Voquezna 20mg Tablets
It is used to treat a certain type of reflux.It is used to treat heartburn.It is used to treat syndromes caused by lots of stomach acid.It is used to treat a certain type of infection (H. pylori) that causes GI (gastrointestinal) ulcers.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Potassium-competitive acid blocker (PCAB)
Pharmacologic Class
Potassium-competitive acid blocker (PCAB)
Pregnancy Category
Not available
FDA Approved
Oct 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Voquezna is a medicine used to treat stomach acid-related problems like heartburn and ulcers. It works by blocking a pump in your stomach that makes acid, helping to reduce the amount of acid and allow your stomach and esophagus to heal. It's also used with antibiotics to get rid of a specific bacteria (H. pylori) that can cause ulcers.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but be sure to swallow the tablet whole - do not chew, break, or crush it. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who can also inform you about any local drug take-back programs.
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 more than 12 hours since the missed dose (or 4 hours if you are taking the medication for H. pylori treatment), skip the missed dose and resume your regular dosing 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 your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but be sure to swallow the tablet whole - do not chew, break, or crush it. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who can also inform you about any local drug take-back programs.
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 more than 12 hours since the missed dose (or 4 hours if you are taking the medication for H. pylori treatment), skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take exactly as prescribed by your doctor, usually once or twice a day.
- Do not crush, chew, or break the tablets; swallow them whole.
- Complete the full course of treatment, even if you feel better, especially for H. pylori eradication.
- Avoid foods and drinks that trigger your acid reflux symptoms (e.g., spicy foods, fatty foods, caffeine, alcohol, carbonated beverages).
- Elevate the head of your bed if you experience nighttime reflux.
- Avoid lying down immediately after meals.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication
Dose Range:
10 - 20 mg
Condition-Specific Dosing:
H. pylori Eradication (Triple Therapy):
20 mg twice daily for 14 days, in combination with amoxicillin and clarithromycin.
H. pylori Eradication (Dual Therapy):
20 mg twice daily for 14 days, in combination with amoxicillin.
Healing of Erosive Esophagitis:
20 mg once daily for 8 weeks.
Maintenance of Healed Erosive Esophagitis:
10 mg once daily for up to 6 months.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed.
Dialysis:
No dose adjustment needed for patients with ESRD on hemodialysis.
Hepatic Impairment:
Mild:
No dose adjustment needed (Child-Pugh A).
Moderate:
For H. pylori eradication: 10 mg twice daily. For erosive esophagitis: 10 mg once daily (Child-Pugh B).
Severe:
Not recommended (Child-Pugh C).
Pharmacology
Mechanism of Action
Vonoprazan is a potassium-competitive acid blocker (PCAB) that reversibly inhibits the H+/K+-ATPase (proton pump) in gastric parietal cells. It competitively binds to the potassium-binding site of the proton pump, thereby inhibiting gastric acid secretion.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly stated as percentage, but rapidly absorbed.
Tmax:
1.5 - 2 hours
FoodEffect:
No clinically significant effect of food on absorption.
Distribution:
Vd:
Approximately 1000 L
ProteinBinding:
Approximately 85%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 7-9 hours
Clearance:
Not available
ExcretionRoute:
Renal (60-70%), Fecal (20-30%)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours)
PeakEffect:
Within 2-3 hours of first dose, maximal acid suppression achieved within a few days of repeated dosing.
DurationOfAction:
Sustained acid suppression for 24 hours or more due to long half-life and accumulation.
Safety & Warnings
Side Effects
Serious 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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of low magnesium levels: mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, decreased appetite, severe upset stomach or vomiting, or an abnormal heartbeat.
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or sudden weight gain.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Bone pain.
Vaginal irritation or discharge.
This medication may increase the risk of a severe form of diarrhea called C. diff-associated diarrhea (CDAD). If you experience stomach pain or cramps, very loose or watery stools, or bloody stools, contact your doctor immediately. Do not attempt to treat diarrhea without consulting your doctor first.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause serious health problems that may not resolve and can be life-threatening. Seek medical help immediately if you notice signs such as red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:
Constipation, diarrhea, stomach pain, or upset stomach.
Bloating.
Change in taste.
Headache.
Signs of a common cold.
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, 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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of low magnesium levels: mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, decreased appetite, severe upset stomach or vomiting, or an abnormal heartbeat.
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or sudden weight gain.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Bone pain.
