Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.
RxNorm 05-Oct-2026 · geprüft 2026-10-25 · 1009 Präparate · 54812 Quellenpassagen · 148 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
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)
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Version 2025-11-11T18:35:00Z · SHA-256 82413695e61cf39577e85c47e382ee60197570a4ae72fe81d6e24e4211cd2d43 · Passage 08cb4669d26fd4170f47a5f99fcf18bde7e922c35f378d07e3e1c1cab8b82945 · Zeichen 6375–8447 im Abschnitt
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)
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Version 2025-11-11T18:35:00Z · SHA-256 82413695e61cf39577e85c47e382ee60197570a4ae72fe81d6e24e4211cd2d43 · Passage 235db82cd2afd722d3066659d7d625c3a96a3162e89ca0b2b4a6f83e7ca9d95d · Zeichen 6173–8675 im Abschnitt
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)
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Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage c938be9b188cbabde88400ddb49de67c2831b955f638dc8fa5306b13f1652968 · Zeichen 6187–9289 im Abschnitt
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)
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Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage f8543c2c8cda6c1a0fcb441c8b738d361d39474d709f5eb46342c2fd917ec3a5 · Zeichen 6637–8576 im Abschnitt
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)
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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)
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Version 2025-12-02T16:00:00Z · SHA-256 441d9e5f9e4b42d645e4bd802abc892cef6574b0be5b3f18d2a96678774ae365 · Passage 51c234e1918855f44c1bb972e14fc32ef0403c1dd2140c6f4cb763ba5bcc0839 · Zeichen 44014–48937 im Abschnitt
Wechselwirkungen · Reyataz
REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 20–21
HOS-112108 · Präparat HOS-093615
20
Medicinal products by Interaction Recommendations concerning co-
therapeutic area administration
Fluticasone propionate The fluticasone propionate plasma levels Co-administration of
intranasal 50 μg 4 times daily increased significantly, whereas the REYATAZ/ritonavir and these
for 7 days intrinsic cortisol levels decreased by glucocorticoids metabolised by
(ritonavir 100 mg capsules twice approximately 86% (90% confidence CYP3A4 is not recommended
daily) interval 82%-89%). Greater effects may be unless the potential benefit of
expected when fluticasone propionate is treatment outweighs the risk of
And inhaled. Systemic corticosteroid effects systemic corticosteroid effects
including Cushing’s syndrome and adrenal (see section 4.4).
Inhaled/Nasal Corticosteroids suppression have been reported in patients A dose reduction of the
receiving ritonavir and inhaled or glucocorticoid should be considered
intranasally administered fluticasone with close monitoring of local and
propionate; this could also occur with systemic effects or a switch to a
other corticosteroids metabolised via the glucocorticoid, which is not a
P450 3A pathway, e.g., budesonide. The substrate for CYP3A4 (e.g.,
effects of high fluticasone systemic beclomethasone). Moreover, in case
exposure on ritonavir plasma levels are yet of withdrawal of glucocorticoids,
unknown. The mechanism of interaction is progressive dose reduction may
CYP3A4 inhibition. have to be performed over a longer
period.
Concomitant use of REYATAZ (with or
without ritonavir) and other Inhaled/Nasal Concomitant use of Inhaled/Nasal
Corticosteroids is expected to produce the Corticosteroids and REYATAZ
same effects. (with or without ritonavir) may
increase plasma concentrations of
Inhaled/Nasal corticosteroids. Use
with caution. Consider alternatives
to Inhaled/Nasal Corticosteroids,
particularly for long-term use.
ERECTILE DYSFUNCTION
PDE5 Inhibitors
Sildenafil, tadalafil, vardenafil Sildenafil, tadalafil, and vardenafil are
Patients should be warned about
metabolised by CYP3A4. Co- these possible side effects when
administration with REYATAZ may result
using PDE5 inhibitors for erectile
in increased concentrations of the PDE5
dysfunction with REYATAZ (see
inhibitor and an increase in PDE5-
section 4.4).
