Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 12

HOS-086192 · Präparat HOS-083284

Analgesics Buprenorphine 16 q24h 100 q12h ↑ 57% ↑ 77% Norbuprenorphine ↑ 33% ↑ 108% Glucuronide metabolites   The increases of plasma levels of buprenorphine and its active metabolite did not lead to clinically significant pharmacodynamic changes in a population of opioid tolerant patients. Adjustment to the dose of buprenorphine or ritonavir may therefore not be necessary when the two are dosed together. When ritonavir is used in combination with another protease inhibitor and buprenorphine, the SmPC of the co-administered protease inhibitor should be reviewed for specific dosing information.

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): buprenorphine (HOS-086193) lead (HOS-085592) protease (HOS-085623)

Wechselwirkungen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 44

HOS-086406 · Präparat HOS-083284

Analgesics Buprenorphine 16 q24h 100 q12h ↑ 57% ↑ 77% Norbuprenorphine ↑ 33% ↑ 108% Glucuronide metabolites   The increases of plasma levels of buprenorphine and its active metabolite did not lead to clinically significant pharmacodynamic changes in a population of opioid tolerant patients. Adjustment to the dose of buprenorphine or ritonavir may therefore not be necessary when the two are dosed together. When ritonavir is used in combination with another protease inhibitor and buprenorphine, the SmPC of the co-administered protease inhibitor should be reviewed for specific dosing information.

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): lead (HOS-085592) protease (HOS-085623) buprenorphine (HOS-086193)

Wechselwirkungen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.5 · PDF-Seite 24–25

HOS-108934 · Präparat HOS-093083

24  of lomitapide are expected to increase. Atorvastatin Atorvastatin: The combination of Kaletra with AUC: ↑ 5.9-fold atorvastatin is not recommended. Cmax: ↑ 4.7-fold If the use of atorvastatin is Due to CYP3A inhibition by considered strictly necessary, the lopinavir/ritonavir. lowest possible dose of atorvastatin should be administered with careful safety monitoring (see section 4.4). Rosuvastatin, 20 mg QD Rosuvastatin: Caution should be exercised and AUC: ↑ 2-fold reduced doses should be Cmax: ↑ 5-fold considered when Kaletra is While rosuvastatin is poorly co-administered with rosuvastatin metabolised by CYP3A4, an (see section 4.4). increase of its plasma concentrations was observed. The mechanism of this interaction may result from inhibition of transport proteins. Fluvastatin or Pravastatin Fluvastatin, Pravastatin: If treatment with an HMG-CoA No clinical relevant interaction reductase inhibitor is indicated, expected. fluvastatin or pravastatin is Pravastatin is not metabolised by recommended. CYP450. Fluvastatin is partially metabolised by CYP2C9. Opioids Buprenorphine, 16 mg QD Buprenorphine: ↔ No dose adjustment necessary.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): lomitapide (HOS-086160) atorvastatin (HOS-086304) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) pravastatin (HOS-086306) buprenorphine (HOS-086193)

Wechselwirkungen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 60–61

HOS-109023 · Präparat HOS-093083

60  No clinical relevant interaction fluvastatin or pravastatin is expected. recommended. Pravastatin is not metabolised by CYP450. Fluvastatin is partially metabolised by CYP2C9. Opioids Buprenorphine, 16 mg Buprenorphine: ↔ No dose adjustment necessary. QD Methadone Methadone: ↓ Monitoring plasma concentrations of methadone is recommended. Oral contraceptives Ethinyl Oestradiol Ethinyl Oestradiol: ↓ In case of co-administration of Kaletra with contraceptives containing ethinyl oestradiol (whatever the contraceptive formulation e.g. oral or patch), additional methods of contraception must be used. Smoking cessation aids Bupropion Buproprion and its active If the co-administration of Kaletra metabolite, hydroxybupropion: with bupropion is judged AUC and Cmax ↓ ~50% unavoidable, this should be done under close clinical monitoring for This effect may be due to bupropion efficacy, without induction of bupropion exceeding the recommended dosage, metabolism. despite the observed induction.

