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How long does it take for dexilant to fully work: Side effects, dosage, uses, and more

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Side effects, dosage, uses, and more

Dexilant can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Dexilant. These lists don’t include all possible side effects.

Some side effects of Dexilant are seen in both adults and children. Others generally affect only children taking the drug.

For more information on the possible side effects of Dexilant, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects in adults

The more common side effects seen in adults using Dexilant can include:

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

More common side effects in children

The more common side effects of Dexilant use in children ages 12 to 17 years old can include:

  • headache
  • abdominal (belly) pain
  • diarrhea
  • the common cold
  • mouth and throat pain

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects in adults and children

Serious side effects from Dexilant aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects, explained in more detail below in “Side effect details,” can include the following:

Side effect details

You may wonder how often certain side effects occur with Dexilant. Here’s more detail on several of the side effects this drug may cause.

Long-term side effects

Using Dexilant long term may raise your risk for having serious side effects.

Long-term side effects seen in people taking Dexilant were:

  • bone fractures, in people who took Dexilant for more than 1 year
  • vitamin B-12 deficiency, in people who took Dexilant for more than 3 years
  • fundic gland polyps (abnormal tissue growths in the stomach), in people who took Dexilant for more than 1 year
  • hypomagnesemia (low magnesium levels), in people who took Dexilant for more than 3 months

To prevent these side effects, your doctor will prescribe the lowest dose of Dexilant that treats your symptoms, for the shortest time possible.

Tell your doctor if you have symptoms of any of these long-term problems. They can do tests to see if you have any of these conditions. If needed, they can prescribe medication to help relieve your symptoms. They may also ask you to switch from Dexilant to a different medication.

Weight gain

Dexilant may cause weight gain. In clinical studies, less than 2% of people taking Dexilant had weight gain.

Talk with your doctor if you’re concerned about gaining weight while taking Dexilant. They can give you some tips to help balance your diet.

Blood pressure

Dexilant may cause high blood pressure. In clinical studies, less than 2% of people taking Dexilant had high blood pressure.

Most people with high blood pressure won’t have symptoms. However, severe high blood pressure can cause symptoms, which can include:

  • headache
  • nausea
  • vomiting
  • shortness of breath
  • nosebleeds
  • blurred or double vision
  • dizziness

Talk with your doctor if you have symptoms of high blood pressure. They may want to monitor your blood pressure. If it’s high, they can prescribe medications to help lower it.

Diarrhea

Dexilant may cause diarrhea. In clinical studies, 4.8% of people who took Dexilant had diarrhea. In comparison, 2.9% of people who took a placebo (a treatment with no active drug) had diarrhea.

If you have diarrhea from taking Dexilant, it will likely go away within a few days. Talk with your doctor if you have diarrhea that doesn’t get better or if you also have a fever. It may be a symptom of a bacterial infection, such as a Clostridioides difficile (C. diff) infection.

C. diff is type of bacteria that naturally occurs in the gut. At normal levels, C. diff is not considered an infection. However, the bacteria can multiply and become an infection.

Your doctor may do tests to check if you have a bacterial infection. If needed, they can prescribe antibiotics to treat your infection.

Stomach pain

Dexilant may cause stomach pain. In clinical studies, about 4% of people who took Dexilant had stomach pain. In comparison, 3.5% of people who took a placebo had stomach pain.

If you have stomach pain, it may go away on its own. Talk with your doctor if you’re concerned about your stomach pain or if it doesn’t get better. They can suggest ways to help relieve your symptoms. They may also ask you to switch from Dexilant to a different medication.

Headache

Dexilant may cause headaches. In clinical studies, less than 2% of adults who took Dexilant had a headache. More than 5% of children ages 12 to 17 years had a headache.

Having a headache isn’t usually considered serious, and it will likely go away on its own. Talk with your doctor if you have a headache that lasts several days. They can suggest ways to help relieve your symptoms.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Dexilant. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. In clinical studies, less than 2% of people taking Dexilant had severe allergic reactions.

Symptoms of a severe allergic reaction can include:

  • rash
  • swelling of your face
  • throat tightness
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Dexilant. They can prescribe medications to help relieve your symptoms. They may also switch you from Dexilant to a different medication.

Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Bone fracture

People taking Dexilant for long periods of time can have bone fractures. In particular, they may have fractures in their hips, wrist, or spine.

Fractures aren’t as likely if you take Dexilant for a short period of time. In a 1-year clinical study, fractures happened in less than 2% of people taking Dexilant. But if you take Dexilant for longer than 1 year, or if you take more than one dose per day, you are more likely to have a bone fracture.

People using Dexilant long term may also be more likely to develop osteoporosis (bone loss). Osteoporosis is sometimes called a “silent disease” because many people don’t notice any symptoms until a bone breaks.

Symptoms of osteoporosis can include:

  • bone fracture from a fall or bumping into furniture
  • severe back pain
  • loss of height
  • posture that’s hunched or stooped over

How DEXILANT (dexlansoprazole) Works

DEXILANT may not be right for everyone. 

Do not take DEXILANT if you are allergic to DEXILANT or any of its ingredients or taking a medicine that contains rilpivirine. 

DEXILANT may not be right for everyone.

Do not take DEXILANT if you are allergic to DEXILANT or any of its ingredients or taking a medicine that contains rilpivirine.

Serious allergic reactions have been reported. Tell your doctor if you get any of the following symptoms with DEXILANT: rash, face swelling, throat tightness, or difficulty breathing. Symptom relief does not rule out other serious stomach conditions.

A type of kidney problem called acute tubulointerstitial nephritis may develop at any time during treatment with proton pump inhibitor (PPI) medicines, including DEXILANT. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.

DEXILANT may increase your risk of getting severe diarrhea. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.

People who are taking multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine.

Some people who take PPIs may develop new or worsening of certain types of lupus erythematosus. Call your doctor right away if you have joint pain or rash on your cheeks or arms that gets worse in the sun.

Talk with your doctor about the possibility of Vitamin B-12 deficiency if you have been on DEXILANT for a long time (more than 3 years).

Low magnesium levels can happen in some people who take a PPI medicine for at least 3 months.

People who take PPI medicines for a long time (especially more than 1 year) have an increased risk of developing a certain type of stomach growth called fundic gland polyps.

DEXILANT is not recommended in children under 2 years of age and may harm them.

The most common side effects of DEXILANT in adults were diarrhea (4.8%), stomach pain (4.0%), nausea (2.9%), common cold (1.9%), vomiting (1.6%), and gas (1.6%).

The most common side effects in children 12 to 17 years of age were headache, stomach pain, diarrhea, and pain or swelling (inflammation) in your mouth, nose or throat.

Before starting DEXILANT, tell your doctor if you are pregnant or plan to become pregnant.

DEXILANT and certain other medicines can affect each other.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor if you are taking methotrexate, rilpivirine, atazanavir, nelfinavir, saquinavir, digoxin, product containing iron, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole, tacrolimus, St. John’s Wort or rifampin. If you are taking DEXILANT with warfarin, you may need to be monitored because serious risks could occur.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed-release capsules

Prescription DEXILANT capsules are used in children age 12 to 17 years for 4 weeks to treat heartburn related to gastroesophageal reflux disease (GERD), for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE), and for up to 16 weeks to continue healing of EE and relief of heartburn. It is not known if DEXILANT is safe and effective in children under age 12 years. DEXILANT is not effective for symptoms of GERD in children under 1 year of age.

In adults, persistent heartburn two or more days a week, despite treatment and diet changes, could be GERD, also known as acid reflux disease (ARD). Prescription DEXILANT capsules are used in adults for 4 weeks to treat heartburn related to GERD, for up to 8 weeks to heal acid-related damage to the lining of the esophagus, and for up to 6 months to continue healing of EE and relief of heartburn. Most damage (erosions) heals in 4 to 8 weeks.

Individual results may vary.

Talk to your doctor or healthcare professional. Please see full Prescribing Information, including Medication Guide for DEXILANT.

Frequently Asked Questions | DEXILANT (dexlansoprazole)

DEXILANT may not be right for everyone. 

Do not take DEXILANT if you are allergic to DEXILANT or any of its ingredients or taking a medicine that contains rilpivirine.  

DEXILANT may not be right for everyone.

Do not take DEXILANT if you are allergic to DEXILANT or any of its ingredients or taking a medicine that contains rilpivirine.

Serious allergic reactions have been reported. Tell your doctor if you get any of the following symptoms with DEXILANT: rash, face swelling, throat tightness, or difficulty breathing. Symptom relief does not rule out other serious stomach conditions.

A type of kidney problem called acute tubulointerstitial nephritis may develop at any time during treatment with proton pump inhibitor (PPI) medicines, including DEXILANT. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.

DEXILANT may increase your risk of getting severe diarrhea. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.

People who are taking multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine.

Some people who take PPIs may develop new or worsening of certain types of lupus erythematosus. Call your doctor right away if you have joint pain or rash on your cheeks or arms that gets worse in the sun.

Talk with your doctor about the possibility of Vitamin B-12 deficiency if you have been on DEXILANT for a long time (more than 3 years).

Low magnesium levels can happen in some people who take a PPI medicine for at least 3 months.

People who take PPI medicines for a long time (especially more than 1 year) have an increased risk of developing a certain type of stomach growth called fundic gland polyps.

DEXILANT is not recommended in children under 2 years of age and may harm them.

The most common side effects of DEXILANT in adults were diarrhea (4.8%), stomach pain (4.0%), nausea (2.9%), common cold (1.9%), vomiting (1.6%), and gas (1.6%).

The most common side effects in children 12 to 17 years of age were headache, stomach pain, diarrhea, and pain or swelling (inflammation) in your mouth, nose or throat.

Before starting DEXILANT, tell your doctor if you are pregnant or plan to become pregnant.

DEXILANT and certain other medicines can affect each other.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor if you are taking methotrexate, rilpivirine, atazanavir, nelfinavir, saquinavir, digoxin, product containing iron, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole, tacrolimus, St. John’s Wort or rifampin. If you are taking DEXILANT with warfarin, you may need to be monitored because serious risks could occur.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed-release capsules

Prescription DEXILANT capsules are used in children age 12 to 17 years for 4 weeks to treat heartburn related to gastroesophageal reflux disease (GERD), for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE), and for up to 16 weeks to continue healing of EE and relief of heartburn. It is not known if DEXILANT is safe and effective in children under age 12 years. DEXILANT is not effective for symptoms of GERD in children under 1 year of age.

