Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · 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 4.8 · PDF-Seite 30

HOS-115893 · Präparat HOS-094369

In patients presenting with marked drug dependence, initial administration of buprenorphine can produce a drug withdrawal syndrome similar to that associated with naloxone (see sections 4.2 and 4.4).

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

Nebenwirkungen · 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 4.8 · PDF-Seite 30

HOS-115894 · Präparat HOS-094369

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.*

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

Wechselwirkungen · Prezista

PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 21–22

HOS-116415 · Präparat HOS-094447

21  Rosuvastatin rosuvastatin AUC ↑ 48%║ When administration of 10 mg once daily rosuvastatin Cmax ↑ 144%║ rosuvastatin and boosted ║ based on published data with PREZISTA is required, it is darunavir/ritonavir recommended to start with the lowest possible dose of rosuvastatin AUC ↑ 93%§ rosuvastatin and titrate up to the rosuvastatin Cmax ↑ 277%§ desired clinical effect while rosuvastatin Cmin ND§ monitoring for safety. § with darunavir/cobicistat 800/150 mg OTHER LIPID MODIFYING AGENTS Lomitapide Based on theoretical considerations Co-administration is boosted PREZISTA is expected to contraindicated (see section 4.3). increase the exposure of lomitapide when co-administered. (CYP3A inhibition) H2-RECEPTOR ANTAGONISTS Ranitidine # Boosted PREZISTA can be darunavir AUC ↔ 150 mg twice daily # darunavir Cmin ↔ co-administered with H2-receptor # darunavir Cmax ↔ antagonists without dose adjustments. IMMUNOSUPPRESSANTS Ciclosporin Not studied. Exposure to these Therapeutic drug monitoring of the Sirolimus immunosuppressants will be increased immunosuppressive agent must be Tacrolimus when co-administered with boosted done when co-administration PREZISTA. occurs. (CYP3A inhibition) Everolimus Concomitant use of everolimus and boosted PREZISTA is not recommended. INHALED BETA AGONISTS Salmeterol Not studied. Concomitant use of Concomitant use of salmeterol and salmeterol and boosted darunavir may boosted PREZISTA is not increase plasma concentrations of recommended. The combination salmeterol. may result in increased risk of cardiovascular adverse event with salmeterol, including QT prolongation, palpitations and sinus tachycardia. NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE Methadone R(-) methadone AUC ↓ 16% No adjustment of methadone individual dose ranging R(-) methadone Cmin ↓ 15% dosage is required when initiating from 55 mg to 150 mg R(-) methadone Cmax ↓ 24% co-administration with boosted once daily PREZISTA. However, adjustment PREZISTA/cobicistat may, in contrast, of the methadone dose may be increase methadone plasma necessary when concomitantly concentrations (see cobicistat SmPC). administered for a longer period of time. Therefore, clinical monitoring is recommended, as maintenance therapy may need to be adjusted in some patients. Buprenorphine/naloxone buprenorphine AUC ↓ 11% The clinical relevance of the 8/2 mg–16/4 mg once buprenorphine Cmin ↔ increase in norbuprenorphine daily buprenorphine Cmax ↓ 8% pharmacokinetic parameters has norbuprenorphine AUC ↑ 46% not been established. Dose norbuprenorphine Cmin ↑ 71% adjustment for buprenorphine may norbuprenorphine Cmax ↑ 36% not be necessary when naloxone AUC ↔ co-administered with boosted PREZISTA but a careful clinical naloxone Cmin ND monitoring for signs of opiate naloxone Cmax ↔ toxicity 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): methadone (HOS-086198) lomitapide (HOS-086160) cobicistat (HOS-088111) rosuvastatin (HOS-086307) buprenorphine (HOS-086193) salmeterol (HOS-086285) tacrolimus (HOS-085202) ranitidine (HOS-085660) everolimus (HOS-086310) naloxone (HOS-109490) sirolimus (HOS-085172) ritonavir (HOS-084521)

Wechselwirkungen · Prezista

PREZISTA 75 mg film-coated tablets PREZISTA 150 mg film-coated tablets PREZISTA 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 64–65

