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 · Levetiracetam ratiopharm
Levetiracetam ratiopharm 250 mg film-coated tablets Levetiracetam ratiopharm 500 mg film-coated tablets Levetiracetam ratiopharm 750 mg film-coated tablets Levetiracetam ratiopharm 1000 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7
HOS-213801 · Präparat HOS-155212
Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not
influence the serum concentrations of existing antiepileptic medicinal products (phenytoin,
carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these
antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
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): lamotrigine (HOS-086242) phenobarbital (HOS-085617) valproic acid (HOS-088515) carbamazepine (HOS-085618) gabapentin (HOS-090745) phenytoin (HOS-084531) primidone (HOS-090551)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-01-26T17:59:00Z · SHA-256 f83b9a6129b8ef5144ae86c3c40558f640cbeaa7f135ea04834f52af3d8864f5 · Passage 3d93f217e5b0a03091325c1814b08fbb37f614d3426166333825c0448bec7ce9 · Zeichen 34–411 im Abschnitt
Wechselwirkungen · Levetiracetam ratiopharm
Levetiracetam ratiopharm 100 mg/ml oral solution · Abschnitt 4.5 · PDF-Seite 27
HOS-213832 · Präparat HOS-155212
Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not
influence the serum concentrations of existing antiepileptic medicinal products (phenytoin,
carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these
antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
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): lamotrigine (HOS-086242) phenobarbital (HOS-085617) valproic acid (HOS-088515) carbamazepine (HOS-085618) gabapentin (HOS-090745) phenytoin (HOS-084531) primidone (HOS-090551)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-01-26T17:59:00Z · SHA-256 f83b9a6129b8ef5144ae86c3c40558f640cbeaa7f135ea04834f52af3d8864f5 · Passage 3d93f217e5b0a03091325c1814b08fbb37f614d3426166333825c0448bec7ce9 · Zeichen 34–411 im Abschnitt
Wechselwirkungen · Levetiracetam Accord
Levetiracetam Accord 250 mg film-coated tablets Levetiracetam Accord 500 mg film-coated tablets Levetiracetam Accord 750 mg film-coated tablets Levetiracetam Accord 1000 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7
HOS-214182 · Präparat HOS-155288
Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not
influence the serum concentrations of existing antiepileptic medicinal products (phenytoin,
carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these
antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
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): lamotrigine (HOS-086242) phenobarbital (HOS-085617) valproic acid (HOS-088515) carbamazepine (HOS-085618) gabapentin (HOS-090745) phenytoin (HOS-084531) primidone (HOS-090551)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-12-09T02:00:00Z · SHA-256 ec3de1977942bc302d179ba3cf5ac8635c815ee58daca279cdcc4d00ec8f450f · Passage 3d93f217e5b0a03091325c1814b08fbb37f614d3426166333825c0448bec7ce9 · Zeichen 34–411 im Abschnitt
Wechselwirkungen · Levetiracetam Actavis Group
Levetiracetam Actavis Group 100 mg/ml oral solution · Abschnitt 4.5 · PDF-Seite 8
HOS-125183 · Präparat HOS-096021
Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not
influence the serum concentrations of existing antiepileptic medicinal products (phenytoin,
carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these
antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
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): lamotrigine (HOS-086242) phenobarbital (HOS-085617) valproic acid (HOS-088515) carbamazepine (HOS-085618) gabapentin (HOS-090745) phenytoin (HOS-084531) primidone (HOS-090551)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-01-26T13:19:00Z · SHA-256 922445385f872a12bb2cbb8705a2e36092efd96aae1726df5bc6e965246270d2 · Passage 3d93f217e5b0a03091325c1814b08fbb37f614d3426166333825c0448bec7ce9 · Zeichen 34–411 im Abschnitt
Wechselwirkungen · Levetiracetam Teva
Levetiracetam Teva 250 mg film-coated tablets Levetiracetam Teva 500 mg film-coated tablets Levetiracetam Teva 750 mg film-coated tablets Levetiracetam Teva 1000 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7
