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Another name for dexilant: KAPIDEX™ (dexlansoprazole) Renamed DEXILANT™ in U.S. to Avoid Name Confusion

KAPIDEX™ (dexlansoprazole) Renamed DEXILANT™ in U.S. to Avoid Name Confusion

Deerfield, Ill., (March 4, 2010) –Takeda Pharmaceuticals North America, Inc. announced today that KAPIDEX™ (dexlansoprazole) will be marketed in the United States under the new product trade name DEXILANT™ (dexlansoprazole). The product is indicated for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE.

After receiving reports of dispensing errors between KAPIDEX and the products Casodex® (bicalutamide) and Kadian® (morphine sulfate extended-release), Takeda, in coordination with the U.S. Food and Drug Administration (FDA), determined that, in the interest of patient safety, a name change would be the best way to minimize future medication errors with KAPIDEX.

It is important to stress that the formulation, indication and approved dosages of DEXILANT will remain the same as KAPIDEX. Markings on the capsules will not change and their appearance will be identical to those marked under the KAPIDEX trade name. DEXILANT will have a new National Drug Code (NDC) number associated with the product. Takeda anticipates that the newly named product DEXILANT will be available toward the end of April 2010.

“Takeda’s first priority is patient safety, which is why we initiated a widespread communications campaign to inform healthcare professionals and pharmacists as soon as we learned about the potential for confusion,” said Robert Spanheimer, M.D., vice president of medical and scientific affairs at Takeda. “Recently, through discussions with the FDA, we agreed that the best way to minimize these dispensing errors was to change the trade name of dexlansoprazole to DEXILANT.”

Takeda is currently working with the FDA to make this change and will conduct an extensive communications campaign to alert both patients and healthcare professionals of DEXILANT. Individuals and healthcare professionals who have questions about this name change should contact Takeda at 1-877- TAKEDA-7.

“New medication names are extensively screened by Takeda prior to adoption to minimize the possibility of confusion once a drug is on the market. The FDA also conducts independent research to further minimize the risk of name confusion prior to acceptance and approval of a product brand name,” said Dean Sundberg, senior vice president of regulatory affairs at Takeda. “Once marketed, however, instances of name confusion occasionally emerge.”

Errors involving DEXILANT or any other products should be reported to the FDA MedWatch program online at www.fda.gov/medwatch.

About KAPIDEX™ (dexlansoprazole) 30 mg and 60 mg delayed release capsules

KAPIDEX is a proton pump inhibitor (PPI), which decreases acid production by turning off many of the acid pumps in the stomach, thus helping to protect the esophagus from acidic reflux so that esophageal inflammation can heal. KAPIDEX combines an enantiomer of lansoprazole with a Dual Delayed Release™ (DDR) formulation designed to provide two separate releases of medication. KAPIDEX, taken once daily, is approved for the healing of all grades of erosive esophagitis (EE) for up to eight weeks, maintaining healing of EE for up to six months, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

Important Safety Information

KAPIDEX is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity and anaphylaxis have been reported with KAPIDEX use. Symptomatic response with KAPIDEX does not preclude the presence of gastric malignancy.

The most commonly reported treatment-emergent adverse reactions (≥2%) include diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%). KAPIDEX must not be co-administered with atazanavir because atazanavir systemic concentrations may be substantially decreased.

KAPIDEX may interfere with the absorption of drugs for which gastric pH is important for bioavailability (e. g., ampicillin esters, digoxin, iron salts, ketoconazole). Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Concomitant tacrolimus use may increase tacrolimus whole blood concentrations.

Please visit the KAPIDEX Web site at www.KAPIDEX.com, and click here for full prescribing information.

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

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Contacts:

Elissa J. Johnsen
Takeda Pharmaceuticals North America
224-554-3185
[email protected]

Amy Losak
Ketchum
646-935-3917
[email protected]

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 this medication has been prescribed because your doctor 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.

What Is Dexilant and What Is It Used For?

Dexilant is a modified version of Prevacid (lansoprazole). It releases medication in two stages. The first is released within an hour of taking the drug. The second release happens about four to five hours later.

Dexilant is available by prescription only, and is usually taken as one 30 mg capsule or one 60 mg capsule once daily, depending on the condition treated. There is no generic version or over-the-counter version of the drug.

Dexilant is broken down by the liver. Therefore, people with liver disease should not take more than 30 mg of Dexilant in a day.

Takeda Pharmaceuticals manufactures Dexilant. The U.S. Food and Drug Administration approved Dexilant for use in adults in January 2009. In 2016, the FDA approved Dexilant to treat certain patients from 12 through 17 years old.

What Is Dexilant Used to Treat?

Dexilant is a heartburn medication approved to treat certain conditions caused by excessive stomach acid. Other PPIs, including Prilosec, Nexium, Prevacid and Protonix, may be approved for different uses than Dexilant.

FDA Approved Uses for Dexilant

  • Healing erosive esophagitis (EE; damage to the esophagus caused by stomach acid)
  • Maintenance of healed EE
  • Relief of heartburn with healed EE
  • Treating gastroesophageal reflux disease (GERD)

Serious Dexilant Side Effects

Dexilant shares many of the same side effects as other proton pump inhibitors. This class of drugs has been on the market since the 1990s, and many studies have clarified the types of side effects that might occur with PPIs.


Possible Dexilant Side Effects

  • Acute interstitial nephritis (AIN)

  • Bone fractures

  • Systemic lupus erythematosus

  • Vitamin B12 deficiency

  • Magnesium deficiency

  • Stomach polyps

  • Heart attack when taken together with certain blood thinners

  • Esophageal cancer

  • Stomach cancer

  • Increased asthma and allergy risks for children

  • Stroke

  • Chronic kidney disease (CKD)

Stopping Dexilant Suddenly Can Cause Health Problems

Stopping a PPI suddenly, especially in people who have been taking one for a long time, can cause symptoms to return at a greater intensity than before. People taking Dexilant or any other proton pump inhibitor should stop only after talking with their doctor and working out a plan to safely stop.

