Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Atazanavir Viatris (previously Atazanavir Mylan)

Atazanavir Viatris 150 mg hard capsules Atazanavir Viatris 200 mg hard capsules Atazanavir Viatris 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 26

HOS-223219 · Präparat HOS-217134

Lomitapide Lomitapide is highly dependent on CYP3A4 Co-administration of for metabolism and co-administration with lomitapide and atazanavir with ritonavir may result in atazanavir with ritonavir increased concentrations. is contraindicated due to a potential risk of markedly increased transaminase levels and hepatotoxicity (see section 4.3). INHALED BETA AGONISTS Salmeterol Co-administration with atazanavir may result Co-administration of in increased concentrations of salmeterol and salmeterol with an increase in salmeterol- associated adverse atazanavir is not events. recommended (see section 4.4). The mechanism of interaction is CYP3A4 inhibition by atazanavir and/or 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): lomitapide (HOS-086160) salmeterol (HOS-086285) ritonavir (HOS-084521)

Wechselwirkungen · Darunavir Viatris (previously Darunavir Mylan)

Darunavir Viatris 75 mg film-coated tablets Darunavir Viatris 150 mg film-coated tablets Darunavir Viatris 300 mg film-coated tablets Darunavir Viatris 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 19–20

HOS-134515 · Präparat HOS-097580

19 INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by Interaction Geometric mean change Recommendations concerning co- therapeutic areas (%) administration Pravastatin pravastatin AUC ↑ 81%¶ When administration of pravastatin 40 mg single dose pravastatin Cmin ND and darunavir co-administered with pravastatin Cmax ↑ 63% low dose ritonavir is required, it is ¶ an up to five-fold increase was seen in recommended to start with the a limited subset of subjects lowest possible dose of pravastatin and titrate up to the desired clinical effect while monitoring for safety. Rosuvastatin rosuvastatin AUC ↑ 48%║ When administration of rosuvastatin 10 mg once daily rosuvastatin Cmax ↑ 144%║ and darunavir co- administered with ║ based on published data with low dose ritonavir is required, it is darunavir/ritonavir recommended to start with the lowest possible dose of rosuvastatin and titrate up to the desired clinical effect while monitoring for safety. OTHER LIPID MODIFYING AGENTS Lomitapide Based on theoretical considerations Co-administration is contraindicated boosted darunavir is expected to (see section 4.3). increase the exposure of lomitapide when co-administered. (CYP3A inhibition) H2-RECEPTOR ANTAGONISTS Ranitidine # darunavir AUC ↔ Darunavir co-administered with low 150 mg twice daily # darunavir Cmin ↔ dose ritonavir can be co- # darunavir Cmax ↔ administered with H2-receptor antagonists without dose adjustments. IMMUNOSUPPRESSANTS Ciclosporin Not studied. Exposure to these Therapeutic drug monitoring of the Sirolimus immunosuppressants will be increased immunosuppressive agent must be Tacrolimus when co-administered with darunavir done when co-administration co-administered with low dose occurs. ritonavir. (CYP3A inhibition) Everolimus Concomitant use of everolimus and darunavir co-administered with low dose ritonavir is not recommended. INHALED BETA AGONISTS Salmeterol Not studied. Concomitant use of Concomitant use of salmeterol and salmeterol and darunavir co- darunavir co-administered with low administered with low dose ritonavir dose ritonavir is not recommended. may increase plasma concentrations of The combination may result in salmeterol. increased risk of cardiovascular adverse event with salmeterol, including QT prolongation, palpitations and sinus tachycardia. NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE Methadone R(-) methadone AUC ↓ 16% No adjustment of methadone dosage individual dose ranging R(-) methadone Cmin ↓ 15% is required when initiating co- from 55 mg to 150 mg once R(-) methadone Cmax ↓ 24% administration with daily darunavir/ritonavir. However, increased methadone dose may be necessary when concomitantly administered for a longer period of time due to induction of metabolism by ritonavir. Therefore, clinical monitoring is recommended, as maintenance therapy may need to be adjusted in some patients.

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): methadone (HOS-086198) lomitapide (HOS-086160) rosuvastatin (HOS-086307) salmeterol (HOS-086285) tacrolimus (HOS-085202) ranitidine (HOS-085660) everolimus (HOS-086310) sirolimus (HOS-085172) ritonavir (HOS-084521) pravastatin (HOS-086306)

Wechselwirkungen · Darunavir Viatris (previously Darunavir Mylan)

Darunavir Viatris 400 mg film-coated tablets Darunavir Viatris 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 62

