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.
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
- Heart rhythm problems (eg, bradycardia, QT prolongation, torsades de pointes, ventricular arrhythmia) or
- Hypokalemia (low potassium in the blood), uncorrected or
- Hypomagnesemia (low magnesium in the blood), uncorrected or
- Mononucleosis or
- Myasthenia gravis (nerve or muscle problem)—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.
- Liver disease (eg, cholestatic jaundice), history of—Should not be used in patients with this condition.
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.
- For treatment of H. pylori infections:
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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