HOS-116530 · Präparat HOS-094447

64  Buprenorphine/naloxone buprenorphine AUC ↓ 11% The clinical relevance of the 8/2 mg–16/4 mg once buprenorphine Cmin ↔ increase in norbuprenorphine daily buprenorphine Cmax ↓ 8% pharmacokinetic parameters has norbuprenorphine AUC ↑ 46% not been established. Dose norbuprenorphine Cmin ↑ 71% adjustment for buprenorphine may norbuprenorphine Cmax ↑ 36% not be necessary when naloxone AUC ↔ co-administered with PREZISTA/ritonavir but a careful naloxone Cmin ND clinical monitoring for signs of naloxone Cmax ↔ opiate toxicity is recommended. Fentanyl Based on theoretical considerations Clinical monitoring is Oxycodone boosted PREZISTA may increase plasma recommended when Tramadol concentrations of these analgesics. co-administering boosted (CYP2D6 and/or CYP3A inhibition) PREZISTA with these analgesics. OESTROGEN-BASED CONTRACEPTIVES Drospirenone Not studied with darunavir/ritonavir. When PREZISTA is co- Ethinylestradiol administered with a drospirenone- (3 mg/0.02 mg once containing product, clinical daily) monitoring is recommended due to the potential for hyperkalaemia.

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): oxycodone (HOS-109487) buprenorphine (HOS-086193) drospirenone (HOS-116422) naloxone (HOS-109490) fentanyl (HOS-086196) ritonavir (HOS-084521) tramadol (HOS-112871)

Wechselwirkungen · Prezista

PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 103–104

HOS-116619 · Präparat HOS-094447

103  Rosuvastatin rosuvastatin AUC ↑ 48%║ When administration of 10 mg once daily rosuvastatin Cmax ↑ 144%║ rosuvastatin and boosted ║ based on published data with PREZISTA is required, it is darunavir/ritonavir recommended to start with the lowest possible dose of rosuvastatin AUC ↑ 93%§ rosuvastatin and titrate up to the rosuvastatin Cmax ↑ 277%§ desired clinical effect while rosuvastatin Cmin ND§ monitoring for safety. § with darunavir/cobicistat 800/150 mg OTHER LIPID MODIFYING AGENTS Lomitapide Based on theoretical considerations Co-administration is boosted PREZISTA is expected to contraindicated (see section 4.3). increase the exposure of lomitapide when co-administered. (CYP3A inhibition) H2-RECEPTOR ANTAGONISTS Ranitidine # Boosted PREZISTA can be darunavir AUC ↔ 150 mg twice daily # darunavir Cmin ↔ co-administered with H2-receptor # darunavir Cmax ↔ antagonists without dose adjustments. IMMUNOSUPPRESSANTS Ciclosporin Not studied. Exposure to these Therapeutic drug monitoring of the Sirolimus immunosuppressants will be increased immunosuppressive agent must be Tacrolimus when co-administered with boosted done when co-administration PREZISTA. occurs. (CYP3A inhibition) Everolimus Concomitant use of everolimus and boosted PREZISTA is not recommended. INHALED BETA AGONISTS Salmeterol Not studied. Concomitant use of Concomitant use of salmeterol and salmeterol and boosted darunavir may boosted PREZISTA is not increase plasma concentrations of recommended. The combination salmeterol. may result in increased risk of cardiovascular adverse event with salmeterol, including QT prolongation, palpitations and sinus tachycardia. NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE Methadone R(-) methadone AUC ↓ 16% No adjustment of methadone individual dose ranging R(-) methadone Cmin ↓ 15% dosage is required when initiating from 55 mg to 150 mg R(-) methadone Cmax ↓ 24% co-administration with boosted once daily PREZISTA. However, adjustment PREZISTA/cobicistat may, in contrast, of the methadone dose may be increase methadone plasma necessary when concomitantly concentrations (see cobicistat SmPC). administered for a longer period of time. Therefore, clinical monitoring is recommended, as maintenance therapy may need to be adjusted in some patients. Buprenorphine/naloxone buprenorphine AUC ↓ 11% The clinical relevance of the 8/2 mg–16/4 mg once buprenorphine Cmin ↔ increase in norbuprenorphine daily buprenorphine Cmax ↓ 8% pharmacokinetic parameters has norbuprenorphine AUC ↑ 46% not been established. Dose norbuprenorphine Cmin ↑ 71% adjustment for buprenorphine may norbuprenorphine Cmax ↑ 36% not be necessary when naloxone AUC ↔ co-administered with boosted PREZISTA but a careful clinical naloxone Cmin ND monitoring for signs of opiate naloxone Cmax ↔ toxicity 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): methadone (HOS-086198) lomitapide (HOS-086160) cobicistat (HOS-088111) rosuvastatin (HOS-086307) buprenorphine (HOS-086193) salmeterol (HOS-086285) tacrolimus (HOS-085202) ranitidine (HOS-085660) everolimus (HOS-086310) naloxone (HOS-109490) sirolimus (HOS-085172) ritonavir (HOS-084521)

