What does dexilant treat

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Almost everyone suffers heartburn from time to time, but if you have frequent heartburn, your doctor may have prescribed Dexilant. Dexilant is marketed as relatively safe – it’s even approved for use by children – but if you take it long term, it can have serious, life-threatening side effects, including chronic and acute kidney failure. If you are suffering kidney problems after taking Dexilant, we’d like to help you.

John Foy and Associates is one of the largest and most well respected medical lawsuit firms in the country. We have been following the research regarding Dexilant’s link to kidney failure, and if you or a loved one has taken Dexilant and then developed kidney failure or kidney disease, we’d like to hear what you have to say. Let us give you a free, no obligation consultation. Call us at 404-400-4000 and get your free consultation today.

Contents

What is Dexilant?

Dexilant belongs to a class of heartburn medications known as proton pump inhibitors, or PPIs. Other common PPIs include Prilosec, Protonix, Prevacid and Nexium. Ordinary over the counter antacids that you might take for occasional heartburn act to neutralize stomach acid. But PPIs have a different effect – they reduce the amount of acid your stomach produces to begin with.

Dexilant is manufactured by Takada Pharmaceutical Company, which introduced the drug in 2009 under the name Kapidex. Because Kapidex was being confused with other, similarly named medications, Takada changed the name to Dexilant in 2010. A generic version, dexlansoprazole, became available in 2017.

What is the proper use of Dexilant?

Dexilant is primarily used to treat chronic heartburn, also known as gastroesophageal reflux disease, gastric reflux, or GERD.

When you eat, your food travels down your esophagus and into your stomach. Between the two, there’s a band of muscle known as the lower esophageal sphincter that opens to let food pass through and then closes to keep that food in the stomach and prevent it from traveling back up into the esophagus. In people who have GERD, the muscle does not function properly, allowing stomach acid and food to return to the esophagus. This causes uncomfortable heartburn symptoms, including a burning pain in the chest or a feeling like food is coming back up into the mouth. GERD is a common disorder, affecting more than 15 million adults.

Ultimately, the best way to treat GERD is to avoid certain foods and make lifestyle changes such as losing weight and giving up smoking. PPIs like Dexilant are designed to provide short-term relief while you work on making these lifestyle changes. But PPIs are often treated as an ultimate solution, and because they are so effective, they are prescribed over and over. It’s not uncommon for a person suffering from GERD to be on PPIs for years, and the true risks have only recently become clear.

What is kidney failure, and how is it related to Dexilant?

Acute kidney failure sounds scary, and it is. If you have acute kidney failure, your kidneys suddenly are no longer able to filter waste out of your blood. This causes waste to accumulate in your bloodstream, upsetting your body’s delicate chemical balance.

Acute kidney failure happens quickly, usually over the course of a few hours or days. It can be fatal if untreated, but if you are otherwise healthy, it can be reversible. A study of Department of Veterans Affairs patients published in 2016 found a link between use of PPIs like Dexilant and development of kidney failure. The study compared 173,321 people who used a PPI with 20,270 patients who used another type of heartburn medication known as an H2 blocker. It found that PPI users may have a 96 percent greater chance of developing kidney failure than people who used H2 blockers. A Canadian study of elderly patients found that PPI use increased the risk of acute kidney injuries by 2.5 to three times.

Acute kidney failure is not the only kidney problem that has been linked to Dexilant. The Veterans Affairs study also found that PPI users were 28 percent more likely to develop chronic kidney disease, also sometimes called chronic kidney failure. Chronic kidney disease diminishes the kidneys’ ability to function, but it may show few signs or symptoms at first. Chronic kidney disease can be managed, but not reversed, and it can lead to end stage kidney failure, also known as end stage renal failure. End stage kidney failure is fatal without dialysis or a kidney transplant.

I take Dexilant. How do I know if I have kidney disease or kidney failure?

Kidney disease can show few symptoms at first, or it can show a wide range of symptoms that could easily be related to something else. The best way to know is to see a doctor who specializes in kidney ailments. However, if you have the following symptoms of acute kidney failure, you should seek medical attention quickly, because acute kidney failure can be fatal if left untreated:

  • Swelling of your hands, feet and face
  • Unusually high blood pressure
  • Confusion
  • Seizures
  • Sudden decrease in the amount of urine

Does the manufacturer know and warn about these side effects?

