Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Rilutek

RILUTEK 50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 4

HOS-085901 · Präparat HOS-083218

In vitro studies using human liver microsomal preparations suggest that CYP 1A2 is the principal isozyme involved in the initial oxidative metabolism of riluzole. Inhibitors of CYP 1A2 (e.g. caffeine, diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) could potentially decrease the rate of riluzole elimination, while inducers of CYP 1A2 (e.g. cigarette smoke, charcoal-broiled food, rifampicin and omeprazole) could increase the rate of riluzole elimination.

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): diclofenac (HOS-085903) amitriptyline (HOS-085911) imipramine (HOS-085907) nicergoline (HOS-085905) caffeine (HOS-085902) theophylline (HOS-085910) diazepam (HOS-085904) clomipramine (HOS-085906) phenacetin (HOS-085909) fluvoxamine (HOS-085908) omeprazole (HOS-085912)

Wechselwirkungen · Arava

Arava 10 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-089665 · Präparat HOS-083907

Effect on caffeine (CYP1A2 substrate) Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo. Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.

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): duloxetine (HOS-089666) tizanidine (HOS-089668) caffeine (HOS-085902) theophylline (HOS-085910) lead (HOS-085592) alosetron (HOS-089667)

Wechselwirkungen · Arava

Arava 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 26

HOS-089734 · Präparat HOS-083907

Effect on caffeine (CYP1A2 substrate) Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo. Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.

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): duloxetine (HOS-089666) tizanidine (HOS-089668) caffeine (HOS-085902) theophylline (HOS-085910) lead (HOS-085592) alosetron (HOS-089667)

Wechselwirkungen · Arava

Arava 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 43

HOS-089794 · Präparat HOS-083907

Effect on caffeine (CYP1A2 substrate) Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo. Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.

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): duloxetine (HOS-089666) tizanidine (HOS-089668) caffeine (HOS-085902) theophylline (HOS-085910) lead (HOS-085592) alosetron (HOS-089667)

Wechselwirkungen · Fuzeon

Fuzeon 90 mg/ml powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 4

HOS-112395 · Präparat HOS-093667

Influence of enfuvirtide on metabolism of concomitant medicinal products: In an in-vivo human metabolism study enfuvirtide, at the recommended dose of 90 mg twice daily, did not inhibit the metabolism of substrates by CYP3A4 (dapsone), CYP2D6 (debrisoquine), CYP1A2 (caffeine), CYP2C19 (mephenytoin), and CYP2E1 (chlorzoxazone).

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): caffeine (HOS-085902) mephenytoin (HOS-109801) chlorzoxazone (HOS-112397) dapsone (HOS-088141)

Wechselwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 8

HOS-114802 · Präparat HOS-094169

A cocktail study was conducted in 16 healthy volunteers with twice-daily 500 mg tipranavir with 200 mg ritonavir capsule administration for 10 days to assess the net effect on the activity of hepatic CYP 1A2 (caffeine), 2C9 (warfarin), 2D6 (dextromethorphan), both intestinal/hepatic CYP 3A4 (midazolam) and P-glycoprotein (P-gp) (digoxin). At steady state, there was a significant induction of CYP 1A2 and a slight induction on CYP 2C9. Potent inhibition of CYP 2D6 and both hepatic and intestinal CYP 3A4 activities were observed. P-gp activity is significantly inhibited after the first dose, but there was a slight induction at steady state. Practical recommendations deriving from this study are displayed below.