HOS-214456 · Präparat HOS-155334
Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not
influence the serum concentrations of existing antiepileptic medicinal products (phenytoin,
carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these
antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
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): lamotrigine (HOS-086242) phenobarbital (HOS-085617) valproic acid (HOS-088515) carbamazepine (HOS-085618) gabapentin (HOS-090745) phenytoin (HOS-084531) primidone (HOS-090551)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-01-26T11:57:00Z · SHA-256 00c2f434cd2af751cf182e14e81590dcb66cb2d00e251e330133d26672f07777 · Passage 3d93f217e5b0a03091325c1814b08fbb37f614d3426166333825c0448bec7ce9 · Zeichen 34–411 im Abschnitt
Wechselwirkungen · Efavirenz Teva
Efavirenz Teva 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 15–16
HOS-215301 · Präparat HOS-155418
15
Medicinal product by Effects on drug levels Recommendation concerning
therapeutic areas Mean percent change in AUC, co-administration with
(dose) Cmax, Cmin with confidence efavirenz
intervals if availablea
(mechanism)
Vigabatrin/efavirenz Interaction not studied. Clinically No dose adjustment is necessary
Gabapentin/efavirenz significant interactions are not for any of these medicinal
expected since vigabatrin and products.
gabapentin are exclusively eliminated
unchanged in the urine and are
unlikely to compete for the same
metabolic enzymes and elimination
pathways as efavirenz.
ANTIDEPRESSANTS
Selective Serotonin Reuptake Inhibitors (SSRIs)
Sertraline/efavirenz Sertraline: Sertraline dose increases should
(50 mg once daily/600 mg once AUC: ↓ 39% (↓ 27 to ↓ 50) be guided by clinical response.
daily) Cmax: ↓ 29% (↓ 15 to ↓ 40) No dose adjustment is necessary
Cmin: ↓ 46% (↓ 31 to ↓ 58) for efavirenz.
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): vigabatrin (HOS-115599) gabapentin (HOS-090745) serotonin (HOS-085477) sertraline (HOS-086247)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2023-03-03T18:18:00Z · SHA-256 d2c4a637bb18ba1e0c98c69218ce14671957659a5aa55fba40e74b1bf5620382 · Passage e27e9ae72c851e114aa5c2ee81c0dc43bac54fa507bcdb52f0b715be7d40555f · Zeichen 43513–44993 im Abschnitt
Wechselwirkungen · Levetiracetam Actavis
Levetiracetam Actavis 250 mg film-coated tablets Levetiracetam Actavis 500 mg film-coated tablets Levetiracetam Actavis 750 mg film-coated tablets Levetiracetam Actavis 1000 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7
HOS-215362 · Präparat HOS-155426
Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not
influence the serum concentrations of existing antiepileptic medicinal products (phenytoin,
carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these
antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
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): lamotrigine (HOS-086242) phenobarbital (HOS-085617) valproic acid (HOS-088515) carbamazepine (HOS-085618) gabapentin (HOS-090745) phenytoin (HOS-084531) primidone (HOS-090551)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-01-26T11:59:00Z · SHA-256 916ec26b98afabaca46e661dbea86bf6238c924e4065aa7e8dde03fecd868db3 · Passage 3d93f217e5b0a03091325c1814b08fbb37f614d3426166333825c0448bec7ce9 · Zeichen 34–411 im Abschnitt
Wechselwirkungen · Pregabalin Viatris Pharma (previously Pregabalin Pfizer)
Pregabalin Viatris Pharma 25 mg hard capsules Pregabalin Viatris Pharma 50 mg hard capsules Pregabalin Viatris Pharma 75 mg hard capsules Pregabalin Viatris Pharma 100 mg hard capsules Pregabalin Viatris Pharma 150 mg hard capsules Pregabalin Viatris Pharma 200 mg hard capsules Pregabalin Viatris Pharma 225 mg hard capsules Pregabalin Viatris Pharma 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 8
HOS-132656 · Präparat HOS-097274
In vivo studies and population pharmacokinetic analysis
Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed
between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam,
oxycodone or ethanol. Population pharmacokinetic analysis indicated that oral antidiabetics, diuretics,
insulin, phenobarbital, tiagabine and topiramate had no clinically significant effect on pregabalin
clearance.