In adults, persistent heartburn two or more days a week, despite treatment and diet changes, could be GERD, also known as acid reflux disease (ARD). Prescription DEXILANT capsules are used in adults for 4 weeks to treat heartburn related to GERD, for up to 8 weeks to heal acid-related damage to the lining of the esophagus, and for up to 6 months to continue healing of EE and relief of heartburn. Most damage (erosions) heals in 4 to 8 weeks.

Individual results may vary.

Talk to your doctor or healthcare professional. Please see full Prescribing Information, including Medication Guide for DEXILANT.

How Long Does It Take for Dexilant to Work: Must-Know Information


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Are you suffering from issues with your heartburn or GERD and not sure how much more you can take?

Have you been prescribed Dexilant, but are growing impatient for it to work?

Heartburn and other issues that cause stomach and esophagus distress are incredibly stressful because they take a toll on nearly every minute of your life.

Every time you sit down to eat, your problems are likely to come back to mind, too. All that you want is a little relief.

So, how long does it take for Dexilant to work, and how does it work, anyway?

Worry no longer since, today, we’ll answer those questions for you so that you can get back to your life.

How Long Does It Take for Dexilant to Work?

Generally speaking, you should see at least mild changes in how you are feeling within one or two days of starting Dexilant.

Dexilant works in a relatively instantaneous way, but it can take a few days for lingering issues from too much stomach acid backing up into your esophagus to be relieved.

It is fairly common, however, for Dexilant to take between seven and ten days to see a noticeable difference, especially if you have erosion that had been happening due to continued or frequent heartburn issues.

At most, you should expect that Dexilant will take no more than two weeks to be noticeably effective.

If there are no significant changes within two weeks, make sure that you take to your doctor about this issue.

How Does Dexilant Work?

Now that you know more about how long you should expect to wait to feel more relief from Dexilant, let’s talk about why you will feel any relief at all by learning more about how this medication works.

1. Helps Lower Acid Production

Like many heartburn medications, Dexilant is a proton pump inhibitor (PPI), which means that it prevents the proton pumps in your stomach from producing as much acid as they typically do.

When your stomach starts to produce less acid, you will feel less heartburn.

You also won’t have as much pain because your esophagus and other related areas of your body will be able to heal from the excessive acid that has been bothering you.

Additionally, Dexilant does not block all of the proton pumps in your stomach since some amount of stomach acid is still needed to process food effectively.

That said, it uses two different types of granules to block some of the pumps so that you can live a more comfortable life.

2. Different From Other PPIs

As Dexilant prevents these pumps from overproducing acid, it also helps to heal portions of the esophagus that may have been damaged from previous heartburn or GERD issues.

Most PPI medications do not this type of bonus side effect.

Additionally, many proton pump inhibitors are single-release medications, which mean all of the medicine is released at once.

Dexilant, on the other hand, is an extended-release medication that contains two doses that are released at different times, about five hours apart.

While it’s not yet clear if this delivery method will make Dexilant more effective or not, it will likely have some beneficial effects.

What Are the Potential Side Effects of Dexilant?

As with all medicines, there are some potential side effects of using Dexilant that you should be aware of if your doctor has not already informed you about these potential risks.

Side effects are very uncommon for Dexilant, but the most common ones are:

  • Diarrhea
  • Stomach pain
  • Nausea
  • Common cold
  • Gas
  • Vomiting

Gas and stomach pain are common side effects of these types of medication because your stomach will have less acid in it, so it has to work harder to process food.

Gas happens because the food that makes it to your large intestine might not as broken down as it was when your stomach was overproducing acid, so your body needs to digest a little bit differently.

It is also important to mention that long-term usage of PPIs, such as Dexilant, may contribute to the development of the following problems:

  • Interstitial nephritis
  • B-12 deficiency
  • Bone fractures
  • Magnesium Deficiency

Essentially, PPIs can increase your risk of the above issues, but it will not directly cause them to occur simply by using Dexilant for a short period.

Is There a More Natural Way to Manage Heartburn?

Now that you know that many drugs like Dexilant aren’t meant to be taken for long periods, are you still sure that it is the right solution to your heartburn problems?

Though they are often taken as long term solutions, these drugs can actually contribute to a variety of health problems for people who take them for extended periods.

If you are looking for a natural and effective way to manage your heartburn, you might want to consider the Heartburn No More program.

Through a natural and holistic approach, this program walks you through the necessary steps to change your life and relieve your heartburn symptoms for good.

Is This the Right Programs for You?

Of course, you need to consider if this is the right option for you or not.

Think about your heartburn severity, the reason that you have been given this medicine, and whether or not it is the first time you are taking it.

If you have had an esophageal issue and your doctor prescribed Dexilant to heal that damage, stick to the Dexilant as was suggested.

If, however, it’s been prescribed as a generic medication to help recurring heartburn symptoms, it might be time to try something like Heartburn No More instead.

Be Patient, Be Practical

Now that you know more about how long does it take for Dexilant to work, be patient!

Substances like PPI must be used for a few days before they reach their peak effectiveness.

Once they start working, you’re sure to notice a difference in the way that your stomach is working and how that is making you feel.

If you have found that PPIs don’t seem like a great choice for your body, remember that you can consider another solution, such as the Heartburn No More or programs that take a more practical and natural approach to help manage your heartburn.

Dexilant Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Diarrhea may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures), signs of lupus (such as rash on nose and cheeks, new or worsening joint pain).

This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn’t stop, abdominal or stomach pain/cramping, fever, blood/mucus in your stool.

If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.

Rarely, proton pump inhibitors (such as dexlansoprazole) have caused vitamin B-12 deficiency. The risk is increased if they are taken every day for a long time (3 years or longer). Tell your doctor right away if you develop symptoms of vitamin B-12 deficiency (such as unusual weakness, sore tongue, or numbness/tingling of the hands/feet).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, signs of kidney problems (such as change in the amount of urine).

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Dexilant (Dexlansoprazole) Usage and Side Effects

Dexilant (dexlansoprazole) is a medication used to treat acid reflux (also called GERD) or heartburn. Dexilant may also be used to heal erosive esophagitis and to maintain the healing of erosive esophagitis. Dexilant is part of a class of medications called proton pump inhibitors (PPI’s). Other medications in this class include omeprazole, pantoprazole and many others.

patrickheagney / Getty Images

How Does Dexilant Work?

Dexilant inhibits the pumps (also called proton pumps) in your stomach that produce stomach acid thus overall reducing the amount of acid that can cause heartburn or reflux. According to studies, Dexilant is also capable of healing previously damaged portions of the esophagus.

Dexilant is different than most medications of its kind because, like an extended-release type of medication, one pill releases two separate doses of the medication. However, the manufacturer states that no conclusions about whether this makes the drug more effective than other similar drugs can be drawn from their studies.

Dosage and Administration of Dexilant

Depending on whether or not you have damage to the esophagus caused by acid reflux (esophageal erosion). Dexilant is taken as a 30 or 60 milligram pill once a day. Your dose may need to be reduced if you have a history of liver problems. Dexilant may be taken with or without food. You should follow the instructions given by your physician and/or pharmacist.

Capsules should never be cut in half, chewed, or crushed as this interferes with the extended-release action of the medication. However, for individuals who cannot swallow pills the capsules may be opened up and the intact granules can be given in applesauce or in water (the granules should not be chewed up but swallowed). Two 30mg capsules cannot be substituted for one 60mg capsule.

The Dexilant SoluTab should be dissolved beneath the tongue 30 minutes prior to a meal. The microgranules should be swallowed without water and not chewed.

If you miss a dose you should take it as soon as possible unless it is almost time for the next dose to be taken in which case the missed dose should be skipped. You should not take two doses at once.

Side Effects of Dexilant

According to the official website for Dexilant, in a study involving over 4,500 people, side effects occurred in a very low percentage of those who took Dexilant. The most common side effects were (in order of most common to least common): diarrhea, stomach pain, nausea, common cold, vomiting, and gas.

Although several PPI-related adverse effects have been reported, their clinical relevance is not yet clear, since the evidence reported in those studies is not at a high enough level, as the majority are based on retrospective observational studies and the reported hazard ratios are low. It is important to administer PPIs only for patients who will gain a substantial clinical benefit and to continue to investigate their adverse effects with high quality prospective studies.

Severe allergic reactions including anaphylaxis have occurred in individuals while taking Dexilant. If you have symptoms of anaphylaxis including swelling of the face, lips, mouth or tongue, difficulty breathing, speaking or swallowing, or wheezing you should go to the emergency room or call 911. You may want to avoid Dexilant if you have had an allergic reaction to a similar medication such as lansoprazole.

Interactions With Other Medications

Certain medications require stomach acid to absorb properly. Because Dexilant interferes with the creation of stomach acid, these medications may not be absorbed if taken with Dexilant. Examples include atazanavir, ampicillin, iron salts, and ketoconazole. Dexilant may also interfere with the medication methotrexate.

A Word From Verywell

Before you take Dexilant, your doctor should have a complete history of your health (current and past illnesses), as well as a list of all medications that you take. Your doctor also needs to know if you are currently pregnant, planning to become pregnant, or are breastfeeding. Sufficient studies on the risks to a developing fetus do not currently exist but similar medications (lansoprazole) have caused birth defects.

It is also advisable to ask your pharmacist to review your current medications to make sure that none of them will interact negatively with Dexilant.

Frequently Asked Questions About Proton Pump Inhibitors

Starting a new medication can be nerve-racking. You may begin to experience side effects. You may have health conditions or take other medicines that can complicate things.

The following questions and answers can act as a resource. They can guide you when speaking with your doctor about whether drugs like Prilosec, Nexium and Prevacid are right for you.

Patients should not use the answers provided to substitute appropriate health care professional advice.

What Are Proton Pump Inhibitors (PPIs)?