The research is becoming clearer all the time that Dexilant and other PPIs cause kidney failure, and lawsuits have been filed. Dexilant’s list of side effects includes “a type of kidney problem called acute interstitial nephritis.” This a kidney inflammation that can lead to chronic kidney disease or acute kidney failure. But Dexilant’s manufacturer doesn’t tell you this, doesn’t warn of a risk of kidney failure, and in fact its website specifically markets this dangerous medication for use in children.

Talk to a Dexilant Kidney Failure Lawsuit Lawyer

At John Foy & Associates, we don’t think you should have to pay for the consequences of a drug company’s irresponsible failure to make a safe drug or warn the public of the potential consequences. We want to get you money to pay for treatment and get things back on track. If you or a loved one has suffered kidney failure after taking Dexilant, let us give you a free consultation. We won’t charge you anything unless we get money for you. Call us at 404-400-4000 or fill out the form to your right and get your FREE consultation today.

Dexilant

Generic Name: dexlansoprazole (DEX lan SOE pra zol)
Brand Name: Dexilant

Medically reviewed by Drugs.com on Jun 25, 2018 – Written by Cerner Multum

  • Overview
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Dexilant is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Dexilant is used to treat heartburn caused by gastroesophageal reflux disease (GERD), and to heal erosive esophagitis (damage to the esophagus from stomach acid).

Dexilant may also be used for purposes not listed in this medication guide.

Important Information

Dexilant can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Dexilant may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking Dexilant long term or more than once per day.

Before taking this medicine

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.

You should not take Dexilant if you are allergic to it, or if you also take a medicine that contains rilpivirine (Complera, Edurant, Odefsey).

Tell your doctor if you have ever had:

  • severe liver disease;

  • osteoporosis;

  • low bone mineral density (osteopenia); or

  • low levels of magnesium in your blood.

You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Dexilant is not approved for use by anyone younger than 12 years old.

How should I take Dexilant?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Dexilant with a full glass of water.

Dexilant may be taken with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

To heal erosive esophagitis and relieve heartburn, Dexilant is usually given for up to 6 months in adults, and for 4 to 16 weeks in children ages 12 through 17. Follow your doctor’s dosing instructions very carefully.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Call your doctor if your symptoms do not improve, or if they get worse while using Dexilant.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Dexilant.

Dexilant may also affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use this medicine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Dexilant?

Dexilant can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Dexilant side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;

  • a seizure (convulsions);

  • sudden pain or trouble moving your hip, wrist, or back;

  • kidney problems–urinating more or less than usual, blood in your urine, swelling, rapid weight gain;

  • low magnesium–dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or

  • new or worsening symptoms of lupus–joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking Dexilant long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use Dexilant for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Dexilant?

Tell your doctor about all your current medicines. Many drugs can affect Dexilant, especially:

  • methotrexate;

  • rifampin;

  • St. John’s wort; or

  • warfarin (Coumadin, Jantoven).

This list is not complete and many other drugs may affect Dexilant. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 14.01.

Medical Disclaimer

More about Dexilant (dexlansoprazole)

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Other brands: Dexilant SoluTab, Kapidex

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Related treatment guides

  • Barrett’s Esophagus
  • Erosive Esophagitis
  • GERD

A drug commonly used to treat acid reflux is linked to a more than doubled risk of developing stomach cancer, researchers have claimed.

Proton pump inhibitors (PPIs) reduce the amount of acid made by the stomach and are used to treat acid reflux and stomach ulcers.

A study published in the journal Gut identified an association between long-term use of the drug and a 2.4 times higher risk of developing stomach cancer. In the UK, there are more than 50m prescriptions for PPIs every year but they have been linked to side-effects and an increased risk of death.

A link between PPIs and a higher stomach cancer risk has previously been identified by academics – but never in a study that first eliminates a type of bacteria suspected of fuelling the illness’s development.

Research by the University of Hong Kong and University College London found that after the Helicobacter pylori was removed, the risk of developing the disease still rose in line with the dose and duration of PPI treatment.

They compared the use of PPI against another drug which limits acid production known as H2 blockers in 63,397 adults. The participants selected had been treated with triple therapy, which combines PPI and antibiotics to kill off the H pylori bacteria over a week, between 2003 and 2012.

Scientists then monitored them until they either developed stomach cancer, died or reached the end of the study at the end of 2015.

During this period, 3,271 people took PPIs for an average of almost three years, while 21,729 participants took H2 blockers. A total of 153 people developed stomach cancer, none of whom tested positive for H plyori but all had long-standing problems with stomach inflammation, the study found.

While H2 blockers were found to have no link to a higher risk of stomach cancer, PPIs was found connected to an increased risk of more than double.

