Esomeprazole Magnesium

Combination Therapy with Clarithromycin and Amoxicillin Clinical Impact: Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions, including potentially fatal arrhythmias, and are contraindicated. Amoxicillin also has drug interactions. See Drug Interactions in prescribing information for amoxicillin.

Concomitant use is not recommended. Esomeprazole magnesium substantially decreases atazanavir plasma concentrations, potentially causing loss of therapeutic effect and drug resistance development.

Combination Therapy with Clarithromycin and Amoxicillin Clinical Impact: Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions, including potentially fatal arrhythmias, and are contraindicated. Intervention: See Contraindications, Warnings and Precautions in prescribing information for clarithromycin.

Concomitant use is not recommended. Esomeprazole magnesium decreases nelfinavir serum levels, potentially reducing therapeutic effectiveness.

Concomitant use with esomeprazole magnesium delayed-release capsules are contraindicated due to decreased antiretroviral exposure.

Concomitant use of esomeprazole 40 mg reduced plasma concentrations of active metabolite of clopidogrel and platelet inhibition.

Concomitant use may elevate and prolong serum concentrations of methotrexate and metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities.

Increased exposure of saquinavir when used concomitantly with esomeprazole may increase toxicity.

Concomitant use increases INR and prothrombin time, potentially leading to abnormal bleeding and death.

CYP2C19 substrate; concomitant use with esomeprazole may alter exposure due to CYP2C19 inhibition.

CYP2C19 substrate; concomitant use with esomeprazole may alter exposure due to CYP2C19 inhibition.

Esomeprazole magnesium may interfere with digoxin bioavailability. Patients should be monitored for digoxin toxicity.

Esomeprazole magnesium may interfere with erlotinib bioavailability due to effects on gastric pH.

7 DRUG INTERACTIONS • May affect plasma levels of antiretroviral drugs - use with atazanavir and nelfinavir is not recommended; if saquinavir is used with esomeprazole magnesium delayed-release capsules, monitor for toxicity and consider saquinavir dose reduction. Patients treated with esomeprazole magnesium delayed-release capsules and digoxin may need to be monitored for digoxin toxicity. (7.2) • Combined inhibitor of CYP2C19 and 3A4 may raise esomeprazole levels.

Esomeprazole magnesium may interfere with iron salts bioavailability due to effects on gastric pH.

Esomeprazole magnesium may interfere with ketoconazole bioavailability due to effects on gastric pH.

Esomeprazole magnesium may interfere with mycophenolate mofetil bioavailability due to effects on gastric pH.

7 DRUG INTERACTIONS • May affect plasma levels of antiretroviral drugs - use with atazanavir and nelfinavir is not recommended; if saquinavir is used with esomeprazole magnesium delayed-release capsules, monitor for toxicity and consider saquinavir dose reduction. Patients treated with esomeprazole magnesium delayed-release capsules and digoxin may need to be monitored for digoxin toxicity. (7.2) • Combined inhibitor of CYP2C19 and 3A4 may raise esomeprazole levels.

Esomeprazole magnesium may increase serum levels of tacrolimus, requiring monitoring.

Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Esomeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which esomeprazole is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH.

Co-administration of esomeprazole 30 mg and diazepam, a CYP2C19 substrate, resulted in a 45% decrease in clearance of diazepam.

Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Esomeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which esomeprazole is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH.

Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Esomeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which esomeprazole is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH.

Ritonavir-containing products: see prescribing information for specific drugs Voriconazole Clinical Impact: Increased exposure of esomeprazole [see Clinical Pharmacology (12.3) ].

Ritonavir-containing products: see prescribing information for specific drugs Voriconazole Clinical Impact: Increased exposure of esomeprazole [see Clinical Pharmacology (12.3) ]. See prescribing information for voriconazole.