Proton pump inhibitors, or PPIs, are a class of prescription and over-the-counter medicines. People use them to stop heartburn and other symptoms of acid reflux.

PPIs reduce stomach acid by blocking an enzyme in the stomach wall.

Popular brands include Prilosec, Nexium and Prevacid. Most people call these heartburn medicines.

What Are PPIs Used to Treat?

The U.S. Food and Drug Administration approved PPIs to treat certain gastrointestinal disorders.

Approved PPI uses include the treatment of:

  • Symptoms of acid reflux or GERD (gastroesophageal reflux disease)
  • Damage caused by acid reflux to the lower esophagus (erosive esophagitis)
  • Stomach and duodenal ulcers
  • Zollinger-Ellison syndrome

People often misuse PPIs to treat simple heartburn.

Differences between Heartburn, Acid Reflux, and GERD

Acid reflux is a medical condition in which acid from the stomach moves into the esophagus.

GERD is a chronic, more serious form of acid reflux. GERD can result in inflammation in the esophagus or even long-term damage that can lead to cancer.

Fact

Despite its name, heartburn has nothing to do with the heart.

Heartburn is a symptom of acid reflux and GERD. It causes mild to severe chest pain, or a burning sensation in the chest, neck or throat.

How Effective Are PPIs in the Treatment of GERD?

Studies show that PPIs can be more effective than h3 blockers in treating GERD.

h3 blockers are another group of medicines that reduce stomach acid. Zantac and Pepcid are part of this group.

h3 blockers work in about half of people with GERD. PPIs can relieve symptoms in almost all patients with GERD.

PPIs take more time to start working compared to h3 blockers. h3 blockers typically work within one hour of being taken. PPIs can take one to four days to start working. But PPIs tend to last longer.

Lawsuit Information

Thousands of PPI lawsuits have been filed in federal court claiming the drugs were responsible for long term kidney problems in some patients. Learn more about currently pending litigation.

View Lawsuits

What Are Some Brands of PPIs and Which PPI Works Best?

Most brands of PPIs work equally well. Some may be better at treating symptoms of GERD, or stomach and peptic ulcers. Others may work better at treating erosive esophagitis or Zollinger-Ellison syndrome.

Nexium and Prevacid are effective in treating most conditions requiring the use of a PPI.

Data is limited on differences among PPIs and the side effects they cause. Available evidence suggests that there is no difference in the short-term. Evidence shows that Nexium may be more likely to cause side effects than Prilosec.

Prilosec and Prevacid may be more likely to cause drug-drug interactions than Protonix and AcipHex.

Long-term risks associated with PPIs are believed to be the same.

All PPIs are chemically similar, but they all contain different active ingredients. An active ingredient is the substance that gives a drug its chemical or biological effect. Inactive ingredients make the drug easier to process in the body.

Registered Nurse Amy Keller illustrates the differences among PPIs.


Types of PPI Brands

Prilosec

Active Ingredient: Omeprazole

What it Treats: Peptic ulcers, GERD, erosive esophagitis

Nexium

Active Ingredient: Esomeprazole

What it Treats: GERD, stomach and peptic ulcers, erosive esophagitis, Zollinger-Ellison syndrome

Prevacid

Active Ingredient: Lansoprazole

What it Treats: Peptic ulcers, erosive esophagitis, GERD, Zollinger-Ellison syndrome

AcipHex

Active Ingredient: Rabeprazole

What it Treats: Peptic and esophageal ulcers, GERD, erosive esophagitis

Protonix

Active Ingredient: Pantoprazole

What it Treats: Erosive esophagitis, Zollinger-Ellison syndrome

Dexilant

Active Ingredient: Dexlansoprazole

What it Treats: GERD, erosive esophagitis, relapse of erosive esophagitis

Zegerid

Active Ingredient: Omeprazole with sodium bicarbonate

What it Treats: Similar to Prilosec

Do I Need a Prescription for a PPI?

Fact

Some PPIs are available without a prescription.

Some PPIs require a prescription. Others are available in over-the-counter versions. Over-the-counter PPIs do not need a prescription.

PPIs available in over-the-counter versions include Prilosec, Nexium, Prevacid and Zegerid.

What Is the Difference Between Prescription and Over-the-Counter PPIs?

Both prescription and over-the-counter PPIs contain the same active ingredients. They also work in the same way, but there are some differences between the two medications.

Prescription and OTC PPIs may have different inactive ingredients. They may come in different forms such as capsules or liquids. They may have different approved uses.

Most over-the-counter medicines also come in lower strengths and dosages than prescription drugs. OTC versions may cost less than prescription versions.

A patient does not need to see a doctor before purchasing over-the-counter drugs. But patients should let their doctor know of any OTC medicines they are taking.

Are PPIs Safe?

Long-term use can cause serious PPI side effects.

Kidney disease, bacterial infections and bone fractures are some of PPIs’ most serious side effects.

Hundreds of patients who suffered from severe kidney injury after taking Nexium, Prilosec or Prevacid filed lawsuits against makers of the drugs.

Who Should Not Take PPIs?

Not all PPIs are recommended for use in children. PPIs approved for pediatric use may be limited in their scope of treatment.

Women who are pregnant (especially in the first trimester) or are planning on becoming pregnant should speak with their doctor about possible risks to unborn fetuses and nursing infants.

Patients should also discuss all health conditions they have and any other medications or supplements they are currently taking with their doctor.

What Are Some Alternatives to Taking PPIs?

Lifestyle changes can help relieve heartburn and symptoms of acid reflux. They can also prevent worsening of the disease and further complications.

Lifestyle changes include dieting, losing weight, exercising, limiting alcohol consumption and not smoking.

Antacids can help to neutralize stomach acid and relieve heartburn. Popular antacids include Alka-Seltzer, Maalox, Mylanta, Rolaids and Tums.

Did You Know

Antacids can help reduce symptoms of acid reflux, but they don’t treat the disease.

h3 blockers can help lessen the frequency and level of symptoms of acid reflux or GERD. Pepcid and Zantac are popular h3 blockers.

How Do You Take a PPI?

PPIs should be taken on an empty stomach, about 30 minutes to one hour before eating breakfast.

Prescription PPIs are generally taken once a day every day for the length of time prescribed. Doctors may prescribe a PPI only “as needed.”

How Long Will I Have to Keep Taking PPIs?

PPIs are generally supposed to be taken for two to eight weeks, depending on the condition being treated. Doctors sometimes prescribe PPIs for a longer period of time.

The U.S. Food and Drug Administration states that over-the-counter PPIs should only be taken for a single 14-day treatment once every four months.


Please seek the advice of a medical professional before making health care decisions.

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Dexilant 30 mg No. 28 capsules with modified release.

Instruction for medical use

of medicinal product

Dexilant ™

Trade name

Dexilant ™

International non-proprietary name

Dexlansoprazole

Dosage form

Capsules with 30 mg of modified

the capsule contains

active substances: dexlansoprazole 30 mg or 60 mg

excipients: sugar crumbs, magnesium carbonate, sucrose, low-substituted hyprolose, hyprolose, hypromellose 2910, talc, titanium dioxide (E 171), copolymer methacrylic acid dispersion , macrogol 8000, polysorbate 80, anhydrous colloidal silicon dioxide, methacrylic acid copolymer (type B), methacrylic acid copolymer (type A), triethyl citrate

Capsule shell:

Carrageenan, potassium chloride, titanium dioxide (E FD1), colorant & C blue

No. 2 aluminum varnish (E132), w iron oxide black (E 172), hypromellose, purified gray ink

 – composition of granulated sugar: sucrose, corn starch;

** – the composition of the dispersion of methacrylic acid copolymer: methacrylic acid, ethyl acrylate, sodium lauryl sulfate, polysorbate;

*** – composition of purified gray ink: iron oxide red (E 172), iron oxide yellow (E 172), dye FD & C blue No. 2 aluminum varnish (E 132), carnauba wax, shellac, glycerin monooleate.

Description

Capsules with an opaque blue cap and an opaque gray body. The TAP logo is printed on the lid in dark gray ink, and the inscription “30” on the body. The contents of the capsules are white to almost white granules

(for a dosage of 30 mg)

Capsules with an opaque blue cap and body. The TAP logo is printed on the lid in dark gray ink, and the inscription “60” on the body. The contents of the capsules are granules from white to almost white (for a dosage of 60 mg)

Pharmacotherapeutic group

Preparations for the treatment of diseases associated with acidity disorders. Antiulcer drugs and drugs for the treatment of gastroesophageal reflux. Proton pump inhibitors. Dexlansoprazole.

ATC code A02BC06

Pharmacological properties

Pharmacokinetics

Dexilant ™ is a drug with a double sustained release of a drug that leads to two different peaks in plasma concentration; the first peak occurs within one to two hours after ingestion, followed by a second peak within four to five hours.The half-life of dexlansoprazole is about one to two hours in healthy people and in patients with symptoms of gastroesophageal reflux disease (GERD). There is no accumulation of dexlansoprazole after multiple and single administration of Dexilant ™ 30 mg or 60 mg, although the average values ​​of the area under the curve (AUCt) and the maximum concentration of the drug achieved in plasma (Cmax) of dexlansoprazole were slightly higher (less than 10%) by 5 1st day than 1st day.

The pharmacokinetics of dexlansoprazole are highly variable, with percent coefficient of variation (CV%) for Cmax, AUC, and oral clearance (CL / F) over 30% percent (see Table 1).

Table 1: Average values ​​(CV%) of pharmacokinetic parameters in patients on the 5th day after taking Dexilant TM

Dose (mg)

Cmax

(ng / ml)

AUC24

(ng h / ml )

CL / F

(l / h)

30

658 (40%)

(N = 44)

3275 (47%)

(N = 43)

11.4 ( 48%)

(N = 43)

60

1397 (51%)

(N = 79)

6529 (60%)

(N = 73)

11.6 (46%)

(N = 41)

Absorption

After oral administration of 30 mg or 60 mg of Dexilant ™ in healthy individuals and patients with symptomatic GERD, the mean Cmax and AUC of dexlansoprazole increased approximately proportionally to the dose.

