Voquezna Triple Pak

Voquezna Triple Pak combines three active ingredients to eradicate *H. pylori*. **Vonoprazan** is a potassium-competitive acid blocker (PCAB) that reversibly inhibits H+, K+-ATPase (proton pump) in gastric parietal cells, suppressing gastric acid secretion. This increases intragastric pH, which enhances the stability and activity of amoxicillin and clarithromycin. **Amoxicillin** is a penicillin-class beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death. **Clarithromycin** is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing peptide chain elongation.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Rarely, some 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, such as severe dizziness or passing out
Signs of kidney problems, such as:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ Significant weight gain
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Fast or abnormal heartbeat
Dizziness or passing out
Confusion
Muscle pain or weakness
Vaginal itching or discharge
Diarrhea, which is common with antibiotics, but rarely can lead to a severe form called C. diff-associated diarrhea (CDAD), which can be life-threatening. If you experience stomach pain, cramps, or very loose, watery, or bloody stools, contact your doctor immediately.
Liver problems, which can be fatal. If you experience signs of liver problems, such as dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor immediately.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. If you experience signs such as 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; or swollen glands, seek medical help immediately.

Other Side Effects

Most people do not experience side effects or only have minor side effects. However, if you experience any of the following side effects or any other side effects that bother you or do not go away, contact your doctor:

Stomach pain or diarrhea
Nose or throat irritation
Change in taste
Headache

This is not a comprehensive list of all possible side effects. If you have questions 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.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are allergic to penicillin.
Existing health conditions, including:
+ Kidney disease or liver disease.
+ Mononucleosis (mono).
+ Previous liver problems after taking clarithromycin or similar medications.
+ Abnormal heart rhythms, such as a prolonged QT interval on an electrocardiogram (ECG).
+ Low levels of magnesium or potassium in your blood.
+ Slow heartbeat.
Medications you are currently taking that may cause abnormal heart rhythms (prolonged QT interval). There are many medications that can have this effect, so consult your doctor or pharmacist if you are unsure.
Any medications, including prescription and over-the-counter drugs, natural products, and vitamins, that should not be taken with this medication. Examples include certain medications for high cholesterol, HIV, infections, migraines, mood disorders, or seizures.
If you are breastfeeding. It is recommended that you do not breastfeed while taking this medication and for at least 2 days after your last dose.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health conditions. This will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you.

This medication may interfere with certain laboratory tests, so be sure to notify all your healthcare providers and laboratory 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.

Do not exceed the recommended duration of treatment, as this may increase the risk of a secondary infection. This medication can cause a type of abnormal heartbeat known as a prolonged QT interval, which may increase the risk of other potentially life-threatening heart rhythm disturbances.

If you have a history of heart disease, discuss this with your doctor, as one study suggested that patients with heart disease who took clarithromycin had a higher risk of death a year or more after treatment. However, other studies have yielded conflicting results.

If you have myasthenia gravis, consult with your doctor, as this condition may worsen during treatment with this medication. Monitor your symptoms closely and contact your doctor if they deteriorate. Older adults (65 years and older) should exercise caution when taking this medication, as they may be more susceptible to side effects.

This medication may impact fertility in males, so discuss this with your doctor if you are concerned about fathering a child. Additionally, birth control pills and other hormone-based contraceptives may be less effective while taking this medication. Consider using alternative forms of birth control, such as condoms, to prevent pregnancy.

If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby.

• Colchicine (in patients with renal or hepatic impairment due to clarithromycin)
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine) due to clarithromycin (risk of acute ergot toxicity)
• Pimozide (due to clarithromycin, risk of QT prolongation and cardiac arrhythmias)
• Lomitapide (due to clarithromycin, risk of significant transaminase elevations)
• HMG-CoA reductase inhibitors (statins) extensively metabolized by CYP3A4 (e.g., simvastatin, lovastatin) due to clarithromycin (risk of myopathy/rhabdomyolysis)

