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.
Wechselwirkungen · Reyataz
REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 8
HOS-112050 · Präparat HOS-093615
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is
contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic
index: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine,
bepridil, triazolam, orally administered midazolam, lomitapide, and ergot alkaloids, particularly
ergotamine and dihydroergotamine (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): quetiapine (HOS-086150) alfuzosin (HOS-086139) cisapride (HOS-085610) lomitapide (HOS-086160) bepridil (HOS-085612) quinidine (HOS-085593) ergot alkaloids (HOS-108807) pimozide (HOS-085600) astemizole (HOS-085608) ergotamine (HOS-086154) terfenadine (HOS-085607) lurasidone (HOS-086148) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-06-29T13:00:00Z · SHA-256 ff5481974bd7c752b73fa0c147cf3e96fc892edc735359fa71817833db471beb · Passage 85781e83a9b10bfbdd236ee812040730eb3a9b3f74e06aebc98fed6a6305ec35 · Zeichen 315–760 im Abschnitt
Wechselwirkungen · Reyataz
REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 24
HOS-112118 · Präparat HOS-093615
The mechanism of interaction is CYP3A4
and UGT1A1 inhibition.
Concentrations of atazanavir (when given
with ritonavir) were not significantly
affected.
Methadone, stable maintenance No significant effect on methadone No dosage adjustment is necessary
dose concentrations was observed. Given that if methadone is co-administered
(atazanavir 400 mg once daily) low dose ritonavir (100 mg twice daily) with REYATAZ.
has been shown to have no significant
effect on methadone concentrations, no
interaction is expected if methadone is co-
administered with REYATAZ, based on
these data.
PULMONARY ARTERIAL HYPERTENSION
PDE5 Inhibitors
Sildenafil Co-administration with REYATAZ may A safe and effective dose in
result in increased concentrations of the combination with REYATAZ has
PDE5 inhibitor and an increase in PDE5- not been established for sildenafil
inhibitor-associated adverse events. when used to treat pulmonary
arterial hypertension. Sildenafil,
The mechanism of interaction is CYP3A4 when used for the treatment of
inhibition by atazanavir and/or ritonavir. pulmonary arterial hypertension, is
contraindicated (see section 4.3).
SEDATIVES
Benzodiazepines
Midazolam Midazolam and triazolam are extensively Co-administration of REYATAZ
Triazolam metabolised by CYP3A4. Co- with triazolam or orally
administration with REYATAZ may cause administered midazolam is
a large increase in the concentration of contraindicated (see section 4.3),
these benzodiazepines. No drug interaction whereas caution should be used
study has been performed for the co- with co-administration of
administration of REYATAZ with REYATAZ and parenteral
benzodiazepines. Based on data for other midazolam. If REYATAZ is co-
CYP3A4 inhibitors, plasma concentrations administered with parenteral
of midazolam are expected to be midazolam, it should be done in an
significantly higher when midazolam is intensive care unit (ICU) or similar
given orally. Data from concomitant use of setting which ensures close clinical
parenteral midazolam with other protease monitoring and appropriate medical
inhibitors suggest a possible 3-4-fold management in case of respiratory
increase in midazolam plasma levels. depression and/or prolonged
sedation. Dosage adjustment for
midazolam should be considered,
especially if more than a single
dose of midazolam is administered.
