Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Xalkori

XALKORI 200 mg hard capsules XALKORI 250 mg hard capsules XALKORI 20 mg granules in capsules for opening XALKORI 50 mg granules in capsules for opening XALKORI 150 mg granules in capsules for opening · Abschnitt 4.5 · PDF-Seite 15

HOS-126281 · Präparat HOS-096239

In vitro studies indicated that crizotinib is an inhibitor of CYP2B6. Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered medicinal products that are metabolised by CYP2B6 (e.g., bupropion, 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): bupropion (HOS-086329) efavirenz (HOS-087947)

Wechselwirkungen · Brintellix

Brintellix 5 mg film-coated tablets Brintellix 10 mg film-coated tablets Brintellix 15 mg film-coated tablets Brintellix 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-128728 · Präparat HOS-096615

Medicinal products lowering the seizure threshold Antidepressants with serotonergic effect can lower the seizure threshold. Caution is advised when concomitantly using other medicinal products capable of lowering the seizure threshold [e.g., antidepressants (tricyclics, SSRIs, SNRIs), neuroleptics (phenothiazines, thioxanthenes and butyrophenones), mefloquine, bupropion, tramadol] (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): bupropion (HOS-086329) mefloquine (HOS-113850) tramadol (HOS-112871)

Wechselwirkungen · Brintellix

Brintellix 5 mg film-coated tablets Brintellix 10 mg film-coated tablets Brintellix 15 mg film-coated tablets Brintellix 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6–7

HOS-128731 · Präparat HOS-096615

6 CYP2D6 inhibitors The exposure to vortioxetine increased 2.3-fold for area under the curve (AUC) when vortioxetine 10 mg/day was co-administered with bupropion (a strong CYP2D6 inhibitor 150 mg twice daily) for 14 days in healthy subjects. Co-administration resulted in a higher incidence of adverse reactions when bupropion was added to vortioxetine than when vortioxetine was added to bupropion. Depending on individual patient response, a lower dose of vortioxetine may be considered if strong CYP2D6 inhibitor (e.g., bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment (see section 4.2).

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): paroxetine (HOS-086246) bupropion (HOS-086329) quinidine (HOS-085593) fluoxetine (HOS-085946)

Wechselwirkungen · Brintellix

Brintellix 5 mg film-coated tablets Brintellix 10 mg film-coated tablets Brintellix 15 mg film-coated tablets Brintellix 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-128746 · Präparat HOS-096615

Following multiple doses of vortioxetine, no inhibitory effect was observed in healthy subjects for the cytochrome P450 isozymes CYP2C19 (omeprazole, diazepam), CYP3A4/5 (ethinyl estradiol, midazolam), CYP2B6 (bupropion), CYP2C9 (tolbutamide, S-warfarin), CYP1A2 (caffeine) or CYP2D6 (dextromethorphan).

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): bupropion (HOS-086329) caffeine (HOS-085902) ethinyl estradiol (HOS-088135) diazepam (HOS-085904) dextromethorphan (HOS-109265) warfarin (HOS-085950) tolbutamide (HOS-086568) midazolam (HOS-086167) omeprazole (HOS-085912)

Wechselwirkungen · Brintellix

Brintellix 20 mg/ml oral drops, solution · Abschnitt 4.5 · PDF-Seite 25

HOS-128777 · Präparat HOS-096615

Medicinal products lowering the seizure threshold Antidepressants with serotonergic effect can lower the seizure threshold. Caution is advised when concomitantly using other medicinal products capable of lowering the seizure threshold [e.g. antidepressants (tricyclics, SSRIs, SNRIs), neuroleptics (phenothiazines, thioxanthenes and butyrophenones), mefloquine, bupropion, tramadol] (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): bupropion (HOS-086329) mefloquine (HOS-113850) tramadol (HOS-112871)

Wechselwirkungen · Brintellix

Brintellix 20 mg/ml oral drops, solution · Abschnitt 4.5 · PDF-Seite 25

HOS-128779 · Präparat HOS-096615

CYP2D6 inhibitors The exposure to vortioxetine increased 2.3-fold for area under the curve (AUC) when vortioxetine 10 mg/day was co-administered with bupropion (a strong CYP2D6 inhibitor 150 mg twice daily) for 14 days in healthy subjects. Co-administration resulted in a higher incidence of adverse reactions when bupropion was added to vortioxetine than when vortioxetine was added to bupropion. Depending on individual patient response, a lower dose of vortioxetine may be considered if a strong CYP2D6 inhibitor (e.g., bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment (see section 4.2).