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): lamotrigine (HOS-086242) tiagabine (HOS-112899) topiramate (HOS-110310) phenobarbital (HOS-085617) valproic acid (HOS-088515) carbamazepine (HOS-085618) oxycodone (HOS-109487) lorazepam (HOS-085981) gabapentin (HOS-090745) ethanol (HOS-089988) phenytoin (HOS-084531)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-24T15:36:00Z · SHA-256 82ee888afd9191364ca2885cfe33f3a6014857efdff1de95ea2361849731a42c · Passage da089224ea0ec4abc0cbed18c715ba22143350e7ab711c5dc56268bbae3381d5 · Zeichen 317–785 im Abschnitt
Wechselwirkungen · Pregabalin Sandoz
Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 7
HOS-133709 · Präparat HOS-097488
In vivo studies and population pharmacokinetic analysis
Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed
between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam,
oxycodone or ethanol. Population pharmacokinetic analysis indicated that oral antidiabetics, diuretics,
insulin, phenobarbital, tiagabine and topiramate had no clinically significant effect on pregabalin
clearance.
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): lamotrigine (HOS-086242) tiagabine (HOS-112899) topiramate (HOS-110310) phenobarbital (HOS-085617) valproic acid (HOS-088515) carbamazepine (HOS-085618) oxycodone (HOS-109487) lorazepam (HOS-085981) gabapentin (HOS-090745) ethanol (HOS-089988) phenytoin (HOS-084531)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-12-02T15:55:00Z · SHA-256 cf6544444859a0bf688557553e6f137bac82b24f016c6d9cb4756ad6de2112ce · Passage da089224ea0ec4abc0cbed18c715ba22143350e7ab711c5dc56268bbae3381d5 · Zeichen 317–785 im Abschnitt
Wechselwirkungen · Dzuveo
Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.5 · PDF-Seite 5
HOS-137931 · Präparat HOS-098113
The concomitant use of CNS depressants including barbiturates, benzodiazepines, neuroleptics or
other opioids, halogen gases or other non-selective CNS depressants (e.g. alcohol) may enhance
respiratory depression.
The concomitant use of opioids and gabapentinoids (gabapentin and pregabalin) increases the risk of
opioid overdose, respiratory depression and death.
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): pregabalin (HOS-112893) gabapentin (HOS-090745)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-08-04T09:41:00Z · SHA-256 11a627f517ef165f1c214a9467017376a3e2707d6037112cbc10731d39d973c1 · Passage 99e830e324d6c18f74fe612d36c2d5fd440eb29e55c1d4ea465479260c00dc0a · Zeichen 1118–1483 im Abschnitt
Wechselwirkungen · Zubsolv
Zubsolv 0.7 mg/0.18 mg sublingual tablets Zubsolv 1.4 mg/0.36 mg sublingual tablets Zubsolv 2.9 mg/0.71 mg sublingual tablets Zubsolv 5.7 mg/1.4 mg sublingual tablets Zubsolv 8.6 mg/2.1 mg sublingual tablets Zubsolv 11.4 mg/2.9 mg sublingual tablets · Abschnitt 4.5 · PDF-Seite 9–10
HOS-138581 · Präparat HOS-098216
Zubsolv should be used cautiously when co-administered with:
• Sedatives such as benzodiazepines or related medicinal products
The concomitant use of opioids with sedative medicinal products such as benzodiazepines or
related medicinal products increases the risk of sedation, respiratory depression, coma and
death because of additive CNS depressant effect. The dose and duration of concomitant use
of sedative medicinal products should be limited (see section 4.4). Patients should be
warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines
while taking this medicinal product and should also be cautioned to use benzodiazepines
concurrently with this medicinal product only as directed by their physician (see
section 4.4).
