Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Epivir

Epivir 150 mg film-coated tablets Epivir 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-085834 · Präparat HOS-083204

The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion via the organic cationic transport system e.g. trimethoprim. Other medicinal products (e.g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine. The nucleoside analogues (e.g. didanosine) like zidovudine, are not eliminated by this mechanism and are unlikely to interact with lamivudine.

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): trimethoprim (HOS-085184) ranitidine (HOS-085660) cimetidine (HOS-085835) didanosine (HOS-085836) zidovudine (HOS-085837)

Wechselwirkungen · Epivir

Epivir 150 mg film-coated tablets Epivir 300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6

HOS-085838 · Präparat HOS-083204

A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) is not significantly altered. Zidovudine has no effect on the pharmacokinetics of lamivudine (see section 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): zidovudine (HOS-085837)

Wechselwirkungen · Epivir

Epivir 10 mg/mL oral solution · Abschnitt 4.5 · PDF-Seite 21

HOS-085872 · Präparat HOS-083204

The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion via the organic cationic transport system e.g. trimethoprim. Other medicinal products (e.g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine. The nucleoside analogues (e.g. didanosine) like zidovudine, are not eliminated by this mechanism and are unlikely to interact with lamivudine.

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): didanosine (HOS-085836) zidovudine (HOS-085837) trimethoprim (HOS-085184) ranitidine (HOS-085660) cimetidine (HOS-085835)

Wechselwirkungen · Epivir

Epivir 10 mg/mL oral solution · Abschnitt 4.5 · PDF-Seite 21

HOS-085873 · Präparat HOS-083204

A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) is not significantly altered. Zidovudine has no effect on the pharmacokinetics of lamivudine (see section 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): zidovudine (HOS-085837)

Wechselwirkungen · Sifrol

SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-086614 · Präparat HOS-083320

Inhibitors/competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules. Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine, and procainamide, may interact with pramipexole resulting in reduced clearance of pramipexole. Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with SIFROL.

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): procainamide (HOS-086617) cimetidine (HOS-085835) pramipexole (HOS-086613) amantadine (HOS-086615) mexiletine (HOS-086341) zidovudine (HOS-085837) cisplatin (HOS-086022) quinine (HOS-086616)

Wechselwirkungen · Sifrol

SIFROL 0.26 mg prolonged-release tablets SIFROL 0.52 mg prolonged-release tablets SIFROL 1.05 mg prolonged-release tablets SIFROL 1.57 mg prolonged-release tablets SIFROL 2.1 mg prolonged-release tablets SIFROL 2.62 mg prolonged-release tablets SIFROL 3.15 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 21

HOS-086639 · Präparat HOS-083320

Inhibitors/competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules. Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine, and procainamide, may interact with pramipexole resulting in reduced clearance of pramipexole. Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with SIFROL.

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): quinine (HOS-086616) procainamide (HOS-086617) cimetidine (HOS-085835) pramipexole (HOS-086613) amantadine (HOS-086615) mexiletine (HOS-086341) zidovudine (HOS-085837) cisplatin (HOS-086022)

Wechselwirkungen · Mirapexin

MIRAPEXIN 0.088 mg tablets MIRAPEXIN 0.18 mg tablets MIRAPEXIN 0.35 mg tablets MIRAPEXIN 0.7 mg tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-086658 · Präparat HOS-083333

Inhibitors/competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules. Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine, and procainamide, may interact with pramipexole resulting in reduced clearance of pramipexole. Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with MIRAPEXIN.

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): quinine (HOS-086616) procainamide (HOS-086617) cimetidine (HOS-085835) pramipexole (HOS-086613) amantadine (HOS-086615) mexiletine (HOS-086341) zidovudine (HOS-085837) cisplatin (HOS-086022)

Wechselwirkungen · Mirapexin

MIRAPEXIN 0.26 mg prolonged-release tablets MIRAPEXIN 0.52 mg prolonged-release tablets MIRAPEXIN 1.05 mg prolonged-release tablets MIRAPEXIN 1.57 mg prolonged-release tablets MIRAPEXIN 2.1 mg prolonged-release tablets MIRAPEXIN 2.62 mg prolonged-release tablets MIRAPEXIN 3.15 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 21

HOS-086680 · Präparat HOS-083333

Inhibitors/competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules. Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine, and procainamide, may interact with pramipexole resulting in reduced clearance of pramipexole. Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with MIRAPEXIN.