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): paroxetine (HOS-086246) bupropion (HOS-086329) quinidine (HOS-085593) fluoxetine (HOS-085946)

Wechselwirkungen · Brintellix

Brintellix 20 mg/ml oral drops, solution · Abschnitt 4.5 · PDF-Seite 26–27

HOS-128789 · Präparat HOS-096615

Following multiple doses of vortioxetine, no inhibitory effect was observed in healthy subjects for the cytochrome P450 isozymes CYP2C19 (omeprazole, diazepam), CYP3A4/5 (ethinyl estradiol, midazolam), CYP2B6 (bupropion), CYP2C9 (tolbutamide, S-warfarin), CYP1A2 (caffeine) or CYP2D6 (dextromethorphan). 26 No pharmacodynamic interactions were observed. No significant impairment, relative to placebo, in cognitive function was observed for vortioxetine following co-administration with a single 10 mg dose of diazepam. No significant effects, relative to placebo, were observed in the levels of sex hormones following co-administration of vortioxetine with a combined oral contraceptive (ethinyl estradiol 30 µg/ levonorgestrel 150 µg).

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): placebo (HOS-088378) bupropion (HOS-086329) levonorgestrel (HOS-089677) caffeine (HOS-085902) ethinyl estradiol (HOS-088135) diazepam (HOS-085904) dextromethorphan (HOS-109265) warfarin (HOS-085950) tolbutamide (HOS-086568) midazolam (HOS-086167) omeprazole (HOS-085912)

Wechselwirkungen · Cresemba

CRESEMBA 200 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 11–12

HOS-128927 · Präparat HOS-096645

11 Digoxin Digoxin: No isavuconazole dose (P-gp substrate) AUCinf: ↑ 25% adjustment necessary. Cmax: ↑ 33% Digoxin: serum digoxin concentrations should be (P-gp inhibition) monitored and used for titration of the digoxin dose. Oral contraceptives Ethinyl oestradiol and Ethinyl oestradiol No isavuconazole dose norethindrone AUCinf: ↑ 8% adjustment necessary. (CYP3A4/5 substrates) Cmax: ↑ 14% Ethinyl oestradiol and Norethindrone norethindrone: no dose AUCinf: ↑ 16% adjustment required. Cmax: ↑ 6% Antitussives Dextromethorphan Dextromethorphan: No isavuconazole dose (CYP2D6 substrate) AUCinf: ↑ 18% adjustment necessary. Cmax: ↑ 17% Dextromethorphan: no dose Dextrorphan (active metabolite): adjustment required. AUCinf: ↑ 4% Cmax: ↓ 2% Benzodiazepines Midazolam Oral midazolam: No isavuconazole dose (CYP3A4/5 substrate) AUCinf: ↑ 103% adjustment necessary. Cmax: ↑ 72% Midazolam: careful monitoring of clinical signs and symptoms (CYP3A4 inhibition) recommended, and dose reduction if required. Antigout agent Colchicine Not studied. No isavuconazole dose (P-gp substrate) Colchicine concentrations may adjustment necessary. increase. Colchicine has a narrow therapeutic index and should be (P-gp inhibition) monitored, dose reduction if required. Natural products Caffeine Caffeine: No isavuconazole dose (CYP1A2 substrate) AUCinf: ↑ 4% adjustment necessary. Cmax: ↓ 1% Caffeine: no dose adjustment required. Smoking cessation aids Bupropion Bupropion: No isavuconazole dose (CYP2B6 substrate) AUCinf: ↓ 42% adjustment necessary. Cmax: ↓ 31% Bupropion: dose increase if required. (CYP2B6 induction) NNRTI, non-nucleoside reverse-transcriptase inhibitor; P-gp, P-glycoprotein. a) % decrease of the mean trough level values b) Indinavir was only studied after a single dose of 400 mg isavuconazole. AUCinf = area under the plasma concentration-time profiles extrapolated to infinity; AUCtau = area under the plasma concentration-time profiles during the 24 h interval at steady state; Cmax = peak plasma concentration; Cmin,ss = trough levels at steady state.