Also see PULMONARY
associated adverse events, including
ARTERIAL HYPERTENSION in
hypotension, visual changes, and priapism.
this table for further information
The mechanism of this interaction is
CYP3A4 inhibition. regarding co-administration of
REYATAZ with sildenafil.
GONADOTROPIN-RELEASING HORMONE (GnRH) RECEPTOR ANTAGONISTS
Elagolix The mechanism of interaction is Concomitant use of elagolix
anticipated increase in elagolix exposure in 200 mg twice daily with
the presence of CYP3A4 inhibition by REYATAZ (with or without
atazanavir and/or ritonavir. ritonavir) for more than 1 month is
not recommended due to the
potential risk of adverse events
such as bone loss and hepatic
transaminase elevations. Limit
concomitant use of elagolix 150 mg
once daily with REYATAZ (with
or without ritonavir) to 6 months.
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) fluticasone (HOS-108914) fluticasone propionate (HOS-086331) elagolix (HOS-112109) budesonide (HOS-086332) propionate (HOS-108915) sildenafil (HOS-086162) ritonavir (HOS-084521) beclomethasone (HOS-086334) vardenafil (HOS-086163)
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Wechselwirkungen · Reyataz
REYATAZ 50 mg oral powder · Abschnitt 4.5 · PDF-Seite 56–57
HOS-112197 · Präparat HOS-093615
56
Medicinal products by Interaction Recommendations
therapeutic area concerning co-administration
Fluticasone propionate The fluticasone propionate plasma levels Co-administration of
intranasal 50 μg 4 times daily increased significantly, whereas the REYATAZ/ritonavir and these
for 7 days intrinsic cortisol levels decreased by glucocorticoids metabolised by
(ritonavir 100 mg capsules approximately 86% (90% confidence CYP3A4 is not recommended
twice daily) interval 82%-89%). Greater effects may be unless the potential benefit of
expected when fluticasone propionate is treatment outweighs the risk of
And inhaled. Systemic corticosteroid effects systemic corticosteroid effects
including Cushing’s syndrome and adrenal (see section 4.4).
Inhaled/Nasal Corticosteroids suppression have been reported in patients A dose reduction of the
receiving ritonavir and inhaled or glucocorticoid should be
intranasally administered fluticasone considered with close
propionate; this could also occur with other monitoring of local and
corticosteroids metabolised via the P450 systemic effects or a switch to
3A pathway, e.g., budesonide. The effects a glucocorticoid, which is not a
of high fluticasone systemic exposure on substrate for CYP3A4 (e.g.,
ritonavir plasma levels are yet unknown. beclomethasone). Moreover, in
The mechanism of interaction is CYP3A4 case of withdrawal of
inhibition. glucocorticoids, progressive
dose reduction may have to be
Concomitant use of REYATAZ (with or performed over a longer
without ritonavir) and other Inhaled/Nasal period.
Corticosteroids is expected to produce the
same effects. Concomitant use of
Inhaled/Nasal Corticosteroids
and REYATAZ (with or
without ritonavir) may increase
plasma concentrations of
Inhaled/Nasal corticosteroids.
Use with caution. Consider
alternatives to Inhaled/Nasal
Corticosteroids, particularly for
long-term use.
ERECTILE DYSFUNCTION
PDE5 Inhibitors
Sildenafil, tadalafil, Sildenafil, tadalafil, and vardenafil are
Patients should be warned
vardenafil metabolised by CYP3A4. Co- about these possible side
administration with REYATAZ may result
effects when using PDE5
in increased concentrations of the PDE5
inhibitors for erectile
inhibitor and an increase in PDE5-
dysfunction with REYATAZ
associated adverse events, including
(see section 4.4).
Also see PULMONARY
hypotension, visual changes, and priapism.
ARTERIAL
The mechanism of this interaction is
CYP3A4 inhibition. HYPERTENSION in this table
for further information
regarding co-administration of
REYATAZ with sildenafil.
