Dexlansoprazole

What is Dexlansoprazole?

• Dexlansoprazole (Dexilant) is a proton pump inhibitor (PPI) used in the therapy of gastroesophageal reflux and peptic ulcer disease. Dexlansoprazole is an isomer of lansoprazole that has a similar spectrum of activity and toxicities.

Dexlansoprazole structure

Dexlansoprazole Structure

What are the uses of this medicine?

• Dexlansoprazole (Dexilant) is a prescription medicine called a proton pump inhibitor (PPI).
• Dexilant reduces the amount of acid in your stomach.

Dexilant is used in people 12 years of age and older:

• for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE)
• for up to 6 months in adults and up to 16 weeks in children 12 to 17 years of age to continue healing of erosive esophagitis and relief of heartburn
• for 4 weeks to treat heartburn related to gastroesophageal reflux disease (GERD)

GERD:

• GERD happens when acid from your stomach enters the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste or burping.

How does this medicine work?

• Dexlansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H+, K+)-ATPase at the secretory surface of the gastric parietal cell.
• Because this enzyme is regarded as the acid (proton) pump within the parietal cell, dexlansoprazole has been characterized as a gastric proton-pump inhibitor, in that it blocks the final step of acid production.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to dexlansoprazole or any of the other ingredients in Dexilant.
• are taking a medicine that contains rilpivirine (EDURANT, COMPLERA, JULUCA) used to treat HIV-1 (Human Immunodeficiency Virus).

What drug interactions can this medicine cause?

• Dexilant may affect how other medicines work, and other medicines may affect how Dexilant works. Especially tell your doctor if you take methotrexate (Otrexup, Rasuvo, Trexall, Reditrex, Xatmep).
• Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with dexlansoprazole may reduce antiviral effect and promote the development of drug resistance.
• Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with dexlansoprazole may increase toxicity of the antiretroviral drugs.
• Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.
• A temporary withdrawal of Dexilant may be considered in some patients receiving high-dose methotrexate.
• Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations.
• Use Dexilant with caution in transplant patients receiving MMF(Mycophenolate mofetil).
• Monitor tacrolimus whole blood trough concentrations. Dose adjustment of tacrolimus may be needed to maintain therapeutic drug concentrations.
• CgA levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors.
• Temporarily stop Dexilant treatment at least 30 days before assessing to allow gastrin levels to return to baseline.
• There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs.
• Avoid concomitant use of St. John's Wort, rifampin with Dexilant.

Is this medicine FDA approved?

• Lansoprazole was the second PPI approved for use in the United States (1995) and dexlansoprazole, a stereoisomer, was approved for use in 2009.

How should this medicine be used?

Recommended dosage: Recommended dosage in patients 12 years of age and older:

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 up to 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 up to 4 weeks.

Dosage Adjustment in Patients with Hepatic Impairment for the Healing of Erosive Esophagitis:

• For patients with moderate hepatic impairment , the recommended dosage is 30 mg Dexilant once daily for up to eight weeks.
• Dexilant is not recommended in patients with severe hepatic impairment.

Administration:

• Take Dexilant with or without food.
• Swallow Dexilant whole. Do not chew the capsules or the granules that are in the capsules.
• If you have trouble swallowing a whole capsule, you can open the capsule and take the contents in applesauce.
• If you miss a dose of Dexilant, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take your next dose at your regular time. Do not take 2 doses at the same time to make up for the missed dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Delayed-release capsules: 30 mg and 60 mg.

This medicine is available in fallowing brand namesː

• Dexilant

What side effects can this medication cause?

The most common side effects of Dexilant in adults include:

• diarrhea
• stomach pain
• nausea
• common cold
• vomiting
• gas

The most common side effects of Dexilant in children 12 to 17 years of age include:

• headache
• stomach pain
• diarrhea
• pain or swelling (inflammation) in your mouth, nose or throat

Other side effects: Serious allergic reactions which may include:

• rash
• face swelling
• throat tightness
• difficulty breathing

Dexilant may cause serious side effects, including:

• acute tubulointerstitial nephritis
• Diarrhea
• Bone fractures
• Certain types of lupus erythematosus
• Vitamin B12 deficiency
• Low magnesium levels in your body
• fundic gland polyps

What special precautions should I follow?

• In adults, symptomatic response with Dexilant does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing
• Published observational studies suggest that PPI therapy like Dexilant may be associated with an increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
• Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Discontinue Dexilant and evaluate patients with suspected acute TIN.
• Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
• Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. Mostly cutaneous; new onset or exacerbation of existing disease; discontinue Dexilant and refer to specialist for evaluation.
• Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than three years) may lead to malabsorption of cyanocobalamin (Vitamin B12) caused by hypo- or achlorhydria. Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
• Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Reported rarely with prolonged treatment with PPIs.
• Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors.
• Concomitant use with PPIs may elevate and/or 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 polyp]s that increases with long-term use, especially beyond one year. Use the shortest duration of therapy.
• Lansoprazole have demonstrated an adverse effect of heart valve thickening. Dexlansoprazole is the R-enantiomer of lansoprazole .Dexilant is not recommended in pediatric patients less than 2 years of age.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypertension
• hot flashes
• contusion
• oropharyngeal pain
• weight loss

Management of overdosage:

• If you take too much Dexilant, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.
• Dexlansoprazole is not expected to be removed from the circulation by hemodialysis.
• In the event of over-exposure, treatment should be symptomatic and supportive.

Can this medicine be used in pregnancy?

• There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk.
• Dexilant may harm your unborn baby. Talk to your doctor about the possible risks to an unborn baby if Dexilant is taken during pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of Dexilant have been established in pediatric patients 12 years to 17 years of age for the healing of all grades of EE, the maintenance of healed EE and relief of heartburn, and treatment of heartburn associated with symptomatic non-erosive GERD.
• The safety and effectiveness of Dexilant have not been established in pediatric patients less than 12 years of age.
• Dexilant is not recommended in children under 2 years of age and may harm them.
• Dexilant is not effective for symptoms of GERD in children under 1 year of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: dexlansoprazole.
• Inactive ingredients: sugar spheres, magnesium carbonate, sucrose, low-substituted hydroxypropyl cellulose, titanium dioxide, hydroxypropyl cellulose, hypromellose 2910, talc, methacrylic acid copolymers, polyethylene glycol 8000, triethyl citrate, polysorbate 80, and colloidal silicon dioxide. The capsule shell is made of hypromellose, carrageenan and potassium chloride. Based on the capsule shell color, blue contains FD&C Blue No. 2 aluminum lake; gray contains black ferric oxide; and both contain titanium dioxide.

Who manufactures and distributes this medicine?

Distributed by: Takeda Pharmaceuticals America, Inc. Lexington, MA

• Dexilant is a trademark of Takeda Pharmaceuticals U.S.A., Inc. registered with the U.S. Patent and Trademark Office.

What should I know about storage and disposal of this medication?

• Store Dexilant at room temperature between 68°F to 77°F (20°C to 25°C).

The antiulcer agents in clinical use

Proton Pump Inhibitors

• Dexlansoprazole
• Esomeprazole
• Lansoprazole
• Omeprazole
• Pantoprazole
• Rabeprazole

Selective Histamine Type 2 Receptor Antagonists or H2 Blockers

• Cimetidine
• Famotidine
• Nizatidine
• Ranitidine

• Dailymed label info on Dexlansoprazole
• FDA Dexlansoprazole

Dexlansoprazole Resources
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