When 60 mg Dexilant ™ granules are mixed with water and administered through a nasogastric tube or orally through a syringe, the bioavailability (Cmax and AUC) of dexlansoprazole is similar to the bioavailability of Dexilant ™ 60 mg as an unopened capsule.

Distribution

The binding of dexlansoprazole to plasma proteins in healthy volunteers ranged from 96% to 99% and was independent at a concentration of 0. 01-20 μg / L. In patients with symptomatic gastroesophageal reflux disease, the apparent volume of distribution (Vz / F) after multiple doses was 40 liters.

Metabolism

Dexlansoprazole is extensively metabolized in the liver by oxidation, reduction and subsequent formation of sulfate, glucuronide and glutathione compounds to inactive metabolites. Oxidative metabolites are formed by the cytochrome P450 (CYP) enzyme system, including hydroxylation, mainly by the CYP2C19 isoenzyme and oxidation to sulfone by the CYP3A4 isoenzyme.

CYP2C19 isoenzyme is a polymorphic hepatic isoenzyme that exhibits three phenotypes in the metabolism of CYP2C19 substrates; fast metabolizers (* 1 / * 1), intermediate metabolizers (* 1 / mutant) and slow metabolizers (mutant / mutant).Dexlansoprazole is the main component circulating in plasma, regardless of the status of the CYP2C19 metabolizer. In intermediate and rapid metabolizers of the CYP2C19 isoenzyme, the main metabolite in the blood plasma is 5-hydroxydexlansoprazole and its glucuronic compound, while in the slow metabolizers of CYP2C19, sulfone is the main metabolite in the blood plasma.

Excretion

After administration of the drug Dexilant ™, dexlansoprazole is not excreted unchanged in the urine.After administration of 14C-labeled dexlansoprazole to six healthy volunteers, about 50.7% (standard deviation (SD): 9.0%) of the administered radioactivity was excreted in the urine and 47.6% (SD: 7.3%) in the feces. Oral clearance in healthy individuals was 11.4-11.6 l / h, respectively, after 5-day use in doses of 30 mg or 60 mg once a day.

Effects of food intake

In studies on the effects of food intake with healthy volunteers, taking Dexilant ™ after meals was compared with taking the drug on an empty stomach; the increase in Cmax ranged from 12% to 55%, the increase in AUC ranged from 9% to 37%, and the Tmax also changed (ranging from a decrease to 0.7 hours to an increase to three hours).

Special patient groups

Pediatric age

The pharmacokinetics of dexlansoprazole in patients under the age of 18 have not been studied.

Elderly age

In the elderly compared with the young, the terminal half-life is significantly increased (2.2 and 1.5 hours, respectively). The systemic exposure (AUC) of dexlansoprazole in the elderly is significantly higher than in younger patients (34% higher).

Gender

When 12 healthy men and 12 healthy women took a single oral dose of Dexilant ™ 60 mg, women showed a higher level of systemic exposure (AUC) (43% higher) than men.This difference does not pose a significant safety issue.

Renal failure

Dexlansoprazole is extensively metabolized in the liver to inactive metabolites, and after oral administration of dexlansoprazole, the parent substance is not detected in the urine. Therefore, the pharmacokinetics of dexlansoprazole is not expected to change in patients with impaired renal function. Studies in patients with impaired renal function have not been conducted. In addition, the pharmacokinetics of lansoprazole did not differ clinically in patients with mild, moderate and severe renal impairment compared with healthy individuals with normal renal function.

Liver dysfunction

In 12 patients with moderate hepatic impairment (class B on the Child-Pugh scale) who received a single oral dose of 60 mg of Dexilant ™, the systemic exposure (AUC) of bound and unbound dexlansoprazole was approximately twice more than in patients with normal liver function. This difference in exposure was not due to a difference in protein binding. Studies in patients with severely impaired liver function have not been conducted.

Pharmacodynamics

Mechanism of action

Dexlansoprazole belongs to the class of antisecretory drugs, is a benzimidazole derivative that suppresses gastric acid secretion by inhibiting H + / K + -ATPase in the parietal cells of the stomach. Since this enzyme is regarded as an acid (β-proton) pump in parietal cells, dexlansoprazole is characterized as an inhibitor of the gastric proton pump, as it blocks the final stage of acid production.

Antisecretory activity

In a crossover study with healthy subjects, the antisecretory effect on 24-hour intragastric pH was assessed when taking Dexilant ™ 60 mg (n = 20) and lansoprazole 30 mg (n = 23) once a day for five days. The results are shown in Table 2.

Table 2. Influence on 24-hour intragastric pH on the 5th day of taking Dexilant ™ and lansoprazole preparations

Dexilant ™ 60 mg

Lansoprazole 30 mg

Average intragastric pH value

4.55

4.13

Time span with intragastric pH> 4,% (hours)

71

(17 hours)

60

(14 hours)

Effect on serum gastrin level

™ Effect of Dexilant serum gastrin concentration was evaluated in approximately 3460 patients in clinical trials up to eight weeks, and in 1023 patients lasting six to 12 months. The average value of fasting gastrin concentration increased in comparison with the control group during treatment with Dexilant ™ 30 mg and 60 mg.In patients treated for more than six months, mean serum gastrin levels increased during approximately the first three months of treatment, and were stable for the remainder of treatment. Mean serum gastrin levels returned to pretreatment levels within one month after discontinuation of the drug.

Increased gastrin causes enterochromaffin-like cell (ECL) hyperplasia and serum chromogranin A (CgA) levels. An increase in CgA levels can cause false positive results in diagnostic tests for neuroendocrine tumors.

Effect on enterochromaffin-like cells (ECL)

When using Dexilant ™ 30 mg, 60 mg or 90 mg for a period up to 12 months, no reports of ECL cell hyperplasia based on gastro-biopsy specimens were received. When lansoprazole was administered to rats up to 150 mg / kg / day throughout life, the development of hypergastrinemia was observed, followed by proliferation of ECL cells and the formation of carcinoid tumors, especially in females.

Effects on cardiac repolarization

When taken at a dose five times the maximum recommended dosage, dexlansoprazole does not prolong the QT interval to any clinically relevant values.

Indications for use

Treatment of erosive esophagitis of any severity;

maintenance therapy for treated erosive esophagitis and relief of heartburn;

for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD)

Dosage and administration

Important information for use

Missed doses: if a dose is missed, take the capsule as soon as possible. However, if you already need to take the next scheduled dose, do not take the missed dose, but take the next dose on time.Do not take two doses at the same time to make up for a missed dose.

Dexilant ™ can be taken with or without food.

Swallow whole; do not chew.

Patients with swallowing problems can open capsules of Dexilant ™ and take with applesauce as follows:

1. Place one tablespoon of applesauce in a clean container.

2. Open the capsule.

3. Pour the granules into the applesauce.

4. Immediately swallow the applesauce with granules. Do not chew the granules. Do not store the granulated applesauce for later use.

Alternatively, the capsules can be administered with water, with an oral syringe, or through a nasogastric tube.

Injection with water using an oral syringe

1. Open the capsule and pour the granules into a clean container with 20 ml of water.

2. Place the entire mixture into the syringe.

3. Gently mix the contents of the syringe to prevent the granules from settling.

4. Immediately put the mixture into your mouth. Do not store the mixture of water and granules for later use.

5. Refill the syringe with 10 ml of water, shake gently and insert into mouth.

6. Refill the syringe with 10 ml of water, shake gently and insert into the mouth.

Administration with water through a nasogastric tube (> 16 French gauge)

1. Open the capsule and pour the granules into a clean container with 20 ml of water.

2. Place the entire mixture into the catheter-tipped syringe.

7. Gently mix the contents of the syringe to prevent sedimentation of the granules and immediately enter the mixture into the stomach through a nasogastric tube. Do not store the mixture of water and granules for later use.

3. Refill the syringe with 10 ml of water, shake gently and pour into the probe.

4. Refill the syringe with 10 ml of water, shake gently and inject into the stomach.

Dexilant ™ is available as 30 mg and 60 mg capsules. Dose recommendations for adults are shown in Table 3.

Table 3. Dexilant ™ Recommendations for dosing in adults

Indication

Recommended dose

Frequency

Treatment of erosive esophagitis

60 mg

Once a day, up to 8 weeks

Supportive eruptive therapy manifestations of heartburn

30 mg

Once a day *, up to 6 months

Symptomatic non-erosive GERD

30 mg

Once a day, up to 4 weeks

* Controlled studies lasted no more than 6 months

Dose adjustment in adult patients with erosive esophagitis and impaired liver function

In patients with moderate hepatic impairment (class B on the Child-Pugh scale), the daily dose should not exceed 30 mg of dexlansoprazole once a day for up to 8 weeks.

The use of Dexilant ™ is not recommended in patients with severe hepatic impairment (class C on the Child-Pugh scale).

Side effects

The following serious side effects are described below, as well as in other sections of the instructions:

Acute interstitial nephritis

Cyanocobalamin (vitamin B12) deficiency

Clostridial diarrhea

Bone fracture

clinical trials

Since clinical trials are conducted under different conditions, the proportion of adverse reactions observed during the trial cannot be directly compared to the proportion of reactions in clinical trials with another drug.In addition, they may not reflect the frequency found in practice.

The safety of Dexilant ™ was evaluated in 4548 patients in controlled and uncontrolled clinical trials, including 863 patients who received treatment for at least six months and 203 patients who received treatment for one year. The studies involved patients between the ages of 18 and 90 (mean age 48), 54% of women, 85% of Caucasians, 8% of blacks, 4% of Asians, and 3% of other races.Six randomized controlled clinical trials have been conducted for the treatment of erosive esophagitis, maintenance therapy for treated erosive esophagitis, and symptomatic GERD. They included 896 patients receiving placebo, 455 patients receiving Dexilant ™ 30 mg, 2218 patients receiving 60 mg, and 1363 patients receiving lansoprazole 30 mg once daily.

The most frequent (at least 2%) undesirable side reactions are diarrhea, flatulence, abdominal pain, nausea, vomiting, upper respiratory tract infections.

Adverse reactions leading to discontinuation of therapy

In controlled clinical trials, the most common reaction leading to discontinuation of Dexilant ™ was diarrhea (0.7%).