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): digoxin (HOS-086172) caffeine (HOS-085902) ritonavir (HOS-084521) dextromethorphan (HOS-109265) warfarin (HOS-085950) midazolam (HOS-086167)

Wechselwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 21–22

HOS-114849 · Präparat HOS-094169

21  CYP 3A4 inhibition by tipranavir/r Others Theophylline Based on data from the cocktail Theophylline plasma No interaction study study where caffeine (CYP1A2 concentrations should be performed substrate) AUC was reduced by monitored during the first two 43%, tipranavir with ritonavir is weeks of co-administration with expected to decrease theophylline Aptivus, co-administered with concentrations. low dose ritonavir, and the theophylline dose should be Induction of CYP 1A2 by increased as needed. tipranavir/r Desipramine tipranavir, co-administered with Dosage reduction and No interaction study low dose ritonavir, is expected to concentration monitoring of performed increase desipramine desipramine is recommended. concentrations

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) caffeine (HOS-085902) theophylline (HOS-085910) ritonavir (HOS-084521)

Wechselwirkungen · Diacomit

Diacomit 250 mg hard capsules · Abschnitt 4.5 · PDF-Seite 5

HOS-115317 · Präparat HOS-094267

Data on the potential for inhibition of CYP1A2 are limited, and therefore, interactions with theophylline and caffeine cannot be excluded because of the increased plasma levels of theophylline and caffeine which may occur via inhibition of their hepatic metabolism, potentially leading to toxicity. Use in combination with stiripentol is not recommended. This warning is not only restricted to medicinal products but also to a considerable number of foods (for example: cola, chocolate, coffee, tea, and energy drinks) and nutritional products aimed at children: Patient should not drink cola drinks, which contain significant quantities of caffeine or chocolate, which contains trace amounts of theophylline (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): caffeine (HOS-085902) theophylline (HOS-085910)

Wechselwirkungen · Diacomit

Diacomit 500 mg hard capsules · Abschnitt 4.5 · PDF-Seite 16

HOS-115383 · Präparat HOS-094267

Data on the potential for inhibition of CYP1A2 are limited, and therefore, interactions with theophylline and caffeine cannot be excluded because of increased plasma levels of theophylline and caffeine which may occur via inhibition of their hepatic metabolism, potentially leading to toxicity. Use in combination with stiripentol is not recommended. This warning is not only restricted to medicinal products but also to a considerable number of foods (for example: cola, chocolate, coffee, tea, and energy drinks) and nutritional products aimed at children: Patient should not drink cola drinks, which contain significant quantities of caffeine or chocolate, which contains trace amounts of theophylline (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): caffeine (HOS-085902) theophylline (HOS-085910)

Wechselwirkungen · Diacomit

Diacomit 250 mg powder for oral suspension in sachet · Abschnitt 4.5 · PDF-Seite 27

HOS-115417 · Präparat HOS-094267

Data on the potential for inhibition of CYP1A2 are limited, and therefore, interactions with theophylline and caffeine cannot be excluded because of increased plasma levels of theophylline and caffeine which may occur via inhibition of their hepatic metabolism, potentially leading to toxicity. Use in combination with stiripentol is not recommended. This warning is not only restricted to medicinal products but also to a considerable number of foods (for example: cola, chocolate, coffee, tea, and energy drinks) and nutritional products aimed at children: Patient should not drink cola drinks, which contain significant quantities of caffeine or chocolate, which contains trace amounts of theophylline (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): caffeine (HOS-085902) theophylline (HOS-085910)

Wechselwirkungen · Diacomit

Diacomit 500 mg powder for oral suspension in sachet · Abschnitt 4.5 · PDF-Seite 38

HOS-115452 · Präparat HOS-094267

Data on the potential for inhibition of CYP1A2 are limited, and therefore, interactions with theophylline and caffeine cannot be excluded because of increased plasma levels of theophylline and caffeine which may occur via inhibition of their hepatic metabolism, potentially leading to toxicity. Use in combination with stiripentol is not recommended. This warning is not only restricted to medicinal products but also to a considerable number of foods (for example: cola, chocolate, coffee, tea, and energy drinks) and nutritional products aimed at children: Patient should not drink cola drinks, which contain significant quantities of caffeine or chocolate, which contains trace amounts of theophylline (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): caffeine (HOS-085902) theophylline (HOS-085910)

Wechselwirkungen · Pantozol Control

PANTOZOL Control 20 mg gastro-resistant tablets · Abschnitt 4.5 · PDF-Seite 5

HOS-121275 · Präparat HOS-095311

Pantoprazole is metabolised in the liver via the cytochrome P450 enzyme system. Interaction studies with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing levonorgestrel and ethinyl oestradiol did not reveal clinically significant interactions. However, an interaction of pantoprazole with other substances which are metabolised by the same enzyme system cannot be excluded.

