Vonoprazan, amoxicillin, and clarithromycin (oral route)

Brand Name

US Brand Name

Voquezna Triple Pak

Description

Vonoprazan, amoxicillin, and clarithromycin combination is used to treat patients with H. pylori infection.

Vonoprazan is a potassium-competitive acid blocker (PCAB). It works by decreasing the amount of acid produced by the stomach. Amoxicillin and clarithromycin both belong to the class of medicines known as antibiotics. They work by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet
Capsule

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Vozquezna® Triple Pak® in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Vozquezna® Triple Pak® in the elderly. However, elderly patients are more likely to have kidney problems and heart rhythm problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Alfuzosin
Alprazolam
Astemizole
Bepridil
Cisapride
Colchicine
Conivaptan
Dihydroergotamine
Domperidone
Dronedarone
Eletriptan
Eplerenone
Ergotamine
Finerenone
Flibanserin
Fluconazole
Gepirone
Isavuconazonium Sulfate
Ivabradine
Ketoconazole
Levoketoconazole
Lomitapide
Lonafarnib
Lovastatin
Lurasidone
Mavacamten
Mesoridazine
Naloxegol
Nelfinavir
Nimodipine
Pacritinib
Pimozide
Piperaquine
Posaconazole
Ranolazine
Rilpivirine
Saquinavir
Silodosin
Simvastatin
Sparfloxacin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir
Abemaciclib
Abiraterone Acetate
Abiraterone Acetate, Micronized
Acalabrutinib
Acecainide
Adagrasib
Ado-Trastuzumab Emtansine
Afatinib
Ajmaline
Alfentanil
Amiloride
Amiodarone
Amisulpride
Amitriptyline
Amlodipine
Amprenavir
Anagrelide
Apalutamide
Apixaban
Apomorphine
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Artemether
Asciminib
Asenapine
Astemizole
Atazanavir
Atogepant
Atorvastatin
Avacopan
Avanafil
Avapritinib
Avatrombopag
Axitinib
Azithromycin
Bedaquiline
Belumosudil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol
Delavirdine
Glipizide
Glyburide
Khat
Linezolid
Prednisone
Repaglinide
Rivaroxaban
Tipranavir

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without food.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Take zidovudine at least 2 hours before or after taking Voquezna® Triple Pak®.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (kit):
- For treatment of H. pylori infections:
  - Adults—20 milligrams (mg) or 1 tablet of vonoprazan, 1000 mg or 2 capsules of amoxicillin, and 500 mg or 1 tablet of clarithromycin 2 times a day for 14 days.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is less than 4 hours, take it as soon as possible. If you miss a dose and it is more than 4 hours, skip the missed dose and take your next dose at the regular time.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects. If your condition does not improve, or if it becomes worse, discuss this with your doctor.

Do not use this medicine together rilpivirine (Edurant®) or products containing rilpivirine (eg, Complera®, Odefsey®), dihydroergotamine (Migranal®), ergotamine (Cafergot®), pimozide (Olap®), lomitapide (Juxtapid®), lovastatin (Mevacor®), lurasidone (Latuda®), or simvastatin (Zocor®). Do not use this medicine together with colchicine (Colcrys®) if you have kidney disease or liver disease. Using these medicines together may increase risk for more serious side effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Talk with your doctor before using this medicine if you plan to have children. Some male patients who use this medicine have become infertile (unable to have children).

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have chest tightness, rash, itching, fast heartbeat, trouble breathing or swallowing, or large, hive-like swelling of the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs while you are using this medicine.

Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness. These may be symptoms of serious skin reactions, including Stevens-Johnson syndrome, acute generalized exanthematous pustulosis (AGEP), toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS).

Check with your doctor right away if you have a change in frequency or amount of urine, blood in the urine, fever, joint pain, loss of appetite, nausea, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after using this medicine. These could be symptoms of a serious kidney problem called acute tubulointerstitial nephritis.

This medicine may cause stomach or bowel problems, including drug-induced enterocolitis syndrome (DIES). It may occur 1 to 4 hours after taking this medicine. Check with your doctor right away if you have blurred vision, cold clammy skin, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fever, pale skin, stomach pain, cramps, or tenderness, sweating, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, or watery or bloody diarrhea.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with insulin or oral diabetes medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

This medicine may cause drowsiness, trouble with thinking, or trouble with controlling body movements when used together with midazolam (Versed®), quetiapine (Seroquel®), or triazolam (Halcion®). Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may increase the risk of bleeding when used together with a blood thinner (eg, warfarin). Check with your doctor right away if you have bleeding gums, coughing up blood, difficulty in breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, paralysis, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Check with your doctor right away if you have pain or tenderness in the fever with or without chills, upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation and torsade de pointes.

This medicine may cause myasthenia gravis (severe muscle weakness). Check with your doctor right away if you have difficulty in breathing, chewing, swallowing, or talking, double vision, drooping eyelids, muscle weakness, or severe tiredness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Acid or sour stomach
anxiety
belching
black, tarry stools
bladder pain
blistering, crusting, irritation, itching, or reddening of the skin
bloated
bloody or cloudy urine
blurred vision
body aches or pain
change in taste
chest pain or tightness
chills
cold flu-like symptoms
constipation
cracked, dry, or scaly skin
cough or hoarseness
diarrhea
difficult, burning, or painful urination
discouragement
dizziness
dry mouth
ear congestion
excess air or gas in stomach or intestines
eye pain
fainting
fast, pounding, or irregular heartbeat or pulse
feeling sad or empty
fever
frequent urge to urinate
full feeling
general feeling of illness
greatly decreased frequency of urination or amount of urine
headache
heartburn
indigestion
irregular heartbeat recurrent
irritability
itching of the vagina or genitals
lack of appetite
loss of interest or pleasure
loss of taste
loss of voice
lower back or side pain
nausea
nervousness
pain or swelling in the arms or legs without any injury
pale skin
passing gas
pounding in the ears
slow or fast heartbeat
sneezing
sore throat
sores, ulcers, or white spots in the mouth or on the lips
stomach bloating, burning, cramping, discomfort, upset, or pain
stuffy or runny nose
swelling around the eyes
swelling of feet or lower legs
swelling or inflammation of the mouth
thick, white vaginal discharge with mild or no odor
trouble breathing
trouble concentrating
trouble sleeping
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
weight loss
white or brownish vaginal discharge

Rare

Muscle aches

Incidence not known

Black, hairy tongue
bleeding gums
blistering, peeling, or loosening of the skin
blood in the urine or stools
cold sweats
coma
confusion
confusion about identity, place, and time
coughing up blood
dark urine
diarrhea, watery and severe, which may also be bloody
difficulty swallowing
feeling of unreality
increased menstrual flow or vaginal bleeding
increased thirst
joint or muscle pain
light-colored stools
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
muscle cramps, spasms, pains, or stiffness
nightmares
nosebleeds
pains in stomach, side, or abdomen, possibly radiating to the back
palpitations
paralysis
pinpoint red spots on skin
prolonged bleeding from cuts
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red irritated eyes
red skin lesions, often with a purple center
seizures
sense of detachment from self or body
shakiness
slurred speech
stiff neck or back
swelling of the body, feet, or ankles
swollen glands
tooth discoloration
unpleasant breath odor
unusual weight gain
vomiting of blood
yellow eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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