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-086313 · Präparat HOS-083284

Phosphodiesterase (PDE5) inhibitors Avanafil 50, single dose 600 q12h ↑ 13-fold ↑ 2.4-fold Concomitant use of avanafil 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): avanafil (HOS-086161)

Wechselwirkungen · Norvir

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

HOS-086477 · Präparat HOS-083284

Phosphodiesterase (PDE5) inhibitors Avanafil 50, single dose 600 q12h ↑ 13-fold ↑ 2.4-fold Concomitant use of avanafil 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): avanafil (HOS-086161)

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 21–22

HOS-108912 · Präparat HOS-093083

21 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.

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) fluticasone (HOS-108914) fluticasone propionate (HOS-086331) avanafil (HOS-086161) budesonide (HOS-086332) propionate (HOS-108915) beclomethasone (HOS-086334)

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 92–93

HOS-109093 · Präparat HOS-093083

92 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.

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) fluticasone (HOS-108914) fluticasone propionate (HOS-086331) avanafil (HOS-086161) budesonide (HOS-086332) propionate (HOS-108915) beclomethasone (HOS-086334)

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 87–88

HOS-116581 · Präparat HOS-094447

87 - 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) lovastatin (HOS-086157) lomitapide (HOS-086160) simvastatin (HOS-086158) domperidone (HOS-114656) avanafil (HOS-086161) naloxegol (HOS-109428) pimozide (HOS-085600) sildenafil (HOS-086162) lurasidone (HOS-086148) triazolam (HOS-086168) midazolam (HOS-086167)

Wechselwirkungen · Prezista

PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 22–23

HOS-116419 · Präparat HOS-094447

22  Fentanyl Based on theoretical considerations Clinical monitoring is Oxycodone boosted PREZISTA may increase plasma recommended when Tramadol concentrations of these analgesics. co-administering boosted (CYP2D6 and/or CYP3A inhibition) PREZISTA with these analgesics. OESTROGEN-BASED CONTRACEPTIVES Drospirenone drospirenone AUC ↑ 58%€ When PREZISTA is Ethinylestradiol drospirenone Cmin ND€ co-administered with a (3 mg/0.02 mg once drospirenone Cmax ↑ 15%€ drospirenone-containing product, daily) ethinylestradiol AUC  30%€ clinical monitoring is recommended due to the potential ethinylestradiol Cmin ND€ for hyperkalaemia. ethinylestradiol Cmax  14%€ € with darunavir/cobicistat Alternative or additional contraceptive measures are Ethinylestradiol ethinylestradiol AUC ↓ 44%β recommended when Norethindrone ethinylestradiol Cmin ↓ 62%β oestrogen-based contraceptives are 35 g/1 mg once daily ethinylestradiol Cmax ↓ 32%β co-administered with boosted norethindrone AUC ↓ 14%β PREZISTA. Patients using norethindrone Cmin ↓ 30%β oestrogens as hormone norethindrone Cmax ↔β replacement therapy should be β with darunavir/ritonavir clinically monitored for signs of oestrogen deficiency. OPIOID ANTAGONIST Naloxegol Not studied. Co-administration of boosted PREZISTA and naloxegol is contraindicated. PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of In an interaction study #, a comparable The combination of avanafil and erectile dysfunction systemic exposure to sildenafil was boosted PREZISTA is Avanafil observed for a single intake of 100 mg contraindicated (see section 4.3). Sildenafil sildenafil alone and a single intake of Concomitant use of other PDE-5 Tadalafil 25 mg sildenafil co-administered with inhibitors for the treatment of Vardenafil PREZISTA and low dose ritonavir. erectile dysfunction with boosted PREZISTA should be done with caution. If concomitant use of boosted PREZISTA with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.

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) oxycodone (HOS-109487) cobicistat (HOS-088111) avanafil (HOS-086161) drospirenone (HOS-116422) naloxegol (HOS-109428) norethindrone (HOS-088136) sildenafil (HOS-086162) fentanyl (HOS-086196) ritonavir (HOS-084521) vardenafil (HOS-086163) tramadol (HOS-112871)

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 65

HOS-116531 · Präparat HOS-094447

Ethinylestradiol ethinylestradiol AUC ↓ 44%β Alternative or additional Norethindrone ethinylestradiol Cmin ↓ 62%β contraceptive measures are 35 g/1 mg once daily ethinylestradiol Cmax ↓ 32%β recommended when norethindrone AUC ↓ 14%β oestrogen-based contraceptives are co-administered with PREZISTA norethindrone Cmin ↓ 30%β and low dose ritonavir. norethindrone Cmax ↔β β with darunavir/ritonavir Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency. OPIOID ANTAGONIST Naloxegol Not studied. Co-administration of boosted PREZISTA and naloxegol is contraindicated. PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of In an interaction study #, a comparable The combination of avanafil and erectile dysfunction systemic exposure to sildenafil was PREZISTA with low dose Avanafil observed for a single intake of 100 mg ritonavir is contraindicated (see Sildenafil sildenafil alone and a single intake of section 4.3). Concomitant use of Tadalafil 25 mg sildenafil co-administered with other PDE-5 inhibitors for the Vardenafil PREZISTA and low dose ritonavir. treatment of erectile dysfunction with PREZISTA co-administered with low dose ritonavir should be done with caution. If concomitant use of PREZISTA co-administered with low dose ritonavir with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.