In some cases, a doctor may be able to prescribe a proton pump inhibitor alternative. But in others, a doctor may determine that continuing Dexilant is a safer option than switching to another treatment.

Dexilant Warnings About Serious Side Effects

The Dexilant label carries several warnings and precautions about potentially serious side effects. But it does not list all potential Dexilant side effects. The FDA requires manufacturers add warnings to a drug label when there is increased scientific evidence of a possible risk.


Dexilant Label Warnings and Precautions

  • Stomach cancer

  • Acute interstitial nephritis (AIN; damage to the tissue of the kidney)

  • Severe diarrhea caused by the bacteria Clostridium difficile

  • Bone fractures

  • Systemic lupus erythematosus

  • Vitamin B12 deficiency

  • Magnesium deficiency

  • Interactions with tests for neuroendocrine tumors

  • Interactions with the drug methotrexate

  • Stomach polyps

Dexilant does not have a boxed warning, the most serious warning the FDA can require.

People should talk with their doctor about other drugs they are taking before taking Dexilant. More than 1,800 drug products may cause proton pump inhibitor interactions if taken with Dexilant or other PPIs.

Common Dexilant Side Effects

Minor Dexilant side effects are more common than serious side effects.


Common Dexilant Side Effects

  • Diarrhea

  • Abdominal pain

  • Nausea

  • Upper respiratory tract infection

  • Vomiting

  • Flatulence

  • Headache

  • Swelling of nasal passages & back of throat

  • Pain in the mouth and nose

Studies Associate Dexilant with Kidney Problems

Many studies have associated long-term PPI use with serious kidney complications since the 1990s. One of these reviewed some of the largest studies of PPI use and found that PPIs can increase the risk of kidney problems. The review included 9 studies of over 2 million total people. Compared with people who did not take PPIs, those treated with PPIs had about a 30 percent to 40 percent increased risk of both short- and long-term kidney damage.

Kidney Problems Associated with Dexilant and other PPIs

  • Kidney failure
  • Kidney disease
  • Kidney injury (acute interstitial nephritis)

Dexilant Acute Kidney Injury (AIN) Risk

Long-term use of Dexilant or other PPIs may increase the risk of a serious kidney injury called acute interstitial nephritis (AIN). AIN is defined by inflammation in the tissue of the kidney. It can often be treated if caught early, but in rare cases it can cause permanent damage.

Left untreated, AIN can lead to metabolic acidosis. That’s a condition in which the kidneys cannot remove acid from the blood. It can cause kidney failure and end-stage kidney disease.


Symptoms of AIN Include

  • Blood in the urine

  • Fever

  • Nausea

  • Vomiting

  • Swelling of any part of the body

  • Water retention

  • Weight gain

  • Fatigue

  • Rash

  • Mental changes (drowsiness, confusion or coma)

  • Changes in urine output (either increased or decreased)

People who experience symptoms of AIN should contact their doctor immediately.

Dexilant and Kidney Disease

Studies have found that people who take PPIs may have a higher risk of serious kidney disease.

A recent review of studies evaluating the association between PPIs and kidney problems included over 2 million total people. Compared with people who did not take PPIs, those treated with PPIs had a 44 percent increased risk for acute kidney injury, a 36 percent increased risk for CKD, and a 42 percent increased risk for end-stage renal disease (ESRD; the last stage of kidney disease, where dialysis may be necessary).

One of the included studies was a 2016 study of US veterans newly treated with acid blocking drugs that was published in the Journal of the American Society of Nephrology. This study compared PPIs with another class of acid blocking drugs called h3 receptor blockers. This study found that after 5 years of treatment, PPI users were 96 percent more likely than h3 receptor blocker users to experience end-stage renal disease, and were 28 percent more likely to develop CKD.

Some studies have found that PPI-associated kidney disease might occur without patients knowing or experiencing any symptoms. Therefore, people taking PPIs may need periodic tests of their kidney function to identify these “silent” side effects of PPIs.

Although studies have found a higher risk for kidney disease in patients treated with PPIs, it is important to remember that these events are still overall not very common. For example, in the US veterans study, the increased risk for ESRD means that about 15 more patients have ESRD for every 100,000 patients treated for 1 year with a PPI instead of a h3 receptor blocker. Likewise, the increased risk for CKD means that about 1100 more patients have CKD for every 100,000 patients treated for 1 year with a PPI instead of a h3 receptor blocker. Patients taking PPIs should speak with doctor about any other conditions that might increase their risk for these side effects and whether PPIs are the best option for them.

Lawsuit Information

Multiple PPIs, including Dexilant, have been named in lawsuits from people who say they suffered serious kidney problems after taking them. Learn more about currently pending litigation.

View Lawsuits

Studies Associate Dexilant with Cancer and Heart Attack Risks

Other studies have shown long-term PPI use may increase the risk of other serious conditions, including cancers and heart attacks.

PPIs may be responsible for many esophageal cancer cases.

A 2018 study published in Cancer Epidemiology found PPIs may be associated with esophageal cancer. Researchers examined the medical records of 796,492 people in Sweden who took PPIs during a 7-year period. Compared with the normal rate of esophageal cancer that would be expected in people not taking PPIs, those who took PPIs experienced esophageal cancer almost 4 times more frequently than expected. However, overall, only 0.13 percent of all patients taking a PPI developed esophageal cancer. The risk of esophageal cancer was no different than expected in people taking h3 receptor blockers.

Another 2017 study from Sweden found PPIs may be associated with stomach cancer. These researchers examined data from 797,067 people who were treated with PPIs for on average 5 years. Compared with the normal rate of stomach cancer that would be expected in people not taking PPIs, those who took PPIs experienced esophageal cancer almost 3.4 times more frequently than expected. Although this is a large increase in risk, only 0.28 percent of patients taking a PPI developed gastric cancer. The risk of stomach cancer was again no different than expected in people taking h3 receptor blockers.

A 2017 study in the journal Gut also found that taking PPIs could more than double the risk of stomach cancer in people taking them for Helicobacter pylori infection, which could cause peptic ulcer disease. H. pylori infection can itself increase the risk for stomach cancer. That same year, the FDA added a gastric-malignancy warning to the labels of Dexilant and other PPIs. The warning advises people to consider screening for gastric cancer if their response to treatment with a PPI is below standard.