Less frequent adverse reactions

Other adverse reactions reported in controlled trials with an incidence of less than 2% are listed below by body system:

Circulatory and lymphatic system disorders: anemia, lymphadenopathy

Cardiac disorders: angina , arrhythmia, bradycardia, chest pain, edema, myocardial infarction, palpitations, tachycardia

Disturbances from the organ of hearing and balance: pain in the ears, tinnitus, dizziness

Disturbances from the endocrine system: goiter

Disturbances from the outside organ of vision: eye irritation, eye swelling

Gastrointestinal tract disorders: abdominal discomfort, tenderness in the abdomen, abnormal stools, anal discomfort, Barrett’s esophagus, bezoar, abnormal sounds in the intestines, breath odor, microscopic colitis , colon polyp, constipation, dry mouth, duodenitis, dyspepsia, dysphagia, enteritis, belching, esophagitis, gastric polyp, gastritis, gastroenteritis, gastrointestinal disorders, gastrointestinal hyperkinetic disorders, GERD, gastrointestinal ulcers and perforation, hematemesis, bloody stools, hemorrhoids, gastric emptying, irritable bowel syndrome , blistering of the oral mucosa, painful bowel movements, proctitis, oral paresthesia, rectal hemorrhage, urge to vomit

General disorders and disorders at the injection site: adverse drug reaction, asthenia, chest pain, chills, abnormal touch, inflammation, inflammation of the mucous membranes, nodular thickening, pain, hyperthermia

Disorders of the liver and biliary tract: biliary colic, cholelithiasis, hepatomegaly

Disorders of the immune system: hypersensitivity

Infectious and parasitic diseases: candidiasis, influenza, influenza oral herpes, pharyngitis, sinus it, viral infection, vulvo-vaginal infections

Injuries, poisoning and complications of procedures: falls, fractures, dislocations of joints, overdose, pain during the procedure, sunburn

Laboratory tests: increased level of alkaline phosphatase, increased level of alanine aminotransferase (ALT) , increased aspartate aminotransferase (AST), increased / decreased bilirubin, increased blood creatinine, increased blood gastrin, increased blood glucose, increased blood potassium, abnormal liver function tests, decreased platelet count, increased total protein, weight gain

Disorders on the part of metabolism and nutrition: changes in appetite, hypercalcemia, hypokalemia

Disorders of the skeletal muscles and connective tissue: arthralgia, arthritis, muscle cramps, musculoskeletal pain, myalgia

Disorders of the nervous system: changes in taste, convulsions , dizziness f, headaches, migraine, memory impairment, paresthesia, psychomotor hyperactivity, tremor, trigeminal neuralgia

Mental disorders: unusual dreams, anxiety, depression, insomnia, libido changes

Kidney and urinary tract disorders: dysvuria, imperative to urination

Reproductive system and breast disorders: dysmenorrhea, dyspareunia, menorrhagia, menstrual irregularities

Respiratory, chest and mediastinal disorders: aspiration, asthma, bronchitis, cough, shortness of breath, hiccups, hyperventilation, congestion respiratory tract, sore throat

Disorders of the skin and subcutaneous tissue: acne, dermatitis, erythema, pruritus, rash, skin lesions, urticaria

Disorders of the cardiovascular system: deep vein thrombosis, hot flashes, hypertension

Additional side reactions reported in long-term uncontrolled ischemia study, which, in the opinion of the treating physician, were associated with taking Dexilant ™, included: anaphylaxis, auditory hallucinations, B-cell lymphoma, bursitis, central obesity, acute cholecystitis, dehydration, diabetes mellitus, dysphonia, epistaxis, folliculitis , gout, shingles, hyperlipidemia, hypothyroidism, an increase in the number of neutrophils, a decrease in the average concentration of hemoglobin in erythrocytes, neutropenia, painful urge to defecate, restless legs syndrome, drowsiness, tonsillitis.

Post-registration experience

The following adverse reactions were identified during the post-registration use of Dexilant ™. Since these reactions have been reported voluntarily from the public in an uncertain amount, it is not always possible to reliably assess the frequency of their occurrence, or establish a causal relationship with drug exposure.

Disorders of the circulatory and lymphatic systems: autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura

Hearing and balance disorders: deafness

Oral disorders: blurred vision

Disorders from the gastrointestinal tract: from the gastrointestinal tract pancreatitis

General disorders and disorders at the injection site: edema of the face

Disorders of the liver and biliary tract: drug-induced hepatitis

Disorders of the immune system: anaphylactic shock (requiring urgent intervention), exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (sometimes fatal)

Infectious and parasitic diseases: clostridial diarrhea

Metabolic and nutritional disorders: hypomagnesemia, hyponatremia

Musculoskeletal system disorders: bone fracture

90 002 Nervous system disorders: cerebrovascular accident, transient ischemic attack

Renal and urinary tract disorders: acute renal failure

Respiratory, chest and mediastinal disorders: laryngeal edema, throat constriction

sides of the skin and subcutaneous tissue: generalized rash, leukocytoclastic vasculitis

Contraindications

hypersensitivity to any of the components of the drug

combined use with drugs containing rilpivirine

acute interstitial nephritis

children age

Tables 4 and 5 describe clinically significant drug interactions with Dexilant ™, the interaction of diagnostic tests and Dexilant ™, as well as recommendations for the prevention of complications.

Table 4. Clinically significant drug interactions with Dexilant ™ and interactions with diagnostic tests

Antiretroviral drugs

Clinical influence:

The effect of proton pump inhibitors (PPIs) on antiretroviral drugs is variable. The clinical significance and the mechanisms underlying these interactions are not always known.

Reducing exposure to certain antiretroviral drugs (eg, rilpivirine, atazanavir, and nelfinavir) while used with dexlansoprazole may reduce the antiviral effect and promote drug resistance.

Increased exposure to other antiretroviral drugs (eg saquinavir) when used with dexlansoprazole may increase the toxicity of antiretroviral drugs.

There are also other antiretroviral drugs that do not result in clinically significant interactions with dexlansoprazole.

Preventive measures:

Products containing rilpivirine: use with Dexilant ™ is contraindicated.

Atazanavir: See Atazanavir Instructions for Use for dosing information.

Nelfinavir: avoid use with Dexilant ™. See the instructions for use of nelfinavir.

Saquinavir: Refer to the saquinavir directions for use and monitor for potential toxicity of saquinavir.

Other antiretrovirals: see instructions for use.

Warfarin

Clinical impact:

Increase in international normalized ratio (INR) and prothrombin time in patients receiving PPI and warfarin at the same time.An increase in INR and prothrombin time can lead to bleeding and even death.

Prevention measures:

Monitoring INR and prothrombin time. Warfarin dose adjustment may be necessary to maintain the target INR range. See instructions for use of warfarin.

Methotrexate

Clinical impact:

Concomitant use of PPIs with methotrexate (mainly in high doses) may increase levels and prolong the presence of serum methotrexate and / or its metabolite hydroxymethotraxate, which can lead to methotrexate toxicity.No formal studies have been conducted on the interaction of high doses of methotrexate with PPIs.

Prevention measures:

Temporary discontinuation of Dexilant ™ in some patients receiving high doses of methotrexate may be considered.

Digoxin

Clinical impact:

Potential increase in digoxin exposure.

Preventive measures:

Monitor the concentration of digoxin. Digoxin dose adjustment may be required to maintain therapeutic drug concentrations.See instructions for use of digoxin.

Drugs whose absorption depends on the pH of the stomach (for example, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole / itraconazole)

Clinical influence:

Dexlansoprazole may reduce the absorption of other drugs by the stomach …

Prevention measures:

Mycophenolate mofetil (MMF): when MMF was used together with PPIs in healthy individuals and in patients after organ transplantation, a decrease in the effect of the active metabolite and mycophenolic acid (IFC) was revealed, possibly due to a decrease in the solubility of MMF at an elevated gastric pH. In post-transplant patients receiving Dexilant ™ and MMF, the clinical significance of reducing the effect of IFC on organ rejection has not been established. Post-transplant patients receiving MMF should use Dexilant ™ with caution.

See instructions for use of other medicines whose absorption depends on the pH of the stomach.

Tacrolimus

Clinical impact:

Potentially higher exposure to tacrolimus, especially in transplant patients who are intermediate or slow metabolizers of CYP2C19.

Preventive measures:

Monitor blood tacrolimus concentration. Tacrolimus dose adjustment may be required to maintain therapeutic drug concentrations. See instructions for use of tacrolimus.

Interaction with diagnostic tests for neuroendocrine tumors

Clinical influence:

Secondary increase in CgA level due to PPI-induced decrease in gastric acidity.Elevated CgA levels can cause false-positive results in diagnostic tests for neuroendocrine tumors.

Preventive measures:

Temporarily stop taking Dexilant ™ at least 14 days before assessing CgA levels and repeat the test if baseline CgA levels were high. If a series of tests are being conducted (for example, for monitoring purposes), then they should be carried out in the same laboratory, as the reference ranges between tests may differ.

Interaction with secretin stimulation test

Clinical influence:

Hyperresponse in the form of gastrin secretion, as a reaction to a secretin stimulation test, may falsely suggest gastrinoma.

Preventive measures:

Temporarily discontinue treatment with Dexilant ™ at least 30 days prior to assessment so that gastrin levels return to baseline.

False positive tetrahydrocannabinol (THC) urinalysis results

Clinical impact:

False positive tetrahydrocannabinol (THC) urine results have been observed in patients receiving PPIs

Prevention measures:

Confirmation of an alternative test requires an alternative.

Table 5. Clinically significant interactions of the drug Dexilant ™ when used together with other drugs CYP2C19 and CYP3A4 inducers

Clinical effect:

Reducing the effect on dexlansoprazole when used simultaneously with strong inducers.

Prevention measures:

St. John’s wort, rifampin: avoid use with Dexilant ™.

Preparations containing ritonavir: see instructions for use.

Inhibitors of CYP2C19 or CYP3A4

Clinical impact:

An increase in the exposure of dexlansoprazole is expected when used simultaneously with strong inhibitors.

Preventive measures:

Voriconazole: see instructions for use.

