Home › NDC Lookup › Ingredients › Vonoprazan Fumarate And Amoxicillin › 81520-0250-14

VOQUEZNA DUAL PAK vonoprazan fumarate and amoxicillin Kit

by Phathom Pharmaceuticals Inc. · 14 BLISTER PACK in 1 CARTON (81520-250-14) / 1 KIT in 1 BLISTER PACK (81520-250-01)

NDC 81520-0250-14

🏷️ FDA NDC (as labeled) 81520-250-14 billing pads the product segment with a zero

Rx only Brand On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 81520-250-14

Product NDC 81520-250

11-digit billing NDC 81520025014

NCPDP billing unit EA — each (per item)

RxCUI 197517, 308191, 2604800, 2604801, 2604802, 2604803, 2604804

Application # NDA215153

SPL Set ID 0cb2ee04-8581-46c8-a781-7be170ab5c86

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2023-11-08

Dosage form KIT

GCN Seq No 083354

GCN 52289

HICL code 047981

Ingredient (HICL) Vonoprazan/Amoxicillin

HIC1 code D

Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System

HIC2 code D4

Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract

HIC3 code D4F

Therapeutic class — specific (HIC3) Anti-Ulcer-H.pylori Agents

AHFS code 08:12.16.08

AHFS class Aminopenicillin Antibiotics

FDB label name VOQUEZNA DUAL PAK

FDB brand name Voquezna Dual Pak

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 81520-250-14 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 81520-0250-14. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Macrolide Antimicrobial class.

Pharmacologic class Macrolide Antimicrobial

Drug family (ATC) Macrolides

How it works Cytochrome P450 3A4 Inhibitors, P-Glycoprotein Inhibitors, Cytochrome P450 3A Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPhathom Pharmaceuticals Inc.

Application holderPHATHOM PHARMACEUTICALS INC

FDA applicationNDA215153 (NDA)

Labeler code81520

First marketedNov 2023

Product typeHuman Prescription Drug

Portfolio4 products on file

🔎 All NDCs from Phathom Pharmaceuticals Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name VOQUEZNA DUAL PAK Ingredient Vonoprazan/Amoxicillin

📖 What it is MedlinePlus · NLM

Amoxicillin is used to treat certain infections caused by bacteria, such as pneumonia, skin, and urinary tract infections eliminate H. pylori, a bacteria that causes ulcers in combination with other medications Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Antibiotics such as amoxicillin will not work for colds, flu, and other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

H. pylori is a type of bacteria that lives in the stomach lining and can cause ulcers and ongoing stomach inflammation. It's tough to eliminate because the stomach's acidic environ...
What exactly is H. pylori, and why do I need two or three medications to treat it?
Yes — they're different regimens. Voquezna Dual Pak contains vonoprazan and amoxicillin, taken three times a day. Voquezna Triple Pak adds clarithromycin and is taken twice a day....
Does it matter which pak I was prescribed — Dual or Triple?

📖 Read our full Vonoprazan and Amoxicillin guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Red / Yellow / White

ShapeOval

ImprintGG;C9

Size19 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$7.499	$104.98 / 14 kit
Medicaid paysCMS SDUD · 12 mo	$828.25	$11,595.47 / 14 kit
Medicare drug plans payPart D · Q2 2026	$7.96	$111.45 / 14 kit

NADAC price history (per ea) — tap or hover for the price & month

Flat over the last 5 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Voquezna Dual Pakthis 81520-0250-14	Phathom	1 kit	$7.499	—	Availability likely	—

About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2022

First FDA approval

May 2022

📍

2026

Currently FDA-listed

4 years listed

🛡️

2032

Latest patent/protection listed

not a guaranteed launch date

🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved May 3, 2022 RLD RS ⏳ ~5.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book

US 9186411 — drug product

US 7977488 — drug substance

Exclusivity NCE

Exclusivity GAIN

2022 2024 2026 2028 2030 2032

Today

LOE

Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo

🏛️FDA exclusivity

FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.

🧪Product / substance patents

Patents covering the active ingredient, product, formulation, or related drug features.

🎯Method-of-use patents

Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.

🛈 What do these terms mean?

Patent: Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent: Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent: Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent: A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label: A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity: FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV: A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS: Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating: FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity): The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)

Patent	Type	Use code	Expires
US 9186411 ↗	Drug product	—	Aug 11, 2030
US 7977488 ↗	Drug substance	—	Apr 10, 2030

FDA exclusivity

Code	What it grants	Expires
NCE	New Chemical Entity (5-year)	May 3, 2027
GAIN	Qualified Infectious Disease Product (+5-year)	May 3, 2032

Common questions

Is there a generic version of VOQUEZNA DUAL PAK?

No FDA-approved generic equivalent is currently listed in the FDA Orange Book for VOQUEZNA DUAL PAK. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until May 2032 — an estimate, not a guaranteed launch date.

The FDA approved a generic — why can’t I get it at my pharmacy yet?

FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.

Why do different websites show different generic release dates?

Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.

What does “FDA listed” mean?

It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).

What does “current Orange Book estimate” mean?

It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.

Can a generic come out before the last patent expires?

Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.

Can a generic come out after the listed dates?

Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.

What is the difference between patents and exclusivity?

Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.

Why are there multiple patent dates?

One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.

Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 81520-0250-14, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

273

Units reimbursed last 4 qtrs

272

Gross reimbursed last 4 qtrs

$225.3K

Avg / prescription

$825.21

Avg / unit

$828.25

Latest quarter Q4 2025

81Rx

Medicaid pays / ea

$828.25

gross reimbursed

NADAC / ea

$7.4988

acquisition cost

Spread

+$820.75

+10945% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

96% FFS

Fee-for-service · 262 Rx Managed care · 11 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.01.3

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 New York 1.3 /100k

2 Kentucky 0.2 /100k

3 California 0.0 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Voquezna Dual Pak — the program that covers self-administered drugs. 1 manufacturer.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Voquezna Dual Pak. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$311.9K

Claims incl. refills

366

Beneficiaries

358

Spend / beneficiary

$871.26

Spend / claim

$852.22

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
81520-0250-14 You're viewing this	14 BLISTER PACK in 1 CARTON (81520-250-14) / 1 KIT in 1 BLISTER PACK (81520-250-01)	2023-11-08	Active

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	✓ Available
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	✓ Available

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 81520-250-14, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 81520-0250-14, written without dashes as 81520025014. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 81520-0250-14, the first segment (81520) is the labeler code FDA assigned to Phathom Pharmaceuticals Inc.; the middle segment (0250) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (14) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Phathom Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Phathom Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE VOQUEZNA TRIPLE PAK, is a co-packaged product containing vonoprazan, a potassium-competitive acid blocker (PCAB), amoxicillin, a penicillin class antibacterial, and clarithromycin, a macrolide antimicrobial, indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults. ( 1.1 ) VOQUEZNA DUAL PAK, is a co-packaged product containing vonoprazan, a PCAB, and amoxicillin, a penicillin class antibacterial, indicated for the treatment of H. pylori infection in adults. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK and other antibacterial drugs, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.2 )

1.1Helicobacter pylori Infection VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK are indicated for the treatment of Helicobacter pylori ( H. pylori ) infection in adults [see Clinical Studies (14) ].

1.2Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK and other antibacterial drugs, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION VOQUEZNA TRIPLE PAK : The recommended dosage is vonoprazan 20 mg plus amoxicillin 1,000 mg plus clarithromycin 500 mg, each given twice daily (morning and evening, 12 hours apart), with or without food, for 14 days. ( 2.1 ) VOQUEZNA DUAL PAK : The recommended dosage is vonoprazan 20 mg twice daily (morning and evening) plus amoxicillin 1,000 mg, three times a day (morning, mid-day, and evening), with or without food, for 14 days. ( 2.2 ) See full prescribing information for the recommended dosage for patients with renal or hepatic impairment.

( 2.3 , 2.4 )

2.1Recommended Dosage for VOQUEZNA TRIPLE PAK VOQUEZNA TRIPLE PAK is a co-packaged product containing vonoprazan tablets, amoxicillin capsules, and clarithromycin tablets each given twice daily (in the morning and evening, 12 hours apart) with or without food, for 14 days [see Clinical Pharmacology (12.3) ] . The recommended adult oral dosage of VOQUEZNA TRIPLE PAK is the following: In the morning, take 20 mg of vonoprazan (one oval pale red tablet), 1,000 mg of amoxicillin (two yellow capsules), and 500 mg of clarithromycin (one oval white tablet) In the evening, take 20 mg of vonoprazan (one oval pale red tablet), and 1,000 mg of amoxicillin (two yellow capsules), and 500 mg of clarithromycin (one oval white tablet)

2.2Recommended Dosage for VOQUEZNA DUAL PAK VOQUEZNA DUAL PAK is a co-packaged product containing vonoprazan tablets and amoxicillin capsules given with or without food, for 14 days [see Clinical Pharmacology (12.3) ] . The recommended adult oral dosage of VOQUEZNA DUAL PAK is the following: In the morning, take 20 mg of vonoprazan (one oval pale red tablet) and 1,000 mg of amoxicillin (two yellow capsules) Mid-day, take 1,000 mg of amoxicillin (two yellow capsules) In the evening, take 20 mg of vonoprazan (one oval pale red tablet) and 1,000 mg of amoxicillin (two yellow capsules)

2.3Recommended Dosage in Patients with Renal Impairment The recommended dosage of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK in adult patients with renal impairment is described in Table 1 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ]. Table 1: Recommended Dosage of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK in Patients with Renal Impairment Estimated GFR Recommended Dosage VOQUEZNA TRIPLE PAK VOQUEZNA DUAL PAK 30 mL/minute or greater 20 mg vonoprazan twice daily 1,000 mg amoxicillin twice daily 500 mg clarithromycin twice daily 20 mg vonoprazan twice daily 1,000 mg amoxicillin three times daily Less than 30 mL/minute Use is not recommended

2.4Recommended Dosage in Patients with Hepatic Impairment The recommended dosage of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK in adult patients with hepatic impairment is described in Table 2 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ]. Table 2: Recommended Dosage of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK in Patients with Hepatic Impairment Classification Recommended Dosage VOQUEZNA TRIPLE PAK VOQUEZNA DUAL PAK Child-Pugh Class A 20 mg vonoprazan twice daily 1,000 mg amoxicillin twice daily 500 mg clarithromycin twice daily 20 mg vonoprazan twice daily 1,000 mg amoxicillin three times daily Child-Pugh Class B Use is not recommended Child-Pugh Class C Use is not recommended

2.5Missed Doses If a dose is missed, administer VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK as soon as possible, within 4 hours after the missed dose. If more than 4 hours have passed, skip the missed dose and administer the next dose on the regularly scheduled time. Patients should continue the normal dosing schedule until the medication is completed.