A 2015 study published in the journal PLOS One found that long-term PPI use was associated with an increased risk of heart attacks among patients with GERD. Another study in PLOS One found an association between PPI use and fatal heart failure among people with coronary artery disease.

Dexilant Lawsuits and Kidney Damage

People who suffered serious kidney problems after taking Dexilant have filed lawsuits over their injuries. Dexilant lawsuits are among thousands filed against manufacturers of several different brands of PPIs. The lawsuits have been combined in a multidistrict litigation (MDL) in a New Jersey federal court. MDLs allow several similar lawsuits to move more quickly through the legal process.

As of November 2019, there were 13,492 lawsuits pending in the proton pump inhibitor MDL.

People who filed PPI lawsuits claim Dexilant or other PPIs caused kidney disease, injury or other serious conditions.

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.

Glossary of Terms | 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.

Patient Information for 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 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.

90,000

Clinical Research Channel: Doxirazole, Dexilant – Clinical Research Register

Intervention

Intervention type:

Drug

Intervention name:

Doxirazole

Description:

1 capsule contains 60 mg Dexlansoprazole

Arm Group label:

A Test

Another name:

Dexilant

Intervention type:

Medicine

Intervention name:

Dexilant

Description:

1 capsule contains 60 mg dexlansoprazole.

Arm Group label:

B Link

Eligibility

Criteria:

Inclusion criteria: – 1. Healthy man or woman aged 18 to 55 years inclusive. 2. Body weight within 15% of the normal range according to the accepted normal values ​​for body mass index (BMI). 3. Medical demographic data without evidence of clinically significant deviation from normal health. 4. The results of clinical and laboratory research within the normal range or with deviation.it is not a clinically relevant investigator. 5. Subject is not allergic to study medications. Exclusion Criterion: – 1. Subjects with known allergies to the test foods. 2. Subjects whose BMI values ​​were outside the normal range. 3. Pregnant women who are breastfeeding. or birth control pills. 4. Medical demographic data with clinical confirmation of significant deviation from normal health. 5. Clinically significant laboratory results.6. Acute infection. during the period before the first administration of the study drug. 7. History of intake or drug use of alcohol. 8. Subject does not agree not to take any prescription or over-the-counter drugs for the weeks leading up to the first study 2 drug intake and until the end of the study. 9. Subject follows a special diet (eg vegetarian). 10. Subject does not agree not to consume any foods or products, such as represent-xanthenes, such as caffeine (coffee, tea, cola, chocolate, etc.).48 hours prior to the study, administer any study period prior to the last sample in each appropriate period. 11. Subject does not agree not to consume any beverages or foods containing grapefruit. 7 days before the first injection of the study drug until the end of the study. 12. Subject has a history of severe medical conditions that directly affected the study. 13. Participation in a bioequality study or clinical study within the last 6 years.weeks before the first study drug is administered. 14. Subject intends to be hospitalized within 3 months of the first study drug. administration. 15. Subjects, upon completion of the study, would donate more than 500 ml of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml after 120 days, 1500 ml after 180 days, 2000 ml after 270 days, 2500 ml of blood after 1 year.

Floor:

All

Minimum age:

18 years old

Maximum age:

55 years

Healthy volunteers:

Accepts healthy volunteers

How can I replace the drug Odeston

October 16,

Dear Doctor,

According to the results of numerous tests, in a local clinic, I was diagnosed with GERD and prescribed to take pariet 20mg for 4 weeks, then switch to 10 mg for 2 months.And also, once a month, take the drug odeston for 10 days (once a day before lunch)
and for 3 months, take Creon at a dose of 10,000 at dinner. The doctor who prescribed the treatment for me told me not to show up before my course of treatment was over, and to my words that I had heartburn from the drug odeston, she said that this could not be.

After I continued to take the drug odeston, I started to burp with air (every half hour), which was previously only after eating (rarely in intervals).On the 10th day of taking the drug Odeston, my condition worsened so much, compared to what it was before the start of treatment, that I had to start taking phosphalugel additionally.

Could you advise how I can replace the drug odeston, tk. it is impossible to get an appointment with another gastroenterologist in our city, but to come to Moscow for a consultation with me so far
does not work?

Ultrasound of the abdominal organs showed no pathological changes in the internal organs, and gastroscopy showed slight inflammation of the duodenum and stomach, as well as the presence of bile in the stomach.(All prescribed blood tests are good. The test for Helicobacter pylori is negative.)

Thank you for your attention and cooperation.

Best regards, Elizabeth.

Nikita Novozhilov

Gastroenterologist

Dear Elizabeth!
The drug odeston is a selective antispasmodic, aimed mainly at relaxing the sphincter of Oddi (a valve that closes the common bile duct at the point where it flows into the duodenum).
This drug is not directly related to the treatment of GERD and is not included in the recommendations for the treatment of this pathology.
However, it is known that GERD is often combined with other disorders and diseases of the digestive system, including disorders of the gallbladder and the already mentioned sphincter of Oddi.
Indeed, in case of suspicion of spasm / dysfunction of the sphincter of Oddi, the drug odeston copes well with increased tone (at least we assume so, because.Since there are currently no methods in clinical practice to objectively measure the tone of the sphincter of Oddi).
I dare to suggest that the doctor suspected you of something similar, and therefore decided to prescribe this medicine.

The drug odeston has an undesirable effect: its intake is often combined with a sensation of irritation of the mucous membranes. Sometimes this requires discontinuation of the drug.

For drugs of the antacid / enveloping class, the role in the treatment of pathology of the digestive system is very modest: they are either auxiliary drugs (for example, for temporary protection of mucous membranes), or symptomatic therapy – elimination of symptoms. Antacids do not change anything in digestion per se.
This means that you can use them if there is no other possibility of treatment or the prescribed treatment does not help immediately.