• The concomitant use of Zubsolv with gabapentinoids (gabapentin and pregabalin) may
result in respiratory depression, hypotension, profound sedation, coma or death (see section
4.4).
• Other central nervous system depressants, other opioid derivatives (e.g. methadone,
analgesics and antitussives), certain antidepressants, sedative H1-receptor antagonists,
barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related
substances: these combinations increase central nervous system depression. The reduced
level of alertness can make driving and using machines hazardous.
• Furthermore, adequate analgesia may be difficult to achieve when administering a full opioid
agonist in patients receiving buprenorphine/naloxone. Therefore the potential to overdose
with a full agonist exists, especially when attempting to overcome buprenorphine partial
agonist effects, or when buprenorphine plasma levels are declining
• Serotonergic medicinal products, such as MAO inhibitors, selective serotonin re-uptake
inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic
antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is
increased (see section 4.4)
• naltrexone and nalmefene are opioid antagonists that can block the pharmacological effects
of buprenorphine. Co-administration during buprenorphine/naloxone treatment is
9
contraindicated due to the potentially dangerous interaction that may precipitate a sudden
onset of prolonged and intense opioid withdrawal symptoms (see section 4.3).
• CYP3A4 inhibitors: an interaction study of buprenorphine with ketoconazole (a potent
inhibitor of CYP3A4) resulted in increased Cmax and AUC (area under the curve) of
buprenorphine (approximately 50 % and 70 % respectively) and, to a lesser extent, of
norbuprenorphine Patients receiving Zubsolv should be closely monitored, and may require
dose-reduction if combined with potent CYP3A4 inhibitors (e.g. protease inhibitors like
ritonavir, nelfinavir or indinavir or azole antifungals such as ketoconazole or itraconazole,
macrolide antibiotics).
• CYP3A4 inducers: Concomitant use of CYP3A4 inducers with buprenorphine may
decrease buprenorphine plasma concentrations, potentially resulting in sub-optimal
treatment of opioid dependence with buprenorphine. It is recommended that patients
receiving buprenorphine/naloxone should be closely monitored if inducers (e.g.
phenobarbital, carbamazepine, phenytoin, rifampicin) are co-administered. The dose of
buprenorphine or the CYP3A4 inducer may need to be adjusted accordingly.
• The concomitant use of monoamine oxidase inhibitors (MAOI) might produce
exaggeration of the effects of opioids, based on experience with morphine.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): indinavir (HOS-084518) pregabalin (HOS-112893) norepinephrine (HOS-090547) nelfinavir (HOS-084520) methadone (HOS-086198) protease (HOS-085623) phenobarbital (HOS-085617) ketoconazole (HOS-084513) clonidine (HOS-088594) carbamazepine (HOS-085618) naltrexone (HOS-115836) nalmefene (HOS-115837) morphine (HOS-086053) gabapentin (HOS-090745) serotonin (HOS-085477) itraconazole (HOS-084516) ritonavir (HOS-084521) phenytoin (HOS-084531)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-12-08T09:49:00Z · SHA-256 5abf2fbb0a7fd36ed1be04f576c9d6b4a021a25a707c692fa21b326376a4f2b5 · Passage 36507a34d513c06aeda586e977de80135455da379f00364e466d3a649d3e2c11 · Zeichen 232–4044 im Abschnitt
Wechselwirkungen · Buvidal
Buvidal 8 mg prolonged-release solution for injection Buvidal 16 mg prolonged-release solution for injection Buvidal 24 mg prolonged-release solution for injection Buvidal 32 mg prolonged-release solution for injection · Abschnitt 4.5 · PDF-Seite 8
HOS-140298 · Präparat HOS-098498
Buprenorphine should be used cautiously when co-administered with:
• naltrexone and nalmefene: These are opioid antagonists that can block the pharmacological
effects of buprenorphine. For opioid-dependent patients currently receiving buprenorphine
treatment, naltrexone may precipitate a sudden onset of prolonged and intense opioid
withdrawal symptoms. For patients currently receiving naltrexone treatment, the intended
therapeutic effects of buprenorphine administration may be blocked by naltrexone.