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS VOQUEZNA TRIPLE PAK : Carton of 14 daily administration packs for morning and evening dosing, each containing the following three drug products ( 3.1 ): Tablets: Vonoprazan 20 mg Capsules: Amoxicillin 500 mg Tablets: Clarithromycin 500 mg VOQUEZNA DUAL PAK : Carton of 14 daily administration packs for morning, mid-day, and evening dosing, each containing the following two drug products ( 3.2 ): Tablets: Vonoprazan 20 mg Capsules: Amoxicillin 500 mg

3.1VOQUEZNA TRIPLE PAK VOQUEZNA TRIPLE PAK is a co-package consisting of 14 administration packs for morning and evening dosing. Each administration pack contains the following three drug products: Vonoprazan Tablets, 20 mg: pale red, oval, film-coated tablets debossed V20 on one side and plain on the other side. Amoxicillin Capsules, 500 mg: yellow, opaque, hard gelatin capsules imprinted with AMOX 500 on one side and GG 849 on the other side.

Clarithromycin Tablets, 500 mg: white, oval, film-coated debossed GG C9 on one side and plain on the other side.

3.2VOQUEZNA DUAL PAK VOQUEZNA DUAL PAK is a co-package consisting of 14 administration packs for morning, mid-day, and evening dosing. Each administration pack contains the following two drug products: Vonoprazan Tablets, 20 mg: pale red, oval, film-coated tablets debossed V20 on one side and plain on the other side. Amoxicillin Capsules, 500 mg: yellow, opaque, hard gelatin capsules imprinted with AMOX 500 on one side and GG 849 on the other side.

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK : Known hypersensitivity to vonoprazan, amoxicillin or any other beta-lactams, clarithromycin or any other macrolide antimicrobial or any component of VOQUEZNA TRIPLE PAK. ( 4.1 ) Known hypersensitivity to vonoprazan, amoxicillin or any other beta-lactams or any component of VOQUEZNA DUAL PAK. ( 4.1 ) Rilpivirine-containing products.

( 4.1 ) VOQUEZNA TRIPLE PAK Due to the Clarithromycin Component : Pimozide. ( 4.2 ) Lomitapide, lovastatin, and simvastatin. ( 4.2 ) Ergot alkaloids (ergotamine or dihydroergotamine).

( 4.2 ) Colchicine in renal or hepatic impairment. ( 4.2 ) History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin. ( 4.2 ) Lurasidone.

( 4.2 )

4.1Contraindications to VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK Hypersensitivity Reactions VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are contraindicated in patients with a known hypersensitivity to any component of VOQUEZNA TRIPLE PAK: vonoprazan, amoxicillin (or other β-lactam antibacterials, e.g., penicillins and cephalosporins), or clarithromycin (or other macrolide antibacterial drugs, e.g., erythromycin) or VOQUEZNA DUAL PAK: vonoprazan or amoxicillin (or other β-lactam antibacterials, e.g., penicillins and cephalosporins) [see Warnings and Precautions (5.1) ].

Rilpivirine-containing Products VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are contraindicated with rilpivirine-containing products [see Drug Interactions (7) ].

4.2Additional Contraindications to VOQUEZNA TRIPLE PAK Due to the Clarithromycin Component Serious Adverse Reactions/Risks Due to Drug Interactions Because of the clarithromycin component, VOQUEZNA TRIPLE PAK is contraindicated with concomitant use of: Pimozide: There have been postmarketing reports of drug interactions when clarithromycin is co-administered with pimozide, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes ) most likely due to inhibition of metabolism of these drugs by clarithromycin.

Fatalities have been reported [see Warnings and Precautions (5.2) and Drug Interactions (7) ]. Lipid-lowering Agents: Lomitapide, simvastatin, and lovastatin [see Warnings and Precautions (5.2) and Drug Interactions (7) ] Ergot Alkaloids: Ergotamine or dihydroergotamine [see Drug Interactions (7) ] Colchicine in patients with renal or hepatic impairment [see Warnings and Precautions (5.2) and Drug Interactions (7) ] Lurasidone: Coadministration of clarithromycin and lurasidone may lead to an increase in lurasidone exposure and the potential for serious adverse reactions [see Drug Interactions (7) ] .

Cholestatic Jaundice/Hepatic Dysfunction VOQUEZNA TRIPLE PAK is contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK : Hypersensitivity Reactions : Serious and occasionally fatal reactions (e.g., anaphylaxis) have been reported with components of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. If hypersensitivity reactions occur, discontinue VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK and institute immediate therapy (e.g., anaphylaxis management). ( 5.1 ) Acute Tubulointerstitial Nephritis : Discontinue VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK and evaluate patients.

( 5.1 ) Severe Cutaneous Adverse Reactions (SCAR) : Discontinue VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK at the first signs or symptoms of SCAR or other signs of hypersensitivity and consider further evaluation. ( 5.1 ) Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. If this occurs, discontinue VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK and institute appropriate therapy.

( 5.1 ) Clostridioides difficile -associated diarrhea (CDAD) : Evaluate if diarrhea occurs with VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. ( 5.1 ) VOQUEZNA TRIPLE PAK Due to the Clarithromycin Component : QT Prolongation : Avoid VOQUEZNA TRIPLE PAK in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia ( torsades de pointes ), hypokalemia/hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics. ( 5.2 ) Hepatotoxicity : Discontinue if signs and symptoms of hepatitis occur with VOQUEZNA TRIPLE PAK.