Wechselwirkungen · Celsentri

CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12–13

HOS-118470 · Präparat HOS-094825

12 Ribavirin Ribavirin has not been studied, no CELSENTRI 300 mg interaction is expected. twice daily and ribavirin can be co-administered without dose adjustment. DRUG ABUSE Methadone Not studied, no interaction expected. CELSENTRI 300 mg twice daily and methadone can be co-administered without dose adjustment. Buprenorphine Not studied, no interaction expected. CELSENTRI 300 mg twice daily and buprenorphine can be co-administered without dose adjustment. LIPID LOWERING MEDICINAL PRODUCTS Statins Not studied, no interaction expected. CELSENTRI 300 mg twice daily and statins can be co-administered without dose adjustment. ANTIARRHYTHMICS Digoxin 0.25 mg Digoxin. AUCt: ↔ 1.00 CELSENTRI 300 mg Single Dose Digoxin. Cmax: ↔ 1.04 twice daily and digoxin (maraviroc 300 mg BID) Maraviroc concentrations not can be co-administered measured, no interaction expected. without dose adjustment.

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) digoxin (HOS-086172) buprenorphine (HOS-086193) ribavirin (HOS-088127)

Wechselwirkungen · Celsentri

CELSENTRI 20 mg/mL oral solution · Abschnitt 4.5 · PDF-Seite 38–39

HOS-118509 · Präparat HOS-094825

38 Fluconazole Fluconazole is considered to be a CELSENTRI 300 mg twice moderate CYP3A4 inhibitor. daily should be administered Population PK studies suggest that a with caution when dose adjustment of maraviroc is not co-administered with required. fluconazole. ANTIVIRALS Anti-HBV Pegylated interferon Pegylated interferon has not been CELSENTRI 300 mg twice studied, no interaction is expected. daily and pegylated interferon can be co-administered without dose adjustment. Anti-HCV Ribavirin Ribavirin has not been studied, no CELSENTRI 300 mg twice interaction is expected. daily and ribavirin can be co-administered without dose adjustment. DRUG ABUSE Methadone Not studied, no interaction expected. CELSENTRI 300 mg twice daily and methadone can be co-administered without dose adjustment. Buprenorphine Not studied, no interaction expected. CELSENTRI 300 mg twice daily and buprenorphine can be co-administered without dose adjustment. LIPID LOWERING MEDICINAL PRODUCTS Statins Not studied, no interaction expected. CELSENTRI 300 mg twice daily and statins can be co-administered without dose adjustment. ANTIARRHYTHMICS Digoxin 0.25 mg Digoxin. AUCt: ↔ 1.00 CELSENTRI 300 mg twice Single Dose Digoxin. Cmax: ↔ 1.04 daily and digoxin can be (maraviroc 300 mg BID) Maraviroc concentrations not co-administered without dose measured, no interaction expected. adjustment.

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) digoxin (HOS-086172) buprenorphine (HOS-086193) ribavirin (HOS-088127) fluconazole (HOS-087945)

Wechselwirkungen · Effentora

Effentora 100 micrograms buccal tablets Effentora 200 micrograms buccal tablets Effentora 400 micrograms buccal tablets Effentora 600 micrograms buccal tablets Effentora 800 micrograms buccal tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-209216 · Präparat HOS-154273

Partial opioid agonists/antagonists The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended. They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients.