Daily use of PPIs was associated with a risk of developing the illness that was more than four times higher (4.55) than those who used it weekly. Similarly, when the drug was used for more than a year, the risk of developing stomach cancer rose five-fold, and as high as eight-fold after three or more years, the findings showed.

The study concluded no firm cause and effect could be drawn, but doctors should “exercise caution when prescribing long-term PPIs … even after successful eradication of H plyori”.

Responding to the study, Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said: “Many observational studies have found adverse effects associated with PPIs.

“The most plausible explanation for the totality of evidence on this is that those who are given PPIs, and especially those who continue on them long-term, tend to be sicker in a variety of ways than those for whom they are not prescribed.”

Kapidex

The safety of KAPIDEX (dexlansoprazole delayed release capsules) was evaluated in 4548 patients in controlled and uncontrolled clinical studies, including 863 patients treated for at least 6 months and 203 patients treated for one year. Patients ranged in age from 18 to 90 years (median age 48 years), with 54% female, 85% Caucasian, 8% Black, 4% Asian, and 3% other races. Six randomized controlled clinical trials were conducted for the treatment of EE, maintenance of healed EE, and symptomatic GERD, which included 896 patients on placebo, 455 patients on KAPIDEX (dexlansoprazole delayed release capsules) 30 mg, 2218 patients on KAPIDEX (dexlansoprazole delayed release capsules) 60 mg, and 1363 patients on lansoprazole 30 mg once daily.

As clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Most Commonly Reported Adverse Reactions

The most common adverse reactions ( ≥ 2%) that occurred at a higher incidence for KAPIDEX (dexlansoprazole delayed release capsules) than placebo in the controlled studies are presented in Table 2.

Table 2: Incidence of Treatment-Emergent Adverse Reactions in Controlled Studies

Adverse Reactions Resulting in Discontinuation

In controlled clinical studies, the most common adverse reaction leading to discontinuation from KAPIDEX (dexlansoprazole delayed release capsules) therapy was diarrhea (0.7%).

Other Adverse Reactions

Other adverse reactions that were reported in controlled studies at an incidence of less than 2% are listed below by body system:

Blood and Lymphatic System Disorders: anemia, lymphadenopathy

Cardiac Disorders: angina, arrhythmia, bradycardia, chest pain, edema, myocardial infarction, palpitation, tachycardia

Ear and Labyrinth Disorders: ear pain, tinnitus, vertigo

Endocrine Disorders: goiter

Eye Disorders: eye irritation, eye swelling

Gastrointestinal Disorders: abdominal discomfort, abdominal tenderness, abnormal feces, anal discomfort, Barrett’s esophagus, bezoar, bowel sounds abnormal, breath odor, colitis microscopic, colonic polyp, constipation, dry mouth, duodenitis, dyspepsia, dysphagia, enteritis, eructation, esophagitis, gastric polyp, gastritis, gastroenteritis, gastrointestinal disorders, gastrointestinal hypermotility disorders, GERD, GI ulcers and perforation, hematemesis, hematochezia, hemorrhoids, impaired gastric emptying, irritable bowel syndrome, mucus stools, nausea and vomiting, oral mucosal blistering, painful defecation, proctitis, paresthesia oral, rectal hemorrhage

General Disorders and Administration Site Conditions: adverse drug reaction, asthenia, chest pain, chills, feeling abnormal, inflammation, mucosal inflammation, nodule, pain, pyrexia

Hepatobiliary Disorders: biliary colic, cholelithiasis, hepatomegaly

Immune System Disorders: hypersensitivity

Infections and Infestations: candida infections, influenza, nasopharyngitis, oral herpes, pharyngitis, sinusitis, viral infection, vulvo-vaginal infection

Injury, Poisoning and Procedural Complications: falls, fractures, joint sprains, overdose, procedural pain, sunburn

Laboratory Investigations: ALP increased, ALT increased, AST increased, bilirubin decreased/increased, blood creatinine increased, blood gastrin increased, blood glucose increased, blood potassium increased, liver function test abnormal, platelet count decreased, total protein increased, weight increase

Metabolism and Nutrition Disorders: appetite changes, hypercalcemia, hypokalemia

Musculoskeletal and Connective Tissue Disorders: arthralgia, arthritis, muscle cramps, musculoskeletal pain, myalgia

Nervous System Disorders: altered taste, convulsion, dizziness, headaches, migraine, memory impairment, paresthesia, psychomotor hyperactivity, tremor, trigeminal neuralgia

Psychiatric Disorders: abnormal dreams, anxiety, depression, insomnia, libido changes