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) protease (HOS-085623) sildenafil (HOS-086162) ritonavir (HOS-084521) triazolam (HOS-086168) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-06-29T13:00:00Z · SHA-256 ff5481974bd7c752b73fa0c147cf3e96fc892edc735359fa71817833db471beb · Passage be486e27c0486d810d40c1b37da9b7f69c7a35ad1fcade19cc1e1d57a1b71724 · Zeichen 71400–75434 im Abschnitt
Wechselwirkungen · Reyataz
REYATAZ 50 mg oral powder · Abschnitt 4.5 · PDF-Seite 44
HOS-112157 · Präparat HOS-093615
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ
with ritonavir is contraindicated with medicinal products that are substrates of CYP3A4 and have a
narrow therapeutic index: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride,
pimozide, quinidine, bepridil, triazolam, orally administered midazolam, lomitapide, and ergot
alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3). Co-administration of
REYATAZ with grazoprevir-containing products, including elbasvir/grazoprevir fixed-dose
combination is contraindicated because of the increase in grazoprevir and elbasvir plasma
concentrations and potential for the increase in risk of ALT elevations associated with increased
grazoprevir concentrations (see section 4.3). Co-administration of REYATAZ with
glecaprevir/pibrentasvir fixed-dose combination is contraindicated because of the potential increase in
the risk of ALT elevations due to a significant increase in glecapreir and pibrentasvir plasma
concentrations (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): quetiapine (HOS-086150) elbasvir (HOS-108814) alfuzosin (HOS-086139) cisapride (HOS-085610) pibrentasvir (HOS-086298) lomitapide (HOS-086160) bepridil (HOS-085612) quinidine (HOS-085593) glecaprevir (HOS-086297) grazoprevir (HOS-108815) pimozide (HOS-085600) astemizole (HOS-085608) ergotamine (HOS-086154) ritonavir (HOS-084521) terfenadine (HOS-085607) lurasidone (HOS-086148) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-06-29T13:00:00Z · SHA-256 ff5481974bd7c752b73fa0c147cf3e96fc892edc735359fa71817833db471beb · Passage 8c472f02d161fbf877b321685a02acd6721db094612098433562a9a244834b35 · Zeichen 315–1385 im Abschnitt
Wechselwirkungen · Reyataz
REYATAZ 50 mg oral powder · Abschnitt 4.5 · PDF-Seite 60–61
HOS-112205 · Präparat HOS-093615
60
Medicinal products by Interaction Recommendations
therapeutic area concerning co-administration
SEDATIVES
Benzodiazepines
Midazolam Midazolam and triazolam are extensively Co-administration of
Triazolam metabolised by CYP3A4. Co- REYATAZ with triazolam or
administration with REYATAZ may cause orally administered midazolam
a large increase in the concentration of is contraindicated (see
these benzodiazepines. No drug interaction section 4.3), whereas caution
study has been performed for the co- should be used with co-
administration of REYATAZ with administration of REYATAZ
benzodiazepines. Based on data for other and parenteral midazolam. If
CYP3A4 inhibitors, plasma concentrations REYATAZ is co-administered
of midazolam are expected to be with parenteral midazolam, it
significantly higher when midazolam is should be done in an intensive
given orally. Data from concomitant use of care unit (ICU) or similar
parenteral midazolam with other protease setting which ensures close
inhibitors suggest a possible 3-4-fold clinical monitoring and
increase in midazolam plasma levels. appropriate medical
management in case of
respiratory depression and/or
prolonged sedation. Dosage
adjustment for midazolam
should be considered,
especially if more than a single
dose of midazolam is
administered.
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): protease (HOS-085623) triazolam (HOS-086168) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-06-29T13:00:00Z · SHA-256 ff5481974bd7c752b73fa0c147cf3e96fc892edc735359fa71817833db471beb · Passage f250a428a827d9b8c4affc6ad5576eaf38f2ba45cfd4b7267c714a1454016b78 · Zeichen 76500–79065 im Abschnitt
Wechselwirkungen · Lysodren
Lysodren 500 mg tablets · Abschnitt 4.5 · PDF-Seite 5
HOS-112484 · Präparat HOS-093689
Substances metabolised through cytochrome P450: Mitotane has been shown to have an inductive
effect on cytochrome P450 enzymes. Therefore, the plasma concentrations of the substances
metabolised via cytochrome P450 may be modified. In the absence of information on the specific
P450 isoenzymes involved, caution should be taken when co-prescribing active substances
metabolised by this route such as, among others, anticonvulsants, rifabutin, rifampicin, griseofulvin
and St. John’s wort (Hypericum perforatum). Particularly, mitotane has been shown to have an
inductive effect on cytochrome 3A4. Therefore, the plasma concentrations of the substances
metabolised via cytochrome 3A4 may be modified. Caution should be taken when co-prescribing
active substances metabolised by this pathway such as, among others, sunitinib, etoposide and
midazolam and dose should be adjusted as appropriate when coadministered with mitotane.