Effect of dexlansoprazole on other drugs

Cytochrome P 450

Dexlansoprazole is partially metabolized by CYP2C19 and CYP3A4.

In vitro studies have shown that dexlansoprazole does not inhibit CYP isoforms 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1 or 3A4.Thus, no clinically significant interactions with drugs that are metabolized by these CYP enzymes are expected. In addition, in vivo studies have shown that Dexilant ™ does not affect the pharmacokinetics of phenytoin (CYP2C9 substrate) or theophylline (CYP1A2 substrate). Although in vitro studies have shown that Dexilant ™ can inhibit CYP2C19 in vivo; An in vivo study of drug interactions among the rapid and intermediate metabolizers of CYP2C19 showed that Dexilant ™ does not affect the pharmacokinetics of diazepam (CYP2C19 substrate).

Clopidogrel

Clopidogr

DEKSILANT instructions for use, price in pharmacies in Ukraine, analogues, composition, indications | DEXILANT hard capsules with modified release from Takeda Pharmaceuticals

pharmacodynamics. Dexlansoprazole belongs to the class of antisecretory compounds that are substituted benzimidazoles that suppress gastric acid secretion by specifically inhibiting the activity of (H + , K + ) -ATPase on the secretory surface of gastric parietal cells.Because this enzyme system is considered the acid (proton) pump of parietal cells, dexlansoprazole is classified as a proton pump inhibitor that blocks the final stage of acid production.

Pharmacokinetics. Absorption. After oral administration of the drug Dexilant at a dose of 30 or 60 mg by healthy volunteers and patients with symptomatic gastroesophageal reflux disease, the mean C max and AUC of dexlansoprazole increased almost proportionally to the dose.

In the case of mixing 60 mg of Dexilant granules with water and applying through a nasogastric tube or orally using a syringe, the bioavailability (C max and AUC) of dexlansoprazole is the same as when using 60 mg of Dexilant in the form of an intact capsule.

Food intake does not affect the AUC of dexlansoprazole.

Distribution. The binding of dexlansoprazole to plasma proteins in healthy volunteers ranged from 96 to 99% and in the range of 0.01–20 μg / ml did not depend on the concentration of the drug.In patients with symptomatic gastroesophageal reflux disease, the apparent volume of distribution (Vz / F) after multiple doses was 40 liters.

Metabolism. Dexlansoprazole is extensively metabolized in the liver by oxidation, reduction and further formation of sulfate, conjugation with glucuronide and glutathione to inactive metabolites. Oxidized metabolites are formed by the cytochrome P450 (CYP) enzyme system, including hydroxylation mainly by CYP2C19, and oxidation to sulfone by CYP3A4.

CYP2C19 is a polymorphic liver enzyme that exhibits three phenotypes in the metabolism of CYP2C19 substrates: fast metabolizers, intermediate metabolizers, and slow metabolizers. Dexlansoprazole is the main constituent circulating in blood plasma, regardless of the metabolic status of CYP2C19. In fast and moderate CYP2C19 metabolizers, the main plasma metabolites are 5-hydroxydexlansoprazole and its glucuronic conjugate, while in slow CYP2C19 metabolizers, the main plasma metabolite is dexlansoprazole sulfone.

Derivation. After administration of the drug Dexilant, dexlansoprazole is not excreted unchanged in the urine. After administration of dexlansoprazole labeled with 14 C to 6 healthy volunteers, about 50.7% (standard deviation: 9.0%) of the administered radioactivity was excreted in the urine and 47.6% (standard deviation: 7.3%) in the feces. The established clearance (Cl / F) in healthy volunteers was 11.4–11.6% after 5-day use at a dose of 30 or 60 mg 1 time per day.

Special patient groups

Age: pediatric population. The pharmacokinetics of dexlansoprazole in patients under 12 years of age have not been studied.

Patients aged 12 to 17 years. The pharmacokinetics of dexlansoprazole was studied in 36 patients aged 12–17 years with symptomatic non-erosive gastroesophageal reflux disease in a multicenter study. Patients were randomized to receive Dexilant 30 mg or 60 mg once daily for 7 days. The average values ​​of C max and AUC of dexlansoprazole in patients aged 12-17 years were 105% and 88%, respectively, compared with these values ​​in adult patients when using the drug at a dose of 30 mg and 81% and 78%, respectively, when using the drug in dose of 60 mg.

Age: elderly patients . The final T ½ dexlansoprazole is significantly longer in elderly patients compared with young patients (2.2 and 1.5 hours, respectively). The systemic exposure (AUC) of dexlansoprazole in elderly patients is higher (34%) than in younger patients.

Floor . A study involving 12 male and 12 female patients who received a single oral dose of 60 mg of Dexilant showed that women had a higher systemic exposure (AUC) (43%) than men.This difference in exposure does not affect the safety profile of the drug.

Renal failure . Dexlansoprazole is extensively metabolized in the liver to inactive metabolites, therefore, the original active substance is not restored in the urine after oral administration of dexlansoprazole. Therefore, the pharmacokinetics of dexlansoprazole are not expected to differ in patients with renal impairment. No studies have been conducted in patients with renal impairment.In addition, the pharmacokinetics of lansoprazole were not clinically different in patients with mild, moderate and severe renal impairment compared with healthy volunteers.

Liver failure . A study involving 12 patients with moderate hepatic impairment (class B on the Child-Pugh scale), who received a single oral dose of 60 mg of Dexilant, showed that the systemic exposure of bound and unbound dexlansoprazole was approximately 2 times higher compared with healthy volunteers.This difference in exposure is not related to a difference in plasma protein binding. A study involving patients with severe hepatic impairment (class C on the Child-Pugh scale) has not been conducted (see APPLICATION).

  • Treatment of all stages of erosive esophagitis in patients aged 12 years and older for up to 8 weeks;
  • maintenance treatment for erosive esophagitis and heartburn relief in patients 12 years of age and older for up to 6 months in adults and 16 weeks in patients 12–17 years of age;
  • Treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease in patients aged 12 years and older for 4 weeks.

Recommended dosage regimen of Dexilant for patients aged 12 years and older:

Readings Recommended dose of Dexilant Duration of treatment
Treatment of erosive esophagitis 1 capsule 60 mg once a day Up to 8 weeks
Maintenance treatment for erosive esophagitis and heartburn relief 1 capsule 30 mg once a day Controlled studies did not exceed 6 months in adult patients and 16 weeks in patients aged 12-17 years
Treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease 1 capsule 30 mg once a day 4 weeks

Dexilant can be used regardless of food intake.The capsules should be swallowed whole and not chewed.

Patients who have difficulty swallowing capsules. Applesauce . Place 1 tablespoon of applesauce in a clean container. Open the capsule, pour the intact granules into the applesauce and take immediately. Do not chew the granules. Do not store applesauce with granules for later use.

Alternatively, the contents of the capsules can be injected with water using a syringe or nasogastric tube.

Oral administration with water using a syringe . Open the capsule and pour the granules into a clean container with 20 ml of water. Fill the syringe with the mixture formed. Shake the syringe lightly to prevent the granules from settling. Introduce the mixture into the mouth and swallow immediately. Do not store the water / granule mixture for later use. Add 10 ml of water to the syringe, shake gently and take the mixture. Once again add 10 ml of water to the syringe, shake gently and take.

Application with water using a nasogastric tube (size ≥16 French) .Open the capsule and pour the granules into a clean container with 20 ml of water. Fill the syringe catheter with the mixture formed. Shake the syringe catheter lightly to prevent the granules from settling. Immediately inject the mixture through a nasogastric tube into the stomach. Do not store the water / granule mixture for later use. Add 10 ml of water to the syringe catheter, shake gently and inject the mixture. Once again add 10 ml of water to the syringe catheter, shake gently and inject.

Missed doses . If a dose is missed, the missed dose should be taken as soon as possible.However, if it is necessary to take the next dose of the drug according to the schedule, do not use the missed dose, but take the next one on time. It is not recommended to take a double dose of the drug at the same time to make up for a missed dose.

Dose adjustment for patients with hepatic impairment in the treatment of erosive esophagitis. Patients with mild hepatic impairment (class A on the Child-Pugh scale) do not require dose adjustment of Dexilant. In a study in adult patients with moderate hepatic impairment (class B on the Child-Pugh scale), who received a single dose of 60 mg of Dexilant, a significant increase in the systemic effect of dexlansoprazole was noted compared to healthy volunteers.Therefore, in patients with moderate hepatic impairment (class B on the Child-Pugh scale), a dose reduction is recommended for the treatment of erosive esophagitis. For persons with moderate hepatic impairment (class B on the Child-Pugh scale), the maximum daily dose for the treatment of erosive esophagitis is 30 mg 1 time per day for 8 weeks. Studies of patients with severe hepatic impairment (class C on the Child-Pugh scale) have not been conducted, therefore, the drug should not be used in this category of patients.

hypersensitivity to the active substance and any component of the drug. There have been reports of the development of hypersensitivity reactions, including anaphylaxis (see SIDE EFFECTS). It has been reported about the development of acute interstitial nephritis with the use of other proton pump inhibitors, including lansoprazole, the R-enantiomer of which is dexlansoprazole (see SPECIAL INSTRUCTIONS). Proton pump inhibitors, including Dexilant, should not be used concomitantly with drugs containing rilpivirine (seeINTERACTIONS).

the development of such serious adverse reactions was reported: acute interstitial nephritis, cyanocobalamin deficiency (vitamin B 12 ), Clostridium difficile -associated diarrhea, bone fractures, hypomagnesemia, cutaneous lupus erythematosus and systemic lupus erythematosus (SLE), fundus polyps (see SPECIAL INSTRUCTIONS).

Diarrhea, abdominal pain, nausea, upper respiratory tract infections, vomiting, flatulence are the most common side effects with a frequency of ≥2% that have been recorded during placebo-controlled clinical trials.Diarrhea (0.7%) was the most common adverse reaction reported in controlled clinical trials that led to drug discontinuation. Below are the adverse reactions with a frequency of <2%.

Blood and lymphatic system disorders: anemia, lymphadenopathy.

From the cardiovascular system: angina pectoris, arrhythmia, bradycardia, chest pain, edema, myocardial infarction, palpitations, tachycardia.