( 5.2 ) Serious Adverse Reactions Due to Concomitant Use with Other Drugs : Serious adverse reactions can occur with VOQUEZNA TRIPLE PAK due to drug interactions of clarithromycin with colchicine, some lipid lowering agents, some calcium channel blockers, and other drugs. ( 5.2 ) Embryo-Fetal Toxicity : Based on the findings from animal studies and human observational studies in pregnant women treated with clarithromycin, VOQUEZNA TRIPLE PAK is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate.

( 5.2 ) Myasthenia Gravis : Exacerbation of myasthenia gravis can occur with VOQUEZNA TRIPLE PAK since it has been reported in patients receiving clarithromycin tablets. ( 5.2 )

5.1Warnings and Precautions for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity reactions (e.g., anaphylaxis, anaphylactic shock, rash, erythema multiforme, and Henoch-Schonlein purpura) have been reported with components of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK [see Contraindications (4.1) ]. Before initiating therapy with VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, macrolide antibacterial drugs or other allergens.

Discontinue VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK immediately and institute appropriate treatment if hypersensitivity occurs. Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been reported with vonoprazan, a component of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK [see Adverse Reactions (6.1) ] . If suspected, discontinue VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK and evaluate patients with suspected acute TIN.

Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the components of VOQUEZNA TRIPLE PAK: vonoprazan, amoxicillin, and clarithromycin and VOQUEZNA DUAL PAK: vonoprazan and amoxicillin [see Adverse Reactions (6.2) ] . In addition, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with amoxicillin and clarithromycin.

Discontinue VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK at the first signs or symptoms of SCAR or other si…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.1) ] Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.1) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.1) ] QT Prolongation [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Serious Adverse Reactions Due to Concomitant Use with Other Drugs [see Warnings and Precautions (5.2) ] Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.2) ] VOQUEZNA TRIPLE PAK : Most common adverse reactions (≥ 2%) were dysgeusia, diarrhea, vulvovaginal candidiasis, headache, abdominal pain, and hypertension.

( 6.1 ) VOQUEZNA DUAL PAK : Most common adverse reactions (≥ 2%) were diarrhea, abdominal pain, vulvovaginal candidiasis, and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Phathom Pharmaceuticals, Inc. at toll-free phone 1-888-775-7428 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ) .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions with VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK The safety of VOQUEZNA TRIPLE PAK was evaluated in 675 adult patients (aged 20 to 82 years) in clinical trials in the United States, Europe and Japan and VOQUEZNA DUAL PAK was evaluated in 348 adult patients (aged 20 to 80 years) in a clinical trial in the United States and Europe.

All the patients were screened and found to be positive for H. pylori infection. The safety of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK was evaluated in a randomized, controlled, double-blind triple therapy/open-label dual therapy study conducted in the United States and Europe in treatment-naïve H. pylori -positive adult patients. Patients were randomized 1:1:1 to vonoprazan 20 mg twice daily plus amoxicillin 1,000 mg twice daily plus clarithromycin 500 mg twice daily (VOQUEZNA TRIPLE PAK) or vonoprazan 20 mg twice daily plus amoxicillin 1,000 mg three times daily (VOQUEZNA DUAL PAK) or lansoprazole 30 mg twice daily plus amoxicillin 1,000 mg twice daily plus clarithromycin 500 mg twice daily (LAC) administered for 14 consecutive days.

A total of 346 patients received VOQUEZNA TRIPLE PAK in the study, 348 received VOQUEZNA DUAL PAK and 345 received LAC. These patients had a mean age of 51 years (range 20 to 87 years); 62.2% were female, 89.3% were White, 7.4% Black or African American, 1.5% were Asian and 1.8% were others with 72.5% non-Hispanic or Latino. Adverse Reactions Leading to Discontinuation Treatment discontinuation due to an adverse reaction occurred in 2.3% (8/346) of the VOQUEZNA TRIPLE PAK-treated patients, 0.9% (3/348) of the VOQUEZNA DUAL PAK-treated patients and 1.2% (4/345) of the LAC-treated patients.

The most common adverse reactions leading to discontinuation of VOQUEZNA TRIPLE PAK were diarrhea (0.6%) and hypertension (0.6%) and the most common adverse reaction leading to discontinuation of VOQUEZNA DUAL PAK was rash (0.6%). Most Common Adverse Reactions The adverse reactions occurring in ≥2% of patients are described in Table 3. Table 3: Adverse Reactions Occurring in ≥2% of Adult Patients Receiving VOQUEZNA DUAL PAK or VOQUEZNA TRIPLE PAK Adverse Reactions VOQUEZNA DUAL PAK VOQUEZNA TRIPLE PAK LAC (N=348) n (%) (N=346) n (%) (N=345) n (%) Diarrhea 18 (5.2) 14 (4.0) 33 (9.6) Dysgeusia Dysgeusia also includes taste disorder.

2 (0.6) 16 (4.6) 21 (6.1) Vulvovaginal candidiasis Vulvovaginal candidiasis includes: urogenital infection fungal, vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginal pruritus, pruritus genita…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Collated drug interaction information for the individual components in VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK is summarized below. Drug interaction studies with VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK have not been conducted. These recommendations are based on either drug interaction trials or predicted interactions due to the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy [see Clinical Pharmacology (12.3) ] .