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): rifabutin (HOS-086262) etoposide (HOS-086021) sunitinib (HOS-109453) griseofulvin (HOS-091156) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-03-11T11:11:00Z · SHA-256 8857f8543d9dfcf9df89b956cb88735a9c924712c239c2879d16e7b6e36c86ba · Passage 33ffffa577eb2424a7b8528ae3d95c1068738efbcf5b41830673b01453bc3bf5 · Zeichen 546–1471 im Abschnitt
Wechselwirkungen · Emend
EMEND 125 mg hard capsules EMEND 80 mg hard capsules · Abschnitt 4.5 · PDF-Seite 5–6
HOS-112520 · Präparat HOS-093697
5
Midazolam
The potential effects of increased plasma concentrations of midazolam or other benzodiazepines
metabolised via CYP3A4 (alprazolam, triazolam) should be considered when co-administering these
medicinal products with EMEND (125 mg/80 mg).
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): alprazolam (HOS-086171) triazolam (HOS-086168) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-10-24T11:24:00Z · SHA-256 afd6062a51e59b36e448c9117685894e4529fcde2f5e673f4401f91bb32d7081 · Passage 9283b56525cd8268f7f278eb5e5e54ff213c77eec0da0f29a8d07e58a1efddb8 · Zeichen 4593–4842 im Abschnitt
Wechselwirkungen · Emend
EMEND 125 mg hard capsules EMEND 80 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6
HOS-112521 · Präparat HOS-093697
EMEND increased the AUC of midazolam, a sensitive CYP3A4 substrate, 2.3-fold on Day 1 and
3.3-fold on Day 5, when a single oral dose of 2 mg midazolam was co-administered on Days 1 and 5
of a regimen of EMEND 125 mg on Day 1 and 80 mg/day on Days 2 to 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): midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-10-24T11:24:00Z · SHA-256 afd6062a51e59b36e448c9117685894e4529fcde2f5e673f4401f91bb32d7081 · Passage b09c1c0dec4ce6835805f1960bad16cbd2b0521b165f8093b1c7877986571e00 · Zeichen 4844–5098 im Abschnitt
Wechselwirkungen · Emend
EMEND 125 mg hard capsules EMEND 80 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6
HOS-112522 · Präparat HOS-093697
In another study with intravenous administration of midazolam, EMEND was given as 125 mg on
Day 1 and 80 mg/day on Days 2 and 3, and 2 mg midazolam was given intravenously prior to the
administration of the 3-day regimen of EMEND and on Days 4, 8, and 15. EMEND increased the
AUC of midazolam 25 % on Day 4 and decreased the AUC of midazolam 19 % on Day 8 and 4 % on
Day 15. These effects were not considered clinically important.
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): midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-10-24T11:24:00Z · SHA-256 afd6062a51e59b36e448c9117685894e4529fcde2f5e673f4401f91bb32d7081 · Passage 977d699524a2bbee0b6285495a2b2588c4f73496dd259a1f23d6c6cc1845f945 · Zeichen 5100–5530 im Abschnitt
Wechselwirkungen · Emend
EMEND 125 mg hard capsules EMEND 80 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6
HOS-112523 · Präparat HOS-093697
In a third study with intravenous and oral administration of midazolam, EMEND was given as 125 mg
on Day 1 and 80 mg/day on Days 2 and 3, together with ondansetron 32 mg Day 1, dexamethasone
12 mg Day 1 and 8 mg Days 2-4. This combination (i.e. EMEND, ondansetron and dexamethasone)
decreased the AUC of oral midazolam 16 % on Day 6, 9 % on Day 8, 7 % on Day 15 and 17 % on
Day 22. These effects were not considered clinically important.