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): nalbuphine (HOS-120563) buprenorphine (HOS-086193) pentazocine (HOS-120564)

Wechselwirkungen · Instanyl

Instanyl 50 micrograms/dose nasal spray, solution Instanyl 100 micrograms/dose nasal spray, solution Instanyl 200 micrograms/dose nasal spray, solution · Abschnitt 4.5 · PDF-Seite 8

HOS-120562 · Präparat HOS-095157

The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended. They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependent patients.

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): nalbuphine (HOS-120563) buprenorphine (HOS-086193) pentazocine (HOS-120564)

Wechselwirkungen · Instanyl

Instanyl 50 micrograms nasal spray, solution in single-dose container Instanyl 100 micrograms nasal spray, solution in single-dose container Instanyl 200 micrograms nasal spray, solution in single-dose container · Abschnitt 4.5 · PDF-Seite 20

HOS-120587 · Präparat HOS-095157

The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended. They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependent patients.

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): nalbuphine (HOS-120563) buprenorphine (HOS-086193) pentazocine (HOS-120564)

Wechselwirkungen · Instanyl

Instanyl 50 micrograms/dose nasal spray, solution Instanyl 100 micrograms/dose nasal spray, solution Instanyl 200 micrograms/dose nasal spray, solution · Abschnitt 4.5 · PDF-Seite 34

HOS-120611 · Präparat HOS-095157

The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended. They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependent patients.

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): nalbuphine (HOS-120563) buprenorphine (HOS-086193) pentazocine (HOS-120564)

Wechselwirkungen · PecFent

PecFent 100 micrograms/spray nasal spray, solution PecFent 400 micrograms/spray nasal spray, solution · Abschnitt 4.5 · PDF-Seite 8

HOS-212302 · Präparat HOS-154864

The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended. They have high affinity to opioid receptors with relatively low intrinsic activity and, therefore, partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependent patients.

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): nalbuphine (HOS-120563) buprenorphine (HOS-086193) pentazocine (HOS-120564)

Wechselwirkungen · Sancuso

SANCUSO 3.1 mg/24 hours transdermal patch · Abschnitt 4.5 · PDF-Seite 4

HOS-214212 · Präparat HOS-155296

For serotonergic medicinal products (e.g. SSRIs and SNRIs, buprenorphine, opiods or other serotonergic medicinal products), there have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic medicinal products (including SSRIs and SNRIs).

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) serotonin (HOS-085477)

Wechselwirkungen · Efavirenz Teva

Efavirenz Teva 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 19

HOS-215323 · Präparat HOS-155418

In a study of HIV infected intravenous drug users, co-administration of efavirenz with methadone resulted in decreased plasma levels of methadone and signs of opiate withdrawal. The methadone dose was increased by a mean of 22% to alleviate withdrawal symptoms. Buprenorphine/naloxone/ Buprenorphine: Despite the decrease in efavirenz AUC: ↓ 50% buprenorphine exposure, no patients exhibited withdrawal Norbuprenorphine: symptoms. Dose adjustment of AUC: ↓ 71% buprenorphine or efavirenz may not be necessary when Efavirenz: co-administered. No clinically significant pharmacokinetic interaction a 90% confidence intervals unless otherwise noted. b 95% confidence intervals.

