride (HOS-085610) ergot alkaloids (HOS-108807) lead (HOS-085592) grazoprevir (HOS-108815) ergotamine (HOS-086154) ergonovine (HOS-086153) dihydroergotamine (HOS-086152) vardenafil (HOS-086163)

Gegenanzeigen · Levitra

Levitra 5 mg film-coated tablets Levitra10 mg film-coated tablets Levitra 20 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-111576 · Präparat HOS-093557

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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

Gegenanzeigen · Levitra

Levitra 5 mg film-coated tablets Levitra10 mg film-coated tablets Levitra 20 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-111577 · Präparat HOS-093557

The co-administration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated (see sections 4.5 and 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): nitric oxide (HOS-088773) amyl nitrite (HOS-088775)

Gegenanzeigen · Levitra

Levitra 5 mg film-coated tablets Levitra10 mg film-coated tablets Levitra 20 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-111579 · Präparat HOS-093557

Levitra is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous phosphodiesterase 5 (PDE5) inhibitor exposure (see section 4.4).

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

Gegenanzeigen · Levitra

Levitra 5 mg film-coated tablets Levitra10 mg film-coated tablets Levitra 20 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-111580 · Präparat HOS-093557

Medicinal products for the treatment of erectile dysfunction should generally not be used in men for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure [New York Heart Association III or IV]).

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

Gegenanzeigen · Levitra

Levitra 5 mg film-coated tablets Levitra10 mg film-coated tablets Levitra 20 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-111581 · Präparat HOS-093557

The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: - severe hepatic impairment (Child-Pugh C), - end stage renal disease requiring dialysis, - hypotension (blood pressure <90/50 mmHg), - recent history of stroke or myocardial infarction (within the last 6 months), - unstable angina and known hereditary retinal degenerative disorders such as retinitis pigmentosa.

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

Gegenanzeigen · Levitra

Levitra 5 mg film-coated tablets Levitra10 mg film-coated tablets Levitra 20 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-111582 · Präparat HOS-093557

Concomitant use of vardenafil with the potent CYP3A4 inhibitors ketoconazole and itraconazole (oral form) is contraindicated in men older than 75 years.

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): ketoconazole (HOS-084513) itraconazole (HOS-084516)

Gegenanzeigen · Levitra

Levitra 5 mg film-coated tablets Levitra10 mg film-coated tablets Levitra 20 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-111583 · Präparat HOS-093557

Concomitant use of vardenafil with HIV protease inhibitors such as ritonavir and indinavir is contraindicated, as they are very potent inhibitors of CYP3A4 (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): indinavir (HOS-084518) protease (HOS-085623) ritonavir (HOS-084521)

Gegenanzeigen · Levitra

Levitra 5 mg film-coated tablets Levitra10 mg film-coated tablets Levitra 20 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-111584 · Präparat HOS-093557

The co-administration of PDE5 inhibitors, including vardenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (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): riociguat (HOS-086293) lead (HOS-085592)

Gegenanzeigen · Levitra

Levitra 10 mg orodispersible tablets · Abschnitt 4.3 · PDF-Seite 18

HOS-111621 · Präparat HOS-093557

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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

Gegenanzeigen · Levitra

Levitra 10 mg orodispersible tablets · Abschnitt 4.3 · PDF-Seite 18

HOS-111622 · Präparat HOS-093557

The co-administration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated (see sections 4.5 and 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): nitric oxide (HOS-088773) amyl nitrite (HOS-088775)