Voquezna Dual Pak
It is used to treat a certain type of infection (H. pylori) that causes GI (gastrointestinal) ulcers.
Drug Class
H. pylori Eradication Agent
Pharmacologic Class
Potassium-Competitive Acid Blocker (PCAB) & Beta-Lactam Antibiotic
Pregnancy Category
Not available
FDA Approved
Nov 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Voquezna Dual Pak is a combination medicine used to treat stomach infections caused by a bacteria called H. pylori. It contains two drugs: vonoprazan, which reduces stomach acid, and amoxicillin, an antibiotic that kills bacteria.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from this medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. This combination pack contains two different medications, so make sure you understand how to take each one. If you have any questions, consult with your doctor or pharmacist.
You can take this medication with or without food. Continue taking it as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of any unused or expired medication. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it has been 4 hours or more since the missed dose, skip it and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from this medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. This combination pack contains two different medications, so make sure you understand how to take each one. If you have any questions, consult with your doctor or pharmacist.
You can take this medication with or without food. Continue taking it as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of any unused or expired medication. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it has been 4 hours or more since the missed dose, skip it and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take the medication exactly as prescribed for the full 14 days, even if you feel better, to ensure the infection is fully cleared.
- Do not stop taking the medication early without consulting your doctor.
- Avoid alcohol consumption during treatment, as it can worsen stomach upset and is generally not recommended with antibiotics.
- Maintain good hydration to prevent dehydration, especially if experiencing diarrhea.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Vonoprazan 20 mg orally twice daily and Amoxicillin 1000 mg orally three times daily for 14 days.
Condition-Specific Dosing:
H. pylori eradication:
Vonoprazan 20 mg BID + Amoxicillin 1000 mg TID for 14 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment for vonoprazan. Amoxicillin: No adjustment for CrCl >30 mL/min.
Moderate:
No dose adjustment for vonoprazan. Amoxicillin: For CrCl 10-30 mL/min, amoxicillin 500 mg every 12 hours. However, VOQUEZNA DUAL PAK is NOT recommended due to fixed-dose combination.
Severe:
Vonoprazan: Not studied, caution advised. Amoxicillin: For CrCl <10 mL/min, amoxicillin 500 mg every 24 hours. VOQUEZNA DUAL PAK is NOT recommended for CrCl <30 mL/min.
Dialysis:
Amoxicillin: 500 mg every 24 hours, plus an additional dose during and at the end of dialysis. VOQUEZNA DUAL PAK is NOT recommended.
Hepatic Impairment:
Mild:
No dose adjustment for vonoprazan (Child-Pugh A). No adjustment for amoxicillin.
Moderate:
Vonoprazan: Reduce vonoprazan to 10 mg once daily (Child-Pugh B). Amoxicillin: No adjustment. VOQUEZNA DUAL PAK is NOT recommended due to fixed-dose combination.
Severe:
Vonoprazan: Reduce vonoprazan to 10 mg once daily (Child-Pugh C). Amoxicillin: No adjustment. VOQUEZNA DUAL PAK is NOT recommended due to fixed-dose combination.
Pharmacology
Mechanism of Action
Vonoprazan is a potassium-competitive acid blocker (PCAB) that reversibly inhibits H+, K+-ATPase in gastric parietal cells, thereby suppressing gastric acid secretion. Amoxicillin is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to bacterial cell lysis and death.
Pharmacokinetics
Absorption:
Bioavailability:
Vonoprazan: Not explicitly stated, but rapidly absorbed. Amoxicillin: 70-90%
Tmax:
Vonoprazan: ~1.5-2 hours. Amoxicillin: ~1-2 hours
FoodEffect:
Vonoprazan: No clinically significant effect. Amoxicillin: Minimal effect.