Renal and Urinary Disorders: dysuria, micturition urgency

Reproductive System and Breast Disorders: dysmenorrhea, dyspareunia, menorrhagia, menstrual disorder

Respiratory, Thoracic and Mediastinal Disorders: aspiration, asthma, bronchitis, cough, dyspnoea, hiccups, hyperventilation, respiratory tract congestion, sore throat

Skin and Subcutaneous Tissue Disorders: acne, dermatitis, erythema, pruritis, rash, skin lesion, urticaria

Vascular Disorders: deep vein thrombosis, hot flush, hypertension

Additional adverse reactions that were reported in a long-term uncontrolled study and were considered related to KAPIDEX (dexlansoprazole delayed release capsules) by the treating physician included: anaphylaxis, auditory hallucination, B-cell lymphoma, central obesity, cholecystitis acute, decreased hemoglobin, dehydration, diabetes mellitus, dysphonia, epistaxis, folliculitis, gastrointestinal pain, gout, herpes zoster, hyperglycemia, hyperlipidemia, hypothyroidism, increased neutrophils, MCHC decrease, neutropenia, oral soft tissue disorder, rectal tenesmus, restless legs syndrome, somnolence, thrombocythemia, tonsillitis.

Other adverse reactions not observed with KAPIDEX (dexlansoprazole delayed release capsules) , but occurring with the racemate lansoprazole can be found in the lansoprazole package insert, ADVERSE REACTIONS section.

Adverse reactions have been identified during post-approval of KAPIDEX (dexlansoprazole delayed release capsules) . As these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Eye Disorders: blurred vision

Gastrointestinal Disorders: oral edema

General Disorders and Administration Site Conditions: facial edema

Immune System Disorders: anaphylactic shock (requiring emergency intervention),

Stevens-Johnsons syndrome, toxic epidermal necrolysis (some fatal)

Respiratory, Thoracic and Mediastinal Disorders: pharyngeal edema, throat tightness

Skin and Subcutaneous Tissue Disorders: generalized rash, leucocytoclastic vasculitis

Read the entire FDA prescribing information for Kapidex (Dexlansoprazole Delayed Release Capsules)

DEXILANT has a second release of GERD medicine that arrives later in the day

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 interstitial 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. 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. 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 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 gastroesophageal reflux disease (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 4–8 weeks. Individual results may vary. Talk to your doctor or healthcare professional. Please see full Prescribing Information, including Medication Guide for DEXILANT.

DEXILANT is available in 60 mg and 30 mg delayed-release capsules

  • Daily treatment with any acid-suppressing medications over a long period of time (e.g., > 3 years) may lead to malabsorption or a deficiency of cyanocobalamin (Vitamin B-12).
  • Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.
  • Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity which may cause false positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop DEXILANT treatment ≥ 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high.
  • Concomitant use of PPIs with methotrexate may elevate and prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of DEXILANT.
  • PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially > 1 year. Use the shortest duration of PPI therapy appropriate to the condition being treated.
  • Most commonly reported adverse reactions in adults were diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%).
  • The adverse reaction profile in patients age 12 to 17 years was similar to adults. The most commonly reported adverse reactions in patients age 12 to 17 years (≥ 5%) were headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain.
  • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with DEXILANT may reduce antiviral effect. Avoid concomitant use of nelfinavir with DEXILANT. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with DEXILANT may increase toxicity of the antiretroviral drugs.
  • Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time (PT). Increases in INR and PT may lead to abnormal bleeding and even death.
  • DEXILANT may interfere with absorption of drugs for which gastric pH is important for bioavailability (e.g., digoxin, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil , ketoconazole/itraconazole). Use DEXILANT with caution in transplant patients receiving MMF.
  • Concomitant tacrolimus use may increase tacrolimus whole blood concentrations.
  • A hyper-response in gastrin secretion in response to the secretin stimulation test may falsely suggest gastrinoma. Temporarily stop DEXILANT treatment ≥ 30 days before assessing to allow gastrin levels to return to baseline.
  • Avoid concomitant use of DEXILANT with St. John’s Wort or rifampin due to decreased exposure of DEXILANT.
  • No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C). The use of DEXILANT is not recommended for these patients.

Indications

DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed-release capsules are indicated in patients ≥ age 12 years for:

  • Healing all grades of erosive esophagitis (EE) for up to 8 weeks
  • Maintaining healing of EE and relief of heartburn for up to 6 months in adults and up to 16 weeks in patients age 12 to 17 years
  • Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks

Use of DEXILANT in patients age 12 to 17 years is supported by evidence from adequate and well-controlled studies of DEXILANT capsules in adults with additional safety, efficacy and pharmacokinetic data in patients age 12 to 17 years.