HOS-134631 · Präparat HOS-097580

OTHER LIPID MODIFYING AGENTS Lomitapide Based on theoretical considerations Co-administration is contraindicated boosted darunavir is expected to (see section 4.3). increase the exposure of lomitapide when co-administered. (CYP3A inhibition) H2-RECEPTOR ANTAGONISTS Ranitidine # darunavir AUC ↔ Boosted darunavir can be co- 150 mg twice daily # darunavir Cmin ↔ administered with H2-receptor # darunavir Cmax ↔ antagonists without dose adjustments. IMMUNOSUPPRESSANTS Ciclosporin Not studied. Exposure to these Therapeutic drug monitoring of the Sirolimus immunosuppressants will be immunosuppressive agent must be Tacrolimus increased when co-administered done when co-administration occurs. Everolimus with boosted darunavir. (CYP3A Concomitant use of everolimus and inhibition) boosted darunavir is not recommended. INHALED BETA AGONISTS Salmeterol Not studied. Concomitant use of Concomitant use of salmeterol and salmeterol and boosted darunavir boosted darunavir is not may increase plasma concentrations recommended. The combination may of salmeterol. result in increased risk of cardiovascular adverse event with salmeterol, including QT prolongation, palpitations and sinus tachycardia. NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE Methadone R(-) methadone AUC ↓ 16% R(-) No adjustment of methadone dosage individual dose ranging from methadone Cmin ↓ 15% R(-) is required when initiating co- 55 mg to 150 mg once daily methadone Cmax ↓ 24% administration with boosted darunavir. However, adjustment of Darunavir/cobicistat may, in the methadone dose may be contrast, increase methadone necessary when concomitantly plasma concentrations (see administered for a longer period of cobicistat SmPC). time. Therefore, clinical monitoring is recommended, as maintenance therapy may need to be adjusted in some patients.

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): methadone (HOS-086198) lomitapide (HOS-086160) cobicistat (HOS-088111) salmeterol (HOS-086285) tacrolimus (HOS-085202) ranitidine (HOS-085660) everolimus (HOS-086310) sirolimus (HOS-085172)

Wechselwirkungen · Darunavir Krka

Darunavir Krka 400 mg film-coated tablets Darunavir Krka 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 20

HOS-225730 · Präparat HOS-217490

OTHER LIPID MODIFYING AGENTS Lomitapide Based on theoretical considerations Co-administration is contraindicated boosted darunavir is expected to increase (see section 4.3). the exposure of lomitapide when co- administered. (CYP3A inhibition) H2-RECEPTOR ANTAGONISTS # Ranitidine darunavir AUC ↔ Boosted darunavir can be co- # 150 mg twice daily darunavir Cmin ↔ administered with H2-receptor # darunavir Cmax ↔ antagonists without dose adjustments. IMMUNOSUPPRESSANTS Ciclosporin Not studied. Exposure to these Therapeutic drug monitoring of the Sirolimus immunosuppressants will be increased immunosuppressive agent must be Tacrolimus when co-administered with boosted done when co-administration occurs. darunavir. (CYP3A inhibition) Concomitant use of everolimus and Everolimus boosted darunavir is not recommended. INHALED BETA AGONISTS Salmeterol Not studied. Concomitant use of Concomitant use of salmeterol and salmeterol and boosted darunavir may boosted darunavir is not increase plasma concentrations of recommended. The combination may salmeterol. result in increased risk of cardiovascular adverse event with salmeterol, including QT prolongation, palpitations and sinus tachycardia. NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE Methadone R(-) methadone AUC ↓ 16% No adjustment of methadone dose is individual dose ranging from R(-) methadone Cmin ↓ 15% required when initiating co- 55 mg to 150 mg once daily R(-) methadone Cmax ↓ 24% administration with boosted darunavir /cobicistat may, in contrast, darunavir. However, adjustment of increase methadone plasma concentrations the methadone dose may be (see cobicistat SmPC). necessary when concomitantly administered for a longer period of time. Therefore, clinical monitoring is recommended, as maintenance therapy may need to be adjusted in some patients. Buprenorphine/naloxone buprenorphine AUC ↓ 11% The clinical relevance of the increase 8/2 mg–16/4 mg once daily buprenorphine Cmin ↔ in norbuprenorphine buprenorphine Cmax ↓ 8% pharmacokinetic parameters has not norbuprenorphine AUC ↑ 46% been established. Dose adjustment norbuprenorphine Cmin ↑ 71% for buprenorphine may not be norbuprenorphine Cmax ↑ 36% necessary when co-administered with

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): methadone (HOS-086198) lomitapide (HOS-086160) cobicistat (HOS-088111) buprenorphine (HOS-086193) salmeterol (HOS-086285) tacrolimus (HOS-085202) ranitidine (HOS-085660) everolimus (HOS-086310) naloxone (HOS-109490) sirolimus (HOS-085172)