Clarithromycin (a component of VOQUEZNA TRIPLE PAK) is a strong CYP3A inhibitor. Concomitant use of VOQUEZNA TRIPLE PAK with a drug(s) primarily metabolized by CYP3A may cause elevations in CYP3A substrate drug's concentrations that could increase or prolong both therapeutic and adverse effects of the concomitant drug. Table 4: Effects of Other Drugs on VOQUEZNA TRIPLE PAK Strong or Moderate CYP3A Inducers Clinical Effect Vonoprazan and clarithromycin are CYP3A substrates.

Strong or moderate CYP3A inducers may decrease exposure of vonoprazan and clarithromycin [see Clinical Pharmacology (12.3) ] , which may reduce the effectiveness of VOQUEZNA TRIPLE PAK. Prevention or Management Avoid concomitant use with VOQUEZNA TRIPLE PAK. Probenecid Clinical Effect Amoxicillin undergoes tubular secretion.

Probenecid may increase amoxicillin exposure by blocking its renal tubular secretion, which may increase the risk of VOQUEZNA TRIPLE PAK adverse reactions. Prevention or Management Closely monitor for signs or symptoms of increased or prolonged adverse reactions associated with amoxicillin when used with VOQUEZNA TRIPLE PAK. Allopurinol Clinical Effect Increase in the incidence of rashes is reported in patients receiving both allopurinol and amoxicillin together compared to patients receiving amoxicillin alone.

It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients. Prevention or Management Discontinue allopurinol at the first appearance of skin rash when used concomitantly 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. Itraconazole Clinical Effect Both clarithromycin and itraconazole are substrates and inhibitors of CYP3A, potentially leading to a bi-directional drug interaction when administered concomitantly. VOQUEZNA TRIPLE PAK's use with strong CYP3A4 inhibitors may lead to increases in clarithromycin exposure, which may increase the risk of VOQUEZNA TRIPLE PAK adverse reactions.

Prevention or Management Patients taking itraconazole with VOQUEZNA TRIPLE PAK should be monitored closely for signs or symptoms of increased or prolonged adverse reactions associated with itraconazole and clarithromycin. Antivirals Clinical Effect Clarithromycin is a CYP3A4 substrate and inhibitor. Use of VOQUEZNA TRIPLE PAK with antivirals that are CYP3A substrates, inducers, or CYP3A inhibitors may potentially lead to bi-directional drug interactions leading to alterations in exposure of clarithromycin and/or CYP3A substrates, which may increase the risk of adverse reactions or loss of effectiveness [see Clinical Pharmacology (12.3) ] .

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. Ritonavir (CYP3A inhibitor) Use of VOQUEZNA TRIPLE PAK with ritonavir is not recommended in patients with decreased renal function.

Etravirine (CYP3A inducer) Avoid concomitant use with VOQUEZNA TRIPLE PAK. Table 5: Effects of Other Drugs on VOQUEZNA DUAL PAK Strong or Moderate CYP3A Inducers Clinical Effect Vonoprazan is a CYP3A substrate. Strong or moderate CYP3A inducers may…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Geriatrics : VOQUEZNA TRIPLE PAK increased risk of torsades de pointes due to the clarithromycin component. ( 8.5 ) Renal Impairment : Use is not recommended in severe renal impairment. ( 8.6 ) Hepatic Impairment : Use is not recommended in moderate and severe hepatic impairment. ( 8.7 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK during pregnancy. Healthcare providers are encouraged to register patients by calling 1-866-609-1612 or visiting https://voqueznapregnancyregistry.com/ . Risk Summary VOQUEZNA TRIPLE PAK Based on findings from animal studies and observational studies in pregnant women with use of clarithromycin, use of VOQUEZNA TRIPLE PAK is not recommended in pregnant women except in clinical circumstances where no alternative therapy is appropriate.

There are no adequate and well-controlled studies of VOQUEZNA TRIPLE PAK in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If VOQUEZNA TRIPLE PAK is used during pregnancy, advise pregnant women of the potential risk to a fetus. No reproductive and developmental toxicity studies with the combination of vonoprazan, amoxicillin, and/or clarithromycin were conducted.

VOQUEZNA DUAL PAK There are no adequate and well-controlled studies of VOQUEZNA DUAL PAK in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Individual Components of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK Clarithromycin: Published observational studies in pregnant women have demonstrated adverse effects on pregnancy outcomes, including an increased risk of miscarriage and in some studies an increased incidence of fetal malformations (see Data ) .

In animal reproduction studies, administration of oral clarithromycin to pregnant mice, rats, rabbits, and monkeys during the period of organogenesis produced malformations in rats (cardiovascular anomalies) and mice (cleft palate) at clinically relevant doses. Fetal effects in mice, rats, and monkeys (e.g., reduced fetal survival, body weight, body weight gain) and implantation losses in rabbits were generally considered to be secondary to maternal toxicity (see Data ) . Vonoprazan: Available data from pharmacovigilance reports with vonoprazan use in pregnant women are not sufficient to evaluate for a drug-associated risk for major birth defects, miscarriage or other adverse maternal or fetal outcomes.

In pregnant rats, no adverse effects were noted after oral administration of vonoprazan during organogenesis at approximately 27 times the maximum recommended human dose (MRHD) based on AUC exposure comparisons. In a pre- and postnatal development (PPND) study, pups from dams orally administered vonoprazan during organogenesis and through lactation, exhibited liver discoloration, which in follow-up mechanistic animal studies was associated with necrosis, fibrosis, and hemorrhage at a dose approximately 22 times the MRHD based on AUC comparisons which were likely attributable to exposure during lactation [see Use in Specific Populations (8.2) ] .