GONADOTROPIN-RELEASING HORMONE (GnRH) RECEPTOR ANTAGONISTS
Elagolix The mechanism of interaction is anticipated Concomitant use of elagolix
increase in elagolix exposure in the 200 mg twice daily with
presence of CYP3A4 inhibition by REYATAZ (with or without
atazanavir and/or ritonavir. ritonavir) for more than
1 month is not recommended
due to the potential risk of
adverse events such as bone
loss and hepatic transaminase
elevations. Limit concomitant
use of elagolix 150 mg once
daily with REYATAZ (with or
without ritonavir) to 6 months.
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) fluticasone (HOS-108914) fluticasone propionate (HOS-086331) elagolix (HOS-112109) budesonide (HOS-086332) propionate (HOS-108915) sildenafil (HOS-086162) ritonavir (HOS-084521) beclomethasone (HOS-086334) vardenafil (HOS-086163)
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Version 2026-06-29T13:00:00Z · SHA-256 ff5481974bd7c752b73fa0c147cf3e96fc892edc735359fa71817833db471beb · Passage 48a34194fe14fdb331f424e7223a33e7800beb55222a98a47e4c5a5060800d73 · Zeichen 57743–64096 im Abschnitt
Wechselwirkungen · Aptivus
Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 17
HOS-114835 · Präparat HOS-094169
Inhibition of CYP 3A4 by
tipranavir/r.
Oral contraceptives / Oestrogens
Ethinyl oestradiol Ethinyl oestradiol Cmax ↓ 52% The concomitant administration
0.035 mg / Norethindrone Ethinyl oestradiol AUC ↓ 43% with Aptivus, co-administered
1.0 mg QD with low dose ritonavir, is not
(TPV/r 750/200 mg BID) Mechanism unknown recommended. Alternative or
additional contraceptive measures
Norethindrone Cmax ↔ are to be used when oestrogen
Norethindrone AUC ↑ 27% based oral contraceptives are co-
administered with Aptivus and
Tipranavir ↔ low dose ritonavir. Patients using
oestrogens as hormone
replacement therapy should be
clinically monitored for signs of
oestrogen deficiency (see
sections 4.4 and 4.6).
Phosphodiesterase 5 (PDE5) inhibitors
Sildenafil Co-administration of tipranavir Particular caution should be used
Vardenafil and low dose ritonavir with when prescribing the
No interaction study PDE5 inhibitors is expected to phosphodiesterase (PDE5)
performed substantially increase PDE5 inhibitors sildenafil or vardenafil
concentrations and may result in in patients receiving Aptivus, co-
an increase in PDE5 inhibitor- administered with low dose
associated adverse events ritonavir.
including hypotension, visual A safe and effective dose has not
changes and priapism. been established when used with
Aptivus, co-administered with
CYP 3A4 inhibition by low dose ritonavir. There is
tipranavir/ r increased potential for PDE5
inhibitor-associated adverse
events (which include visual
disturbances, hypotension,
prolonged erection, and syncope).
Co-administrationof
Aptivus/ritonavir with sildenafil,
when used to treat pulmonary
arterial hypertension, is
contraindicated.
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): norethindrone (HOS-088136) sildenafil (HOS-086162) ritonavir (HOS-084521) vardenafil (HOS-086163)
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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)
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Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 46fd073076a452542b46d19575ef31721f4438f76a3fc3b4ddbcf4388fa73f42 · Zeichen 68873–72741 im Abschnitt
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)
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Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 7e2682f4793647612f16068252562b75c65aee0f142e04d17e1e64986c872546 · Zeichen 60739–63894 im Abschnitt
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)
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Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 53e0febc21778baf0cd734e4641645b6ed035e132d52ecd7b62207df9c2eaa53 · Zeichen 68281–74416 im Abschnitt
Wechselwirkungen · Intelence
INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets · Abschnitt 4.5 · PDF-Seite 13–14
HOS-119744 · Präparat HOS-095005
13
IMMUNOSUPPRESSANTS
Cyclosporin Not studied. Etravirine is expected to decrease Co-administration with
Sirolimus plasma concentrations of cyclosporine, systemic
Tacrolimus sirolimus and tacrolimus. immunosuppressants should
be done with caution because
plasma concentrations of
cyclosporin, sirolimus and
tacrolimus may be affected
when co-administered with
INTELENCE.