The safety and effectiveness of DEXILANT have not been established in patients < 12 years of age.

Please see full Prescribing Information, including Medication Guide for DEXILANT.

Dexilant – Dosage

dexlansoprazole capsule, delayed release

Dosage & Administration

  • Recommended dosage in patients 12 years of age and older:
  • See full prescribing information for complete dosing information for DEXILANT by indication and age group and dosage adjustment in patients with hepatic impairment. (2.1, 2.2)

Administration Instructions ( 2.3 ):

  • Take without regard to food.
  • Swallow whole; do not chew.
  • See full prescribing information for alternative administration options.

recommended dosage in patients 12 years of age & older

Table 1. Recommended DEXILANT Capsules Dosage Regimen by Indication in Patients 12 Years of Age and Older

Indication Dosage of DEXILANT Capsules Duration

Healing of EE

One 60 mg capsule once daily.

Up to 8 weeks.

Maintenance of Healed EE and Relief of Heartburn

One 30 mg capsule once daily.

Controlled studies did not extend beyond 6 months in adults and 16 weeks in patients 12 to 17 years of age.

Symptomatic Non-Erosive GERD

One 30 mg capsule once daily.

4 weeks.

dosage adjustment in patients with hepatic impairment for the healing of erosive esophagitis

For patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dosage is 30 mg DEXILANT once daily for up to eight weeks. DEXILANT is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) .

important administration information

  • Take without regard to food.
  • Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.
  • Swallow whole; do not chew.
  • For patients who have trouble swallowing capsules, DEXILANT capsules can be opened and administered with applesauce as follows:
    • 1.Place one tablespoonful of applesauce into a clean container.
    • 2.Open capsule.
    • 3.Sprinkle intact granules on applesauce.
    • 4.Swallow applesauce and granules immediately. Do not chew granules. Do not save the applesauce and granules for later use.
  • Alternatively, the capsule can be administered with water via oral syringe or nasogastric (NG) tube.
  • Administration with Water in an Oral Syringe
    • 5.Open the capsule and empty the granules into a clean container with 20 mL of water.
    • 6.Withdraw the entire mixture into a syringe.
    • 7.Gently swirl the syringe in order to keep granules from settling.
    • 8.Administer the mixture immediately into the mouth. Do not save the water and granule mixture for later use.
    • 9.Refill the syringe with 10 mL of water, swirl gently, and administer.
    • 10.Refill the syringe again with 10 mL of water, swirl gently, and administer.
  • Administration with Water via a NG Tube (≥16 French)
    • 11.Open the capsule and empty the granules into a clean container with 20 mL of water.
    • 12.Withdraw the entire mixture into a catheter-tip syringe.
    • 13.Swirl the catheter-tip syringe gently in order to keep the granules from settling, and immediately inject the mixture through the NG tube into the stomach. Do not save the water and granule mixture for later use.
    • 14.Refill the catheter-tip syringe with 10 mL of water, swirl gently, and flush the tube.
    • 15.Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer.

dexlansoprazole (Dexilant, Kapidex)

Brand Names: Dexilant, Kapidex

Generic Name: dexlansoprazole

  • What is dexlansoprazole (Dexilant, Kapidex)?
  • What are the possible side effects of dexlansoprazole (Dexilant, Kapidex)?
  • What is the most important information I should know about dexlansoprazole (Dexilant, Kapidex)?
  • What should I discuss with my healthcare provider before taking dexlansoprazole (Dexilant, Kapidex)?
  • How should I take dexlansoprazole (Dexilant, Kapidex)?
  • What happens if I miss a dose (Dexilant, Kapidex)?
  • What happens if I overdose (Dexilant, Kapidex)?
  • What should I avoid while taking dexlansoprazole (Dexilant, Kapidex)?
  • What other drugs will affect dexlansoprazole (Dexilant, Kapidex)?
  • Where can I get more information (Dexilant, Kapidex)?

What is dexlansoprazole (Dexilant, Kapidex)?

Dexlansoprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Dexlansoprazole is used to treat heartburn caused by gastroesophageal reflux disease (GERD), and to heal erosive esophagitis (damage to the esophagus from stomach acid).

Dexlansoprazole may also be used for purposes not listed in this medication guide.