Vaginal irritation or discharge.
This medication may increase the risk of a severe form of diarrhea called C. diff-associated diarrhea (CDAD). If you experience stomach pain or cramps, very loose or watery stools, or bloody stools, contact your doctor immediately. Do not attempt to treat diarrhea without consulting your doctor first.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause serious health problems that may not resolve and can be life-threatening. Seek medical help immediately if you notice signs such as red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:
Constipation, diarrhea, stomach pain, or upset stomach.
Bloating.
Change in taste.
Headache.
Signs of a common cold.
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, 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 persistent abdominal pain
- Difficulty swallowing or painful swallowing
- Vomiting blood or material that looks like coffee grounds
- Black, tarry stools (melena)
- Chest pain (especially if accompanied by shortness of breath, sweating, or pain radiating to arm/jaw - seek emergency care)
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a history of kidney disease or liver disease, as these conditions may affect how your body processes the medication.
If you are taking any other medications, including prescription and over-the-counter drugs, natural products, or vitamins, that may interact with this drug. Certain medications used to treat HIV, seizures, cancer, and other conditions should not be taken with this medication. There are many other drugs that may also interact with this medication, so it is crucial to disclose all medications you are currently taking.
If you are breastfeeding, as this medication is not recommended for use during breastfeeding. You should not breastfeed while taking this drug.
This is not an exhaustive list of all potential interactions or health problems that may be affected by this medication. Therefore, it is vital to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will enable them to verify that it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a history of kidney disease or liver disease, as these conditions may affect how your body processes the medication.
If you are taking any other medications, including prescription and over-the-counter drugs, natural products, or vitamins, that may interact with this drug. Certain medications used to treat HIV, seizures, cancer, and other conditions should not be taken with this medication. There are many other drugs that may also interact with this medication, so it is crucial to disclose all medications you are currently taking.
If you are breastfeeding, as this medication is not recommended for use during breastfeeding. You should not breastfeed while taking this drug.
This is not an exhaustive list of all potential interactions or health problems that may be affected by this medication. Therefore, it is vital to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will enable them to verify that it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests should be conducted as directed by your doctor to monitor your condition.
Do not exceed the prescribed duration of treatment with this medication. Taking it for longer than recommended by your doctor may lead to adverse effects.
This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
If you experience any of the following symptoms, contact your doctor immediately: throat pain, chest pain, severe abdominal pain, difficulty swallowing, or signs of a bleeding ulcer, such as black, tarry, or bloody stools, vomiting blood, or coffee ground-like vomit. These symptoms may indicate a more severe health issue.
Long-term use of this medication, particularly in high doses or for more than a year, may increase the risk of hip, spine, and wrist fractures in individuals with osteoporosis (weak bones). This risk may be higher if you are over 50 years old. If you have risk factors for osteoporosis, such as a family history, alcohol consumption, smoking, steroid use, or seizure medication, discuss your risks with your doctor and take necessary precautions.
Prolonged use of this medication (typically more than three months) may lead to rare cases of low magnesium levels, often occurring after one year of treatment. This condition may cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your magnesium levels.
This medication can prevent other drugs from being absorbed by the body. If you are taking other medications, consult your doctor or pharmacist to determine if you should take them at a different time than this medication.
The risk of developing stomach growths called fundic gland polyps may be higher in individuals taking this medication for more than a year. If you have concerns, discuss them with your doctor.
Rarely, long-term treatment (typically more than three years) with this type of medication has been associated with low vitamin B-12 levels. If you experience symptoms such as shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness or tingling in your arms or legs, contact your doctor immediately.
If you are pregnant or plan to become pregnant, inform your doctor to discuss the benefits and risks of using this medication during pregnancy.
Do not exceed the prescribed duration of treatment with this medication. Taking it for longer than recommended by your doctor may lead to adverse effects.
This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
If you experience any of the following symptoms, contact your doctor immediately: throat pain, chest pain, severe abdominal pain, difficulty swallowing, or signs of a bleeding ulcer, such as black, tarry, or bloody stools, vomiting blood, or coffee ground-like vomit. These symptoms may indicate a more severe health issue.
Long-term use of this medication, particularly in high doses or for more than a year, may increase the risk of hip, spine, and wrist fractures in individuals with osteoporosis (weak bones). This risk may be higher if you are over 50 years old. If you have risk factors for osteoporosis, such as a family history, alcohol consumption, smoking, steroid use, or seizure medication, discuss your risks with your doctor and take necessary precautions.