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) bupropion (HOS-086329) digoxin (HOS-086172) caffeine (HOS-085902) colchicine (HOS-086147) norethindrone (HOS-088136) dextromethorphan (HOS-109265) midazolam (HOS-086167)

Wechselwirkungen · Cresemba

CRESEMBA 40 mg hard capsules CRESEMBA 100 mg hard capsules · Abschnitt 4.5 · PDF-Seite 34–35

HOS-129000 · Präparat HOS-096645

34 Antigout agent Colchicine Not studied. No isavuconazole dose (P-gp substrate) Colchicine concentrations may adjustment necessary. increase. Colchicine has a narrow therapeutic index and should be (P-gp inhibition) monitored, dose reduction if required. Natural products Caffeine Caffeine: No isavuconazole dose (CYP1A2 substrate) AUCinf: ↑ 4% adjustment necessary. Cmax: ↓ 1% Caffeine: no dose adjustment required. Smoking cessation aids Bupropion Bupropion: No isavuconazole dose (CYP2B6 substrate) AUCinf: ↓ 42% adjustment necessary. Cmax: ↓ 31% Bupropion: dose increase if required. (CYP2B6 induction) NNRTI, non-nucleoside reverse-transcriptase inhibitor; P-gp, P-glycoprotein. a) % decrease of the mean trough level values b) Indinavir was only studied after a single dose of 400 mg isavuconazole. AUCinf = area under the plasma concentration-time profiles extrapolated to infinity; AUCtau = area under the plasma concentration-time profiles during the 24 h interval at steady state; Cmax = peak plasma concentration; Cmin,ss = trough levels at steady state.

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) bupropion (HOS-086329) caffeine (HOS-085902) colchicine (HOS-086147)

Gegenanzeigen · Mysimba

Mysimba 8 mg/90 mg prolonged-release tablets · Abschnitt 4.3 · PDF-Seite 3–4

HOS-130313 · Präparat HOS-096899

• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. • Patients with uncontrolled hypertension (see section 4.4) • Patients with a current seizure disorder or a history of seizures (see section 4.4) • Patients with a known central nervous system tumour • Patients undergoing acute alcohol or benzodiazepine withdrawal • Patients with a history of bipolar disorder • Patients receiving any concomitant treatment containing bupropion or naltrexone • Patients with a current or previous diagnosis of bulimia or anorexia nervosa • Patients currently dependent on opioids including opioid-containing medication, patients 3  treated with opioid agonists used in opioid dependence (e.g., methadone, buprenorphine), or patients in acute opioid withdrawal (see sections 4.4 and 4.5) • Patients receiving concomitant administration of monoamine oxidase inhibitors (MAOI). At least 14 days should elapse between discontinuation of MAOI and initiation of treatment with naltrexone/bupropion (see section 4.5) • Patients with severe hepatic impairment (see sections 4.2 and 5.2) • Patients with end-stage renal failure (see sections 4.2 and 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): methadone (HOS-086198) buprenorphine (HOS-086193)

Wechselwirkungen · Mysimba

Mysimba 8 mg/90 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-130314 · Präparat HOS-096899

Monoamine oxidase inhibitors (MAOI)

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

Wechselwirkungen · Mysimba

Mysimba 8 mg/90 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-130315 · Präparat HOS-096899

Since monoamine oxidase A and B inhibitors also enhance the catecholaminergic pathways, by a different mechanism from bupropion, naltrexone/bupropion must not be used with MAOI (see section 4.3).

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

Wechselwirkungen · Mysimba

Mysimba 8 mg/90 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-130316 · Präparat HOS-096899

Opioids Naltrexone/bupropion is contraindicated in patients currently dependent on opioids including opioid- containing medication, patients treated with opioid agonists used in opioid dependence (e.g., methadone, buprenorphine), or patients in acute opioid withdrawal (see sections 4.3 and 4.4). Due to the antagonistic effect of naltrexone at the opioid receptor, patients taking naltrexone/bupropion may not fully benefit from treatment with opioid-containing medicinal products, such as cough and cold remedies, antidiarrhoeal preparations and opioid analgesics.