These effects were not observed at the next lower dose in this study, which was approximately equal to the MRHD based on AUC comparison, however they were seen at clinically relevant exposures in dose range finding studies in rats (see Data ) . Amoxicillin: Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with amoxicillin use have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Reproduction studies with amoxicillin have been performed in mice and rats (5 and 10 times the human dose 2 g human dose for mice and rats, respectively, 3 and 6 times the 3 g human dose for mice and…

🤰 Pregnancy ~3 min read ▾

There was no evidence of harm to the fetus due to amoxicillin. The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the United States general popul…

🧒 Pediatric Use 21 words ▾

8.4Pediatric Use Safety and effectiveness of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK in pediatric patients have not been established.

🧓 Geriatric Use ~2 min read ▾

8.5Geriatric Use Geriatric Use for the Individual Components of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK Amoxicillin and Clarithromycin Amoxicillin and clarithromycin are known to be substantially excreted by the kidney, and the risk of adverse reactions to these drugs may be greater in patients with impaired renal function and it may be useful to monitor renal function [see Use in Specific Populations (8.6) ]. Vonoprazan There were 218 patients aged 65 years and older in the clinical study of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK for the treatment of H. pylori infection [see Clinical Studies (14) ].

Of the total number of vonoprazan-treated subjects (N=694), there were 153 (22.0%) patients aged 65 years and older and 18 (2.6%) patients were aged 75 years and older. No overall differences in safety or effectiveness were observed between these patients and younger adult patients. Amoxicillin An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects.

These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, and it may be useful to monitor renal function.

Clarithromycin In a steady-state study in which healthy elderly subjects (65 years to 81 years of age) were given 500 mg of clarithromycin every 12 hours, the maximum serum concentrations and area under the curves of clarithromycin and 14-OH clarithromycin were increased compared to those achieved in healthy young adults. These changes in pharmacokinetics parallel known age-related decreases in renal function. In clinical trials, elderly patients did not have an increased incidence of adverse reactions when compared to younger patients.

Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients [see Warnings and Precautions (5.2) ]. Most reports of acute kidney injury with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem, nifedipine) involved elderly patients 65 years of age or older [see Warnings and Precautions (5.2) ]. Especially in elderly patients, there have been reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, some of which occurred in patients with renal insufficiency.

Deaths have been reported in some patients [see Contraindications (4.2) and Warnings and Precautions (5.2) ].

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE No information is available on accidental overdosage of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK in humans. In case of an overdose, patients should contact a physician, poison control center, or emergency room. The available overdosage information for each of the individual components in VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are summarized below: Vonoprazan There have been no reports of overdose with vonoprazan.

In clinical studies, a single dose of 120 mg resulted in no serious adverse reactions. Vonoprazan is not removed from the circulation by hemodialysis. If overdose occurs, treatment should be symptomatic and supportive.

Amoxicillin In case of amoxicillin overdosage, discontinue medication, treat symptomatically and institute supportive measures as needed. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms. Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin.

Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. Renal impairment appears to be reversible with cessation of drug administration.

High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin can be removed from circulation by hemodialysis. Clarithromycin Overdosage of clarithromycin can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea, and diarrhea.

Treat adverse reactions accompanying overdosage by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum concentrations are not expected to be appreciably affected by hemodialysis or peritoneal dialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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.

Clarithromycin is a macrolide antimicrobial drug [see Microbiology (12.4) ]. Acid suppression enhances the replication of H. pylori bacteria and the stability and effectiveness of antimicrobials in the treatment of H. pylori infection.

12.2Pharmacodynamics Vonoprazan Antisecretory Activity Following a single 20 mg dose of vonoprazan, the onset of the antisecretory effect as measured by intragastric pH occurs within 2 to 3 hours. The elevated intragastric pH compared to placebo is maintained for over 24-hours after dosing. The inhibitory effect of vonoprazan on acid secretion increases with repeated daily dosing and antisecretory effect reached steady state by Day 4 with a mean (SD) 24-hour intragastric pH of 6.0 (1.5) following 20 mg once daily dose (not an approved recommended dosage).

The antisecretory effect of vonoprazan decreases following drug discontinuation although intragastric pH remained elevated compared to placebo for 24 to 48 hours following the dose on Day 7. Cardiac Electrophysiology At a dose 6 times the maximum recommended dose, vonoprazan does not prolong the QT interval to any clinically relevant extent. Serum Gastrin Effects In clinical trials conducted in adult patients with erosive esophagitis, treatment with vonoprazan increased baseline serum gastrin concentrations.

Mean gastrin levels remained elevated with the recommended daily dose of vonoprazan for the treatment of erosive esophagitis and the mean serum gastrin levels returned to normal within 4 weeks of discontinuation of treatment. Increased gastrin causes enterochromaffin-like cell hyperplasia and increased serum CgA levels. The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors [see Warnings and Precautions (5.1) and Drug Interactions (7) ].

12.3Pharmacokinetics Pharmacokinetic (PK) parameters for vonoprazan 20 mg after a single dose (not an approved recommended dosage) and at steady state following twice daily administration are summarized in Table 8. Table 8: Mean (%CV) Pharmacokinetic Parameters for Vonoprazan Following a Single Dose or at Steady State Following Twice Daily Dosing PK Parameter Single Dose (N=10) Steady State (N=32) C max = Maximum plasma concentration; AUC 0-12h = Area under the plasma concentration-time curve from time 0 to the end of the 12-hour dosing interval; T max = Time to reach C max ; t 1/2 = Elimination half-life, CL/F = Apparent oral clearance, V z /F = Apparent oral volume of distribution.

