Pronunciation:

a-mox-i-SIL-in, von-OH-pra-zan

Brand Names:

• Voquezna Dual Pak

Dosage Forms:

• Tablet
• Capsule

Uses of This Medicine:

Vonoprazan and amoxicillin 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 belongs to the class of medicines known as antibiotics. It works 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.

Before Using This Medicine:

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.

Children—

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

Older adults—

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

Breast-feeding—

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.

Other medicines—

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.

• Rilpivirine

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.

• Apalutamide
• Atazanavir
• Bosentan
• Carbamazepine
• Cenobamate
• Chlortetracycline
• Cholera Vaccine, Live
• Cilostazol
• Clopidogrel
• Cyclosporine
• Demeclocycline
• Desogestrel
• Dienogest
• Doxycycline
• Drospirenone
• Efavirenz
• Enzalutamide
• Eravacycline
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etravirine
• Fosphenytoin
• Gestodene
• Levonorgestrel
• Lorlatinib
• Lumacaftor
• Lymecycline
• Meclocycline
• Mestranol
• Methacycline
• Methotrexate
• Minocycline
• Mitotane
• Modafinil
• Mycophenolate Mofetil
• Nafcillin
• Nelfinavir
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Oxytetracycline
• Phenobarbital
• Phenytoin
• Primidone
• Rifabutin
• Rifampin
• Rolitetracycline
• Sarecycline
• St John's Wort
• Sulfasalazine
• Tacrolimus
• Tetracycline
• Tigecycline
• Venlafaxine
• Warfarin

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
• Khat
• Probenecid

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or
• Mononucleosis—Use with caution. May make these conditions worse.

• Kidney disease, severe or
• Liver disease, moderate to severe—Use is not recommended in patients with these conditions.

Proper Use of This Medicine:

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.

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 (capsules and tablets):
  • For treatment of H. pylori infections:
    • Adults—20 milligrams (mg) or 1 tablet of vonoprazan 2 times a day and 1000 mg or 2 capsules of amoxicillin 3 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 While Using This Medicine:

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 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®). Using these medicines together may increase risk for more serious side effects.

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 and toxic epidermal necrolysis.

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.

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 or vitamin supplements.

Side Effects of This Medicine:

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:

More common

Diarrhea

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

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

Incidence not known

Black, hairy tongue

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

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

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

nosebleeds

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

stiff neck or back

swollen glands

unpleasant breath odor

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.