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capsule, blue/gray, imprinted with TAP, 30

647640175_PB

capsule, blue, imprinted with TAP, 60

What are the possible side effects of dexlansoprazole (Dexilant, Kapidex)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • a seizure (convulsions);
  • sudden pain or trouble moving your hip, wrist, or back;
  • kidney problems–urinating more or less than usual, blood in your urine, swelling, rapid weight gain;
  • low magnesium–dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
  • new or worsening symptoms of lupus–joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking dexlansoprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use dexlansoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dexlansoprazole (Dexilant, Kapidex)?

Dexlansoprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Dexlansoprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking this medicine long term or more than once per day.

PMC

Dexlansoprazole in the treatment of gastroesophageal reflux disease

At present, the basic indication for using dexlansoprazole is gastroesophageal reflux disease in all its forms, i.e. non-erosive reflux disease (NERD) with symptoms present during the day or at night causing sleep disorders, and erosive oesophagitis of all severity grades. A particularly intensive treatment suppressing the secretion of gastric acid is necessary in patients with severe erosive oesophagitis (grades C and D according to the Los Angeles classification, in which coalescing epithelial erosions involve a considerable part or the entire oesophageal circumference). Healing such severe lesions requires a powerful suppressive effect on the secretion of acidic gastric juice using fixed therapeutic doses in maintenance treatment, because the incidence of recurrence of erosive oesophagitis in this form of GERD exceeds 90% during 6 months .

It is known that some GERD patients (17–35%) treated with omeprazole or other proton pump inhibitors continue experiencing symptoms of the disease . Studies show that up to 35.4% of patients and 34.8% of physicians are not fully satisfied with the outcome of treatment based on traditional PPIs . The resistance to hyposecretory treatment can arise from a variety of factors. Some of them are physician-related (incorrect diagnosis, inappropriate drug dose, insufficiently long treatment), others – patient-related (lack of compliance, genotypic differences determining drug metabolism), and yet others – drug-related (duration of maintaining gastric pH above 4). One of the causes underlying the inefficacy of PPIs in the treatment of GERD can also be non-acidic reflux or nocturnal acid breakthrough in the stomach accompanied by sleep disorders . Another problem relates to inappropriate diagnosis, with GERD diagnosed instead of functional heartburn, eosinophilic oesophagitis, early achalasia of the cardia, autoimmune diseases or coexisting mental disorders . Therefore, aside from the verification of diagnosis, other options should also be considered in an attempt to improve therapeutic outcomes, such as prolongation of therapy, dose increase or substitution of the inhibitor for another. The newest of them is dexlansoprazole. A comparative study performed in healthy volunteers to determine the effect of a single dose of dexlansoprazole 60 mg and esomeprazole 40 mg on the mean gastric pH value over 24 h and the percentage of time with pH > 4 has revealed the following statistically significant differences: 4.3 vs. 3.7 (p = 0.003) and 58% vs. 48% (p < 0.001), respectively .

As opposed to studies comparing the effect of different PPIs used to date on the production of hydrochloric acid in the stomach in physiological conditions in healthy volunteers, there have been no significant differences in terms of their clinical efficacy in the treatment of GERD patients, however very favourable results for dexlansoprazole, obtained in well-designed clinical trials, have been published in recent years.

Clinical trials have assessed the efficacy of dexlansoprazole in GERD in aspects related to the subsidence of daytime and nocturnal symptoms including sleep disorders, healing of mucosal injury in erosive oesophagitis and maintenance of the healing effect on erosive lesions. In one of the trials, involving patients with the non-erosive form of the disease, heartburn was eliminated within 4 weeks in 50% of the patients receiving dexlansoprazole MR at a dose of 60 mg, in 55% of the patients treated with the 30 mg dose, and in 19% of the placebo patients . An indirect comparison of randomized studies assessing the activity of two proton pump inhibitors in the isomeric form – dexlansoprazole 60 and esomeprazole 40 – in the elimination of symptoms and healing of erosions in GERD patients has shown the two PPIs to have a similar efficacy in healing, and dexlansoprazole to be much more effective in alleviating symptoms in NERD patients . As expected, due to its unique pharmacodynamic properties, dexlansoprazole brings a considerable relief to patients suffering from night-time heartburn and sleep disorders caused by GERD. In a 4-week study of 947 patients diagnosed with the non-erosive form of GERD divided into groups receiving the study drug at doses of 30 or 60 mg or placebo, based on patients’ assessment dexlansoprazole 30 mg has provided a statistically significant higher percentage of days without heartburn for 24 h and heartburn-free nights (54.9% and 80.8%, respectively) than the placebo (18.5% and 51.7%, respectively). Importantly, the other study dose (60 mg) failed to provide any additional benefit over the 30 mg dose . Another randomized multicentre trial has involved 305 patients with night-time heartburn and GERD-related sleep disorders. The patients took 30 mg of dexlansoprazole or placebo once daily for a total of 4 weeks. The study drug ensured a statistically significant higher percentage of heartburn-free nights (73.1%) than placebo (35.7%), and the proportions of patients without sleep disorders after the therapy were, respectively, 69.7% vs. 47.9% (p < 0.001) .