Unfortunately, not seeing you and not having documentary evidence of deviations from the norm identified / absent in your case, I have no professional, legal or moral right to advise you something specific.
Since the adoption of the law on telemedicine, we have the right to carry out repeated consultations of previously examined patients with the results of the examination or in the course of therapy, this is logical, because.j. a well-known patient with a known diagnosis may not really need an objective examination.
On the contrary, at the initial visit it is very important to “look” the stomach with your hands, check all the symptoms and directly find out the objective status

Best regards, Doctor N.V. Novozhilov

Therapy / drugs

Roster

Composition for 1 capsule 30 mg 90 100

Active ingredient: dexlansoprazole 30 mg

Excipients: sugar crumbs 1 (from 500 microns to 710 microns) 28. 8 mg, magnesium carbonate 11.5 mg, sucrose 41.5 mg, low-substituted hyprolose 8.64 mg, 0.34 mg hyprolose, hypromellose 2910 7.54 mg, talc 16.64 mg, titanium dioxide 5.5 mg, dispersion of methacrylic acid copolymer 2 90 110 9.66 mg, macrogol-8000 0.96 mg, polysorbate-80 0.44 mg, colloidal silicon dioxide 0.09 mg, methacrylic acid and methyl methacrylate copolymer [1: 2] 15.95 mg, methacrylic acid and methyl methacrylate copolymer [1: 1] 5.32 mg, triethyl citrate 2.12 mg;

Capsule shell: carrageenan 0.192-0.624 mg, potassium chloride 0.144-0.48 mg, titanium dioxide 2.4768 mg, dye FD & C blue No. 2 aluminum varnish 0.3456 mg, iron dye black oxide 0.0576 mg, hypromellose q.s. up to 48 mg, purified gray ink for marking 3 trace amounts.

1 Composition of sugar crumbs: sucrose 18-26.352 mg, corn starch 2.448-10.8 mg; 2 Composition of the dispersion of methacrylic acid copolymer: methacrylic acid 4.4436 mg, ethyl acrylate 4. 2504 mg, sodium lauryl sulfate 0.2254 mg, polysorbate-80 0.7406 mg;

Composition for 1 capsule 60 mg 90 100

Active ingredient: dexlansoprazole 60 mg

Excipients: sugar crumbs 1 (from 500 microns to 710 microns) 40.0 mg, magnesium carbonate 16.0 mg, sucrose 39.52 mg, low-substituted hyprolose 12.0 mg, hyprolose 0.48

mg, hypromellose 2910 10.5067 mg, talc 27.5499 mg, titanium dioxide 6.9933 mg, dispersion of methacrylic acid copolymer 2 90 110 7.02 mg, macrogol-8000 0.7 mg, polysorbate-80 0.32 mg, colloidal silicon dioxide 0.13 mg, methacrylic acid and methyl methacrylate copolymer [1: 2] 31.9 mg, methacrylic acid and methyl methacrylate copolymer [1: 1] 10.64 mg, triethyl citrate 4.24 mg.

Capsule shell: carrageenan 0.24-0.78 mg, potassium chloride 0.18-0.6 mg, titanium dioxide 2.52 mg, FD&C blue No. 2 aluminum varnish 1.08 mg, hypromellose qs up to 60 mg, purified gray ink for marking 3 trace amounts.

1 Composition of sugar crumbs: sucrose 25-36.6 mg, corn starch 3.4-15 mg;

2 Composition of the dispersion of methacrylic acid copolymer: methacrylic acid 3.2292 mg, ethyl acrylate 3.0888 mg, sodium lauryl sulfate 0.1638 mg, polysorbate-80 0.5382 mg;
3 Gray ink purified for marking consists of iron oxide red dye, iron oxide yellow dye, FD & C blue No. 2 dye aluminum varnish, carnauba wax, shellac, glyceryl monooleate.

Description

Dose 30 mg

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

Dose 60 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.Contents of capsules – granules from white to almost white

Pharmacotherapeutic group: gastric glands secretion lowering agent – proton pump inhibitor

ATX code: A02BC06

Methodical development of a practical lesson

Ministry of Health of the Trans-Baikal Territory

State vocational educational institution

“Chita Medical College”

Methodical development

Practical training for teachers

Topic “Clinical pharmacology of antiulcer drugs”

Drug therapy

Section 2. “Clinical and pharmacological approaches to the selection and use of drugs for diseases”

Specialty 33.02.01 Pharmacy

Chita – 2018

The methodological development is based on the work program

of the academic discipline “Pharmacotherapy” in specialty 33.02.01 “Pharmacy”, for training mid-level specialists on the basis of basic general education.

Author of the methodological development:

Lecturer Zabrodina L.A.

Considered at a meeting of the cyclic methodological commission “Pharmacy”

Minutes No. from “” 2018.

Chairman of the CMC I. I. Komogortseva

Approved:

Methodist Fedotova N.M.

Methodical development

Practical lesson

Specialty: Pharmacy

UD Pharmacotherapy

Section 2. Clinical and pharmacological approaches to the selection and use of drugs for diseases

Topic 2.6. Clinical pharmacology of antiulcer drugs.

Type of occupation: acquisition of practical skills.

Form of carrying out: practical lesson.

Objectives of the lesson:

Training:

1. Dispensing drugs and providing advice to customers in order to ensure responsible self-treatment.

2. Control of students’ knowledge.

Tasks: after studying the topic, the student should

Be able to:

  • inform when dispensing drugs used in the treatment of gastric ulcer and duodenal ulcer;

  • select synonyms taking into account international non-proprietary names

  • conduct a dialogue with the buyer when dispensing OTC drugs.

Know:

  • etiology and pathogenesis of gastric ulcer and 12-p. intestines;

  • principles of pharmacotherapy of gastric ulcer and 12 duodenal ulcer;

  • classification of antiulcer drugs;

  • classification of antispasmodic drugs;

  • classification of gastroprotective drugs.

  • classification of prokinetic drugs

  • content of the concept of responsible self-medication;

  • stages of the sale, the behavior of the pharmacist at each stage;

  • informing buyers when dispensing medicinal product.