On the part of the organ of hearing and balance: ear pain, tinnitus, vertigo.

From the endocrine system: goiter.

From the side of the organ of vision: eye irritation, swelling of the eyes.

On the part of the digestive system: discomfort in the abdomen, soreness of the abdomen, upset stools, discomfort in the anus, Barrett’s esophagus, bezoar, abnormal noises of the intestinal tract, bad breath, microscopic colitis, colon polyps, constipation, dryness in mouth, duodenitis, dyspepsia, dysphagia, enteritis, belching, esophagitis, stomach polyp, gastritis, gastroenteritis, disorders of the stomach and duodenum, gastroesophageal reflux disease, ulcers and perforation of stomach ulcers and intestinal tract, hemorrhoids evacuation of food from the stomach, irritable bowel syndrome, mucous stools, ulcers of the oral mucosa, painful defecation, proctitis, oral paresthesia, rectal bleeding, urge to vomit.

General disorders: asthenia, chest pain, chills, soreness, inflammation, inflammation of the mucous membrane, formation of nodular thickening, pain, fever.

From the liver and biliary tract: hepatic colic, cholelithiasis, hepatomegaly.

Immune system disorders: hypersensitivity reactions.

Infections and invasions: infections caused by microorganisms of the genus Candida , influenza, nasopharyngitis, oral herpes, pharyngitis, sinusitis, viral infections, infections of the external genital organs and vagina.

Injuries, poisoning and complications of procedures: falls, fractures, sprains of the joint, pain, photosensitivity.

Laboratory tests: increase in the level of ALT, AST, ALP, increase / decrease in the level of bilirubin, increase in the level of creatinine, gastrin, glucose, potassium in the blood, deviations in liver function tests, decrease in platelet levels, increase in total protein, increase in body weight.

Metabolic and nutritional disorders: appetite changes, hypercalcemia, hypokalemia.

From the musculoskeletal system and connective tissue: arthralgia, arthritis, spasms, musculoskeletal pain, myalgia.

From the nervous system: change in taste, convulsions, dizziness, headache, migraine, memory impairment, paresthesia, psychomotor hyperactivity, tremor, trigeminal neuralgia.

From the side of the psyche: sleep disturbance, anxiety, depression, insomnia, changes in libido.

From the kidneys and urinary tract: dysuria, urgency to urinate.

Reproductive system and mammary glands: dysmenorrhea, pain during intercourse, hypermenorrhea, menstrual irregularities.

Respiratory system: aspiration, BA, bronchitis, cough, shortness of breath, hiccups, hyperventilation, congestion in the respiratory system, sore throat.

Skin and subcutaneous tissue disorders: acne, dermatitis, erythema, pruritus, rash, skin lesions, urticaria.

From the vascular system: deep vein thrombosis, hot flashes, hypertension.

In the course of a long-term uncontrolled study, additional adverse reactions were described that were considered by doctors to be related to the use of Dexilant. These reactions include anaphylaxis, auditory hallucinations, B-cell lymphoma, bursitis, central obesity, acute cholecystitis, dehydration, diabetes mellitus, dysphonia, epistaxis, folliculitis, goiter, herpes zoster, hyperlipidemia, hypothyroidism, decreased neutrophil levels average concentration of hemoglobin in erythrocytes, neutropenia, tenesmus, restless legs syndrome, lethargy, tonsillitis.

Children . The safety of Dexilant was evaluated during controlled and uncontrolled clinical trials in which 166 patients aged 12 to 17 years participated for the treatment of symptomatic non-erosive gastroesophageal reflux disease, erosive esophagitis and for the maintenance treatment of erosive esophagitis and heartburn relief.

The adverse reaction profile was similar to that in adult patients. The most common adverse reactions that occurred in ≥5% of patients were headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain.

Adverse reactions recorded in the post-marketing period (frequency and presence of a causal relationship have not been established)

Blood and lymphatic system disorders: autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura.

On the part of the organ of hearing and balance: deafness.

From the side of the organ of vision: blurred vision.

From the digestive system: oral edema, pancreatitis.

General disorders: edema of the face.

From the liver and biliary tract: hepatitis caused by the administration of the drug.

From the immune system: anaphylactic shock (requires urgent treatment), exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (may be fatal).

Infections and invasions: Clostridium difficile -associated diarrhea.

Metabolic and nutritional disorders: hypomagnesemia, hyponatremia.

From the side of the musculoskeletal system: bone fractures.

From the nervous system: cerebrovascular accident, transient ischemic attack.

From the kidneys and urinary tract: ARF.

From the respiratory system: swelling of the pharynx, sore throat.

Skin and subcutaneous tissue disorders: generalized rash, leukocytoclastic vasculitis.

existing malignant neoplasms of the stomach. In adult patients, a symptomatic response to therapy with Dexilant does not exclude the presence of malignant neoplasms of the stomach. In adult patients with a suboptimal response or early recurrence of symptoms after completion of proton pump inhibitor treatment, additional follow-up and diagnostic investigations should be evaluated. In older patients, endoscopic examination should be considered.

Acute interstitial nephritis .With the use of proton pump inhibitors, including lansoprazole, the development of acute interstitial nephritis was observed. Acute interstitial nephritis can develop at any time with the use of proton pump inhibitors and, in general, can be associated with idiopathic hypersensitivity reactions. If acute interstitial nephritis develops, the use of Dexilant should be discontinued (see CONTRAINDICATIONS).

Cyanocobalamin deficiency (vitamin B 12 ) .Daily intake of any drugs that suppress acid secretion for a long period (for example, more than 3 years) can lead to malabsorption of cyanocobalamin (vitamin B 12 ), hypo- and achlorhydria. There are rare reports of the development of cyanocobalamin deficiency when treated with drugs that suppress gastric acid secretion. This information should be taken into account if clinical symptoms associated with a deficiency of cyanocobalamin are observed in patients using Dexilant.

Clostridium difficile-associated diarrhea . Several observational studies suggest that proton pump inhibitors such as Dexilant may increase the risk of Clostridium difficile -associated diarrhea, especially among hospitalized patients. This diagnosis should be considered for diarrhea that does not improve (see SIDE EFFECTS).

Patients at risk of Clostridium difficile -associated diarrhea should be treated with proton pump inhibitors at the lowest recommended dose and for the shortest time, in accordance with the disease to be treated.

Bone fractures. Several observational studies suggest that proton pump inhibitors may increase the risk of osteoporotic fractures of the femur, wrist, or vertebrae. The risk of fractures increased in patients who took the drugs in high doses, repeatedly during the day, or in the case of long-term treatment (for ≥1 year). Patients at risk of osteoporotic fractures should receive appropriate treatment and use proton pump inhibitors at the lowest recommended dose and for the shortest period.Patients at risk of osteoporotic fractures should be treated according to existing guidelines (see APPLICATION, SIDE EFFECTS).

Cutaneous lupus erythematosus and SLE . In patients treated with proton pump inhibitors, there have been reports of the development or exacerbation of cutaneous lupus erythematosus and SLE. In most cases, cutaneous lupus erythematosus was observed.

The most common form of cutaneous lupus erythematosus reported in patients treated with proton pump inhibitors was subacute cutaneous lupus erythematosus; the disease developed over several weeks to several years with continuous therapy in patients of different ages (from infants to the elderly).As a rule, histological changes were observed without involving the organ in the pathological process.

Patients receiving proton pump inhibitors reported less SLE than cutaneous lupus erythematosus. SLE associated with proton pump inhibitors is generally milder than non-drug-induced SLE. The onset of SLE is usually observed within days to years after starting treatment, mainly in young to old patients.In most patients, the disease is characterized by the appearance of a rash, however, there have also been reports of arthralgia and cytopenia.

Proton pump inhibitors should be avoided for longer than is medically necessary. If signs or symptoms of cutaneous lupus erythematosus or SLE appear in patients receiving Dexilant, the drug should be discontinued and the patient should be referred to an appropriate specialist for examination. In most patients, after discontinuation of proton pump inhibitors, there is an improvement in the condition within 4 to 12 weeks.

Serologic test results (eg, for the presence of antinuclear antibodies) may be positive and the readings may remain elevated for a long period of time compared to the duration of clinical manifestations.

Hypomagnesemia. Rarely, with the use of proton pump inhibitors for at least 3 months, hypomagnesemia (symptomatic and asymptomatic) was observed in patients, more often after 1 year of treatment. Serious adverse reactions include tetany, arrhythmias, and seizures.Most patients receive replacement therapy for the treatment of hypomagnesemia and stop using proton pump inhibitors. In individuals who are likely to take long-term medications or are using proton pump inhibitors with digoxin, or drugs that can lead to hypomagnesemia (such as diuretics), blood magnesium levels should be monitored before and periodically during treatment (see ADVERSE EFFECTS).

Investigation of neuroendocrine tumors .Plasma chromogranin A (CgA) levels increase in the presence of a drug-induced decrease in gastric acidity. An increase in CgA levels can lead to false positive results in the diagnosis of neuroendocrine tumors. The physician should temporarily discontinue dexlansoprazole therapy at least 14 days before the CgA level is assessed. The study should be repeated if the CgA level at initial assessment is high. The same laboratory should be used to perform sequential studies (e.g. monitoring), since the range of test values ​​may differ (see.INTERACTIONS).

Interaction with methotrexate. It has been reported that the simultaneous use of proton pump inhibitors and methotrexate (mainly in high doses) can increase the concentration and lengthen the period of the presence of methotrexate and / or its metabolite in the serum and lead to the development of methotrexate toxicity. When using methotrexate in high doses, some patients are advised to temporarily stop taking proton pump inhibitors (see INTERACTIONS).

Polyps of the fundic glands . The use of proton pump inhibitors is associated with an increased risk of fundic gland polyps, which increases with prolonged use, mainly after a year. Fundic gland polyps are detected by chance during endoscopy, since they have an asymptomatic course. Proton pump inhibitors should be used as soon as possible for the pathology for which treatment is prescribed.