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) naloxone (HOS-109490)

Wechselwirkungen · Tybost

Tybost 150 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10

HOS-218340 · Präparat HOS-216199

For coadministration of cutaneously-administered corticosteroids sensitive to CYP3A inhibition, refer to the prescribing information of the corticosteroid for conditions or uses that augment its systemic absorption. ORAL ANTI-DIABETICS Metformin Interaction not studied. Careful patient monitoring and dose adjustment of metformin is recommended Cobicistat reversibly inhibits in patients who are taking Tybost. MATE1, and concentrations of metformin may be increased when co-administered with cobicistat. NARCOTIC ANALGESICS Methadone Methadone: No dose adjustment of methadone is AUC: ↔ required. Cmax: ↔ Cmin: ↔ Buprenorphine/Naloxone Buprenorphine: No dose adjustment of cobicistat is AUC: ↑ 35% required. Cmax: ↔ Cmin: ↑ 66%

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) naloxone (HOS-109490) metformin (HOS-091032)

Wechselwirkungen · Stribild

Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 16–17

HOS-218480 · Präparat HOS-216207

16 Medicinal product by therapeutic Effects on drug levels Recommendation concerning areas Mean percent change in AUC, Cmax, co-administration with Stribild Cmin1 Buprenorphine/Naloxone/ Buprenorphine: No dose adjustment of Elvitegravir/Cobicistat AUC: ↑ 35% buprenorphine/naloxone is Cmin: ↑ 66% required. Cmax: ↔

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) naloxone (HOS-109490)

Gegenanzeigen · Selincro

Selincro 18 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-127538 · Präparat HOS-096425

Patients taking opioid agonists (such as opioid analgesics, opioids for substitution therapy with opioid agonists (e.g. methadone) or partial agonists (e.g. buprenorphine)) (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): methadone (HOS-086198) buprenorphine (HOS-086193)

Wechselwirkungen · Latuda

Latuda 18.5 mg film-coated tablets Latuda 37 mg film-coated tablets Latuda 74 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 5–6

HOS-128657 · Präparat HOS-096607

5 Latuda should be used cautiously when co-administered with other serotonergic agents, such as buprenorphine/opioids, 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).

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) buprenorphine (HOS-086193) serotonin (HOS-085477)

Wechselwirkungen · Rezolsta

REZOLSTA 800 mg/150 mg film-coated tablets REZOLSTA 675 mg/150 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 16–17

HOS-220484 · Präparat HOS-216626

16 IMMUNOSUPPRESSANTS Ciclosporin Based on theoretical Therapeutic drug monitoring of Sirolimus considerations REZOLSTA is the immunosuppressive agent Tacrolimus expected to increase these must be done when immunosuppressant plasma co-administration occurs. concentrations. (CYP3A inhibition) Everolimus Concomitant use of everolimus and REZOLSTA is not recommended. INHALED BETA AGONISTS Salmeterol Based on theoretical Concomitant use of salmeterol considerations REZOLSTA is and REZOLSTA is not expected to increase salmeterol recommended. The combination plasma concentrations. may result in increased risk of (CYP3A inhibition) cardiovascular adverse event with salmeterol, including QT prolongation, palpitations and sinus tachycardia. NARCOTIC ANALGESICS/TREATMENT OF OPIOID DEPENDENCE Buprenorphine/naloxone Based on theoretical Dose adjustment for considerations REZOLSTA may buprenorphine may not be increase buprenorphine and/or necessary when co-administered norbuprenorphine plasma with REZOLSTA but a careful concentrations. clinical monitoring for signs of opiate toxicity is recommended. Methadone Based on theoretical No adjustment of methadone considerations REZOLSTA may dosage is expected when increase methadone plasma initiating co-administration with concentrations. REZOLSTA. Clinical monitoring is recommended, as maintenance With ritonavir-boosted darunavir, therapy may need to be adjusted a small decrease in methadone in some patients. plasma concentrations was observed. Consult the Summary of Product Characteristics for darunavir for further details. Fentanyl Based on theoretical Clinical monitoring is Oxycodone considerations REZOLSTA may recommended when Tramadol increase plasma concentrations of co-administering REZOLSTA these analgesics. with these analgesics. (CYP2D6 and/or CYP3A inhibition) OESTROGEN-BASED CONTRACEPTIVES Drospirenone (3 mg once daily) drospirenone AUC ↑ 58% Alternative or additional drospirenone Cmax ↑ 15% contraceptive measures are drospirenone Cmin ND recommended when oestrogen based contraceptives are co Ethinylestradiol (0.02 mg once ethinylestradiol AUC ↓ 30% administered with REZOLSTA. daily) ethinylestradiol Cmax ↓ 14% Patients using oestrogens as ethinylestradiol Cmin ND hormone replacement therapy should be clinically monitored for Norethindrone Based on theoretical signs of oestrogen deficiency. considerations REZOLSTA may When REZOLSTA is alter norethindrone plasma co-administered with a concentrations. drospirenone-containing product, (CYP3A inhibition, UGT/SULT clinical monitoring is induction) recommended due to the potential for hyperkalaemia.

