Esomeprazole Magnesium Delayed Release Capsules

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.

Esomeprazole magnesium substantially decreases atazanavir plasma concentrations (AUC decreased by 94%), which may result in loss of therapeutic effect and development of drug resistance.

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.

Esomeprazole magnesium decreases nelfinavir serum levels (AUC decreased by 92%), which may result in loss of therapeutic effect and development of drug resistance.

Concomitant use is contraindicated due to decreased antiretroviral exposure and reduced antiviral effect.

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

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

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

Concomitant use may increase INR and prothrombin time, leading to abnormal bleeding and even death.

Esomeprazole magnesium may increase systemic exposure of cilostazol and its active metabolite. Consider dose reduction.

CYP2C19 substrate; concomitant use with esomeprazole may alter citalopram exposure.

Esomeprazole magnesium may interfere with digoxin bioavailability. Patients may need monitoring 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, monitor for toxicity and consider saquinavir dose reduction. Patients treated with esomeprazole magnesium and digoxin may need to be monitored for digoxin toxicity. ( 7.2 ) Combined inhibitor of CYP 2C19 and 3A4 may raise esomeprazole levels.( 7.3 ) Clopidogrel: esomeprazole magnesium decreases exposure to the active metabolite of clopidogrel.

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, monitor for toxicity and consider saquinavir dose reduction. Patients treated with esomeprazole magnesium and digoxin may need to be monitored for digoxin toxicity. ( 7.2 ) Combined inhibitor of CYP 2C19 and 3A4 may raise esomeprazole levels.( 7.3 ) Clopidogrel: esomeprazole magnesium decreases exposure to the active metabolite of clopidogrel.

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.