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): fluvastatin (HOS-086305) pravastatin (HOS-086306) buprenorphine (HOS-086193) methadone (HOS-086198) bupropion (HOS-086329)

Wechselwirkungen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 95–96

HOS-109101 · Präparat HOS-093083

95 Immunosuppressants Cyclosporin, Sirolimus Cyclosporin, Sirolimus More frequent therapeutic (rapamycin), and (rapamycin), Tacrolimus: concentration monitoring is Tacrolimus Concentrations may be increased recommended until plasma levels of due to CYP3A inhibition by these products have been stabilised. lopinavir/ritonavir. Lipid lowering agents Lovastatin and Lovastatin, Simvastatin: Since increased concentrations of Simvastatin Markedly increased plasma HMG-CoA reductase inhibitors concentrations due to CYP3A may cause myopathy, including inhibition by lopinavir/ritonavir. rhabdomyolysis, the combination of these agents with Kaletra is contraindicated (see section 4.3). Lipid-modifying agents Lomitapide CYP3A4 inhibitors increase the Concomitant use of Kaletra with exposure of lomitapide, with lomitapide is contraindicated (see strong inhibitors increasing prescribing information for exposure approximately 27-fold. lomitapide) (see section 4.3). Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of lomitapide are expected to increase. Atorvastatin Atorvastatin: The combination of Kaletra with AUC: ↑ 5.9-fold atorvastatin is not recommended. If Cmax: ↑ 4.7-fold the use of atorvastatin is considered Due to CYP3A inhibition by strictly necessary, the lowest lopinavir/ritonavir. possible dose of atorvastatin should be administered with careful safety monitoring (see section 4.4). Rosuvastatin, 20 mg QD Rosuvastatin: Caution should be exercised and AUC: ↑ 2-fold reduced doses should be considered Cmax: ↑ 5-fold when Kaletra is co-administered While rosuvastatin is poorly with rosuvastatin (see section 4.4). metabolised by CYP3A4, an increase of its plasma concentrations was observed. The mechanism of this interaction may result from inhibition of transport proteins. Fluvastatin or Fluvastatin, Pravastatin: If treatment with an HMG-CoA Pravastatin No clinical relevant interaction reductase inhibitor is indicated, expected. fluvastatin or pravastatin is Pravastatin is not metabolised by recommended. CYP450. Fluvastatin is partially metabolised by CYP2C9. Opioids Buprenorphine, 16 mg Buprenorphine: ↔ No dose adjustment necessary. QD Methadone Methadone: ↓ Monitoring plasma concentrations of methadone 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): sirolimus (HOS-085172) tacrolimus (HOS-085202) lovastatin (HOS-086157) simvastatin (HOS-086158) lomitapide (HOS-086160) atorvastatin (HOS-086304) rosuvastatin (HOS-086307) fluvastatin (HOS-086305) pravastatin (HOS-086306) buprenorphine (HOS-086193) methadone (HOS-086198)

Wechselwirkungen · Reyataz

REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 23–24

HOS-112117 · Präparat HOS-093615

23 Medicinal products by Interaction Recommendations concerning co- therapeutic area administration OPIOIDS Buprenorphine, once daily, Buprenorphine AUC: ↑67% Co-administration with REYATAZ stable maintenance dose Buprenorphine Cmax: ↑37% with ritonavir warrants clinical (atazanavir 300 mg once daily Buprenorphine Cmin: ↑69% monitoring for sedation and with ritonavir 100 mg once daily) cognitive effects. A dose reduction Norbuprenorphine AUC: ↑105% of buprenorphine may be Norbuprenorphine Cmax: ↑61% considered. Norbuprenorphine Cmin: ↑101%

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): buprenorphine (HOS-086193) ritonavir (HOS-084521)