Distribution:
Vd:
Vonoprazan: ~1 L/kg. Amoxicillin: ~0.3-0.4 L/kg
ProteinBinding:
Vonoprazan: ~85%. Amoxicillin: ~17-20%
CnssPenetration:
Vonoprazan: Limited. Amoxicillin: Limited (increased with inflamed meninges)
Elimination:
HalfLife:
Vonoprazan: ~7-9 hours. Amoxicillin: ~1-1.5 hours (normal renal function)
Clearance:
Not available
ExcretionRoute:
Vonoprazan: Renal (60-70%), Fecal (10-20%). Amoxicillin: Primarily renal (60% unchanged)
Unchanged:
Vonoprazan: <1% in urine. Amoxicillin: ~60% in urine
Pharmacodynamics
OnsetOfAction:
Vonoprazan: Rapid (within hours). Amoxicillin: Rapid
PeakEffect:
Vonoprazan: Within 2-4 hours. Amoxicillin: Within 1-2 hours
DurationOfAction:
Vonoprazan: >24 hours (acid suppression). Amoxicillin: Dependent on dosing frequency
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of drug-induced enterocolitis syndrome, a type of allergic reaction, such as:
+ Vomiting within 1 to 4 hours after taking this medication
+ Diarrhea within 24 hours after taking this medication
+ Pale or gray skin
+ Feeling tired or unwell
+ Signs of low blood pressure, including severe dizziness or passing out
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Vaginal itching or discharge
Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form called C. diff-associated diarrhea (CDAD) may occur. This can lead to a life-threatening bowel problem. If you experience:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
+ Contact your doctor right away. Do not treat diarrhea without consulting your doctor.
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions
+ These reactions can affect body organs and be fatal. Seek medical help immediately if you notice:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in your mouth, throat, nose, eyes, genitals, or any areas of skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands
Other Possible Side Effects
Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Stomach pain or diarrhea
* Nose or throat irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of drug-induced enterocolitis syndrome, a type of allergic reaction, such as:
+ Vomiting within 1 to 4 hours after taking this medication
+ Diarrhea within 24 hours after taking this medication
+ Pale or gray skin
+ Feeling tired or unwell
+ Signs of low blood pressure, including severe dizziness or passing out
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Vaginal itching or discharge
Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form called C. diff-associated diarrhea (CDAD) may occur. This can lead to a life-threatening bowel problem. If you experience:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
+ Contact your doctor right away. Do not treat diarrhea without consulting your doctor.
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions
+ These reactions can affect body organs and be fatal. Seek medical help immediately if you notice:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in your mouth, throat, nose, eyes, genitals, or any areas of skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands
Other Possible Side Effects
Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Stomach pain or diarrhea
* Nose or throat irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or watery diarrhea, especially if it contains blood or mucus (may indicate C. difficile infection)
- Signs of allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing
- Severe stomach pain or cramping
- Unusual bleeding or bruising
- Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you are allergic to penicillin.
Existing health conditions, such as kidney disease or liver disease.
If you have been diagnosed with mononucleosis (mono).
Any medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins, as some may interact with this medication. Specifically, certain medications used to treat HIV, infections, seizures, and other conditions should not be taken with this drug.
If you are breastfeeding, as you should not breastfeed while taking this medication and for at least 2 days after your last dose.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health status. Never start, stop, or change the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you are allergic to penicillin.
Existing health conditions, such as kidney disease or liver disease.
If you have been diagnosed with mononucleosis (mono).
Any medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins, as some may interact with this medication. Specifically, certain medications used to treat HIV, infections, seizures, and other conditions should not be taken with this drug.
If you are breastfeeding, as you should not breastfeed while taking this medication and for at least 2 days after your last dose.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health status. Never start, stop, or change the dosage of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug may interfere with certain laboratory tests, so be sure to notify your healthcare providers and lab personnel that you are taking it.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable tests to use, as this medication may affect the results.
Do not take this medication for longer than prescribed, as this can increase the risk of a second infection.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
When taking this medication, be aware that birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy. To minimize the risk of unintended pregnancy, use an additional form of birth control, such as a condom, in conjunction with your regular birth control method.
If you are pregnant or plan to become pregnant, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication during pregnancy with you.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable tests to use, as this medication may affect the results.
Do not take this medication for longer than prescribed, as this can increase the risk of a second infection.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
When taking this medication, be aware that birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy. To minimize the risk of unintended pregnancy, use an additional form of birth control, such as a condom, in conjunction with your regular birth control method.
If you are pregnant or plan to become pregnant, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication during pregnancy with you.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Electrolyte disturbances (rare)
- Renal dysfunction (with very high amoxicillin doses)
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive and symptomatic. Hemodialysis may be used to remove amoxicillin from circulation.