T max (h), median (range) 2.5 (1.0-4.0) 3.0 (1.0-6.0) C max (ng/mL) 25.2 (39.7) 37.8 (36.1) AUC 0-12h (ng*hr/mL) 154.8 (25.2) 272.5 (30.5) t 1/2 (h) 7.1 (10.1) 6.8 (22.7) CL/F (L/h) 97.3 (36.3) 81.3 (35.7) V z /F (L) 1001 (39.6) 782.7 (34.4) Vonoprazan Absorption Vonoprazan exhibits time independent pharmacokinetics and steady state concentrations are achieved by Day 3 to 4. After multiple doses of vonoprazan ranging from 10 mg (0.5 times the lowest approved recommended single dosage) to 40 mg (2 times the highest approved recommended single dosage) once daily for 7 days in healthy subjects, C max and AUC values for vonoprazan increased in an approximately dose-proportional manner.

Steady state mean plasma exposure of vonoprazan fo…

🧬 Mechanism of Action 146 words ▾

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING VOQUEZNA TRIPLE PAK is a co-package containing: Vonoprazan Tablets, 20 mg: pale red, oval, film-coated tablets debossed V20 on one side and plain on the other side. Amoxicillin Capsules, 500 mg: yellow, opaque, hard gelatin capsules imprinted with AMOX 500 on one side and GG 849 on the other side. Clarithromycin Tablets, 500 mg: white, oval, film-coated tablets debossed GG C9 on one side and plain on the other side.

Vonoprazan tablets, amoxicillin capsules, and clarithromycin tablets are supplied in separate blister cavities within the same blister card. Each unit of use carton (NDC 81520-255-14) contains 56 tablets and 56 capsules divided into 14 daily dose blister cards. Each daily blister card contains two vonoprazan tablets (20 mg each), four amoxicillin capsules (500 mg each), and two clarithromycin tablets (500 mg each), and indicates which tablets and capsules need to be taken in the morning and evening.

Store between 20°C and 25°C (68°F and 77°F). Brief exposure to 15°C to 30°C (59°F to 86°F) permitted (see USP Controlled Room Temperature). Protect from light.

VOQUEZNA DUAL PAK is a co-package containing: Vonoprazan Tablets, 20 mg: pale red, oval, film-coated tablets debossed V20 on one side and plain on the reverse side. Amoxicillin Capsules, 500 mg: yellow, opaque, hard gelatin capsules imprinted with AMOX 500 on one side and GG 849 on the other side. Vonoprazan tablets and amoxicillin capsules are supplied in separate blister cavities within the same blister card.

Each unit of use carton (NDC 81520-250-14) contains 28 tablets and 84 capsules divided into 14 daily dose blister cards. Each daily blister card contains two vonoprazan tablets (20 mg each) and six amoxicillin capsules (500 mg each) and indicates which tablets and capsules need to be taken in the morning, mid-day, and evening. Store between 20°C and 25°C (68°F and 77°F).

Brief exposure to 15°C to 30°C (59°F to 86°F) permitted (see USP Controlled Room Temperature).

📦 Storage and Handling 169 words ▾

Store between 20°C and 25°C (68°F and 77°F). Brief exposure to 15°C to 30°C (59°F to 86°F) permitted (see USP Controlled Room Temperature). Protect from light.

Brief exposure to 15°C to 30°C (59°F to 86°F) permitted (see USP Controlled Room Temperature).

📋 Description ~2 min read ▾

11 DESCRIPTION VOQUEZNA TRIPLE PAK contains vonoprazan tablets, 20 mg, amoxicillin capsules, 500 mg, and clarithromycin tablets, 500 mg for oral administration. VOQUEZNA DUAL PAK contains vonoprazan tablets, 20 mg and amoxicillin capsules, 500 mg for oral administration. Vonoprazan Tablets Vonoprazan (as the fumarate), is a potassium-competitive acid blocker (PCAB).

Chemically, it is 1 H -pyrrole-3-methanamine, 5-(2-fluorophenyl)- N -methyl-1-(3-pyridinylsulfonyl)-, (2 E )-2-butenedioate (1:1). Its empirical formula is C 17 H 16 FN 3 O 2 S∙C 4 H 4 O 4 with a molecular weight of 461.5. Vonoprazan has the following structure: Vonoprazan fumarate is white to nearly white crystals or crystalline powder which melts at 194.8°C.

Vonoprazan fumarate is soluble in dimethyl sulfoxide; sparingly soluble in N,N –dimethylacetamide, slightly soluble in N,N -dimethylformamide, methanol, and water; very slightly soluble in ethanol (99.5); and practically insoluble in 2-propanol, acetone, 1-octanol, and acetonitrile. Each film-coated tablet contains 20 mg of vonoprazan, present as 26.72 mg of vonoprazan fumarate and the following inactive ingredients: ascorbic acid, croscarmellose sodium, ferric oxide red, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol 8000, and titanium dioxide.

Chemical structure Amoxicillin Capsules Amoxicillin is a penicillin class antibacterial, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2 S , 5 R , 6 R )-6-[( R )-(-)-2-amino-2-( p- hydroxyphenyl) acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. The molecular formula is C 16 H 19 N 3 O 5 S ∙ 3H 2 O and the molecular weight is 419.45.