• alcoholic drinks or medicinal products containing alcohol as alcohol increases the sedative
effect of buprenorphine (see section 4.7).
• benzodiazepines: This combination may result in death due to respiratory depression of central
origin. Therefore, dosages must be closely monitored and this combination must be avoided in
cases where there is a risk of misuse. Patients should be warned that it is extremely dangerous to
self-administer non-prescribed benzodiazepines whilst taking this product, and should also be
cautioned to use benzodiazepines concurrently with this product only as directed by their
physician (see section 4.4).
• gabapentinoids: The concomitant use of Buvidal with gabapentinoids (gabapentin and
pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or
death. Therefore, dosages must be closely monitored and this combination must be avoided in
cases where there is a risk of misuse. Patients should be cautioned to use gabapentinoids
concurrently with this product only as directed by their physician (see section 4.4).
• Serotonergic medicinal products, such as MAO inhibitors, selective serotonin re-uptake
inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic
antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is
increased (see section 4.4).
• other central nervous system depressants: Other opioid derivatives (e.g. methadone, analgesics
and antitussives); certain antidepressants, sedative H1-receptor antagonists, barbiturates,
anxiolytics other than benzodiazepines, antipsychotics, clonidine and related substances. These
combinations increase central nervous system depression. The reduced level of alertness can
make driving and using machinery hazardous (see section 4.7).
• opioid analgesics: Adequate analgesia may be difficult to achieve when administering a full
opioid agonist in patients receiving buprenorphine. The potential for overdose also exists with a
full agonist, especially when attempting to overcome buprenorphine partial agonist effects, or
when buprenorphine plasma levels are declining (see section 4.4)
• Buprenorphine is metabolised to norbuprenorphine primarily by CYP3A4. Interaction with co-
administered inducers or inhibitors have been established in studies using transmucosal and
transdermal buprenorphine. Buprenorphine is also metabolised to buprenorphine-3β-
glucuronide by UGT1A1.
• CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased
Cmax and AUC of buprenorphine and norbuprenorphine. Buvidal avoids first-pass effects
and CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, or
azole antifungals such as ketoconazole or itraconazole, or macrolide antibiotics) are
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): indinavir (HOS-084518) pregabalin (HOS-112893) norepinephrine (HOS-090547) nelfinavir (HOS-084520) methadone (HOS-086198) protease (HOS-085623) ketoconazole (HOS-084513) clonidine (HOS-088594) naltrexone (HOS-115836) nalmefene (HOS-115837) gabapentin (HOS-090745) serotonin (HOS-085477) itraconazole (HOS-084516) ritonavir (HOS-084521)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-03-21T17:42:00Z · SHA-256 1ad9ce13109b545d01c45ffd56cec5dc90c2b7294f4e2ae1f7e5e985c1a064eb · Passage 2507cd2f2663aa4a74d791faab2504c7371d895671fa1111e3aab02507c0c573 · Zeichen 58–3582 im Abschnitt
Wechselwirkungen · Buvidal
Buvidal 64 mg prolonged-release solution for injection Buvidal 96 mg prolonged-release solution for injection Buvidal 128 mg prolonged-release solution for injection Buvidal 160 mg prolonged-release solution for injection · Abschnitt 4.5 · PDF-Seite 24
HOS-140339 · Präparat HOS-098498
Buprenorphine should be used cautiously when co-administered with:
• naltrexone and nalmefene: These are opioid antagonists that can block the pharmacological
effects of buprenorphine. For opioid-dependent patients currently receiving buprenorphine
treatment, naltrexone may precipitate a sudden onset of prolonged and intense opioid
withdrawal symptoms. For patients currently receiving naltrexone treatment, the intended
therapeutic effects of buprenorphine administration may be blocked by naltrexone.