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): dexamethasone (HOS-084535) ondansetron (HOS-086052) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-10-24T11:24:00Z · SHA-256 afd6062a51e59b36e448c9117685894e4529fcde2f5e673f4401f91bb32d7081 · Passage e89a86f9bd9675653582dd455df89b4d981dfbcf92b2b749485aef8ad34dc053 · Zeichen 5532–5969 im Abschnitt
Wechselwirkungen · Emend
EMEND 125 mg hard capsules EMEND 80 mg hard capsules · Abschnitt 4.5 · PDF-Seite 6
HOS-112525 · Präparat HOS-093697
An additional study was completed with intravenous administration of midazolam and EMEND.
Intravenous 2 mg midazolam was given 1 hour after oral administration of a single dose of EMEND
125 mg. The plasma AUC of midazolam was increased by 1.5-fold. This effect was not considered
clinically important.
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): midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-10-24T11:24:00Z · SHA-256 afd6062a51e59b36e448c9117685894e4529fcde2f5e673f4401f91bb32d7081 · Passage 7e06fd4b393731f4204799b2a92d5ae250e28219b80b2446bc23261b4a9da302 · Zeichen 5971–6272 im Abschnitt
Wechselwirkungen · Emend
EMEND 125 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 23
HOS-112579 · Präparat HOS-093697
Midazolam
The potential effects of increased plasma concentrations of midazolam or other benzodiazepines
metabolised via CYP3A4 (alprazolam, triazolam) should be considered when co-administering these
medicinal products with EMEND (125 mg/80 mg).
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): alprazolam (HOS-086171) triazolam (HOS-086168) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-10-24T11:24:00Z · SHA-256 afd6062a51e59b36e448c9117685894e4529fcde2f5e673f4401f91bb32d7081 · Passage deeec11f3bbc3a506663309d02a6e82291238b60c2eed802f554c1d2491f51a9 · Zeichen 4541–4787 im Abschnitt
Wechselwirkungen · Emend
EMEND 125 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 23
HOS-112580 · Präparat HOS-093697
EMEND increased the AUC of midazolam, a sensitive CYP3A4 substrate, 2.3-fold on Day 1 and
3.3-fold on Day 5, when a single oral dose of 2 mg midazolam was co-administered on Days 1 and 5
of a regimen of EMEND 125 mg on Day 1 and 80 mg/day on Days 2 to 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): midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-10-24T11:24:00Z · SHA-256 afd6062a51e59b36e448c9117685894e4529fcde2f5e673f4401f91bb32d7081 · Passage b09c1c0dec4ce6835805f1960bad16cbd2b0521b165f8093b1c7877986571e00 · Zeichen 4789–5043 im Abschnitt
Wechselwirkungen · Emend
EMEND 125 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 23
HOS-112581 · Präparat HOS-093697
In another study with intravenous administration of midazolam, EMEND was given as 125 mg on
Day 1 and 80 mg/day on Days 2 and 3, and 2 mg midazolam was given intravenously prior to the
administration of the 3-day regimen of EMEND and on Days 4, 8, and 15. EMEND increased the
AUC of midazolam 25 % on Day 4 and decreased the AUC of midazolam 19 % on Day 8 and 4 % on
Day 15. These effects were not considered clinically important.
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): midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-10-24T11:24:00Z · SHA-256 afd6062a51e59b36e448c9117685894e4529fcde2f5e673f4401f91bb32d7081 · Passage 977d699524a2bbee0b6285495a2b2588c4f73496dd259a1f23d6c6cc1845f945 · Zeichen 5045–5475 im Abschnitt
Wechselwirkungen · Emend
EMEND 125 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 23
HOS-112582 · Präparat HOS-093697
In a third study with intravenous and oral administration of midazolam, EMEND was given as 125 mg
on Day 1 and 80 mg/day on Days 2 and 3, together with ondansetron 32 mg Day 1, dexamethasone
12 mg Day 1 and 8 mg Days 2-4. This combination (i.e. EMEND, ondansetron and dexamethasone)
decreased the AUC of oral midazolam 16 % on Day 6, 9 % on Day 8, 7 % on Day 15 and 17 % on
Day 22. These effects were not considered clinically important.