Developing:

  • to develop cognitive activity and logical thinking;

  • develop the ability to compare, generalize and analyze the material studied; solve situational tasks and test tasks for the formation of heuristic thinking;

  • Formation of speech culture skills, striving to learn new things;

  • forming OK 1. Understand the essence and social significance of your future profession, show a steady interest in it.

  • Formation of OK 2. Organize your own activities, choose standard methods and ways of performing professional tasks, evaluate their effectiveness and quality.

  • OK formation 3. Make decisions in standard and non-standard situations and be responsible for them.

  • formation of OK 4. Search and use the information necessary for the effective performance of professional tasks, professional and personal development.

  • OK formation 5. Use information and communication technologies in professional activities.

Educational:

  • Formation of a scientific ideological position, education of students the basic qualities of a pharmacist: erudition, good breeding, attentiveness;

  • to form the professional orientation of the individual and communication skills;

  • foster respect for the identity of the buyer.

Interdisciplinary and intradisciplinary communications:

Interdisciplinary – modular communications :

Intradisciplinary communications :

Clinical pharmacology of drugs

anti-inflammatory drugs

Clinical pharmacology of drugs

anti-pharmacology Recommended literature for self-study:

Basic educational:

  1. Pharmacology: textbook and workshop for SPE / E.V. Konopleva.- M.: Yurayt Publishing House, 2016.- 446 pp .- Series: Professional Education.

  2. Clinical pharmacology. In 2v. T 2: textbook and workshop for universities / E.V. Konopleva.- M.: Yurayt Publishing House, 2015.- 346 pp .- Series: Specialist

Additional:

  1. Clinical Pharmacology: textbook / N. V. Kuznetsov. – 2nd ed., Rev. and add. – M .: GEOTAR-Media, 2013 .– 272 p. SPO series – ISBN 978-5-9704-2647-0 .

Electronic resources

  1. Electronic edition based on: Clinical Pharmacology: textbook / N.V. Kuznetsov. – 2nd ed., Rev. and add. – M .: GEOTAR-Media, 2013 .– 272 p. The SPO series is ISBN 978-5-9704-2647-0.

  2. Electronic library. http://www.studentlibrary.ru

  3. Electronic library http://www.medcollegelib.ru

  4. Russian Encyclopedia of Medicines (RLS): http : // www . rlsnet . ru

  5. Vidal Handbook. Medicines in Russia: http : // www . vidal . ru

Teaching tools:

Information tools: reference literature:

  • Mashkovsky M. D. “Medicines”, Moscow: LLC Edition “New Wave”, 2013

  • Vidal.Medicines in Russia, Moscow, 2013

  1. computer

Visual aids: a set of preparations on the topic, handouts (synonymous tables)

Stages of classes and control of their assimilation

n / p Methods

Stages of classes

each stage (description of students’ activities)

Forms of control, levels of assimilation

Example –

time

1

Introductory part

Organizational moment

Greet the teacher.

Occupy jobs.

Listen carefully to the teacher.

3 min

2

Motivation

Objectives of the lesson

They comprehend the role of this lesson, set goals and objectives, formulate the meaning of the topic, connection with the present, prospects for the development of the issue.

5 min

3

Actualization of basic knowledge (control of the initial level)

Students answer control questions

Frontal control

20 min

4

Main part of the lesson

Students individually complete the task 1

Working with synonymous tables

2. Individually work with written situational tasks

3. Business game “Selling in a pharmacy” in a simulation center

Oral and written control, self-control

120 min

5

Final part:

Final control

Students write the test (Appendix No. 1)

Written control

10 min

Summing up

Listen to the teacher, comprehend what he said, evaluate their work together with the teacher

5 min

902 Reflection 24min

Homework

The teacher tells the students the homework, explains the methodology for its implementation

2 min

The first stage

The teacher greets the students. Accepts the report of the person on duty, draws attention to the appearance of the students. Checks the readiness of the audience and group for the session. Marks absent. Fills in the log.

Stage Two

Provides motivation and, together with students, formulates the topic and purpose of the session.

Motivation.

Stomach ulcer is one of the most common diseases of the gastrointestinal tract, characterized by the formation of a small defect on the gastric mucosa, as a result of aggressive action on the mucous membrane of certain factors (hydrochloric acid, bile, pepsin).It is a chronic disease, therefore it alternates with periods of exacerbations and remissions. A stomach ulcer is an irreversible disease, since a scar is formed on the area of ​​the gastric mucosa affected by the ulcer, and it does not have a functional ability even after treatment.

Drug therapy is the main component in the treatment of peptic ulcer disease exacerbation. Over the past 10-15 years, the arsenal of antiulcer drugs has been replenished with new active drugs.

All pharmacotherapeutic agents used in the treatment of peptic ulcer disease can be divided into three large groups:

  • locally acting agents aimed at suppressing the aggressive properties of gastric contents;

  • drugs that increase the protective properties of the mucous membrane;

  • affecting the central neurohumoral regulation of the gastro-duodenal system.

Given the high requirements for pharmacists in their professional activities, it is necessary to have knowledge of the pharmacological classification of drugs, their pharmacokinetics and pharmacodynamics, respectively, use and side effects. All of this is necessary for the pharmacist in his daily professional practice of providing advice to buyers in order to ensure responsible self-medication.

Purpose of the lesson:

Consolidation and generalization of knowledge about the drugs used for the treatment of gastric ulcer and 12 p-intestine and the implementation of elements of a business game in order to consolidate the formation of professional competencies when dispensing drugs from pharmacy organizations

Third stage …

The teacher controls the initial level of knowledge in the form of a frontal survey.

Frontal survey questions.

  1. Give the definition of gastric ulcer and 12-p. intestines;

  2. What is the etiology and pathogenesis of gastric ulcer and 12-p. intestines;

  3. List the principles of pharmacotherapy of gastric ulcer and 12 duodenal ulcer;

  4. List which pharmacological groups are used for the treatment of gastric ulcer and 12-p. intestines?

  5. Tell us the classification of proton pump inhibitors

  6. Tell us the classification of antacid drugs.

  7. Tell us the classification of antacid drugs.

  8. Adverse drug reactions of antacids.

  9. Tell us the classification of blockers H 2 – histamine receptors.

  10. Adverse drug reactions of group H 2 – histamine receptors.

  11. Tell us the classification of H + K + – ATPase blockers.

  12. Adverse drug reactions of H + K + – ATPase blockers.

  13. Give a definition to the concept of Helicobacter pylori therapy. The most commonly used drugs.

  14. Tell us about the classification of gastroprotective drugs.

  15. Tell us about the classification of prokinetic drugs.

  16. Tell us the classification of antispasmodic drugs.

The teacher evaluates the students’ answers.

