Vonoprazan Fumarate

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

Combination Therapy with Clarithromycin and/or Amoxicillin Clinical Effect Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions, including potentially fatal arrhythmias, and is contraindicated. Prevention or Management See Contraindications and Warnings and Precautions in the prescribing information for clarithromycin.

Vonoprazan reduces intragastric acidity, which may alter absorption of rilpivirine, leading to changes in safety and/or effectiveness.

Atazanavir Avoid concomitant use with VOQUEZNA TRIPLE PAK. Atazanavir Avoid concomitant use with VOQUEZNA DUAL PAK.

Vonoprazan is a CYP2C19 inhibitor and may reduce plasma concentrations of clopidogrel's active metabolite, reducing platelet inhibition.

There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with disopyramide and quinidine. There have been postmarketing reports of hypoglycemia with the concomitant administration of clarithromycin and disopyramide. Prevention or Management Disopyramide Avoid concomitant use with VOQUEZNA TRIPLE PAK.

Omeprazole Clinical Effect Clarithromycin concentrations in the gastric tissue and mucus were increased by concomitant administration of omeprazole [see Clinical Pharmacology (12.3) ] . Prevention or Management Avoid concomitant use of VOQUEZNA TRIPLE PAK with omeprazole.

Strong or moderate CYP3A inducers may decrease exposure of vonoprazan and clarithromycin, reducing effectiveness of VOQUEZNA TRIPLE PAK.

Increased incidence of rashes reported with concurrent allopurinol and amoxicillin use compared to amoxicillin alone.

Lovastatin Simvastatin Atorvastatin Use VOQUEZNA TRIPLE PAK with caution. In situations where the concomitant use of VOQUEZNA TRIPLE PAK with atorvastatin or pravastatin cannot be avoided, atorvastatin dose should not exceed 20 mg daily and pravastatin dose should not exceed 40 mg daily.

Vonoprazan is a CYP2C19 inhibitor and may increase exposure of cilostazol; monitor for adverse reactions.

Vonoprazan is a CYP2C19 inhibitor and may increase exposure of citalopram; monitor for adverse reactions.

Bi-directional CYP3A interaction may increase clarithromycin exposure, increasing risk of adverse reactions; close monitoring recommended.

Lovastatin Simvastatin Atorvastatin Use VOQUEZNA TRIPLE PAK with caution.

Prevention or Management Midazolam Closely monitor patients for signs or symptoms of increased or prolonged central nervous system effects (e.g., somnolence and confusion) and refer to the CYP3A substrate prescribing information for dosage adjustments when used concomitantly with VOQUEZNA TRIPLE PAK.

Probenecid may increase amoxicillin exposure by blocking renal tubular secretion, increasing risk of adverse reactions.

Prevention or Management Saquinavir (CYP3A substrate and inhibitor) Use VOQUEZNA TRIPLE PAK with caution. See saquinavir prescribing information for instructions when saquinavir (with or without ritonavir) is co-administered with clarithromycin. Prevention or Management Saquinavir (CYP3A substrate and inhibitor) Use VOQUEZNA TRIPLE PAK with caution.

Lovastatin Simvastatin Atorvastatin Use VOQUEZNA TRIPLE PAK with caution.

Alprazolam Triazolam Calcium Channel Blockers Clinical Effect Clarithromycin is a strong CYP3A inhibitor.

Amlodipine Diltiazem Nifedipine Ergot Alkaloids Clinical Effect Clarithromycin is a strong CYP3A inhibitor.

High urine concentrations of ampicillin or amoxicillin may cause false-positive results when using glucose tests based on the Benedict's copper reduction reaction that determines the amount of reducing substances like glucose in the urine. High urine concentrations of ampicillin or amoxicillin may cause false-positive results when using glucose tests based on the Benedict's copper reduction reaction that determines the amount of reducing substances like glucose in the urine.

Other Drugs (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Effect Vonoprazan reduces intragastric acidity [see Clinical Pharmacology (12.2) ] , which may decrease the absorption of drugs reducing their effectiveness. Other Drugs (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Effect Vonoprazan reduces intragastric acidity [see Clinical Pharmacology (12.2) ] , which may decrease the absorption of drugs reducing their effectiveness.

Other Drugs (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Effect Vonoprazan reduces intragastric acidity [see Clinical Pharmacology (12.2) ] , which may decrease the absorption of drugs reducing their effectiveness. Other Drugs (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Effect Vonoprazan reduces intragastric acidity [see Clinical Pharmacology (12.2) ] , which may decrease the absorption of drugs reducing their effectiveness.

Pravastatin Fluvastatin Use of a statin that is not dependent on CYP3A metabolism (e.g., fluvastatin) can be considered.

Other Drugs (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Effect Vonoprazan reduces intragastric acidity [see Clinical Pharmacology (12.2) ] , which may decrease the absorption of drugs reducing their effectiveness. Other Drugs (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Effect Vonoprazan reduces intragastric acidity [see Clinical Pharmacology (12.2) ] , which may decrease the absorption of drugs reducing their effectiveness.

There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with alfentanil, methylprednisolone, cilostazol, bromocriptine, vinblastine, phenobarbital, and St.

Nelfinavir Other Antiretroviral Drugs See the prescribing information of other antiretroviral drugs dependent on gastric pH for absorption prior to concomitant use with VOQUEZNA TRIPLE PAK. Nelfinavir Other Antiretroviral Drugs See the prescribing information of other antiretroviral drugs dependent on gastric pH for absorption prior to concomitant use with VOQUEZNA DUAL PAK.

Amlodipine Diltiazem Nifedipine Ergot Alkaloids Clinical Effect Clarithromycin is a strong CYP3A inhibitor.

Other Drugs (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Effect Vonoprazan reduces intragastric acidity [see Clinical Pharmacology (12.2) ] , which may decrease the absorption of drugs reducing their effectiveness. Other Drugs (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Effect Vonoprazan reduces intragastric acidity [see Clinical Pharmacology (12.2) ] , which may decrease the absorption of drugs reducing their effectiveness.

In situations where the concomitant use of VOQUEZNA TRIPLE PAK with atorvastatin or pravastatin cannot be avoided, atorvastatin dose should not exceed 20 mg daily and pravastatin dose should not exceed 40 mg daily. Pravastatin Fluvastatin Use of a statin that is not dependent on CYP3A metabolism (e.g., fluvastatin) can be considered.

Dofetilide Procainamide Sotalol Quinidine Colchicine Clinical Effect Clarithromycin is an inhibitor of CYP3A and the efflux transporter, P-glycoprotein (P-gp).

See saquinavir prescribing information for instructions when saquinavir (with or without ritonavir) is co-administered with clarithromycin. Ritonavir (CYP3A inhibitor) Use of VOQUEZNA TRIPLE PAK with ritonavir is not recommended in patients with decreased renal function. See saquinavir prescribing information for instructions when saquinavir (with or without ritonavir) is co-administered with clarithromycin.

Alprazolam Triazolam Calcium Channel Blockers Clinical Effect Clarithromycin is a strong CYP3A inhibitor.