• Other CYP3A4 substrates (e.g., ticagrelor, oral anticoagulants like warfarin/DOACs, cyclosporine, tacrolimus, sildenafil, midazolam, triazolam, alprazolam, quetiapine, some calcium channel blockers like verapamil, amlodipine, diltiazem) due to clarithromycin (increased drug levels and toxicity)
• QT-prolonging drugs (e.g., antiarrhythmics, antipsychotics, tricyclic antidepressants, fluoroquinolones) due to clarithromycin (additive QT prolongation risk)
• Digoxin (increased digoxin levels due to clarithromycin)
• Oral contraceptives (potential decreased efficacy of oral contraceptives due to amoxicillin)
• Methotrexate (increased methotrexate levels due to amoxicillin)
• Mycophenolate mofetil (decreased mycophenolic acid exposure due to clarithromycin)
• Rifabutin, Rifampin, Rifapentine (decreased clarithromycin levels, increased rifamycin levels)
• Phenytoin, Carbamazepine, Valproate (altered levels of anticonvulsants and clarithromycin)
• Theophylline (increased theophylline levels due to clarithromycin)
• Zidovudine (decreased zidovudine levels due to clarithromycin)

• Drugs requiring acidic gastric pH for absorption (e.g., atazanavir, nelfinavir, iron salts, ketoconazole, itraconazole) due to vonoprazan (decreased absorption)
• Drugs requiring basic gastric pH for absorption (e.g., some oral iron preparations, some oral chemotherapy agents) due to vonoprazan (increased absorption)
• Warfarin (increased INR due to clarithromycin and amoxicillin)
• Sulfonylureas (risk of hypoglycemia due to clarithromycin)
• Cimetidine, Omeprazole (may increase amoxicillin levels)
• Probenecid (increases amoxicillin levels)
• Fluconazole (may increase clarithromycin levels)

• Antacids (may delay absorption of amoxicillin)

• Diarrhea (especially severe or bloody, suggestive of C. difficile-associated diarrhea)
• Abdominal pain
• Nausea/Vomiting
• Taste disturbance (dysgeusia, metallic taste)
• Headache
• Rash, itching, hives (signs of allergic reaction)
• Signs of liver injury (e.g., jaundice, dark urine, fatigue)
• Signs of cardiac arrhythmias (e.g., palpitations, dizziness, syncope)

Voquezna Triple Pak is Pregnancy Category C. Clarithromycin (one of the components) has been associated with adverse developmental outcomes in animal studies and some human observational studies suggest a possible increased risk of major malformations, particularly cardiovascular, when clarithromycin is used during the first trimester. Amoxicillin is generally considered safe in pregnancy (Category B). Vonoprazan has no human data, but animal studies show no adverse effects. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.

Clarithromycin and amoxicillin are excreted into breast milk. Vonoprazan excretion into breast milk is unknown. Due to the potential for serious adverse reactions in the breastfed infant (e.g., disruption of infant gut flora, sensitization, diarrhea, thrush) from clarithromycin and amoxicillin, and unknown risks from vonoprazan, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Clarithromycin is rated L3 (Moderate Concern) by LactMed.

Safety and effectiveness of Voquezna Triple Pak in pediatric patients have not been established. Not recommended for use in pediatric patients.

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 clarithromycin dose adjustment. Use with caution, monitoring for adverse effects and drug interactions.

• This is a 14-day regimen; emphasize completion of the full course to patients to maximize eradication rates and minimize resistance.
• Clarithromycin causes a common metallic or bitter taste disturbance (dysgeusia) which can affect adherence. Advise patients about this side effect.
• Counsel patients on the significant drug-drug interactions, especially with clarithromycin (CYP3A4 inhibitor), and review all concomitant medications.
• Monitor for signs of C. difficile-associated diarrhea (CDAD), which can occur during or after antibiotic therapy.
• Vonoprazan, as a PCAB, provides more potent and consistent acid suppression than traditional PPIs, which may contribute to higher eradication rates, especially in patients with CYP2C19 polymorphisms affecting PPI metabolism.
• Consider susceptibility testing for *H. pylori* if initial eradication fails, especially given increasing clarithromycin resistance.

• Bismuth quadruple therapy (bismuth subsalicylate, metronidazole, tetracycline, PPI/H2RA)
• Concomitant therapy (PPI, amoxicillin, clarithromycin, metronidazole)
• Sequential therapy (PPI + amoxicillin for 5 days, then PPI + clarithromycin + metronidazole for 5 days)
• Levofloxacin-based triple therapy (PPI, amoxicillin, levofloxacin)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your 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 taken, the amount, and the time it occurred.