The healing of reflux erosive oesophagitis has been investigated in two randomized active controlled studies spanning 8 weeks, conducted in a total of 4,092 patients with endoscopically confirmed erosive oesophagitis based on the Los Angeles classification. The analysis showed that after 8 weeks of treatment with dexlansoprazole 60 mg the lesions had been healed in 92.3–93.1% of the patients compared to 86.1–91.5% of the patients receiving 30 mg of lansoprazole across the entire treated group. In the subgroup of subjects with moderate or severe erosive oesophagitis (grades C and D), the percentages were: 88.9% of the patients cured with the study drug and 74.5% cured with lansoprazole. It must be stressed that the same clinical sample was also used for studying dexlansoprazole at a dose of 90 mg, however without confirming any additional benefits .

Reflux erosive oesophagitis is characterized by a high propensity for recurrence. The disease recurs in 89–90% of cases during 6–12 months. In patients with grades C and D reducing the dose of a proton pump inhibitor is sufficient for causing a recurrence in up to 41% of cases over a 6-month period . Consequently, a multi-centre randomized placebo-controlled clinical trial was conducted in a group of 445 patients who successfully completed a therapy of erosive oesophagitis, as verified by endoscopic evidence. The maintenance of the therapeutic effect and the alleviation of symptoms were assessed for dexlansoprazole at doses of 30 and 60 mg, compared to placebo, for a period of 6 months. The maintenance of healing rates in reflux oesophagitis achieved for the medicinal product at both doses were 74.9% and 82.5% respectively, and were thus significantly higher than for placebo (27.2%) both in the whole study group and in the subgroup of patients with more severe oesophagitis (grades C and D). The percentage for the maintenance of heartburn relief during the study was also higher in a statistically significant manner. The median of the percentage of heartburn-free days over 24 h was 96.1%, 90.9% and 28.6% for the 30 and 60 mg doses of the drug and the placebo, respectively, and the median of the percentage of heartburn-free nights was 98.9%, 96.2% and 71.7% . In maintenance treatment, during six months of study, there was no statistically significant difference in activity between the 30 and 60 mg doses. The results show that dexlansoprazole 60 mg provides high (92%) healing rates of erosive oesophagitis over a period of 8 weeks, and dexlansoprazole 30 mg effectively maintains the healing of lesions associated with reflux erosive oesophagitis .

An interesting multi-centre single-blind study has been conducted in a group of 178 patients with symptomatic GERD, who were previously successfully treated with a proton pump inhibitor taken twice a day. The study patients received dexlansoprazole 30 mg in the morning and placebo in the evening for 6 weeks in blind sample conditions. A good control of symptoms was defined as a mean weekly number of heartburn episodes smaller than or equal to 1. Following the change of treatment from a PPI taken twice a day to dexlansoprazole 30 mg once daily, heartburn continued to be well-controlled in 88% of the patients .

Acid reflux drugs linked to increased stomach cancer risk

“A drug commonly used to treat acid reflux is linked to a more than doubled risk of developing stomach cancer,” reports The Guardian.

Researchers wanted to investigate whether there’s a link between medicines known as proton pump inhibitors (PPIs) and stomach cancer. Widely used PPIs include esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole.

PPIs are used to treat acid reflux and protect the stomach lining, have been linked to stomach cancer before.

But they’re also used to treat H. pylori, a bacterial infection that can also cause reflux-like symptoms and is known to raise the risk of stomach cancer. This somewhat complicates the picture.

Researchers from Hong Kong studied 63,397 people who’d been treated for stomach infection with H. pylori bacteria.

Even after the bacteria had been killed, those who took PPIs on a long-term basis were more likely to be diagnosed with stomach cancer in the following 7 to 8 years of follow-up.

Because of the study design, we can’t tell if PPIs were the cause of the increased stomach cancer risk. It could also have been down to other factors.

It’s important to keep the results in proportion. Long-term use of PPIs was linked to around 4 additional stomach cancers cases per 10,000 people per year.

PPIs are one of the most widely prescribed types of drug. But people who use them shouldn’t be particularly concerned by this study: an increase in a very small risk is still a very small risk.