• alcoholic drinks or medicinal products containing alcohol as alcohol increases the sedative
effect of buprenorphine (see section 4.7).
• benzodiazepines: This combination may result in death due to respiratory depression of central
origin. Therefore, dosages must be closely monitored and this combination must be avoided in
cases where there is a risk of misuse. Patients should be warned that it is extremely dangerous to
self-administer non-prescribed benzodiazepines whilst taking this product, and should also be
cautioned to use benzodiazepines concurrently with this product only as directed by their
physician (see section 4.4).
• gabapentinoids: The concomitant use of Buvidal with gabapentinoids (gabapentin and
pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or
death. Therefore, dosages must be closely monitored and this combination must be avoided in
cases where there is a risk of misuse. Patients should be cautioned to use gabapentinoids
concurrently with this product only as directed by their physician (see section 4.4).
• Serotonergic medicinal products, such as MAO inhibitors, selective serotonin re-uptake
inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic
antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is
increased (see section 4.4).
• other central nervous system depressants: Other opioid derivatives (e.g. methadone, analgesics
and antitussives); certain antidepressants, sedative H1-receptor antagonists, barbiturates,
anxiolytics other than benzodiazepines, antipsychotics, clonidine and related substances. These
combinations increase central nervous system depression. The reduced level of alertness can
make driving and using machinery hazardous (see section 4.7).
• opioid analgesics: Adequate analgesia may be difficult to achieve when administering a full
opioid agonist in patients receiving buprenorphine. The potential for overdose also exists with a
full agonist, especially when attempting to overcome buprenorphine partial agonist effects, or
when buprenorphine plasma levels are declining (see section 4.4)
• Buprenorphine is metabolised to norbuprenorphine primarily by CYP3A4. Interaction with co-
administered inducers or inhibitors have been established in studies using transmucosal and
transdermal buprenorphine. Buprenorphine is also metabolised to buprenorphine-3β-
glucuronide by UGT1A1.
• CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased
Cmax and AUC of buprenorphine and norbuprenorphine. Buvidal avoids first-pass effects
and CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, or
azole antifungals such as ketoconazole or itraconazole, or macrolide antibiotics) are
expected to have less effects on buprenorphine metabolism when co-administered with
Buvidal as compared to when co-administered with sublingual buprenorphine. When
switching from sublingual buprenorphine to Buvidal, patients may need to be monitored
to ensure plasma buprenorphine levels are adequate.
Patients already on Buvidal who start treatment with CYP3A4 inhibitors should be
treated with weekly Buvidal and be monitored for signs and symptoms of overtreatment.
Conversely, if a patient who is concomitantly treated with Buvidal and a 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): indinavir (HOS-084518) pregabalin (HOS-112893) norepinephrine (HOS-090547) nelfinavir (HOS-084520) methadone (HOS-086198) protease (HOS-085623) ketoconazole (HOS-084513) clonidine (HOS-088594) naltrexone (HOS-115836) nalmefene (HOS-115837) gabapentin (HOS-090745) serotonin (HOS-085477) itraconazole (HOS-084516) ritonavir (HOS-084521)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-03-21T17:42:00Z · SHA-256 1ad9ce13109b545d01c45ffd56cec5dc90c2b7294f4e2ae1f7e5e985c1a064eb · Passage a29834a297e58897f230ac85a5938fedfb1c445658da5ff294f0999631e2634e · Zeichen 58–4215 im Abschnitt
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