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): quinine (HOS-086616) procainamide (HOS-086617) cimetidine (HOS-085835) pramipexole (HOS-086613) amantadine (HOS-086615) mexiletine (HOS-086341) zidovudine (HOS-085837) cisplatin (HOS-086022)

Wechselwirkungen · Viramune

Viramune 200 mg tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-088085 · Präparat HOS-083615

Zidovudine Zidovudine AUC  0.72 Zidovudine and Viramune can be 100-200 mg TID (0.60-0.96) co-administered without dose Zidovudine Cmin ND adjustments Zidovudine Cmax  0.70 (0.49-1.04) Granulocytopenia is commonly Nevirapine: Zidovudine had no associated with zidovudine. effect on its pharmacokinetics. Therefore, patients who receive nevirapine and zidovudine concomitantly and especially paediatric patients and patients who receive higher zidovudine doses or patients with poor bone marrow reserve, in particular those with advanced HIV disease, have an increased risk of granulocytopenia. In such patients haematological parameters should be carefully monitored.

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): zidovudine (HOS-085837)

Wechselwirkungen · Viramune

Viramune 50 mg/5 mL oral suspension · Abschnitt 4.5 · PDF-Seite 34

HOS-088187 · Präparat HOS-083615

Zidovudine Zidovudine AUC  0.72 Zidovudine and Viramune can be 100-200 mg TID (0.60-0.96) co-administered without dose Zidovudine Cmin ND adjustments Zidovudine Cmax  0.70 (0.49-1.04) Granulocytopenia is commonly Nevirapine: Zidovudine had no associated with zidovudine. effect on its pharmacokinetics. Therefore, patients who receive nevirapine and zidovudine concomitantly and especially paediatric patients and patients who receive higher zidovudine doses or patients with poor bone marrow reserve, in particular those with advanced HIV disease, have an increased risk of granulocytopenia. In such patients haematological parameters should be carefully monitored. NNRTIs Efavirenz Efavirenz AUC  0.72 (0.66-0.86) It is not recommended to co- 600 mg QD Efavirenz Cmin  0.68 (0.65-0.81) administer efavirenz and Viramune Efavirenz Cmax  0.88 (0.77-1.01) (see section 4.4), because of additive toxicity and no benefit in terms of efficacy over either NNRTI alone (for results of 2NN study, see section 5.1).

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): zidovudine (HOS-085837) efavirenz (HOS-087947)

Wechselwirkungen · Viramune

Viramune 400 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 58–59

HOS-088279 · Präparat HOS-083615

58 Zidovudine Zidovudine AUC  0.72 Zidovudine and Viramune can be 100-200 mg TID (0.60-0.96) co-administered without dose Zidovudine Cmin ND adjustments Zidovudine Cmax  0.70 (0.49-1.04) Granulocytopenia is commonly Nevirapine: Zidovudine had no associated with zidovudine. effect on its pharmacokinetics. Therefore, patients who receive nevirapine and zidovudine concomitantly and especially paediatric patients and patients who receive higher zidovudine doses or patients with poor bone marrow reserve, in particular those with advanced HIV disease, have an increased risk of granulocytopenia. In such patients haematological parameters should be carefully monitored.

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): zidovudine (HOS-085837)

Gegenanzeigen · Combivir

Combivir 150 mg/300 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-088506 · Präparat HOS-083663

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

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

Gegenanzeigen · Combivir

Combivir 150 mg/300 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3

HOS-088507 · Präparat HOS-083663

Zidovudine is contraindicated in patients with abnormally low neutrophil counts (<0.75 x 109/L), or abnormally low haemoglobin levels (<7.5 g/dL or 4.65 mmol/L). Combivir is therefore contraindicated in these patients (see section 4.4).

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

Wechselwirkungen · Combivir

Combivir 150 mg/300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-088508 · Präparat HOS-083663

Combivir contains lamivudine and zidovudine, therefore any interactions identified for these individually are relevant to Combivir. Clinical studies have shown that there are no clinically significant interactions between lamivudine and zidovudine.

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

Wechselwirkungen · Combivir

Combivir 150 mg/300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-088509 · Präparat HOS-083663

Zidovudine is primarily metabolised by UGT enzymes; co-administration of inducers or inhibitors of UGT enzymes could alter zidovudine exposure. Lamivudine is cleared renally. Active renal secretion of lamivudine in the urine is mediated through organic cation transporters (OCTs); co-administration of lamivudine with OCT inhibitors or nephrotoxic drugs may increase lamivudine exposure.

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

Wechselwirkungen · Combivir

Combivir 150 mg/300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-088510 · Präparat HOS-083663

Lamivudine and zidovudine are not significantly metabolised by cytochrome P450 enzymes (such as CYP 3A4, CYP 2C9 or CYP 2D6) nor do they inhibit or induce this enzyme system. Therefore, there is little potential for interactions with antiretroviral protease inhibitors, non-nucleosides and other medicinal products metabolised by major P450 enzymes.

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): protease (HOS-085623)

Wechselwirkungen · Combivir

Combivir 150 mg/300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-088511 · Präparat HOS-083663

Interaction studies have only been performed in adults. The list below should not be considered exhaustive but is representative of the classes studied.