NARCOTIC ANALGESICS
Methadone R(-) methadone No changes in methadone
individual dose ranging AUC ↔ 1.06 (0.99-1.13) dosage were required based
from 60 mg to 130 mg Cmin ↔ 1.10 (1.02-1.19) on clinical status during or
once daily Cmax ↔ 1.02 (0.96-1.09) after the period of
S(+) methadone INTELENCE
AUC ↔ 0.89 (0.82-0.96) co-administration.
Cmin ↔ 0.89 (0.81-0.98)
Cmax ↔ 0.89 (0.83-0.97)
etravirine
AUC ↔a
Cmin ↔a
Cmax ↔a
PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS
Sildenafil 50 mg single sildenafil Concomitant use of PDE-5
dose AUC ↓ 0.43 (0.36-0.51) inhibitors with INTELENCE
Tadalafil Cmin ND may require dose adjustment
Vardenafil Cmax ↓ 0.55 (0.40-0.75) of the PDE-5 inhibitor to
N-desmethyl-sildenafil attain the desired clinical
AUC ↓ 0.59 (0.52-0.68) effect.
Cmin ND
Cmax ↓ 0.75 (0.59-0.96)
PLATELET AGGREGGATION INHIBITORS
Clopidogrel In vitro data show that etravirine has inhibitory As a precaution it is
properties on CYP2C19. It is therefore possible recommended that
that etravirine may inhibit the metabolism of concomitant use of etravirine
clopidogrel to its active metabolite by such and clopidogrel should be
inhibition of CYP2C19 in vivo. The clinical discouraged.
relevance of this interaction has not been
demonstrated.
PROTON PUMP INHIBITORS
Omeprazole etravirine INTELENCE can be
40 mg once daily AUC ↑ 1.41 (1.22-1.62) co-administered with proton
Cmin ND pump inhibitors without dose
Cmax ↑ 1.17 (0.96-1.43) adjustments.
SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS)
Paroxetine paroxetine INTELENCE can be
20 mg once daily AUC ↔ 1.03 (0.90-1.18) co-administered with
Cmin ↓ 0.87 (0.75-1.02) paroxetine without dose
Cmax ↔ 1.06 (0.95-1.20) adjustments.
etravirine
AUC ↔ 1.01 (0.93-1.10)
Cmin ↔ 1.07 (0.98-1.17)
Cmax ↔ 1.05 (0.96-1.15)
a
Comparison based on historic control.
b
Study was conducted with tenofovir disoproxil fumarate 300 mg once daily
Note: In drug-drug interaction studies, different formulations and/or doses of etravirine were used which led to similar
exposures and, therefore, interactions relevant for one formulation are relevant for the other.
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): paroxetine (HOS-086246) tadalafil (HOS-086316) methadone (HOS-086198) serotonin (HOS-085477) clopidogrel (HOS-087927) tacrolimus (HOS-085202) tenofovir disoproxil fumarate (HOS-110471) sirolimus (HOS-085172) sildenafil (HOS-086162) cyclosporine (HOS-084512) omeprazole (HOS-085912) vardenafil (HOS-086163)
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Wechselwirkungen · Edurant
EDURANT 25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9–10
HOS-213959 · Präparat HOS-155234
9
HMG CO-A REDUCTASE INHIBITORS
Atorvastatin*# atorvastatin AUC ↔ No dose adjustment is required.