Wechselwirkungen · Darunavir Krka

Darunavir Krka 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 55–56

HOS-225814 · Präparat HOS-217490

55 IMMUNOSUPPRESSANTS Ciclosporin Not studied. Exposure to these Therapeutic drug monitoring of the Sirolimus immunosuppressants will be increased immunosuppressive agent must be Tacrolimus when co-administered with darunavir co- done when co-administration occurs. Everolimus administered with low dose ritonavir. Concomitant use of everolimus and (CYP3A inhibition) darunavir co-administered with low dose ritonavir is not recommended. INHALED BETA AGONISTS Salmeterol Not studied. Concomitant use of Concomitant use of salmeterol and salmeterol and darunavir co-administered darunavir co-administered with low with low dose ritonavir may increase dose ritonavir is not recommended. plasma concentrations of salmeterol. The combination may result in increased risk of cardiovascular adverse event with salmeterol, including QT prolongation, palpitations and sinus tachycardia. NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE Methadone R(-) methadone AUC ↓ 16% No adjustment of methadone dose is individual dose ranging from R(-) methadone Cmin ↓ 15% required when initiating co- 55 mg to 150 mg once daily R(-) methadone Cmax ↓ 24% administration with darunavir /ritonavir. However, increased methadone dose may be necessary when concomitantly administered for a longer period of time due to induction of metabolism by ritonavir. Therefore, clinical monitoring is recommended, as maintenance therapy may need to be adjusted in some patients. Buprenorphine/naloxone buprenorphine AUC ↓ 11% The clinical relevance of the increase 8/2 mg–16/4 mg once daily buprenorphine Cmin ↔ in norbuprenorphine buprenorphine Cmax ↓ 8% pharmacokinetic parameters has not norbuprenorphine AUC ↑ 46% been established. Dose adjustment norbuprenorphine Cmin ↑ 71% for buprenorphine may not be norbuprenorphine Cmax ↑ 36% necessary when co-administered with naloxone AUC ↔ darunavir/ritonavir but a careful naloxone Cmin ND clinical monitoring for signs of naloxone Cmax ↔ opiate toxicity is recommended. Fentanyl Based on theoretical considerations Clinical monitoring is recommended Oxycodone boosted darunavir may increase plasma when co-administering boosted Tramadol concentrations of these analgesics. darunavir with these analgesics. (CYP2D6 and/or CYP3A inhibition) OESTROGEN-BASED CONTRACEPTIVES Drospirenone Not studied with darunavir/ritonavir. When darunavir is coadministered Ethinylestradiol with a drospirenone-containing (3 mg/0.02 mg once daily) product, clinical monitoring is recommended due to the potential for hyperkalaemia.

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): methadone (HOS-086198) oxycodone (HOS-109487) buprenorphine (HOS-086193) drospirenone (HOS-116422) salmeterol (HOS-086285) tacrolimus (HOS-085202) everolimus (HOS-086310) naloxone (HOS-109490) sirolimus (HOS-085172) fentanyl (HOS-086196) ritonavir (HOS-084521) tramadol (HOS-112871)

Wechselwirkungen · Symtuza

Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets Symtuza 675 mg/150 mg/200 mg/10 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 15–16

HOS-138495 · Präparat HOS-098200

15 OTHER LIPID MODIFYING AGENTS Lomitapide Based on theoretical Co-administration is considerations, Symtuza is contraindicated (see section 4.3). expected to increase the exposure of lomitapide when co- administered. (CYP3A inhibition) H2-RECEPTOR ANTAGONISTS Cimetidine Based on theoretical Symtuza can be co-administered Famotidine considerations, no mechanistic with H2-receptor antagonists Nizatidine interaction is expected. without dose adjustments. Ranitidine IMMUNOSUPPRESSANTS Ciclosporin Based on theoretical considerations Concentration monitoring of the Sirolimus DRV/COBI is expected to increase immunosuppressive agent must Tacrolimus these immunosuppressant plasma be done when co-administration concentrations. with Symtuza occurs. (CYP3A inhibition) Co-administration of ciclosporin is expected to increase plasma concentrations of tenofovir alafenamide. (P-gp inhibition) Concomitant use of everolimus Everolimus and Symtuza is not recommended. INHALED BETA AGONISTS Salmeterol Based on theoretical considerations Concomitant use of salmeterol DRV/COBI is expected to increase and Symtuza is not salmeterol plasma concentrations. recommended. The combination (CYP3A inhibition) may result in increased risk of cardiovascular adverse events with salmeterol, including QT prolongation, palpitations and sinus tachycardia. NARCOTIC ANALGESICS/TREATMENT OF OPIOID DEPENDENCE Buprenorphine/naloxone Based on theoretical considerations Dose adjustment for DRV/COBI may increase buprenorphine may not be buprenorphine and/or necessary when co-administered norbuprenorphine plasma with Symtuza, but a careful concentrations. clinical monitoring for signs of opiate toxicity is recommended. Methadone Based on theoretical considerations No adjustment of methadone dose DRV/COBI may increase is expected when initiating methadone plasma concentrations. co-administration with Symtuza. Clinical monitoring is With ritonavir-boosted darunavir, a recommended, as maintenance small decrease in methadone therapy may need to be adjusted plasma concentrations was in some patients. observed. Consult the Summary of Product Characteristics for darunavir for further details. Fentanyl Based on theoretical considerations Clinical monitoring is Oxycodone DRV/COBI may increase plasma recommended when Tramadol concentrations of these analgesics. co-administering Symtuza with (CYP2D6 and/or CYP3A these analgesics. inhibition)