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) buprenorphine (HOS-086193)

Wechselwirkungen · Mysimba

Mysimba 8 mg/90 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-130317 · Präparat HOS-096899

Drugs metabolised by cytochrome P450 (CYP) enzymes

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

Wechselwirkungen · Mysimba

Mysimba 8 mg/90 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 8

HOS-130318 · Präparat HOS-096899

Bupropion is metabolised to its major active metabolite hydroxybupropion primarily by the cytochrome P450 CYP2B6; thus, the potential exists for interaction when administered with medicinal products that induce or inhibit CYP2B6. Although not metabolised by the CYP2D6 isoenzyme, bupropion and its main metabolite, hydroxybupropion, inhibit the CYP2D6 pathway and the potential exists to affect medicinal products metabolised by CYP2D6.

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

Wechselwirkungen · Mysimba

Mysimba 8 mg/90 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 8–9

HOS-130319 · Präparat HOS-096899

CYP2D6 substrates In a clinical study, naltrexone/bupropion (32 mg naltrexone hydrochloride /360 mg bupropion hydrochloride daily) was co-administered with a 50 mg dose of metoprolol (a CYP2D6 substrate). Naltrexone/bupropion increased metoprolol AUC and Cmax by approximately 4- and 2-fold, respectively, relative to metoprolol alone. Similar clinical drug interactions resulting in increased 8 pharmacokinetic exposure of CYP2D6 substrates have also been observed with bupropion as a single medicinal product with desipramine and venlafaxine.

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): desipramine (HOS-086249) venlafaxine (HOS-086573) metoprolol (HOS-090094)

Wechselwirkungen · Mysimba

Mysimba 8 mg/90 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-130320 · Präparat HOS-096899

Co-administration of bupropion with drugs that are metabolised by CYP2D6 isozyme including certain antidepressants (SSRIs and many tricyclic antidepressants, e.g. desipramine, imipramine, paroxetine), antipsychotics (e.g., haloperidol, risperidone and thioridazine), beta-blockers (e.g., metoprolol) and Type 1C antiarrhythmics (e.g., propafenone and flecainide), should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medicinal product. Although citalopram is not primarily metabolised by CYP2D6, in one study, bupropion increased the Cmax and AUC of citalopram by 30% and 40%, respectively.

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) citalopram (HOS-087802) propafenone (HOS-084530) desipramine (HOS-086249) flecainide (HOS-086203) imipramine (HOS-085907) risperidone (HOS-086280) thioridazine (HOS-086281) haloperidol (HOS-085602) metoprolol (HOS-090094)

Wechselwirkungen · Mysimba

Mysimba 8 mg/90 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-130325 · Präparat HOS-096899

There have been post-marketing reports of serotonin syndrome, a potentially life-threatening condition, when naltrexone/bupropion was co-administered with a serotonergic agent, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs) and opioids (e.g. tramadol, methadone) (see sections 4.4 and 4.8).

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): norepinephrine (HOS-090547) methadone (HOS-086198) serotonin (HOS-085477) tramadol (HOS-112871)

Wechselwirkungen · Mysimba

Mysimba 8 mg/90 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-130326 · Präparat HOS-096899

Drugs which require metabolic activation by CYP2D6 in order to be effective (e.g., tamoxifen), may have reduced efficacy when administered concomitantly with inhibitors of CYP2D6 such as bupropion. If naltrexone/bupropion is added to the treatment regimen of a patient already receiving a drug metabolised by CYP2D6, the need to decrease the dose of the original medicinal product should be considered, particularly for those concomitant medicinal products with a narrow therapeutic index. When feasible, the option of therapeutic drug monitoring should be considered for medicinal products with a narrow therapeutic index, such as tricyclic antidepressants.

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): tamoxifen (HOS-088380)

Wechselwirkungen · Mysimba

Mysimba 8 mg/90 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-130328 · Präparat HOS-096899

CYP2B6 inducers, inhibitors and substrates Bupropion is metabolised to its major active metabolite hydroxybupropion primarily by the CYP2B6 isozyme. The potential exists for a drug interaction between naltrexone/bupropion and drugs that induce or are substrates of the CYP2B6 isozyme.

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