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): dexamethasone (HOS-084535) ondansetron (HOS-086052) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-10-24T11:24:00Z · SHA-256 afd6062a51e59b36e448c9117685894e4529fcde2f5e673f4401f91bb32d7081 · Passage e89a86f9bd9675653582dd455df89b4d981dfbcf92b2b749485aef8ad34dc053 · Zeichen 5477–5914 im Abschnitt
Wechselwirkungen · Emend
EMEND 125 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 23
HOS-112583 · Präparat HOS-093697
An additional study was completed with intravenous administration of midazolam and EMEND.
Intravenous 2 mg midazolam was given 1 hour after oral administration of a single dose of EMEND
125 mg. The plasma AUC of midazolam was increased by 1.5-fold. This effect was not considered
clinically important.
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): midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-10-24T11:24:00Z · SHA-256 afd6062a51e59b36e448c9117685894e4529fcde2f5e673f4401f91bb32d7081 · Passage 7e06fd4b393731f4204799b2a92d5ae250e28219b80b2446bc23261b4a9da302 · Zeichen 5916–6217 im Abschnitt
Wechselwirkungen · Faslodex
Faslodex 250 mg solution for injection. · Abschnitt 4.5 · PDF-Seite 4
HOS-112834 · Präparat HOS-093769
A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does
not inhibit CYP3A4. Clinical interaction studies with rifampicin (inducer of CYP3A4) and
ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance.
Dose adjustment is therefore not necessary in patients who are receiving fulvestrant and CYP3A4
inhibitors or inducers concomitantly.
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) midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-15T11:20:00Z · SHA-256 9f45335b79490cb1e57dbbfaec134717af9917dfaedd10e130c460e5e802a055 · Passage ea0a3f1fe4585c6575514fd3f0a73de4117069ae78cbcf5c87873c0648b9c24a · Zeichen 0–421 im Abschnitt
Wechselwirkungen · Emselex
Emselex 7.5 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 4
HOS-113074 · Präparat HOS-093835
CYP3A4 substrates
Darifenacin treatment resulted in a modest increase in the exposure of the CYP3A4 substrate
midazolam. However the data available do not indicate that darifenacin changes either midazolam
clearance or bioavailability. It can therefore be concluded that darifenacin administration does not alter
the pharmacokinetics of CYP3A4 substrates in vivo. The interaction with midazolam lacks clinical
relevance, and therefore no dose adjustment is needed for CYP3A4 substrates.
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): midazolam (HOS-086167)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-09-15T12:10:00Z · SHA-256 de750767f67ad57bdc05ce4c855b9a1fcf428d24652a741d2de5aacfc4e7ad1c · Passage c48cc827d98c28167d5b82dcc05e1e5cde830b263a9aebafc943c6d555ccce0c · Zeichen 2740–3226 im Abschnitt
Wechselwirkungen · Emselex
Emselex 15 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 14
HOS-113096 · Präparat HOS-093835
CYP3A4 substrates
Darifenacin treatment resulted in a modest increase in the exposure of the CYP3A4 substrate
midazolam. However the data available do not indicate that darifenacin changes either midazolam
clearance or bioavailability. It can therefore be concluded that darifenacin administration does not alter
the pharmacokinetics of CYP3A4 substrates in vivo. The interaction with midazolam lacks clinical
relevance, and therefore no dose adjustment is needed for CYP3A4 substrates.