Fourth stage

For 120 minutes, students work independently under the guidance of a teacher.

Task number 1.

Working with synonymous tables, each student is given a table with INN and trade names of drugs, he must match the corresponding names.At the same time, he uses reference books, an electronic reference book and reference notebooks compiled by them in their industrial practice according to PM 01.

The teacher monitors the performance of the assignment (Appendix 1)

Assignment No. 2.

Solving situational problems (translating the properties of a drug into benefits)

Motivation: The pharmacist must always remember that the buyer does not need the drug as such, but the direct benefit that he will receive as a result of its use. Indeed, in the process of selling, the buyer constantly thinks about what the use of this drug will give him.

A pharmacist should be able to distinguish between specific drugs and explain the benefits to the interlocutor due to these characteristics. That is, it is important for a pharmacist to be able to translate the properties of a drug into a benefit for the buyer.

Since the needs of different customers, even in similar situations, are different, and each drug has a number of characteristics, the pharmacist must be ready, even when offering one drug, to satisfy different buyers’ motives in different cases.And for this it is important for him to know well the properties of drugs.

You are invited to analyze the properties of the proposed drugs and translate them into a benefit for buyers, that is, to prepare in advance for communication with clients who it would be logical to offer these drugs (Appendix 2)

List of drugs for situational tasks:

Ranitidine, omeprazole, pantoprazole, trimebutin, mebeverin, dompiridone, almagel, gaviscon, rennie, de-nol, misoprostol.

Task number 3.

Business game “Selling in a pharmacy”

The teacher selects a pharmacist and an expert for each role-playing situation (Appendix 4).

Supervises the work of students, taking into account the correctness of the decision, the consistency and completeness of the answer.

A student acting as a pharmacist must conduct a dialogue when selling works according to the proposed algorithm (Appendix 3).

A student – an expert evaluates the actions of a pharmacist taking into account:

– rational choice of medicinal product,

– consultations during vacation,

– business communication ethics,

– communicative competences

Final part:

Students write a pharmacological dictation (application 5).

Assessment of a dictation by a teacher using a five-point system.

At the end of the lesson, the teacher summarizes the results.

Homework: according to the methodological guide to prepare for the topic: Antimicrobial agents.

Appendix 1

Synonymic tables on the topic: Clinical pharmacology of antiulcer drugs

Amoxiclav

Amoxicillin,

De-nol

Klacid

Trichopolum, Metrogyl

Flemoklav

Flemilik II24 Flemoklav

47

generation)

Clarithromycin

tetracyclines (natural)

Tetracycline

penicillins (semisynthetic broad spectrum)

Amoxicillin

Amoxicillin + clavulanic gastric acid

Methropoxide

Dinitrate

Blockers of histamine H2-receptors

II generation

Ranitidine

Dexilant

Zantak

Zulbex

Kvamatel famopsin 900 07

Controloc

Lanzap

Losek

Nexium

Nolpaza

Omez

Omez DSR

Ortanol

Pariet

Ultop

Emanner

Prot.

Rabeprazole

Pantoprazole

Esomeprazole

Dexlansoprazole

Lansoprazole

Proton pump inhibitors in combinations

Dompiredon + omeprazole

Almazole

Almysterium 907 Antacid Almazide 9000-containing Almazole

Antacidicides

Gastal

Gaviscon

Maalox

Aalmagel

Rennie

Phosphalugel

Calcium carbonate + sodium alginate + sodium bicarbonate

A luminium hydroxide-magnesium carbonate

Algeldrate + Magnesium hydroxide + Simethicone

Aluminum phosphate

Systemic action of antacids

Calcium carbonate + Magnesium carbonate

Gastroprotective

Sucralfat Saytotis

902 902

7 Cytotis

Bismuth tripotassium dicitratobismuthate

Prostaglandins

Misoprostol

prokinetics (stimulators motor-evacuation function of the upper GIT)

antagonist of dopamine receptors

Domperidone

Motilium

Buscopan

Ganaton

itopride

Reglan

metoclopramide

Acetylcholine release stimulator

Itoprid hydrochloride

Antispasmodics

M-anticholinergic

Hyoscine butyl bromide

Phosphodiesterase inhibitors Drotaverine

Ditsetel Drotaverine Duspatalin

Neobutin® Nospanum Spazmol

Trimedat® sodium channel blocker

Mebeverin calcium channel blocker

pinaverium bromide antispasmodics myotropic action

Trimebutin

Answers to the task synonymous tables on the topic: Clinical pharmacology of antiulcer drugs

Klacid

Fromelide

tetracyclines (natural)

Tetracycline

penicillins 907 broad-spectrum 7000 70007

penicillin 907 broad-spectrum 7000 ammoxynthetic 7000

Amoxicillin + clavulanic acid

Amoxiclav

Flemoklav

Amoxicillin + metronidazole

Helicocin

9022 4 a bismuth-containing preparation with gastroprotective properties

Bismuth

Dinitrate

De-nol

Blockers of histamine H2-receptors

II generation

Ranitidine

Zantak

III generation

Famatopor proton pump

Omeprazole

Losek

Omez

Ortanol

Ultop

rabeprazole

Pariet

Zulbeks

Pantoprazole

Nolpaza

Kontrolok

esomeprazole

Nexium

Emanera

Dekslansoprazol

Deksilant

Lansoprazole

Lanzap

Proton pump inhibitors in combinations

Dompiredone + omeprazole

Omez DSR

Antacids 90 007

non-systemic Mg- and Al-containing antacid

Algeldrate + Magnesium hydroxide

Maalox almagel

Calcium carbonate + sodium alginate + sodium bicarbonate

Aleviscon

Aluminum hydroxide Magenium-magnesium hydroxide

24 + G224 Simethicone

Almagel NEO

Aluminum phosphate

Phosphalugel

Systemic action of antacids

Calcium carbonate + Magnesium carbonate

Rennie

Gastroprotectors

02 Sucralmurate

4 Gastroprotectors

07 Sucralmurate

4 Gastroprotective

024 Sucralmurate

4

Prostaglandins

Misoprostol

Cytotec

Prokinetics (stimulators of motor-evacuation function of the upper gastrointestinal tract)

