VOQUEZNA DUAL PAK Dosage & Rx Info

Voquezna Dual Pak Generic Name & Formulations

Legal Class

General Description

Vonoprazan 20mg (1 tab), amoxicillin 500mg (1cap); per pack.

Pharmacological Class

Potassium-competitive acid blocker (PCAB) + penicillin.

How Supplied

Triple Pak carton—14 daily dose blister cards (56 tabs + 56 caps); Dual Pak carton—14 daily dose blister cards (28 tabs + 84 caps)

Manufacturer

Phathom Pharmaceuticals, Inc.

Generic Availability

Mechanism of Action

Vonoprazan suppresses basal and stimulated gastric acid secretion at the secretory surface of the gastric parietal cell through inhibition of the H⁺, K⁺-ATPase enzyme system in a potassium competitive manner. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, vonoprazan has been characterized as a type of gastric proton-pump inhibitor, in that it blocks the final step of acid production. Vonoprazan does not require activation by acid. Vonoprazan may selectively concentrate in the parietal cells in both the resting and stimulated states. Vonoprazan binds to the active proton pumps in a noncovalent and reversible manner. Amoxicillin is an antibacterial drug.

Voquezna Dual Pak Indications

Indications

H. pylori infection.

Voquezna Dual Pak Dosage and Administration

Adult

Swallow whole. Vonoprazan 20mg twice daily (in the morning and evening) + amoxicillin 1g three times daily (in the morning, mid-day, and evening) for 14 days.

Children

Not established.

Voquezna Dual Pak Contraindications

Contraindications

Concomitant rilpivirine-containing products.

Voquezna Dual Pak Boxed Warnings

Not Applicable

Voquezna Dual Pak Warnings/Precautions

Warnings/Precautions

Discontinue if hypersensitivity or severe cutaneous reactions occur. Evaluate if diarrhea occurs. Avoid in those with mononucleosis. Moderate to severe hepatic impairment (Child-Pugh B or C), severe renal impairment (eGFR <30mL/min): avoid. Embryo-fetal toxicity. Pregnancy: not recommended (except when no alternatives are appropriate). Nursing mothers: pump/discard milk during and for 2 days after therapy ends.

Voquezna Dual Pak Pharmacokinetics

Absorption

Vonoprazan: steady state concentrations are achieved by Day 3 to 4.

Distribution

Vonoprazan: 85–88% plasma protein bound.

Metabolism

Vonoprazan: Hepatic (CYP3A4/5, CYP2B6, CYP2C19, CYP2C9, CYP2D6).

Elimination

Vonoprazan: Renal (67%), fecal (31%); Half-life: 6.8–7.9 hours.

Voquezna Dual Pak Interactions

Interactions

May be antagonized by strong or moderate CYP3A inducers; avoid. Vonoprazan reduces intragastric acidity which may alter the absorption of antiretrovirals and other drugs (eg, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole); avoid concomitant with atazanavir, nelfinavir. May potentiate CYP3A4 substrates (eg, tacrolimus, cyclosporine); dose reduction of substrate drugs may be needed. May potentiate CYP2C19 substrates (eg, citalopram, cilostazol); monitor closely. May antagonize clopidogrel; monitor and consider alternative therapy. May cause false (+) results in diagnostic tests for neuroendocrine tumors; assess CgA levels at least 14 days after treatment; repeat if initial levels are high.

Voquezna Dual Pak Adverse Reactions

Adverse Reactions

Diarrhea, dysgeusia, abdominal pain, vulvovaginal candidiasis, headache, hypertension, nasopharyngitis.

Voquezna Dual Pak Clinical Trials

See Literature

Voquezna Dual Pak Note

Notes

For Amoxicillin contraindications, warnings/precautions, interactions, and adverse reactions see entry: Amoxicillin.

Voquezna Dual Pak Patient Counseling