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) oxycodone (HOS-109487) buprenorphine (HOS-086193) drospirenone (HOS-116422) salmeterol (HOS-086285) tacrolimus (HOS-085202) everolimus (HOS-086310) naloxone (HOS-109490) norethindrone (HOS-088136) sirolimus (HOS-085172) fentanyl (HOS-086196) tramadol (HOS-112871)

Wechselwirkungen · Rezolsta

REZOLSTA 600 mg/90 mg dispersible tablets · Abschnitt 4.5 · PDF-Seite 51–52

HOS-220570 · Präparat HOS-216626

51 IMMUNOSUPPRESSANTS Ciclosporin Based on theoretical Therapeutic drug monitoring of Sirolimus considerations REZOLSTA is the immunosuppressive agent Tacrolimus expected to increase these must be done when immunosuppressant plasma co-administration occurs. concentrations. (CYP3A inhibition) Everolimus Concomitant use of everolimus and REZOLSTA is not recommended. INHALED BETA AGONISTS Salmeterol Based on theoretical Concomitant use of salmeterol considerations REZOLSTA is and REZOLSTA is not expected to increase salmeterol recommended. The combination plasma concentrations. may result in increased risk of (CYP3A inhibition) cardiovascular adverse event with salmeterol, including QT prolongation, palpitations and sinus tachycardia. NARCOTIC ANALGESICS/TREATMENT OF OPIOID DEPENDENCE Buprenorphine/naloxone Based on theoretical Dose adjustment for considerations REZOLSTA may buprenorphine may not be increase buprenorphine and/or necessary when co-administered norbuprenorphine plasma with REZOLSTA but a careful concentrations. clinical monitoring for signs of opiate toxicity is recommended. Methadone Based on theoretical No adjustment of methadone considerations REZOLSTA may dosage is expected when increase methadone plasma initiating co-administration with concentrations. REZOLSTA. Clinical monitoring is recommended, as maintenance With ritonavir-boosted darunavir, therapy may need to be adjusted a small decrease in methadone in some patients. plasma concentrations was observed. Consult the Summary of Product Characteristics for darunavir for further details. Fentanyl Based on theoretical Clinical monitoring is Oxycodone considerations REZOLSTA may recommended when Tramadol increase plasma concentrations of co-administering REZOLSTA these analgesics. with these analgesics. (CYP2D6 and/or CYP3A inhibition) OESTROGEN-BASED CONTRACEPTIVES Drospirenone (3 mg once daily) drospirenone AUC ↑ 58% Alternative or additional drospirenone Cmax ↑ 15% contraceptive measures are drospirenone Cmin ND recommended when oestrogen based contraceptives are co Ethinylestradiol (0.02 mg once ethinylestradiol AUC ↓ 30% administered with REZOLSTA. daily) ethinylestradiol Cmax ↓ 14% Patients using oestrogens as ethinylestradiol Cmin ND hormone replacement therapy should be clinically monitored for Norethindrone Based on theoretical signs of oestrogen deficiency. considerations REZOLSTA may When REZOLSTA is alter norethindrone plasma co-administered with a concentrations. drospirenone-containing product, (CYP3A inhibition, UGT/SULT clinical monitoring is induction) recommended due to the potential for hyperkalaemia.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): methadone (HOS-086198) oxycodone (HOS-109487) buprenorphine (HOS-086193) drospirenone (HOS-116422) salmeterol (HOS-086285) tacrolimus (HOS-085202) everolimus (HOS-086310) naloxone (HOS-109490) norethindrone (HOS-088136) sirolimus (HOS-085172) fentanyl (HOS-086196) tramadol (HOS-112871)