40 mg once daily atorvastatin Cmin ↓ 15%
atorvastatin Cmax ↑ 35%
rilpivirine AUC ↔
rilpivirine Cmin ↔
rilpivirine Cmax ↓ 9%
PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS
Sildenafil*# sildenafil AUC ↔ No dose adjustment is required.
50 mg single dose sildenafil Cmin NA
sildenafil Cmax ↔
rilpivirine AUC ↔
rilpivirine Cmin ↔
rilpivirine Cmax ↔
Vardenafil Not studied. No dose adjustment is required.
Tadalafil
* The interaction between rilpivirine and the medicinal product was evaluated in a clinical study. All other drug-drug interactions
shown are predicted.
#
This interaction study has been performed with a dose higher than the recommended dose for rilpivirine assessing the maximal effect
on the co-administered medicinal product. The dosing recommendation is applicable to the recommended dose of rilpivirine of 25 mg
once daily.
†
This interaction study has been performed with a dose higher than the recommended dose for rilpivirine.
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) atorvastatin (HOS-086304) sildenafil (HOS-086162) vardenafil (HOS-086163)
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Wechselwirkungen · Edurant
EDURANT 2.5 mg dispersible tablets · Abschnitt 4.5 · PDF-Seite 32
HOS-214010 · Präparat HOS-155234
(inhibition of intestinal P-gp)
ANTIDIABETICS
Metformin* metformin AUC ↔ No dose adjustment is required.
850 mg single dose metformin Cmin NA
metformin Cmax ↔
HERBAL PRODUCTS
St John’s wort Not studied. Significant decreases Rilpivirine must not be used in
(Hypericum perforatum) in rilpivirine plasma concentrations combination with products containing
are expected. St John’s wort as co-administration
may result in loss of therapeutic effect
(induction of CYP3A enzymes) of rilpivirine (see section 4.3).
ANALGESICS
Paracetamol*# paracetamol AUC ↔ No dose adjustment is required.
500 mg single dose paracetamol Cmin NA
paracetamol Cmax ↔
rilpivirine AUC ↔
rilpivirine Cmin ↑ 26%
rilpivirine Cmax ↔
ORAL CONTRACEPTIVES
Ethinylestradiol* ethinylestradiol AUC ↔ No dose adjustment is required.
0.035 mg once daily ethinylestradiol Cmin ↔
Norethindrone* ethinylestradiol Cmax ↑ 17%
1 mg once daily norethindrone AUC ↔
norethindrone Cmin ↔
norethindrone Cmax ↔
rilpivirine AUC ↔*
rilpivirine Cmin ↔*
rilpivirine Cmax ↔*
* based on historic controls
HMG CO-A REDUCTASE INHIBITORS
Atorvastatin*# atorvastatin AUC ↔ No dose adjustment is required.
40 mg once daily atorvastatin Cmin ↓ 15%
atorvastatin Cmax ↑ 35%
rilpivirine AUC ↔
rilpivirine Cmin ↔
rilpivirine Cmax ↓ 9%
PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS
Sildenafil*# sildenafil AUC ↔ No dose adjustment is required.
50 mg single dose sildenafil Cmin NA
sildenafil Cmax ↔
rilpivirine AUC ↔
rilpivirine Cmin ↔
rilpivirine Cmax ↔
Vardenafil Not studied. No dose adjustment is required.
Tadalafil
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) atorvastatin (HOS-086304) norethindrone (HOS-088136) sildenafil (HOS-086162) metformin (HOS-091032) vardenafil (HOS-086163)
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Gegenanzeigen · Adempas
Adempas 0.5 mg film-coated tablets Adempas 1 mg film-coated tablets Adempas 1.5 mg film-coated tablets Adempas 2 mg film-coated tablets Adempas 2.5 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 6
HOS-129020 · Präparat HOS-096659
- Co-administration with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) (see
sections 4.2 and 4.5).
- Severe hepatic impairment (Child Pugh C).
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Pregnancy (see sections 4.4; 4.5 and 4.6).
- Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form
including recreational drugs called ‘poppers’ (see section 4.5).
- Concomitant use with other soluble guanylate cyclase stimulators.
- Treatment initiation for
o children aged 6 to < 12 years with systolic blood pressure < 90 mmHg,
o patients ≥ 12 years with systolic blood pressure < 95 mmHg.
- Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-
IIP) (see section 5.1).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tadalafil (HOS-086316) nitric oxide (HOS-088773) sildenafil (HOS-086162) amyl nitrite (HOS-088775) vardenafil (HOS-086163)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
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Gegenanzeigen · Adempas
Adempas 0.15 mg/mL granules for oral suspension · Abschnitt 4.3 · PDF-Seite 29
HOS-129069 · Präparat HOS-096659
- Co-administration with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) (see
sections 4.2 and 4.5).
- Severe hepatic impairment (Child Pugh C).
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Pregnancy (see sections 4.4; 4.5 and 4.6).
- Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form
including recreational drugs called ‘poppers’ (see section 4.5).
- Concomitant use with other soluble guanylate cyclase stimulators.
- Treatment initiation for
o children aged 6 to < 12 years with systolic blood pressure < 90 mmHg,
o patients ≥ 12 to < 18 years with systolic blood pressure < 95 mmHg.
- Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-
IIP) (see section 5.1).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tadalafil (HOS-086316) nitric oxide (HOS-088773) sildenafil (HOS-086162) amyl nitrite (HOS-088775) vardenafil (HOS-086163)
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Wechselwirkungen · Adempas
Adempas 0.5 mg film-coated tablets Adempas 1 mg film-coated tablets Adempas 1.5 mg film-coated tablets Adempas 2 mg film-coated tablets Adempas 2.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8
HOS-129030 · Präparat HOS-096659
PDE5 inhibitors
Preclinical studies in animal models showed additive systemic blood pressure lowering effect when
riociguat was combined with either sildenafil or vardenafil. With increased doses, over additive effects
on systemic blood pressure were observed in some cases.
In an exploratory interaction study in 7 patients with PAH on stable sildenafil treatment (20 mg
3 times daily) single doses of riociguat (0.5 mg and 1 mg sequentially) showed additive
haemodynamic effects. Doses above 1 mg riociguat were not investigated in this study.
A 12 week combination study in 18 patients with PAH on stable sildenafil treatment (20 mg 3 times
daily) and riociguat (1.0 mg to 2.5 mg 3 times daily) compared to sildenafil alone was performed. In
the long term extension part of this study (non controlled) the concomitant use of sildenafil and
riociguat resulted in a high rate of discontinuation, predominately due to hypotension. There was no
evidence of a favourable clinical effect of the combination in the population studied.
Concomitant use of riociguat with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) is
contraindicated (see sections 4.2 and 4.3).
RESPITE was a 24-week, uncontrolled study to investigate switching from PDE5 inhibitors to
riociguat, in 61 adult PAH patients on stable PDE5 inhibitors. All patients were WHO Functional
Class III and 82% received background therapy with an endothelin receptor antagonist (ERA). For the
transition from PDE5 inhibitors to riociguat, median treatment-free time for sildenafil was 1 day and
for tadalafil 3 days. Overall, the safety profile observed in the study was comparable with that
observed in the pivotal trials, with no serious adverse reactions reported during the transition period.
Six patients (10%) experienced at least one clinical worsening event, including 2 deaths unrelated to
study drug. Changes from baseline suggested beneficial effects in selected patients, e.g. improvement
in 6MWD (+31 m), N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels
(-347 pg/mL), percent distribution of WHO FC I/II/III/IV (2% / 52% / 46% / 0%), and cardiac index
(+0.3 L/min/m2).