Wechselwirkungen · Reyataz

REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 24–25

HOS-112119 · Präparat HOS-093615

24 In case of withdrawal of ritonavir from the recommended atazanavir-boosted regimen (see section 4.4) The same recommendations for drug interactions would apply except:  that co-administration is not recommended with tenofovir, proton pump inhibitors, and buprenorphine and contraindicated with carbamazepine, phenytoin and phenobarbital.  that co-administration with famotidine is not recommended but if required, atazanavir without ritonavir should be administered either 2 hours after famotidine or 12 hours before. No single dose of famotidine should exceed 20 mg, and the total daily dose of famotidine should not exceed 40 mg.  the need to consider that:  co-administration of apixaban, dabigatran, or rivaroxaban and REYATAZ without ritonavir may affect apixaban, dabigatran, or rivaroxaban concentrations  co-administration of voriconazole and REYATAZ without ritonavir may affect atazanavir concentrations  co-administration of fluticasone and REYATAZ without ritonavir may increase fluticasone concentrations relative to fluticasone given alone  if an oral contraceptive is administered with REYATAZ without ritonavir, it is recommended that the oral contraceptive contain no more than 30 μg of ethinyloestradiol  no dose adjustment of lamotrigine is required

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): apixaban (HOS-112091) dabigatran (HOS-112096) rivaroxaban (HOS-086236) voriconazole (HOS-084524) fluticasone (HOS-108914) lamotrigine (HOS-086242) ritonavir (HOS-084521) tenofovir (HOS-088083) buprenorphine (HOS-086193) carbamazepine (HOS-085618) phenytoin (HOS-084531) phenobarbital (HOS-085617) famotidine (HOS-112087)

Wechselwirkungen · Reyataz

REYATAZ 50 mg oral powder · Abschnitt 4.5 · PDF-Seite 60

HOS-112203 · Präparat HOS-093615

The mechanism of interaction is CYP3A4 inhibition by atazanavir and/or ritonavir. OPIOIDS Buprenorphine, once daily, Buprenorphine AUC: ↑67% Co-administration with stable maintenance dose Buprenorphine Cmax: ↑37% REYATAZ with ritonavir (atazanavir 300 mg once daily Buprenorphine Cmin: ↑69% warrants clinical monitoring with ritonavir 100 mg once for sedation and cognitive daily) Norbuprenorphine AUC: ↑105% effects. A dose reduction of Norbuprenorphine Cmax: ↑61% buprenorphine may be Norbuprenorphine Cmin: ↑101% considered.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ritonavir (HOS-084521) buprenorphine (HOS-086193)

Wechselwirkungen · Prialt

Prialt 25 micrograms/mL solution for infusion · Abschnitt 4.5 · PDF-Seite 6

HOS-113017 · Präparat HOS-093821

No data are available regarding the concomitant use of partial opioid agonists (e.g. buprenorphine) with ziconotide.

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): buprenorphine (HOS-086193)

Wechselwirkungen · Prialt

Prialt 100 micrograms/mL solution for infusion · Abschnitt 4.5 · PDF-Seite 22

HOS-113046 · Präparat HOS-093821

No data are available regarding the concomitant use of partial opioid agonists (e.g. buprenorphine) with ziconotide.

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): buprenorphine (HOS-086193)

Wechselwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 18

HOS-114838 · Präparat HOS-094169

Mechanism unknown Meperidine Tipranavir, co-administered with Dosage increase and long-term No interaction study low dose ritonavir, is expected to use of meperidine with Aptivus, performed decrease meperidine co-administered with low dose concentrations and increase ritonavir, are not recommended normeperidine metabolite due to the increased concentrations. concentrations of the metabolite normeperidine which has both analgesic activity and CNS stimulant activity (e.g. seizures). Buprenorphine/Naloxone Buprenorphine ↔ Due to reduction in the levels of the active metabolite Norbuprenorphine AUC  79% norbuprenorphine, co- Norbuprenorphine Cmax  80% administration of Aptivus, co- Norbuprenorphine Cmin  80% administered with low dose ritonavir, and buprenorphine/naloxone may result in decreased clinical efficacy of buprenorphine. Therefore, patients should be monitored for opiate withdrawal syndrome. Immunosupressants Cyclosporin Concentrations of cyclosporin, More frequent concentration Tacrolimus tacrolimus, or sirolimus cannot monitoring of these medicinal Sirolimus be predicted when co- products is recommended until No interaction study administered with tipranavir co- blood levels have been stabilised. performed administered with low dose ritonavir, due to conflicting effect of tipranavir, co-administered with low dose ritonavir, on CYP 3A and P-gp.