Drug Interactions
Contraindicated Interactions
- Rilpivirine (due to vonoprazan)
- Nelfinavir (due to vonoprazan)
- Atazanavir (due to vonoprazan)
Major Interactions
- Methotrexate (increased methotrexate levels due to amoxicillin)
- Warfarin (increased INR due to amoxicillin)
- Drugs requiring acidic gastric pH for absorption (e.g., ketoconazole, itraconazole, erlotinib, iron salts - decreased absorption due to vonoprazan)
- Drugs requiring alkaline gastric pH for absorption (e.g., some oral iron supplements - increased absorption due to vonoprazan)
Moderate Interactions
- Oral contraceptives (reduced efficacy due to amoxicillin)
- Allopurinol (increased risk of rash due to amoxicillin)
- Mycophenolate mofetil (reduced exposure due to vonoprazan)
- Tacrolimus (increased tacrolimus levels due to vonoprazan)
Minor Interactions
- Probenecid (increased amoxicillin levels)
Monitoring
Baseline Monitoring
H. pylori infection confirmation
Rationale: To confirm diagnosis before initiating therapy.
Timing: Prior to treatment initiation
Renal function (CrCl)
Rationale: To assess need for dose adjustment or contraindication for amoxicillin component.
Timing: Prior to treatment initiation
Hepatic function (Child-Pugh score)
Rationale: To assess need for dose adjustment or contraindication for vonoprazan component.
Timing: Prior to treatment initiation
Routine Monitoring
Resolution of symptoms (e.g., dyspepsia, abdominal pain)
Frequency: Daily during treatment, then post-treatment
Target: Symptom improvement/resolution
Action Threshold: Persistent or worsening symptoms may indicate treatment failure or other underlying conditions.
Adverse effects (e.g., diarrhea, nausea, taste disturbance, headache)
Frequency: Daily during treatment
Target: Tolerable side effects
Action Threshold: Severe or persistent adverse effects may require discontinuation or medical evaluation.
Symptom Monitoring
- Diarrhea (especially severe or persistent, suggestive of Clostridioides difficile-associated diarrhea)
- Rash, itching, hives, swelling (signs of allergic reaction)
- Severe abdominal pain or cramping
- Dark urine, yellowing of skin/eyes (signs of liver issues)
- Unusual bleeding or bruising
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of VOQUEZNA DUAL PAK in pregnant women. Amoxicillin is generally considered low risk (Category B). Vonoprazan has not shown adverse effects in animal reproduction studies, but human data are lacking. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk generally considered low for amoxicillin. Vonoprazan human data lacking.
Second Trimester:
Risk generally considered low for amoxicillin. Vonoprazan human data lacking.
Third Trimester:
Risk generally considered low for amoxicillin. Vonoprazan human data lacking.
Lactation
Amoxicillin is excreted in human milk in small amounts and is generally considered compatible with breastfeeding (L1). It may cause diarrhea, candidiasis, or allergic sensitization in the infant. It is unknown if vonoprazan is excreted in human milk. Caution should be exercised when administered to a nursing mother.
Infant Risk:
Low for amoxicillin; unknown for vonoprazan. Monitor infant for diarrhea, rash, or candidiasis.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. VOQUEZNA DUAL PAK is not recommended for use in pediatric patients.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. However, elderly patients are more likely to have decreased renal function, which may require dose adjustment for the amoxicillin component. Monitor renal function.
Clinical Information
Clinical Pearls
- VOQUEZNA DUAL PAK offers a novel PCAB (vonoprazan) in combination with amoxicillin for H. pylori eradication, providing an alternative to traditional PPI-based regimens.
- Adherence to the full 14-day course is critical for successful H. pylori eradication and to minimize the development of antibiotic resistance.
- Patients should be advised to take amoxicillin three times daily, which is a higher frequency than some other H. pylori regimens, to optimize efficacy.
- Due to the amoxicillin component, patients should be screened for penicillin allergies prior to initiation.
- Confirm H. pylori eradication (e.g., via urea breath test or stool antigen test) at least 4 weeks after completing therapy to ensure treatment success.
Alternative Therapies
- Standard triple therapy (PPI + Amoxicillin + Clarithromycin)
- Bismuth quadruple therapy (PPI + Bismuth + Metronidazole + Tetracycline)
- Concomitant therapy (PPI + Amoxicillin + Clarithromycin + Metronidazole)
- Sequential therapy (PPI + Amoxicillin, then PPI + Clarithromycin + Metronidazole)
Cost & Coverage
Average Cost:
Typically high, e.g., $800-$1200+ per 14-day course
Insurance Coverage:
Tier 3 or higher (Specialty/Non-Preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.