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) sildenafil (HOS-086162) vardenafil (HOS-086163)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-05-22T01:00:00Z · SHA-256 3d1a5306a1e99b336747bac1f508fcb4f4b6128739940b8414bff8db32c20c38 · Passage f2b7cfea8dec36ad69c76a802a67a1c0a6d4703dac7be3863930485fd346a484 · Zeichen 775–2943 im Abschnitt
Wechselwirkungen · Adempas
Adempas 0.15 mg/mL granules for oral suspension · Abschnitt 4.5 · PDF-Seite 30–31
HOS-129073 · Präparat HOS-096659
30
PDE5 inhibitors
Preclinical studies in animal models showed additive systemic blood pressure lowering effect when
riociguat was combined with either sildenafil or vardenafil. With increased doses, over additive effects
on systemic blood pressure were observed in some cases.
In an exploratory interaction study in 7 patients with PAH on stable sildenafil treatment (20 mg
3 times daily) single doses of riociguat (0.5 mg and 1 mg sequentially) showed additive
haemodynamic effects. Doses above 1 mg riociguat were not investigated in this study.
A 12 week combination study in 18 patients with PAH on stable sildenafil treatment (20 mg 3 times
daily) and riociguat (1.0 mg to 2.5 mg 3 times daily) compared to sildenafil alone was performed. In
the long term extension part of this study (non controlled) the concomitant use of sildenafil and
riociguat resulted in a high rate of discontinuation, predominately due to hypotension. There was no
evidence of a favourable clinical effect of the combination in the population studied.
Concomitant use of riociguat with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) is
contraindicated (see sections 4.2 and 4.3).
RESPITE was a 24-week, uncontrolled study to investigate switching from PDE5 inhibitors to
riociguat, in 61 adult PAH patients on stable PDE5 inhibitors. All patients were WHO Functional
Class III and 82% received background therapy with an endothelin receptor antagonist (ERA). For the
transition from PDE5 inhibitors to riociguat, median treatment-free time for sildenafil was 1 day and
for tadalafil 3 days. Overall, the safety profile observed in the study was comparable with that
observed in the pivotal trials, with no serious adverse reactions reported during the transition period.
Six patients (10%) experienced at least one clinical worsening event, including 2 deaths unrelated to
study drug. Changes from baseline suggested beneficial effects in selected patients, e.g. improvement
in 6MWD (+31 m), N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels
(-347 pg/mL), percent distribution of WHO FC I/II/III/IV (2% / 52% / 46% / 0%), and cardiac index
(+0.3 L/min/m2).
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) sildenafil (HOS-086162) vardenafil (HOS-086163)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-05-22T01:00:00Z · SHA-256 3d1a5306a1e99b336747bac1f508fcb4f4b6128739940b8414bff8db32c20c38 · Passage 65771a5100bdd3d4be7b9d3693c39e8e7f5aeeb49f7537eaf2901d9a8f359230 · Zeichen 769–2941 im Abschnitt
Wechselwirkungen · Ketoconazole Esteve (previously Ketoconazole HRA)
Ketoconazole Esteve 200 mg tablets · Abschnitt 4.5 · PDF-Seite 14
HOS-132875 · Präparat HOS-097310
↑in plasma concentrations of tolterodine
have been observed
Phosphodiesterase(PD
E5) inhibitors
Sildenafil Tadalafil: Not recommended due to the
Tadalafil AUC: ↑ 4-fold increased risk of adverse reactions.
Vardenafil Cmax: ↑ 1.2-fold
Vardenafil is contraindicated in men
Vardenafil: older than 75 years old (see section
AUC: ↑ 10-fold 4.3).
Cmax: ↑ 4-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): tolterodine (HOS-087792) tadalafil (HOS-086316) sildenafil (HOS-086162) vardenafil (HOS-086163)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-05T12:00:00Z · SHA-256 1463d2e081bcaa454cdfd6129ad3b8e03e3df9233f9d0704cfceba71c89c59b5 · Passage c4f1e0b47aa9290bd23acabe26b7c54c1f3dfc04d67fa1c984998fa1ee5d33ac · Zeichen 29276–29972 im Abschnitt
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.