dopamine receptor antagonist

Domperidone

Motilium

metoclopramide

Reglan

stimulant release acetylcholine

itopride hydrochloride

itopride

Ganaton

antispasmodics

M-anticholinergic

Hyoscine butylbromide

Buscopan

inhibitors of phosphodiesterase

Drotaverine

No-shpa

Drotaverin

Spasmol

Sodium channel blocker

Mebeverin

Duspatalin

Calcium channel blocker

Pinaveria bromide

Dicetele247 Spasmolite

Dicetele247

Neobuvid2 Appendix 2

Response template student

Stage: Solving situational problems

9009 5 “Transfer of drug properties to benefit”

Full name ___________________ MD ___________________

Transfer drug properties to benefit for the buyer

reason for purchasing

Criteria, points

Rating

MD effective 9000 9000 0-4

LP safe

0-3

LP convenient

0-3

the effect will come quickly

(saving time)

0-3

you will save money

(save money)

0-4

is a prestigious company,

is a well-known trademark

(image)

0-2 900 07

Appendix 3

Algorithm for working with the buyer to task No. 3.

  1. Establish contact with the visitor, find out the purpose of visiting the pharmacy.

  2. Correctly indicate the need for prescription dispensing (if necessary).

  3. Indicate the need for a mandatory visit to a specialist.

  4. Ask a pharmacy visitor about the availability of a doctor’s prescription for the drug.

  5. Determination of the symptoms of the disease, for the elimination of which the drug is purchased.

  6. Ask how long the symptoms have been bothering.

  7. Ask the pharmacy visitor for whom the drug is being purchased.

  8. Clarify the special characteristics of the pharmacy visitor (belonging to the risk group for the use of drugs)

  9. Ask about other drugs prescribed simultaneously

  10. Offer the visitor two over-the-counter analogs to choose from.

  11. Offer the first OTC drug as an alternative.

  12. Justify the first proposal of the medicinal product in accordance with the instructions for use. (according to the situation / form of release / manufacturer / dosage / spectrum of action / price /)

  13. Offer a second non-prescription drug as an alternative to the prescription drug.

  14. Justify the second proposal of the medicinal product in accordance with the instructions for use (according to the situation / form of release / manufacturer / dosage / spectrum of action / price /)

  15. Provide the pharmacy visitor with a choice of medicinal product.

  16. Release the medication selected by the visitor.

  17. Apply cash settlement equipment.

  18. Inform about the regimen and doses of the purchased medicinal product.

  19. Inform about the rules for storing the purchased medicinal product at home.

  20. Warn about the need to visit a doctor if symptoms persist.

Appendix 4

Situational tasks for stage 4 of the lesson:

Business game “Selling in a pharmacy”

Problem No. 1

A young woman came to the pharmacy with complaints of heartburn that occurs when diet.

Problem number 2

A 35-year-old patient suffering from gastric ulcer came to the pharmacy for the drug “De-nol”. This drug was not in the pharmacy.

Questions: 1. Can you change the drug?

2. If yes, dispense the drug and offer an over-the-counter drug.

Problem number 3

A young woman came to the pharmacy with complaints of abdominal pain arising from a violation of the diet.

Problem No. 4

A woman came to the pharmacy with a prescription for Omeprazole. Dispense the drug and offer an over-the-counter drug.

Problem No. 5

A patient turned to the pharmacy with a request to sell “Metoclopramide” for the treatment of heartburn, belching. I did not go to a specialist. There is no recipe. From the anamnesis it is known that the patient complains of recurrent heartburn after physical work in an incline, sour belching, nausea, hiccups.

What are your actions?

Problem No. 6

A patient came to the pharmacy with a complaint of heartburn and a request to sell Pantoprazole capsules. The pharmacist refused the patient, indicating that the drug was dispensed with a doctor’s prescription. The patient began to argue with the pharmacist, explaining that he purchases the drug from another pharmacy freely.

Imagine yourself in the place of a pharmacist, what are your actions?

Problem No. 7

A woman came to the pharmacy with a prescription for Ranitidine.

Problem number 8

A man came to the pharmacy with a complaint of diarrhea, explained that he was undergoing treatment for gastric ulcer. I asked the pharmacist to explain the cause of the diarrhea and give something to treat it.

Appendix 5

Questions of the pharmacological dictation:

  1. Peptic ulcer of the stomach and 12 p. Intestines is an acute disease.

  2. Causative agent of gastric ulcer and 12 p.the intestine is staphylococcus aureus.

  3. For the eradication of the causative agent of gastric ulcer and 12 p. Of the intestine, antibiotics are used.

  4. To reduce gastric secretion, proton pump inhibitors are used.

  5. The drug Drotaverin is mandatory for all patients suffering from gastric ulcer and 12 p. Intestines.

  6. Pantoprazole belongs to group H 2 histamine blockers.

  7. A synonym for Omeprazole is Ultop

  8. Hyoscine butylbromide is a myotropic antispasmodic drug

  9. Omeprazole is an over-the-counter drug.

  10. To relieve nausea and vomiting, use the drug Dompiridone

Pharmacological dictation answers:

YES NO

For each correct answer – one point.