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): tenofovir (HOS-088083) nizatidine (HOS-138496) methadone (HOS-086198) cimetidine (HOS-085835) lomitapide (HOS-086160) oxycodone (HOS-109487) famotidine (HOS-112087) buprenorphine (HOS-086193) salmeterol (HOS-086285) tacrolimus (HOS-085202) ranitidine (HOS-085660) everolimus (HOS-086310) naloxone (HOS-109490) sirolimus (HOS-085172) fentanyl (HOS-086196) tramadol (HOS-112871)

Gegenanzeigen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.3 · PDF-Seite 4

HOS-142715 · Präparat HOS-098862

Hypersensitivity to the active substances 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.

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 6–7

HOS-142716 · Präparat HOS-098862

6 Interactions with beta blockers

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

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 7

HOS-142717 · Präparat HOS-098862

Beta adrenergic blockers may weaken or antagonise the effect of salmeterol. Both non-selective and selective β blockers should be avoided unless there are compelling reasons for their use. Potentially serious hypokalaemia may result from β2 agonist therapy (see section 4.4). Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, and diuretics.

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): xanthine (HOS-133925)

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 7

HOS-142719 · Präparat HOS-098862

Salmeterol

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

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 7

HOS-142720 · Präparat HOS-098862

Potent CYP3A4 inhibitors Co-administration of ketoconazole (400 mg orally once daily) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 7 days resulted in a significant increase in plasma salmeterol exposure (1.4- fold Cmax and 15-fold AUC). This may lead to an increase in the incidence of other systemic effects of salmeterol treatment (e.g. prolongation of QTc interval and palpitations) compared with salmeterol or ketoconazole treatment alone (see section 4.4).

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) lead (HOS-085592)

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 7

HOS-142721 · Präparat HOS-098862

Clinically significant effects were not seen on blood pressure, heart rate, blood glucose, and blood potassium levels. Co-administration with ketoconazole did not increase the elimination half-life of salmeterol or increase salmeterol accumulation with repeat dosing.

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) glucose (HOS-088412) potassium (HOS-086929)

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 7

HOS-142723 · Präparat HOS-098862

The concomitant administration of ketoconazole should be avoided, unless the benefits outweigh the potentially increased risk of systemic effects of salmeterol treatment. There is likely to be a similar risk of interaction with other potent CYP3A4 inhibitors (e.g., itraconazole, telithromycin, 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): ketoconazole (HOS-084513) telithromycin (HOS-084523) itraconazole (HOS-084516) ritonavir (HOS-084521)

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 7

HOS-142724 · Präparat HOS-098862

Moderate CYP3A4 inhibitors Co-administration of erythromycin (500 mg orally 3 times a day) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 6 days resulted in a small but non-statistically significant increase in salmeterol exposure (1.4-fold Cmax and 1.2-fold AUC). Co-administration with erythromycin was not associated with any serious adverse effects.

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): erythromycin (HOS-084514)

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 7

HOS-142725 · Präparat HOS-098862

Fluticasone propionate

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

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 7

HOS-142726 · Präparat HOS-098862

Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the gut and liver. Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely.

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

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 7

HOS-142727 · Präparat HOS-098862

In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) administered 100 mg twice daily increased the fluticasone propionate plasma concentrations several hundred-fold, resulting in markedly reduced serum cortisol concentrations. Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected. Cases of Cushing’s syndrome and adrenal suppression have been reported. The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid undesirable effects (see section 4.4).

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): ritonavir (HOS-084521)

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 7

HOS-142728 · Präparat HOS-098862

In a small study in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%. This resulted in a greater reduction of plasma cortisol as compared with fluticasone propionate alone. Co-treatment with other potent CYP3A inhibitors, such as itraconazole, and moderate CYP3A inhibitors, such as erythromycin, is also expected to increase the systemic fluticasone propionate exposure and the risk of systemic undesirable effects. Caution is recommended and long-term treatment with such drugs should, if possible, be avoided.

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) erythromycin (HOS-084514)

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 7

HOS-142729 · Präparat HOS-098862

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased

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

Wechselwirkungen · Seffalair Spiromax

Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder · Abschnitt 4.5 · PDF-Seite 7–8

HOS-142730 · Präparat HOS-098862

7 risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid effects.

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