Dexilant SoluTab (Oral)

Dexlansoprazole is used to treat certain conditions where there is too much acid in the stomach. It is used to treat erosive esophagitis or "heartburn" caused by gastroesophageal reflux disease (GERD), which is when stomach acid flows back into the esophagus.

Dexlansoprazole is a proton pump inhibitor (PPI). It works by reducing the amount of acid made by the stomach.

This medicine is available only with your doctor's prescription.

On October 17, 2017, Dexilant SoluTab (delayed-release disintegrating tablets) was taken off the US market. Dexilant and Kapidex (delayed-release capsules) are still available.

It is important for your doctor to check your or your child's progress during regular visits. This will help your doctor see if this medicine is working properly and decide if you should keep taking it. Blood, urine, and other lab tests may be needed to check for side effects.

Do not take this medicine if you are also using products that contain rilpivirine (Complera®, Edurant®). Using these medicines together may cause unwanted side effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Contact your doctor right away if you have a rash, itching, hoarseness, difficulty breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Contact your doctor right away if you or your child has a change in how often you urinate or the amount of urine, blood in the urine, fever, joint pain, loss of appetite, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after receiving this medicine. These could be signs of a serious kidney problem called acute tubulointerstitial nephritis.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you are concerned about vitamin B12 deficiency.

Serious stomach issues may happen while taking this medicine. Contact your doctor immediately if you or your child has stomach cramps, a bloated feeling, watery and severe diarrhea that may also be bloody, fever, nausea or vomiting, or unusual tiredness or weakness.

Dexlansoprazole may increase your risk of fractures in the hip, wrist, and spine. This risk is higher if you are 50 years old or older, if you take high doses of this medicine, or if you use it for more than one year. Call your doctor right away if you have severe bone pain or have trouble walking or sitting normally.

Cutaneous or systemic lupus erythematosus may develop or worsen in patients taking a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that worsens with sun exposure.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Contact your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely if you take this medicine for more than 1 year, or if you take this medicine along with digoxin (Lanoxin®) or certain diuretics (water pills). Contact your doctor right away if you have convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you use this medicine for more than 1 year. Talk to your doctor if you have concerns.

Do not stop taking this medicine without first checking with your doctor or unless your doctor tells you to do so.

Make sure any doctor or dentist treating you knows you are using this medicine. You may need to stop using this medicine several days before undergoing medical tests.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription (e.g., atazanavir, nelfinavir, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Research has not been done to determine how dexlansoprazole affects children younger than 12 years old. Its safety and effectiveness have not been established. Dexilant is not recommended for children younger than 2 years old and may increase the risk of heart problems (for example, heart valve thickening).

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of dexlansoprazole. However, older patients may be more sensitive to the effects of this medicine compared to younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction is possible. In these cases, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are chosen based on their potential importance and are not all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Acalabrutinib
• Amphetamine
• Atazanavir
• Atezolizumab
• Belumosudil
• Benzphetamine
• Bosutinib
• Capecitabine
• Cefuroxime Axetil
• Dacomitinib
• Dasatinib
• Dextroamphetamine
• Erlotinib
• Fedratinib
• Fluconazole
• Gefitinib
• Infigratinib
• Ketoconazole
• Ledipasvir
• Levoketoconazole
• Lisdexamfetamine
• Mavacamten
• Methamphetamine
• Methotrexate
• Methylphenidate
• Mycophenolate Mofetil
• Nelfinavir
• Neratinib
• Nilotinib
• Octreotide
• Palbociclib
• Pazopanib
• Pexidartinib
• Saquinavir
• Secretin Human
• Selpercatinib
• Sotorasib
• Sparsentan
• Sunitinib
• Tocilizumab
• Velpatasvir
• Vismodegib

Using this medicine with any of the following medicines may increase the risk of certain side effects, but it may be necessary to use both drugs. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Levothyroxine
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at mealtime or with specific types of food, as interactions might happen. Consuming alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are chosen based on their potential significance and are not all-inclusive.

Using this medicine with any of the following may increase the risk of certain side effects but might be unavoidable in some situations. If used together, your doctor may adjust the dose or how often you use this medicine or provide special instructions regarding food, alcohol, or tobacco.

