Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Eucreas

Eucreas 50 mg/850 mg film-coated tablets Eucreas 50 mg/1000 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-209036 · Präparat HOS-154229

Concomitant use of medicinal products that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g. organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir and cimetidine) could increase systemic exposure to metformin.

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): cimetidine (HOS-085835) dolutegravir (HOS-089992) ranolazine (HOS-086141) vandetanib (HOS-119366)

Wechselwirkungen · Janumet

Janumet 50 mg/850 mg film-coated tablets Janumet 50 mg/1 000 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-119365 · Präparat HOS-094931

Concomitant use of medicinal products that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis. Consider the benefits and risks of concomitant use. Close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when such products are co-administered.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): cimetidine (HOS-085835) dolutegravir (HOS-089992) ranolazine (HOS-086141) vandetanib (HOS-119366)

Wechselwirkungen · Velmetia

Velmetia 50 mg/850 mg film-coated tablets Velmetia 50 mg/1 000 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-119404 · Präparat HOS-094939

Concomitant use of medicinal products that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis. Consider the benefits and risks of concomitant use. Close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when such products are co-administered.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): cimetidine (HOS-085835) dolutegravir (HOS-089992) ranolazine (HOS-086141) vandetanib (HOS-119366)

Wechselwirkungen · Efficib

Efficib 50 mg/850 mg film-coated tablets Efficib 50 mg/1 000 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-119693 · Präparat HOS-094997

Concomitant use of medicinal products that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis. Consider the benefits and risks of concomitant use. Close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when such products are co-administered.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): cimetidine (HOS-085835) dolutegravir (HOS-089992) ranolazine (HOS-086141) vandetanib (HOS-119366)

Wechselwirkungen · Intelence

INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets · Abschnitt 4.5 · PDF-Seite 9–10

HOS-119738 · Präparat HOS-095005

9 Integrase Strand Transfer Inhibitors Dolutegravir dolutegravir Etravirine significantly 50 mg once daily AUC ↓ 0.29 (0.26-0.34) reduced plasma Cmin ↓ 0.12 (0.09-0.16) concentrations of Cmax ↓ 0.48 (0.43-0.54) dolutegravir. The effect of etravirine etravirine on dolutegravir AUC ↔a plasma concentrations was Cmin ↔a mitigated by Cmax ↔a co-administration of darunavir/ritonavir or Dolutegravir + dolutegravir lopinavir/ritonavir, and is darunavir/ritonavir AUC↓ 0.75 (0.69-0.81) expected to be mitigated by 50 mg once daily + Cmin ↓ 0.63 (0.52-0.77) atazanavir/ritonavir. 600/100 mg twice daily Cmax ↓ 0.88 (0.78-1.00) etravirine INTELENCE should only be AUC ↔a used with dolutegravir when Cmin ↔a co-administered with Cmax ↔a atazanavir/ritonavir, darunavir/ritonavir, or Dolutegravir + dolutegravir lopinavir/ritonavir. This Lopinavir/ritonavir AUC↔ 1.11(1.02-1.20) combination can be used 50 mg once daily + Cmin ↑ 1.28 (1.13-1.45) without dose adjustment. 400/100 mg twice daily Cmax ↔ 1.07 (1.02-1.13) etravirine AUC ↔a Cmin ↔a Cmax ↔a Raltegravir raltegravir INTELENCE and raltegravir 400 mg twice daily AUC ↓ 0.90 (0.68-1.18) can be used without dose Cmin ↓ 0.66 (0.34-1.26) adjustments. Cmax ↓ 0.89 (0.68-1.15) etravirine AUC ↔ 1.10 (1.03-1.16) Cmin ↔ 1.17 (1.10-1.26) Cmax ↔ 1.04 (0.97-1.12) ANTIARRHYTHMICS Digoxin digoxin INTELENCE and digoxin 0.5 mg single dose AUC ↑ 1.18 (0.90-1.56) can be used without dose Cmin ND adjustments. It is Cmax ↑ 1.19 (0.96-1.49) recommended that digoxin levels be monitored when digoxin is combined with INTELENCE. Amiodarone Not studied. INTELENCE is expected to Caution is warranted and Bepridil decrease plasma concentrations of these therapeutic concentration Disopyramide antiarrhythmics. monitoring, if available, is Flecainide recommended for Lidocaine (systemic) antiarrhythmics when Mexiletine co-administered with Propafenone INTELENCE. Quinidine ANTIBIOTICS Azithromycin Not studied. Based on the biliary elimination INTELENCE and pathway of azithromycin, no drug interactions azithromycin can be used are expected between azithromycin and without dose adjustments. INTELENCE.

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): lopinavir (HOS-086269) atazanavir (HOS-086180) propafenone (HOS-084530) flecainide (HOS-086203) lidocaine (HOS-108866) mexiletine (HOS-086341) bepridil (HOS-085612) dolutegravir (HOS-089992) quinidine (HOS-085593) digoxin (HOS-086172) azithromycin (HOS-088112) disopyramide (HOS-085595) darunavir (HOS-086181) raltegravir (HOS-086187) ritonavir (HOS-084521) amiodarone (HOS-085596)

Wechselwirkungen · Zomarist

Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-210472 · Präparat HOS-154523

Concomitant use of medicinal products that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g. organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir and cimetidine) could increase systemic exposure to metformin.