Prolonged use of this medication (typically more than three months) may lead to rare cases of low magnesium levels, often occurring after one year of treatment. This condition may cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your magnesium levels.
This medication can prevent other drugs from being absorbed by the body. If you are taking other medications, consult your doctor or pharmacist to determine if you should take them at a different time than this medication.
The risk of developing stomach growths called fundic gland polyps may be higher in individuals taking this medication for more than a year. If you have concerns, discuss them with your doctor.
Rarely, long-term treatment (typically more than three years) with this type of medication has been associated with low vitamin B-12 levels. If you experience symptoms such as shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness or tingling in your arms or legs, contact your doctor immediately.
If you are pregnant or plan to become pregnant, inform your doctor to discuss the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. Symptoms would likely be an exaggeration of known side effects.
What to Do:
In case of suspected overdose, contact a poison control center immediately or seek emergency medical attention. Call 1-800-222-1222 for poison control.
Drug Interactions
Major Interactions
- Atazanavir (decreased absorption)
- Nelfinavir (decreased absorption)
- Erlotinib (decreased absorption)
- Rilpivirine (decreased absorption)
Moderate Interactions
- Drugs dependent on gastric pH for absorption (e.g., iron salts, ketoconazole, itraconazole, posaconazole, mycophenolate mofetil)
- CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole, ritonavir - may increase vonoprazan exposure)
- CYP3A4 inducers (e.g., rifampin, St. John's Wort - may decrease vonoprazan exposure)
- Warfarin (monitor INR)
Minor Interactions
- Clopidogrel (no clinically significant interaction)
Monitoring
Baseline Monitoring
Diagnosis confirmation (e.g., endoscopy for EE, H. pylori test)
Rationale: To confirm the indication for treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom resolution
Frequency: Throughout treatment
Target: Reduction or elimination of symptoms (e.g., heartburn, dyspepsia)
Action Threshold: Persistent or worsening symptoms may require re-evaluation of diagnosis or treatment.
H. pylori eradication test (if applicable)
Frequency: At least 4 weeks after completion of antibiotic therapy
Target: Negative test result (e.g., urea breath test, stool antigen test)
Action Threshold: Positive test result indicates need for retreatment.
Symptom Monitoring
- Abdominal pain
- Diarrhea
- Nausea
- Headache
- Constipation
- Dizziness
- Rash
- Signs of allergic reaction (e.g., swelling of face/throat, difficulty breathing)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of vonoprazan in pregnant women. Animal studies have shown some adverse effects at high doses. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Insufficient human data to assess risk.
Second Trimester:
Insufficient human data to assess risk.
Third Trimester:
Insufficient human data to assess risk.
Lactation
There are no data on the presence of vonoprazan in human milk, the effects on the breastfed infant, or the effects on milk production. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for vonoprazan and any potential adverse effects on the breastfed infant from vonoprazan or from the underlying maternal condition.
Infant Risk:
Risk cannot be definitively assessed due to lack of human data. Potential for adverse effects.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. No dose adjustment is generally needed based on age alone, but consider age-related decreases in renal or hepatic function and concomitant diseases.
Clinical Information
Clinical Pearls
- Voquezna (vonoprazan) is the first potassium-competitive acid blocker (PCAB) approved in the U.S., offering an alternative to proton pump inhibitors (PPIs).
- It provides rapid, potent, and sustained acid suppression due to its reversible, competitive binding to the H+/K+-ATPase.
- Unlike PPIs, vonoprazan does not require acid activation and is stable in acid, leading to more consistent acid suppression regardless of food intake.
- It is particularly effective in H. pylori eradication regimens, showing high eradication rates.
- No dose adjustment is needed for renal impairment, including ESRD, which simplifies dosing for these patients.
- Dose adjustments are necessary for moderate and severe hepatic impairment.
Alternative Therapies
- Proton Pump Inhibitors (PPIs) (e.g., omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole)
- Histamine H2-receptor antagonists (H2RAs) (e.g., famotidine, cimetidine, nizatidine)
- Antacids
- Sucralfate
Cost & Coverage
Average Cost:
Highly variable, typically >$500 per 30 tablets
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 safe and effective treatment, 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 for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 details about the medication, including the amount taken and the time it happened, to facilitate prompt and appropriate care.