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): nifedipine (HOS-086289) piroxicam (HOS-110101) diclofenac (HOS-085903) carbamazepine (HOS-085618) levonorgestrel (HOS-089677) digoxin (HOS-086172) caffeine (HOS-085902) theophylline (HOS-085910) diazepam (HOS-085904) ethanol (HOS-089988) metoprolol (HOS-090094) phenytoin (HOS-084531) naproxen (HOS-087936)

Gegenanzeigen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.3 · PDF-Seite 4

HOS-121291 · Präparat HOS-095319

Hypersensitivity to the active substance 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.

Wechselwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.5 · PDF-Seite 5

HOS-121292 · Präparat HOS-095319

Inter-conversion between caffeine and theophylline occurs in preterm newborn infants. These active substances should not be used concurrently.

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): theophylline (HOS-085910)

Wechselwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.5 · PDF-Seite 5

HOS-121293 · Präparat HOS-095319

Cytochrome P450 1A2 (CYP1A2) is the major enzyme involved in the metabolism of caffeine in humans. Therefore, caffeine has the potential to interact with active substances that are substrates for CYP1A2, inhibit CYP1A2, or induce CYP1A2. However, caffeine metabolism in preterm newborn infants is limited due to their immature hepatic enzyme systems.

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

Wechselwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.5 · PDF-Seite 5–6

HOS-121294 · Präparat HOS-095319

5 Although few data exist on interactions of caffeine with other active substances in preterm newborn infants, lower doses of caffeine citrate may be needed following co-administration of active substances which are reported to decrease caffeine elimination in adults (e.g., cimetidine and ketoconazole) and higher caffeine citrate doses may be needed following co-administration of active substances that increase caffeine elimination (e.g., phenobarbital and phenytoin). Where doubt exists about possible interactions, plasma caffeine concentrations should be measured. As bacterial overgrowth in the gut is associated with the development of necrotising enterocolitis, co- administration of caffeine citrate with medicinal products that suppress gastric acid secretion (antihistamine H2 receptor blockers or proton-pump inhibitors) may in theory increase the risk of necrotising enterocolitis (see section 4.4 and 4.8). Concurrent use of caffeine and doxapram might potentiate their stimulatory effects on the cardio- respiratory and central nervous system. If concurrent use is indicated, cardiac rhythm and blood pressure must 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): phenobarbital (HOS-085617) cimetidine (HOS-085835) ketoconazole (HOS-084513) doxapram (HOS-121295) phenytoin (HOS-084531)

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 6

HOS-121296 · Präparat HOS-095319

Summary of the safety profile

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 6

HOS-121297 · Präparat HOS-095319

The known pharmacology and toxicology of caffeine and other methylxanthines predict the likely adverse reactions to caffeine citrate. Effects described include central nervous system (CNS) stimulation such as convulsion, irritability, restlessness and jitteriness, cardiac effects such as tachycardia, arrhythmia, hypertension and increased stroke volume, metabolism and nutrition disorders such as hyperglycaemia. These effects are dose related and may necessitate measurement of plasma levels and dose reduction.

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 6

HOS-121298 · Präparat HOS-095319

Tabulated list of adverse reactions

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 6

HOS-121299 · Präparat HOS-095319

The adverse reactions described in the short- and long-term published literature and obtained from a post-authorisation safety study that can be associated with caffeine citrate are listed below by System Organ Class and Preferred Term (MedDRA).

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