Amoxicillin has the following structure: Each amoxicillin capsule, with yellow opaque cap and body, contains 500 mg amoxicillin as the trihydrate. Inactive ingredients: Capsule shells – ammonium hydroxide, black ferric oxide, gelatin, potassium hydroxide, propylene glycol, shellac, titanium dioxide, and yellow ferric oxide; Capsule contents – magnesium stearate and microcrystalline cellulose. Meets USP Dissolution Test 2.

Chemical structure Clarithromycin Tablets Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- O -methylerythromycin. The molecular formula is C 38 H 69 NO 13 , and the molecular weight is 747.96.

Clarithromycin has the following structure: Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each clarithromycin tablet contains 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, and titanium dioxide.

Chemical structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Patients should be aware that VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK can cause allergic reactions in some individuals. Advise the patient to call their healthcare provider immediately if they develop a new rash, urticaria, drug eruptions, swelling of the face, difficulty in breathing or other symptoms of allergic reactions [see Warnings and Precautions (5.1) and Adverse Reactions (6.2) ]. Acute Tubulointerstitial Nephritis Advise patients to call their healthcare provider if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Warnings and Precautions (5.1) ].

Severe Cutaneous Adverse Reactions Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Warnings and Precautions (5.1) and Adverse Reactions (6.2) ]. Drug Interactions Advise patients that VOQUEZNA TRIPLE PAK or the individual components of VOQUEZNA TRIPLE PAK may interact with some drugs; therefore, advise patients to report to their healthcare provider the use of any other medications including natural substitutes and nutritional supplements.

Diarrhea Advise patients that diarrhea is a common problem caused by antibacterials including amoxicillin and clarithromycin, and it usually ends when the drugs are stopped. However, rarely after receiving treatment with VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose. If this occurs, instruct patients to contact their healthcare provider as soon as possible [see Warnings and Precautions (5.1) ].

Embryo-Fetal Toxicity Advise pregnant patients and females of reproductive potential that if pregnancy occurs while taking VOQUEZNA TRIPLE PAK, there is a potential risk to the fetus due to the clarithromycin component [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1) ]. Advise patients who are exposed to VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK during pregnancy to contact Phathom Pharmaceuticals, Inc. at 1-888-775-7428. Pregnancy Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK during pregnancy [see Use in Specific Populations (8.1) ] .

Lactation Advise breastfeeding women to monitor their infants for diarrhea, vomiting, and rash [see Use in Specific Populations (8.2) ]. Infertility Advise males of reproductive potential that VOQUEZNA TRIPLE PAK may impair fertility [see Use in Specific Populations (8.3) ]. Potential for Dizziness, Vertigo and Confusion There are no data on the effect of VOQUEZNA TRIPLE PAK on the ability to drive or use machines.

However, counsel patients regarding the potential for dizziness, vertigo, confusion, and disorientation, which may occur with clarithromycin, a component of VOQUEZNA TRIPLE PAK. The potential for these adverse reactions should be taken into account before patients drive or use machines. Important Administration Instructions for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK Take with or without food [see Dosage and Administration (2) and Clinical Pharmacology (12.3) ] .

Missed doses : Advise patients that if a dose of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK is missed, administer as soon as possible within 4 hours after the missed dose. If more than 4 hours have passed, skip the missed dose and administer the next dose on the regularly scheduled time. It is important for patients to complete the entire course of therapy [see Dosage and Administration (2) ] .

Counsel patients to continue the full course of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK regardless of whether or not their symptoms impro…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

acute kidney injury: A sudden drop in kidney function over hours or days, which is often reversible if the cause is treated.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

bactericidal: Describes a medicine that kills bacteria outright.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

candidiasis: An infection caused by a yeast called Candida, which can affect the mouth, throat, skin, or other areas.

Child-Pugh: A scoring system doctors use to grade how severe long-term liver disease is, often to help set the right medicine dose.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Clostridioides difficile: A type of gut germ that can overgrow and cause severe, watery diarrhea, often after antibiotic use.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysgeusia: A changed or unpleasant sense of taste, such as a metallic taste.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

esophagitis: Swelling and irritation of the lining of the food pipe, or esophagus.

fertility: The natural ability to become pregnant or to father a child.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

GFR: A measure (glomerular filtration rate) of how well the kidneys filter the blood; lower numbers mean weaker kidney function.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hyperuricemia: A higher-than-normal level of uric acid in the blood, which can lead to gout.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

hypomagnesemia: A lower-than-normal level of magnesium, a mineral, in the blood.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inducer: A substance that speeds up an enzyme, which can lower the levels of drugs that enzyme breaks down.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

interstitial nephritis: Inflammation of the tissue between the kidney's tiny filtering tubes, sometimes triggered by a medicine, that can reduce kidney function.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

maximum recommended dose: The largest amount of a medicine that should be taken within a given period.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myasthenia gravis: A long-term condition where muscles tire and grow weak easily, often affecting the eyes, face, and swallowing.

nasopharyngitis: Inflammation of the nose and throat, commonly known as the common cold.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pruritus: Itching of the skin.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

torsades de pointes: A rare but dangerous fast heart rhythm that can cause fainting and, in the worst cases, become life-threatening.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

ventricular fibrillation: A life-threatening, chaotic rhythm in the heart's lower chambers that stops the heart from pumping blood effectively.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 81520-0200-30 · Phathom 81520-0255-14 · Phathom →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

VOQUEZNA DUAL PAK vonoprazan fumarate and amoxicillin Kit

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Kit / multi-component package

Questions about this listing

📄 Full prescribing information FDA SPL

12 CLINICAL PHARMACOLOGY

🔗 Related NDC lookups

💊 Related drugs in this class