Where did the story come from?

The study, published in the peer-reviewed journal Gut, was done by researchers from the University of Hong Kong and University College London. No information about funding was included.

Most of the UK media reports seized on the higher risk figures reported in the study, which applied only to people taking PPIs daily for at least 3 years.

The headlines should have made it clear that while the results suggested a statistically significant increase in risk, this doesn’t always translate into a clinically significant increase.

But most articles also included expert comments stating that the absolute risk of cancer was low and the study doesn’t prove PPIs are the cause of the risk.

What kind of research was this?

This population-based cohort study is a good type of study for looking for links between factors (such as PPIs and stomach cancer), but can’t prove that one factor causes the other.

What did the research involve?

Researchers identified everyone who’d had successful treatment for H. pylori infection in a Hong Kong database, and followed them for an average of 7 years.

Successful treatment (eradication) is often known as triple therapy, as it involves taking 3 different antibiotics in combination.

The researchers looked at who used PPIs after H. pylori treatment, and who got stomach cancer.

After adjusting their figures to take account of possible confounding factors, they looked at whether people taking PPIs were more likely to get stomach cancer.

The researchers also identified a cohort of 142,460 people taking PPIs who didn’t receive triple therapy treatment for H. pylori.

PPIs are used to treat stomach discomfort caused by acid reflux, which could mean that people start taking them because they already have symptoms of stomach cancer.

To avoid overestimating the effect of PPIs, researchers excluded people who’d been prescribed PPIs in the 6 months before a diagnosis of stomach cancer.

Researchers adjusted for age, sex and other illnesses, but were unable to adjust for diet, family history of cancer, and socio-economic status – or adjust properly for alcohol or tobacco use and obesity – because these factors weren’t routinely recorded in the database.

What were the basic results?

In total, 153 of the 63,397 people in the study got stomach cancer (0.24% of the total):

  • Those who had a history of successful treatment for H. pylori and used PPIs at least weekly were more likely to be diagnosed with stomach cancer. This group of people had a more than twofold, or 244%, increase in chances of stomach cancer (adjusted hazard ratio 2.44, 95% confidence interval 1.42 to 4.20).
  • There was no increase in risk for those taking H2RAs (a different type of reflux medication).
  • The increased risk with PPIs amounted to 4.29 additional cancers per 10,000 people per year (95% CI 1.25 to 9.54).
  • The risk was higher for people taking them long term and daily – an eightfold, or 834%, increase in risk (HR 8.34, 95% CI 2.02 to 34.1).

When comparing rates of stomach cancer between people using PPIs who did and didn’t have a history of H. pylori treatment:

  • The incidence of stomach cancer was 1.0 per 10,000 in people without previous treatment, compared with 8.1 per 10,000 in people who had been treated.

How did the researchers interpret the results?

The researchers said: “To our knowledge this is the first study to demonstrate that long-term PPI use, even after H. pylori eradication therapy, is still associated with an increased risk of gastric cancer.”

They added: “Physicians should therefore exercise caution when prescribing long-term PPIs to these patients.”

Conclusion

PPIs are commonly used medicines for acid reflux. This may seem like alarming news for the many people in the UK who take them, but it’s important to remember that the overall risk of stomach cancer is still very low.

This study has several limitations that mean we should be cautious about the results:

  • This type of study can’t prove PPIs caused the increased risk of cancer. The increased risk could be down to other factors.
  • Researchers were unable to adjust their figures to take account of some relevant confounding factors, such as alcohol and tobacco use, as these weren’t routinely recorded.
  • Almost all the patients in the study were Chinese. Asians are known to have a higher risk of developing stomach cancer than other populations, so the results may not be applicable to the general UK population.

But PPIs, like most drugs, do have side effects. They’re not usually intended to be taken long term.

If you’re taking them regularly, it may be worth discussing with your doctor whether you still need to. There could be alternative treatments that would be of more benefit.

Analysis by Bazian
Edited by NHS Website

Links to the headlines

Acid reflux drug linked to more than doubled risk of stomach cancer – study

The Guardian, 31 October 2017

Heartburn pills raise chance of developing stomach cancer by eight times

The Sun, 1 November 2017

Over-the-counter and prescription acid reflux pills taken by millions ‘raise the risk of stomach cancer by up to eight-fold’ if they are used regularly

Mail Online, 31 October 2017

Links to the science

Cheung KS. Chan EW, Wong AYS, et al.

Long-term proton pump inhibitors and risk of gastric cancer development after treatment for Helicobacter pylori: a population-based study

Gut. Published online October 31 2017

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