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): cimetidine (HOS-085835) dolutegravir (HOS-089992) ranolazine (HOS-086141) vandetanib (HOS-119366)

Wechselwirkungen · Icandra (previously Vildagliptin / metformin hydrochloride Novartis)

Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-210509 · Präparat HOS-154531

Concomitant use of medicinal products that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g. organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir and cimetidine) could increase systemic exposure to metformin.

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): cimetidine (HOS-085835) dolutegravir (HOS-089992) ranolazine (HOS-086141) vandetanib (HOS-119366)

Wechselwirkungen · Ristfor

Ristfor 50 mg/850 mg film-coated tablets Ristfor 50 mg/1 000 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-213131 · Präparat HOS-155044

Concomitant use of medicinal products that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis. Consider the benefits and risks of concomitant use. Close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when such products are co-administered.

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): cimetidine (HOS-085835) dolutegravir (HOS-089992) ranolazine (HOS-086141) vandetanib (HOS-119366)

Wechselwirkungen · Jentadueto

Jentadueto 2.5 mg/850 mg film-coated tablets Jentadueto 2.5 mg/1 000 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7–8

HOS-214077 · Präparat HOS-155256

7 Organic cation transporters (OCT) Metformin is a substrate of both transporters OCT1 and OCT2. Co-administration of metformin with • Inhibitors of OCT1 (such as verapamil) may reduce efficacy of metformin. • Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efficacy of metformin. • Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration. • Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efficacy and renal elimination of metformin.

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): isavuconazole (HOS-085186) cimetidine (HOS-085835) crizotinib (HOS-116818) dolutegravir (HOS-089992) lead (HOS-085592) olaparib (HOS-130501) ranolazine (HOS-086141) vandetanib (HOS-119366) verapamil (HOS-090602)

Gegenanzeigen · Tivicay

Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 4

HOS-129148 · Präparat HOS-096689

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Medicinal products with narrow therapeutic windows that are substrates of organic cation transporter 2 (OCT2), including but not limited to fampridine (also known as dalfampridine; see section 4.5).

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dalfampridine (HOS-124191)

Gegenanzeigen · Tivicay

Tivicay 5 mg dispersible tablets · Abschnitt 4.3 · PDF-Seite 34

HOS-129187 · Präparat HOS-096689

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Medicinal products with narrow therapeutic windows that are substrates of organic cation transporter 2 (OCT2), including but not limited to fampridine (also known as dalfampridine; see section 4.5).

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): dalfampridine (HOS-124191)

Wechselwirkungen · Tivicay

Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-129150 · Präparat HOS-096689

Effect of other agents on the pharmacokinetics of dolutegravir

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

Wechselwirkungen · Tivicay

Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-129151 · Präparat HOS-096689

All factors that decrease dolutegravir exposure should be avoided in the presence of integrase class resistance.

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

Wechselwirkungen · Tivicay

Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-129152 · Präparat HOS-096689

Dolutegravir is eliminated mainly through metabolism by UGT1A1. Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, Pgp, and BCRP; therefore, medicinal products that induce those enzymes may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir (see Table 3). Co-administration of dolutegravir and other medicinal products that inhibit these enzymes may increase dolutegravir plasma concentration (see Table 3).

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

Wechselwirkungen · Tivicay

Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-129153 · Präparat HOS-096689

The absorption of dolutegravir is reduced by certain anti-acid agents (see Table 3).

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

Wechselwirkungen · Tivicay

Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-129154 · Präparat HOS-096689

Effect of dolutegravir on the pharmacokinetics of other agents

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

Wechselwirkungen · Tivicay

Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6–7

HOS-129155 · Präparat HOS-096689

In vivo, dolutegravir did not have an effect on midazolam, a CYP3A4 probe. Based on in vivo and/or in vitro data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of any major enzyme or transporter such as CYP3A4, CYP2C9 and P-gp (for more information see section 5.2). 6 In vitro, dolutegravir inhibited the renal organic cation transporter 2 (OCT2) and multidrug and toxin extrusion transporter (MATE) 1. In vivo, a 10-14% decrease of creatinine clearance (secretory fraction is dependent on OCT2 and MATE-1 transport) was observed in patients. In vivo, dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OCT2 and/or MATE-1 (e.g. fampridine [also known as dalfampridine], metformin) (see Table 3).

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

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): creatinine (HOS-086273) dalfampridine (HOS-124191) metformin (HOS-091032) midazolam (HOS-086167)

Wechselwirkungen · Tivicay

Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-129156 · Präparat HOS-096689

In vitro, dolutegravir inhibited the renal uptake transporters, organic anion transporters (OAT1) and OAT3. Based on the lack of effect on the in vivo pharmacokinetics of the OAT substrate tenofovir, in vivo inhibition of OAT1 is unlikely. Inhibition of OAT3 has not been studied in vivo. Dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OAT3.

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): tenofovir (HOS-088083)

Wechselwirkungen · Tivicay

Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-129158 · Präparat HOS-096689

Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in Table 3.

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

Wechselwirkungen · Tivicay

Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-129159 · Präparat HOS-096689

Interaction table Interactions between dolutegravir and co-administered medicinal products are listed in Table 3 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”, concentration at end of dosing interval as “Cτ”).

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