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) avanafil (HOS-086161) naloxegol (HOS-109428) norethindrone (HOS-088136) sildenafil (HOS-086162) ritonavir (HOS-084521) vardenafil (HOS-086163)

Wechselwirkungen · Prezista

PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 104–105

HOS-116620 · Präparat HOS-094447

104  Fentanyl Based on theoretical considerations Clinical monitoring is Oxycodone boosted PREZISTA may increase plasma recommended when Tramadol concentrations of these analgesics. co-administering boosted (CYP2D6 and/or CYP3A inhibition) PREZISTA with these analgesics. OESTROGEN-BASED CONTRACEPTIVES Drospirenone drospirenone AUC ↑ 58%€ When PREZISTA is co- Ethinylestradiol drospirenone Cmin ND€ administered with a drospirenone- (3 mg/0.02 mg once drospirenone Cmax ↑ 15%€ containing product, clinical daily) ethinylestradiol AUC  30%€ monitoring is recommended due to the potential for hyperkalaemia. ethinylestradiol Cmin ND€ ethinylestradiol Cmax  14%€ Alternative or additional € with darunavir/cobicistat contraceptive measures are recommended when Ethinylestradiol ethinylestradiol AUC ↓ 44%β oestrogen-based contraceptives are Norethindrone ethinylestradiol Cmin ↓ 62%β co-administered with boosted 35 g/1 mg once daily ethinylestradiol Cmax ↓ 32%β PREZISTA. Patients using norethindrone AUC ↓ 14%β oestrogens as hormone norethindrone Cmin ↓ 30%β replacement therapy should be norethindrone Cmax ↔β clinically monitored for signs of β with darunavir/ritonavir oestrogen deficiency. OPIOID ANTAGONIST Naloxegol Not studied. Co-administration of boosted PREZISTA and naloxegol is contraindicated. PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of In an interaction study #, a comparable The combination of avanafil and erectile dysfunction systemic exposure to sildenafil was boosted PREZISTA is Avanafil observed for a single intake of 100 mg contraindicated (see section 4.3). Sildenafil sildenafil alone and a single intake of Concomitant use of other PDE-5 Tadalafil 25 mg sildenafil co-administered with inhibitors for the treatment of Vardenafil PREZISTA and low dose ritonavir. erectile dysfunction with boosted PREZISTA should be done with caution. If concomitant use of boosted PREZISTA with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended. For the treatment of Not studied. Concomitant use of A safe and effective dose of pulmonary arterial sildenafil or tadalafil for the treatment of sildenafil for the treatment of hypertension pulmonary arterial hypertension and pulmonary arterial hypertension Sildenafil boosted PREZISTA may increase plasma co-administered with boosted Tadalafil concentrations of sildenafil or tadalafil. PREZISTA has not been (CYP3A inhibition) established. There is an increased potential for sildenafil-associated adverse events (including visual disturbances, hypotension, prolonged erection and syncope). Therefore, co-administration of boosted PREZISTA and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3). Co-administration of tadalafil for the treatment of pulmonary arterial hypertension with boosted PREZISTA is not recommended.

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) oxycodone (HOS-109487) cobicistat (HOS-088111) avanafil (HOS-086161) drospirenone (HOS-116422) naloxegol (HOS-109428) norethindrone (HOS-088136) sildenafil (HOS-086162) fentanyl (HOS-086196) ritonavir (HOS-084521) vardenafil (HOS-086163) tramadol (HOS-112871)

Gegenanzeigen · Spedra

Spedra 50 mg tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-127403 · Präparat HOS-096405

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 · Spedra

Spedra 50 mg tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-127404 · Präparat HOS-096405

Patients who are using any form of organic nitrate or nitric oxide donors (such as amyl nitrite) (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): nitric oxide (HOS-088773) amyl nitrite (HOS-088775)

Gegenanzeigen · Spedra

Spedra 50 mg tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-127405 · Präparat HOS-096405

The co-administration of type 5 phosphodiesterase (PDE5) inhibitors, including avanafil, 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 · Spedra

Spedra 50 mg tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-127406 · Präparat HOS-096405

Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease before prescribing Spedra.

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