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): meperidine (HOS-114839) ritonavir (HOS-084521) buprenorphine (HOS-086193) naloxone (HOS-109490) tacrolimus (HOS-085202) sirolimus (HOS-085172)

Gegenanzeigen · Suboxone

Suboxone 2 mg/0.5 mg sublingual tablets Suboxone 8 mg/2 mg sublingual tablets Suboxone 16 mg/4 mg sublingual tablets · Abschnitt 4.3 · PDF-Seite 5

HOS-115835 · Präparat HOS-094369

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Severe respiratory insufficiency Severe hepatic impairment Acute alcoholism or delirium tremens. Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence.

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): naltrexone (HOS-115836) nalmefene (HOS-115837)

Gegenanzeigen · Suboxone

Suboxone 2 mg/0.5 mg sublingual film Suboxone 4 mg/1 mg sublingual film Suboxone 8 mg/2 mg sublingual film Suboxone 12 mg/3 mg sublingual film · Abschnitt 4.3 · PDF-Seite 22

HOS-115868 · Präparat HOS-094369

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 • Severe respiratory insufficiency • Severe hepatic impairment • Acute alcoholism or delirium tremens • Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence

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): naltrexone (HOS-115836) nalmefene (HOS-115837)

Wechselwirkungen · Suboxone

Suboxone 2 mg/0.5 mg sublingual tablets Suboxone 8 mg/2 mg sublingual tablets Suboxone 16 mg/4 mg sublingual tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-115838 · Präparat HOS-094369

Buprenorphine/naloxone should not be taken together with:

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

Wechselwirkungen · Suboxone

Suboxone 2 mg/0.5 mg sublingual tablets Suboxone 8 mg/2 mg sublingual tablets Suboxone 16 mg/4 mg sublingual tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-115839 · Präparat HOS-094369

• Alcoholic drinks or medicinal products containing alcohol, as alcohol increases the sedative effect of buprenorphine (see section 4.7).

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

Wechselwirkungen · Suboxone

Suboxone 2 mg/0.5 mg sublingual tablets Suboxone 8 mg/2 mg sublingual tablets Suboxone 16 mg/4 mg sublingual tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-115840 · Präparat HOS-094369

Suboxone should be used cautiously when co-administered with:

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

Wechselwirkungen · Suboxone

Suboxone 2 mg/0.5 mg sublingual tablets Suboxone 8 mg/2 mg sublingual tablets Suboxone 16 mg/4 mg sublingual tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-115841 · Präparat HOS-094369

• 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).

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

Wechselwirkungen · Suboxone

Suboxone 2 mg/0.5 mg sublingual tablets Suboxone 8 mg/2 mg sublingual tablets Suboxone 16 mg/4 mg sublingual tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-115842 · Präparat HOS-094369

• The concomitant use of Suboxone with gabapentinoids (gabapentin and pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or death (see section 4.4).

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): gabapentin (HOS-090745) pregabalin (HOS-112893)

Wechselwirkungen · Suboxone

Suboxone 2 mg/0.5 mg sublingual tablets Suboxone 8 mg/2 mg sublingual tablets Suboxone 16 mg/4 mg sublingual tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-115845 · Präparat HOS-094369

• 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.

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) clonidine (HOS-088594)

Wechselwirkungen · Suboxone

Suboxone 2 mg/0.5 mg sublingual tablets Suboxone 8 mg/2 mg sublingual tablets Suboxone 16 mg/4 mg sublingual tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-115847 · Präparat HOS-094369

• 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.

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