Evaluation criteria:

“5” up to 5% of incorrect answers,

“4” up to 15% of incorrect answers,

“3” up to 30% of incorrect answers,

“2” more than 30% of incorrect answers …

ulybkaolya – LiveJournal

We continue the conversation.Let’s start with skin care regimen change , what is it?
The first and very important step in acne treatment is to temporarily stop or at least limit the use of any hygiene products that come into contact with the skin of the face (or other area of ​​the body where there are acne). The ideal option is to completely exclude any hygiene products that come into contact with the skin where there are acne (any type of skin care products for the face and body skin, any types of soaps, shampoos, washing powders).This is due to the fact that certain substances that make up hygiene products can cause irritation or increased sensitivity and inflammation (dermatitis), especially when the skin loses its integrity (as in the case of acne). Also, most cleaning products can disrupt the normal course of skin renewal processes, which in turn, as already shown above, can lead to acne and blackheads.
If you cannot completely eliminate household chemicals from your environment, try at least:
– use soap only to wash your hands;
– if you are worried about acne on the body, then use ordinary laundry soap or hypoallergenic washing powder without fragrances, as well as shampoos without fragrances for washing clothes;
– If you are worried about acne on your face, wash your face only with clean running water (warm or cool) or grass.

Somali Secret Soap Leaf Face Cleanser (Qasil)

Herbal powder for washing face and body Veda Vedica

It is advisable to follow these rules at least until a visible and tangible improvement in the condition of the skin. After that, you can gradually add the skin care products you need as you continue the treatment.
Since the exclusion of some cosmetic or household products (for example, cosmetics) can cause significant inconvenience, sooner or later these products will need to be returned to circulation.
To do this without harming your skin:
1. Try to wait at least 3-4 weeks after starting your acne treatment. As the structure and normal functioning of the skin is restored under the influence of treatment, its sensitivity to various irritants will decrease. Consequently, foods that may have irritated you before starting treatment may lose this ability when you start using them after a break.
2. Products should be administered ONCE every 2 weeks, this is due to the fact that the skin’s reaction to a particular product can be assessed no earlier than 2 weeks after the start of its use.
If during the first 2 weeks after the introduction of a certain product you do not notice any noticeable deterioration in the condition of the skin, you can proceed to testing the next product. If, on the contrary, you notice that the skin condition has worsened, you will need to stop using this product and find a replacement for it.

Now about keratolytics
Keratolytics are drugs that help dissolve the bonds between dying skin cells and facilitate their exfoliation.They also reduce the production of sebum and help remove it from the pores of the skin.
The most effective keratolytics are:
1. Beta-hydroxy acids (salicylic acid 2-3%)

The best representatives:

2. Alpha-hydroxy acids (glycolic acid 5-10%, mandelic acid 10-15% )

For glycolic acid see here

Mandelic this is a hit, of course, times and peoples

3. Topical retinoids (retinoid acids in the form of gels / creams / lotions)
– Tretinoin (Retin-A)

Creams – 0.05%

Airol

Aknelis – 0.1%

Inside – Vesanoid.

– Adapalene (Differin)

– Tazarotene

Since the action of keratolotics is to improve the separation of dying skin cells and cleanse the pores of the skin, they should be considered rather as means that prevent the development of acne in the future , not remedies that treat acne that have already appeared.
Immediately after you start using keratolytics, the acne that you already have will remain in place and disappear, maybe only a little faster than before the start of treatment. Moreover, even after the start of treatment, new acne will appear. However, if you continue the treatment, its prophylactic effect will manifest itself and over time you will have fewer and fewer new acne.
Since keratolytics prevent new pimples, rather than treat existing pimples, they should be applied to the entire surface of the skin where pimples appear (for example, all over the face), and not just to areas where pimples are already present.
If after 8 weeks of continuous and correct use (details on how to use a particular tool are described below), you decide that the problem has not been solved enough, you can try a new tool, again relying on the criteria presented in theoretical part I.

Benzoyl Peroxide

Benzoyl Peroxide has two properties that make it very effective in treating acne: it has a destructive effect on bacteria and promotes the exfoliation of old skin cells.Despite its widespread use all over the world, so far no cases of bacterial resistance to this substance have been recorded. This fact greatly distinguishes benzoyl peroxide from antibiotics, against which bacteria often develop strong defenses. On the market, you can find various products containing benzoyl peroxide in a concentration of 1 to 10%. According to some studies, the optimal concentration is 5%, which has a fairly high efficiency (compared to less concentrated solutions) and comparatively harmless to the skin (compared to more concentrated solutions).Many people who start treating acne with drugs containing benzoyl peroxide find that they cause severe skin irritation. However, in most cases, as the skin gets used to the treatment, this side effect will go away. If, after starting to use a 5% solution of benzoyl peroxide, you notice severe irritation, you can replace it with a less concentrated solution and return to the 5% solution after a while. It is also worth starting with less concentrated solutions because for some people good results in terms of eliminating acne can be seen with the systematic use of 2.5% solutions of benzoyl peroxide.

Baziron

Topical antibiotics

Clindamycin is considered the most effective topical antibiotic in terms of acne treatment. The maximum effectiveness of treatment with Clindamycin is observed in cases of its combination with benzoyl peroxide preparations and topical retinoids.

Dalacin

In addition to Clindamycin preparations, topical preparations containing Erythromycin can also be used.

Combining topical antibiotics with benzoyl peroxide improves acne treatment and prevents microbial resistance to antibiotics. Therefore, at the moment, treatment of acne with topical antibiotics alone without benzoyl peroxide is not recommended.
In pharmacies, you can find preparations containing both benzoyl peroxide and clindamycin.

Indoxil

Oral antibiotics

Oral antibiotics are medicines in the form of tablets or capsules.These medicines should only be used as directed and under the supervision of a physician. Tetracycline is currently considered the drug of choice in the treatment of acne.
Here is such an option together with Nystatin, so that the thrush does not cover.

Tetracycline with nystatin

Some studies have shown that tetracycline is as effective as or even better than some other antibiotics in some cases, it is usually cheaper, and in addition to the harmful effect on P.acnes has a pronounced anti-inflammatory effect.

Isotretinoin (retinoid intended for oral administration)

Isotretinoin has a complex effect and helps to eliminate all the main factors involved in the formation of acne: it inhibits the production of sebum by the sebaceous glands, slows down cell division in the orifices of the pores and thus prevents clogged pores, has an indirect destructive effect on P. acnes and has a pronounced anti-inflammatory effect.