Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Voquezna Dual Pak

Descriptions


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.

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™ Dual 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™ 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.

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.

  • 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
  • Omadacycline
  • 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

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

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

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

  1. Diarrhea

Less common

  1. Acid or sour stomach
  2. anxiety
  3. belching
  4. black, tarry stools
  5. bladder pain
  6. blistering, crusting, irritation, itching, or reddening of the skin
  7. bloated
  8. bloody or cloudy urine
  9. blurred vision
  10. body aches or pain
  11. change in taste
  12. chest pain or tightness
  13. chills
  14. cold flu-like symptoms
  15. constipation
  16. cracked, dry, or scaly skin
  17. cough or hoarseness
  18. diarrhea
  19. difficult, burning, or painful urination
  20. discouragement
  21. dizziness
  22. dry mouth
  23. ear congestion
  24. excess air or gas in stomach or intestines
  25. eye pain
  26. fainting
  27. feeling sad or empty
  28. fever
  29. frequent urge to urinate
  30. full feeling
  31. general feeling of illness
  32. greatly decreased frequency of urination or amount of urine
  33. headache
  34. heartburn
  35. indigestion
  36. irregular heartbeat recurrent
  37. irritability
  38. itching of the vagina or genitals
  39. lack of appetite
  40. loss of interest or pleasure
  41. loss of taste
  42. loss of voice
  43. lower back or side pain
  44. nausea
  45. nervousness
  46. pain or swelling in the arms or legs without any injury
  47. pale skin
  48. passing gas
  49. pounding in the ears
  50. slow or fast heartbeat
  51. sneezing
  52. sore throat
  53. sores, ulcers, or white spots in the mouth or on the lips
  54. stomach bloating, burning, cramping, discomfort, upset, or pain
  55. stuffy or runny nose
  56. swelling around the eyes
  57. swelling of feet or lower legs
  58. swelling or inflammation of the mouth
  59. thick, white vaginal discharge with mild or no odor
  60. trouble breathing
  61. trouble concentrating
  62. trouble sleeping
  63. unusual bleeding or bruising
  64. unusual tiredness or weakness
  65. vomiting
  66. weight loss
  67. white or brownish vaginal discharge

Incidence not known

  1. Black, hairy tongue
  2. bleeding gums
  3. blistering, peeling, or loosening of the skin
  4. blood in the urine or stools
  5. confusion about identity, place, and time
  6. coughing up blood
  7. dark urine
  8. diarrhea, watery and severe, which may also be bloody
  9. difficulty swallowing
  10. feeling of unreality
  11. increased menstrual flow or vaginal bleeding
  12. increased thirst
  13. joint or muscle pain
  14. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  15. light-colored stools
  16. nosebleeds
  17. palpitations
  18. paralysis
  19. pinpoint red spots on skin
  20. prolonged bleeding from cuts
  21. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  22. red irritated eyes
  23. red skin lesions, often with a purple center
  24. seizures
  25. sense of detachment from self or body
  26. stiff neck or back
  27. swollen glands
  28. unpleasant breath odor
  29. vomiting of blood
  30. 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.