Use during pregnancy and lactation.Pregnancy. No studies have been conducted with dexlansoprazole in pregnant women to investigate the risks associated with taking Dexilant. In animal studies to study the effect on reproductive function, there were no effects on the development of the embryo / fetus with oral administration of dexlansoprazole and lansoprazole. The estimated baseline risk of serious birth defects and termination of pregnancy for this group of patients is unknown.

Breastfeeding .There are no data on the excretion of dexlansoprazole in human breast milk, the effect on a breastfed infant, or the effect on milk excretion. However, lansoprazole and its metabolites are present in the milk of lactating animals. The developmental and health benefits of breastfeeding should be weighed against the mother’s clinical need for Dexilant and any possible side effects on the breastfed baby due to Dexilant or the mother’s current illness.

Children. Dexilant is not recommended for the treatment of gastroesophageal reflux disease symptoms in children 1 month to 1 year of age because lansoprazole (racemic mixture) has not been shown to be effective in a multicenter, double-blind, controlled trial. In a preclinical study, lansoprazole has shown adverse reactions such as thickening of the heart valve and changes in bone tissue.

Due to the lack of data on the safety and efficacy of the drug Dexilant, its use in this age group of patients is not recommended for children under 12 years of age.

The safety and efficacy of Dexilant have been established for patients aged 12 to 17 years in the treatment of all stages of erosive esophagitis, in the case of maintenance treatment of erosive esophagitis and relief of heartburn and treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease. The possibility of using the drug Dexilant in this age group is confirmed by data obtained in the course of appropriate well-controlled studies of the use of the drug Dexilant in adult patients and additional data on safety, efficacy and pharmacokinetics in patients aged 12 to 17 years.

The profile of adverse reactions in patients aged 12 to 17 years is similar to that in adult patients.

The ability to influence the reaction rate when driving or operating other mechanisms. It is necessary to take into account the possible development of adverse reactions (see SIDE EFFECTS).

information below notes clinically significant drug interactions and changes in the results of diagnostic studies when used simultaneously with Dexilant, as well as measures to prevent or eliminate them.

For more information on interactions with proton pump inhibitors, see the instructions for use of the respective medicinal products.

Drugs and diagnostic tests on which Dexilant has a clinically significant effect

Antiretroviral drugs. Clinical Impact. The effect of proton pump inhibitors on antiretroviral drugs is variable. The clinical significance and mechanisms of these interactions are not known in all cases:

  • Reduced exposure to certain antiretroviral drugs (eg rilpivirin, atazanavir, and nelfinavir) when combined with dexlansoprazole can weaken the antiviral effect and lead to the development of drug resistance;
  • Increased exposure to other antiretroviral drugs (eg saquinavir) when combined with dexlansoprazole may increase the toxicity of antiretroviral drugs;
  • There are other antiretrovirals for which interactions with dexlansoprazole are not clinically relevant.

Preparations containing rilpivirine : Combined use with Dexilant is contraindicated (see CONTRAINDICATIONS).

Atazanavir . See the dosage instructions for atazanavir.

Nelfinavir . Simultaneous use with Dexilant should be avoided. See instructions for use of nelfinavir.

Saquinavir . See instructions for use of saquinavir; monitoring of potential toxic effects of saquinavir is indicated.

Other antiretroviral drugs . See instructions for medical use.

Warfarin . Clinical Impact. There is an increase in INR and prothrombin time in patients who are simultaneously receiving proton pump inhibitors and warfarin. An increase in INR and prothrombin time can lead to pathological bleeding and even death.

Events . Monitoring of INR and prothrombin time is required.Adjustment of the warfarin dose may be required to maintain the target INR level. See instructions for use of warfarin.

Methotrexate . Clinical Impact. The simultaneous use of proton pump inhibitors and methotrexate (mainly in high doses) can lead to an increase and lengthening of the retention of the concentrations of methotrexate and / or its metabolite hydroxymethotrexate in serum, which can lead to the toxic effects of methotrexate. Formal studies to study the interaction with the use of high doses of methotrexate and proton pump inhibitors have not been performed (see.SPECIAL INSTRUCTIONS).

Events . In some patients receiving high doses of methotrexate, the possibility of temporarily discontinuing the use of Dexilant should be considered.

Digoxin . Clinical Impact. Exposure to digoxin may be increased.

Events . Monitoring of digoxin concentrations is required. To maintain therapeutic concentrations of digoxin, dose adjustment of the latter may be required. Cm.instructions for the use of digoxin.

Medicines whose absorption depends on the pH in the stomach (eg iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole / itraconazole) . Clinical Impact. Dexlansoprazole can reduce the absorption of other drugs through its effect on reducing stomach acidity.

Events . Mofetila mycophenolate . With the simultaneous use of proton pump inhibitors in healthy individuals and in transplant patients receiving mycophenolate mofetil, there have been reports of a decrease in the exposure of the active metabolite (mycophenolic acid), which may be associated with a decrease in the solubility of mycophenolate mofetil at an elevated gastric pH.The clinical significance of reduced mycophenolic acid exposure for the risk of graft rejection in transplant patients receiving Dexilant and mycophenolate mofetil has not been established. Patients who have undergone transplantation and who receive mycophenolate mycophenolate should take Dexilant with caution.

See instructions for use for other preparations, absorption of which depends on the pH level of the stomach.

Tacrolimus . Clinical impact. Possible increased exposure to tacrolimus, especially in transplant patients with moderate to low CYP2C19 activity.

Events . Monitoring of trough concentrations of tacrolimus in whole blood is necessary. Dose adjustments may be required to maintain therapeutic concentrations of tacrolimus. See instructions for use of tacrolimus.

Influence on the results of studies of markers of neuroendocrine tumors .Clinical Impact.

The decrease in gastric acidity caused by the use of proton pump inhibitors leads to a secondary increase in the level of chromogranin A (CgA). An increase in CgA levels can lead to false positive results in the diagnosis of neuroendocrine tumors (see SPECIAL INSTRUCTIONS).

Events . Temporary cessation of therapy with Dexilant is necessary at least 14 days before the determination of CgA levels and consideration of the possibility of retesting if the level of CgA is high on the first test.The same laboratory should be used to perform sequential studies (eg monitoring), since the reference range of test values ​​may differ between laboratories.

Influence on the results of a stimulation test with secretin . Clinical Impact. The response in the form of gastrin hypersecretion during a stimulation test with secretin can lead to an erroneous diagnosis of gastrinoma.

Events . It is necessary to temporarily discontinue treatment with Dexilant at least 30 days before the test so that gastrin secretion can return to its original level.

False positive urine test result for tetrahydrocannabinol . Clinical Impact. There have been reports that patients taking proton pump inhibitors have received false-positive urine screening tests for the presence of tetrahydrocannabinol.

Events . Alternative confirmatory research methods should be considered to confirm positive results.

Preparations and substances that have a clinically significant effect on Dexilant when combined use

Inductors CYP2C19 or CYP3A4 .Clinical Impact. It is possible to reduce the exposure of dexlansoprazole when used with powerful inducers.

Events. St. John’s wort preparations, rifampin . Combined use with Dexilant should be avoided.

Medicines containing ritonavir . See instructions for medical use.

Inhibitors of CYP2C19 or CYP3A4 . Clinical Impact. When used with powerful inhibitors, an increase in the exposure of dexlansoprazole is provided.

Events. Voriconazole . See instructions for medical use.

serious cases of Dexilant drug overdose were not recorded. Repeated use of Dexilant at a dose of 120 mg and a single dose of 300 mg did not lead to death or the development of other severe adverse reactions. It was reported about the development of serious side effects (AH) and the occurrence of non-serious side effects (hot flashes, contusion, oropharyngeal pain, weight loss) when using Dexilant at a dose of 60 mg 2 times a day.

Dexlansoprazole is not cleared from the bloodstream by hemodialysis. In case of an overdose, symptomatic and supportive therapy is performed.

at a temperature not exceeding 25 ° C, out of the reach of children.

Added date: 06/17/2021

GANATON tablets: 33 reviews from real people. All reviews about the drugs on the site

Ganaton is a drug for the treatment of gastritis and lowering the acidity level, when heartburn suffers, bloating worries, thinness may appear against the background of the disease, and what surprised me when I read the instructions, pills are prescribed even for anorekia.And, of course, to relieve pain.

I bought a pack of 40 tablets, as I thought that I needed almost so much for the prescribed course, there was very little left. All packages have the same dosage of 50 mg. The active basic substance is itoprid hydrochloride.

The packaging is white in color, on the right there is a place that you need to press and a tab appears, which you need to pull to open the packaging, that is, no one opened it before you, which is very pleasing.

Composition, active ingredient and auxiliary substances are on the back of the box.

… read more

Dispensed by prescription, they just didn’t sell it to me.

On the side of the box, the batch number, I checked – matches the number on the blisters themselves. In the center – the date of manufacture and the date until which it is recommended to use – 2019. The shelf life is quite long.

Tablet manufacturer – JAPAN. What makes me happy is that most of the time their drugs work.

The package contains instructions and several lozenges, like 4 pieces, each with 10)
The tablets are small round in shape, with a pattern in the center.I don’t smell the smell, not bitter. They are swallowed without problems due to their tiny size.

Indications for use and contraindications are indicated, by the way, there are NOT SO MANY contraindications. It is forbidden for pregnant and lactating women, children, and with an ulcer in an open form, as the doctor said.

Side effects are also indicated. Breast enlargement, dizziness, rash and itching, diarrhea, or constipation may occur.

I can say I was lucky, I did not have a single side effect, well, I did not take the pills for long, I was prescribed them for 7 days.

Before admission, I suffered from stomach pains, constant rumbling in my stomach, it was like a drum, all the last listed symptoms disappeared right there, from the first days of admission, but my stomach was still aching, especially if it was not possible to eat according to the regimen. In addition, I have intestinal dysbiosis, which aggravates my problem and there have been cracks in the rectum. Therefore, I drank pills at the same time as Acipol, so that there was less stress. And the doctor recommended me to take mukofalk as well. I do not presume to judge the treatment regimen, but I took everything strictly according to the doctor’s prescription.Ganaton drank three times a day BEFORE meals, about half an hour.

One course was not enough for me and after three months I was prescribed again. So I can’t give 5 stars, because there were pills in my practice that helped me faster and more efficiently.