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

Wechselwirkungen · Combivir

Combivir 150 mg/300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-088512 · Präparat HOS-083663

Drugs by Therapeutic Area Interaction Recommendation Geometric mean change (%) concerning co- (Possible mechanism) administration ANTIRETROVIRAL MEDICINAL PRODUCTS Didanosine/Lamivudine Interaction not studied. No dosage adjustment necessary. Didanosine /Zidovudine Interaction not studied. Stavudine/Lamivudine Interaction not studied. Combination not Stavudine/Zidovudine In vitro antagonism of anti-HIV recommended. activity between stavudine and zidovudine could result in decreased efficacy of both drugs. ANTI-INFECTIVE PRODUCTS Atovaquone/Lamivudine Interaction not studied. As only limited data available Atovaquone/Zidovudine Zidovudine AUC 33% the clinical significance is (750 mg twice daily with Atovaquone AUC  unknown. food/200 mg thrice daily) Clarithromycin/Lamivudine Interaction not studied. Separate administration of Clarithromycin/Zidovudine Zidovudine AUC 12% Combivir and clarithromycin (500 mg twice daily/100 mg by at least 2 hours every 4 hours) Trimethoprim/sulfamethoxazole Lamivudine: AUC 40% No Combivir dosage (Co-trimoxazole)/Lamivudine adjustment necessary, unless (160 mg/800 mg once daily for Trimethoprim: AUC  patient has renal impairment 5 days/300 mg single dose) Sulfamethoxazole: AUC  (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): didanosine (HOS-085836) stavudine (HOS-088080) atovaquone (HOS-086266) clarithromycin (HOS-084517) trimethoprim (HOS-085184) sulfamethoxazole (HOS-084533)

Wechselwirkungen · Combivir

Combivir 150 mg/300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7

HOS-088513 · Präparat HOS-083663

(organic cation transporter When concomitant inhibition) administration with co- Trimethoprim/sulfamethoxazole Interaction not studied. trimoxazole is warranted, (Co-trimoxazole)/Zidovudine patients should be monitored clinically. High doses of trimethoprim/

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): trimethoprim (HOS-085184) sulfamethoxazole (HOS-084533)

Wechselwirkungen · Combivir

Combivir 150 mg/300 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7–8

HOS-088514 · Präparat HOS-083663

7  sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis have not been studied and should be avoided. ANTIFUNGALS Fluconazole/Lamivudine Interaction not studied. As only limited data are Fluconazole/Zidovudine Zidovudine AUC 74% available the clinical (400 mg once daily/200 mg significance is not known. thrice daily) (UGT inhibition) Monitor for signs of zidovudine toxicity (see section 4.8). ANTIMYCOBACTERIALS Rifampicin/Lamivudine Interaction not studied. Insufficient data to Rifampicin/Zidovudine (600 Zidovudine AUC 48% recommend dosage mg once daily/200 mg thrice adjustment. daily) (UGT induction) ANTICONVULSANTS Phenobarbital/Lamivudine Interaction not studied. Insufficient data to Phenobarbital/Zidovudine Interaction not studied. recommend dosage adjustment. Potential to slightly decrease zidovudine plasma concentrations through UGT induction. Phenytoin/Lamivudine Interaction not studied. Monitor phenytoin Phenytoin/Zidovudine Phenytoin AUC  concentrations. Valproic acid/Lamivudine Interaction not studied. As only limited data are Valproic acid/Zidovudine Zidovudine AUC 80% available the clinical (250 mg or 500 mg thrice significance is not known. daily/100 mg thrice daily) (UGT inhibition) Monitor for signs of zidovudine toxicity (see section 4.8). ANTIHISTAMINES (HISTAMINE H1 RECEPTOR ANTAGONISTS) Ranitidine/Lamivudine Interaction not studied. No dosage adjustment necessary. Clinically significant interaction unlikely. Ranitidine eliminated only in part by renal organic cation transport system. Ranitidine/Zidovudine Interaction not studied Cimetidine/Lamivudine Interaction not studied. No dosage adjustment necessary. Clinically significant interaction unlikely. Cimetidine eliminated only in part by renal organic cation transport system. Cimetidine/Zidovudine Interaction not studied. CYTOTOXICS Cladribine/Lamivudine Interaction not studied Therefore the concomitant use of lamivudine with cladribine In vitro lamivudine inhibits the is not recommended intracellular phosphorylation of (see section 4.4) cladribine leading to a potential risk of cladribine loss of

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): sulfamethoxazole (HOS-084533) fluconazole (HOS-087945) phenobarbital (HOS-085617) phenytoin (HOS-084531) valproic acid (HOS-088515) histamine (HOS-088516) ranitidine (HOS-085660) cimetidine (HOS-085835) cladribine (HOS-085842)