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): midazolam (HOS-086167)
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Version 2025-09-15T12:10:00Z · SHA-256 de750767f67ad57bdc05ce4c855b9a1fcf428d24652a741d2de5aacfc4e7ad1c · Passage c48cc827d98c28167d5b82dcc05e1e5cde830b263a9aebafc943c6d555ccce0c · Zeichen 2740–3226 im Abschnitt
Wechselwirkungen · Noxafil
Noxafil 40 mg/mL oral suspension · Abschnitt 4.5 · PDF-Seite 7
HOS-114238 · Präparat HOS-094063
Effects of posaconazole on other medicinal products
Posaconazole is a potent inhibitor of CYP3A4. Co-administration of posaconazole with CYP3A4
substrates may result in large increases in exposure to CYP3A4 substrates as exemplified by the
effects on tacrolimus, sirolimus, atazanavir and midazolam below. Caution is advised during co-
administration of posaconazole with CYP3A4 substrates administered intravenously and the dose of
the CYP3A4 substrate may need to be reduced. If posaconazole is used concomitantly with CYP3A4
substrates that are administered orally, and for which an increase in plasma concentrations may be
associated with unacceptable adverse reactions, plasma concentrations of the CYP3A4 substrate
and/or adverse reactions should be closely monitored and the dose adjusted as needed. Several of the
interaction studies were conducted in healthy volunteers in whom a higher exposure to posaconazole
occurs compared to patients administered the same dose. The effect of posaconazole on CYP3A4
substrates in patients might be somewhat lower than that observed in healthy volunteers, and is
expected to be variable between patients due to the variable posaconazole exposure in patients. The
effect of co-administration with posaconazole on plasma levels of CYP3A4 substrates may also be
variable within a patient, unless posaconazole is administered in a strictly standardised way with food,
given the large food effect on posaconazole exposure (see section 5.2).
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): atazanavir (HOS-086180) tacrolimus (HOS-085202) sirolimus (HOS-085172) midazolam (HOS-086167)
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Version 2026-03-24T12:21:00Z · SHA-256 bfc2a27f2fb2c982d1e4beb55db11eb1ad163481d32f08c94b54ec38f96ef5b5 · Passage 4d8db9ab4da5f528b9b3b32a3fa059c0528f3fbadeee7292b4ed0e2e55753a06 · Zeichen 3087–4569 im Abschnitt
Wechselwirkungen · Noxafil
Noxafil 40 mg/mL oral suspension · Abschnitt 4.5 · PDF-Seite 8
HOS-114243 · Präparat HOS-094063
Midazolam and other benzodiazepines metabolised by CYP3A4
In a study in healthy volunteers, posaconazole oral suspension (200 mg once daily for 10 days)
increased the exposure (AUC) of intravenous midazolam (0.05 mg/kg) by 83 %. In another study in
healthy volunteers, repeat dose administration of posaconazole oral suspension (200 mg twice daily
for 7 days) increased the Cmax and AUC of intravenous midazolam (0.4 mg single dose) by an average
of 1.3 and 4.6-fold (range 1.7 to 6.4-fold), respectively; Posaconazole oral suspension 400 mg twice
daily for 7 days increased the intravenous midazolam Cmax and AUC by 1.6 and 6.2-fold (range 1.6 to
7.6-fold), respectively. Both doses of posaconazole increased Cmax and AUC of oral midazolam (2 mg
single oral dose) by 2.2 and 4.5-fold, respectively. In addition, posaconazole oral suspension (200 mg
or 400 mg) prolonged the mean terminal half-life of midazolam from approximately 3-4 hours to
8-10 hours during co-administration.
Due to the risk of prolonged sedation, it is recommended that dose adjustments of benzodiazepine that
are metabolised by CYP3A4 (e.g. midazolam, triazolam, alprazolam) should be considered when
posaconazole is administered concomitantly (see section 4.4) and also refer to the SmPC of the
corresponding benzodiazepines metabolised by CYP3A4.
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): alprazolam (HOS-086171) triazolam (HOS-086168) midazolam (HOS-086167)
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Version 2026-03-24T12:21:00Z · SHA-256 bfc2a27f2fb2c982d1e4beb55db11eb1ad163481d32f08c94b54ec38f96ef5b5 · Passage 43f1fb0eee43c47da9c703a407d1a5cb733f223a13639fbdf525190edc314902 · Zeichen 6006–7328 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.