Description
Vonoprazan is used to treat erosive esophagitis and heartburn, conditions where there is too much acid in the stomach. This medicine is also used to treat heartburn caused by non-erosive gastroesophageal reflux disease (GERD). It is also used in combination with antibiotics (eg, amoxicillin, clarithromycin) to treat an infection caused by H. pylori bacteria. Vonoprazan is a potassium-competitive acid blocker. It works by decreasing the amount of acid produced by the stomach.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
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 vonoprazan 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 vonoprazan in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
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.
- Abemaciclib
- Acalabrutinib
- Alfentanil
- Amiloride
- Apalutamide
- Astemizole
- Atazanavir
- Avacopan
- Axitinib
- Bedaquiline
- Bemetizide
- Bendroflumethiazide
- Benzhydrocodone
- Benzthiazide
- Bosentan
- Bosutinib
- Brigatinib
- Budesonide
- Bumetanide
- Canrenoate
- Canrenone
- Carbamazepine
- Cenobamate
- Ceritinib
- Chlorothiazide
- Chlorthalidone
- Cilostazol
- Cisapride
- Citalopram
- Clindamycin
- Clopamide
- Clopidogrel
- Cobimetinib
- Codeine
- Colchicine
- Conivaptan
- Crizotinib
- Cyclopenthiazide
- Cyclosporine
- Cyclothiazide
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
- Hypocalcemia (low calcium in the blood) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood), history of or
- Osteoporosis (thinning of the bones) or
- Vitamin B12 deficiency—Use with caution. May make these conditions worse.
- Kidney disease, severe or
- Liver disease, moderate to severe—Use with caution in patients with erosive esophagitis. The effects may be increased because of slower removal of the medicine from the body.
- Kidney disease, severe or
- Liver disease, severe—Use is not recommended for the treatment of H. pylori infection.
Proper Use
Take this medicine exactly 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.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Swallow the table whole. Do not chew or crush it.
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 (tablets):
- For healing of erosive esophagitis and relief of heartburn:
- Adults—20 milligrams (mg) once a day for 8 weeks.
- Children—Use and dose must be determined by your doctor.
- For maintenance of healed erosive esophagitis and relief of heartburn:
- Adults—10 milligrams (mg) once a day for up to 6 months.
- Children—Use and dose must be determined by your doctor.
- For relief of heartburn caused by non-erosive gastroesophageal reflux disease (GERD):
- Adults—10 milligrams (mg) once a day for 4 weeks.
- Children—Use and dose must be determined by your doctor.
- For treatment of H. pylori infection:
- Adults—20 milligrams (mg) together with 1000 mg amoxicillin and 500 mg clarithromycin, each taken 2 times a day for 14 days or 20 mg taken 2 times a day together with 1000 mg amoxicillin 3 times a day for 14 days.
- Children—Use and dose must be determined by your doctor.
- For healing of erosive esophagitis and relief of heartburn:
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.
For erosive esophagitis and heartburn: If you miss a dose and it is within 12 hours of your usual time, take it as soon as possible. If you miss a dose and it is more than 12 hours after the missed dose, skip the missed dose and take your next dose at the regular time.
For H. pylori infection: If you miss a dose and it is within 4 hours of your usual time, take it as soon as possible. If you miss a dose and it is more than 4 hours after the missed dose, 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 very 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 take 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, check with your doctor.
Do not use vonoprazan if you are also using medicines containing rilpivirine (Edurant®, Complera®). Using these medicines together may cause unwanted side effects.
This medicine is usually given with amoxicillin (Amoxil®) alone, or with amoxicillin and clarithromycin (Biaxin®) to treat ulcers caused by H. pylori infection. Be sure you understand the risks and proper use of any other medicines your doctor prescribes.
Check with your doctor right away if you have a change in frequency of urination 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.
Diarrhea may occur while taking this medicine alone or together with antibiotics. Check with your doctor immediately if you have stomach cramps, a bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea or vomiting, or unusual tiredness or weakness.
This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you use high doses or use it for one year or more. Call your doctor right away if you have severe bone pain or are unable to walk or sit normally.
This medicine may cause serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. 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.
Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.
This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are using it together with digoxin (Lanoxin®) or certain diuretics (water pills). Check with your doctor right away if you have convulsions (seizures), a fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.
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.
This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you are using this medicine for more than 1 year. Talk to your doctor if you have concerns.
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
- Burning feeling in the chest or stomach
- indigestion
- stomach upset
- tenderness in the stomach area
Less common
- Anxiety
- black, tarry stools
- bladder pain
- bloody or cloudy urine
- blurred vision
- body or muscle pain
- chest pain
- cold flu-like symptoms
- cough
- diarrhea
- difficult, burning, or painful urination
- discouragement
- dizziness
- eye pain
- fainting
- fast, pounding, or irregular heartbeat or pulse
- feeling sad or empty
- fever or chills
- frequent urge to urinate
- full or bloated feeling
- general feeling of illness
- headache
- irregular heartbeat recurrent
- irritability
- itching of the vagina or genitals
- joint pain
- lack of appetite
- lower back or side pain
- loss of interest or pleasure
- loss of taste or smell
- loss of voice
- nausea or vomiting
- nervousness
- pain or swelling in the arms or legs without any injury
- pale skin
- pounding in the ears
- slow or fast heartbeat
- sneezing
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain
- stuffy or runny nose
- swelling of the body or feet and ankles
- swollen glands
- thick, white vaginal discharge with mild or no odor
- trouble breathing
- trouble concentrating
- trouble sleeping
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain
Rare
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- difficulty swallowing
- dizziness or lightheadedness
- dry mouth
- excess air or gas in the stomach
- fainting
- feeling of constant movement of self or surroundings
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- lack of loss of strength
- loss of consciousness
- sensation of spinning
- sweating
- tingling of the hands or feet
- unexplained weight loss
- vomiting
Incidence not known
- Bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- chest tightness
- dark urine
- decreased urine
- drowsiness
- hives, itching, skin rash
- joint or muscle pain
- light-colored stools
- loss of appetite
- mood or mental changes
- muscle cramps, pain, spasms, or twitching
- numbness or tingling in the hands, feet, or lips
- pinpoint red spots on the skin
- 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
- trembling
- vomiting of blood
- watery and severe diarrhea, which may also be bloody
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Acid or sour stomach
- belching
- constipation
- passing gas
- pressure in the stomach
- stomach discomfort
- swelling of abdominal or stomach area
- swelling or inflammation of the mouth
- white or brownish vaginal discharge
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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