• Cranberry

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Diarrhea or
• Hypomagnesemia (low magnesium in the blood), history of or
• Osteoporosis (bone problem) or
• Seizures, history of or
• Systemic lupus erythematosus (SLE)—Use with caution. May worsen these conditions.

• Liver disease, moderate—Use with caution. The effects may be stronger because the body removes the medicine more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain, discomfort, tightness, or heaviness
• confusion
• continuing stomach pain
• diarrhea
• difficult or labored breathing
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• headache
• incoherent speech
• joint pain, stiffness, or swelling
• lightheadedness, dizziness, or fainting
• muscle pain, cramps, or weakness
• nausea
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the arms, jaw, leg, back, or neck
• pounding in the ears
• rash, hives
• shakiness in the legs, arms, hands, or feet
• sweating
• swelling of the eyelids, face, lips, hands, or feet
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• unusual bleeding or bruising
• vomiting
• vomiting of blood or material that looks like coffee grounds
• watery or bloody diarrhea

Incidence not known

• Black, tarry stools
• blistering, peeling, or loosening of the skin
• blood in the urine
• bloody nose
• bone fracture
• chills
• confusion
• cough
• decreased urine output
• drowsiness
• dry mouth
• heavier menstrual periods
• increased thirst
• itching
• joint or muscle pain
• loss of appetite
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasms (tetany) or twitching
• numbness and tingling around the mouth, fingertips, or feet
• painful or difficult urination
• pinpoint red spots on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach cramps
• swelling of the body, feet, or ankles
• swollen glands
• trembling
• trouble speaking, thinking or walking
• unusual tiredness or weakness
• unusual weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Abnormal dreams
• body aches or pain
• bloated or full feeling
• burning or itching around the anus
• change in taste or bad, unusual, or unpleasant (after) taste
• continuing ringing or buzzing or other unexplained noise in the ears
• difficult or painful urination
• difficulty with moving
• ear congestion
• ear pain
• excess air or gas in the stomach or bowels
• falls
• feeling of constant movement of self or surroundings
• loss in sexual ability, desire, drive, or performance
• loss of voice
• metallic taste
• muscle or bone pain
• passing gas
• redness of the face, neck, arms, and occasionally, upper chest
• runny or stuffy nose
• sensation of spinning
• sneezing
• sunburn
• trouble sleeping

Incidence not known

• Blurred vision
• decreased interest in sexual intercourse
• inability to have or keep an erection

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Dexilant
• Dexilant SoluTab
• Kapidex

Available Dosage Forms:

• Capsule, Delayed Release

Therapeutic Class: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Proton Pump Inhibitor

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you are taking the delayed-release capsule:

• You may take this medicine with or without food.
• Swallow it whole. If you cannot swallow the capsule whole, you may open it and pour the contents into a tablespoon of applesauce. Swallow the mixture right away without chewing. Do not store the mixed medicine for later use.
• If Dexilant® is given through an oral syringe: Open the capsule and pour the medicine into a clean container with 20 milliliters (mL) of water. Use an oral syringe to draw up the water and granule mixture. Swirl the syringe gently to keep the granules from settling. Give the mixture directly into the mouth right away. Do not store the mixed medicine for later use. To rinse any leftover medicine in the syringe, refill the syringe with 10 mL of water, swirl gently and swallow the water. Repeat with an additional 10 mL of water.
• If Dexilant® is given through a feeding tube: Open the capsule and pour the medicine into a clean container with 20 mL of water. Get the mixed medicine into a catheter-tip syringe. Swirl the syringe gently to keep the granules from settling, and inject the medicine into the NG tube right away. Refill the syringe with the 10 mL of water. Swirl it gently, and inject it into the tube to rinse any leftover medicine through the tube. Repeat with an additional 10 mL of water.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (delayed-release capsules): For treatment of erosive esophagitis (EE): Adults and children 12 years of age and older—60 milligrams (mg) once a day for up to 8 weeks. To prevent erosive esophagitis from coming back and for relief of heartburn, your doctor may want you to take 30 mg once a day for up to 6 months. Children younger than 12 years of age—Use and dose must be determined by your doctor. Children younger than 2 years of age—Use of Dexilant is not recommended. For treatment of gastroesophageal reflux disease (GERD): Adults and children 12 years of age and older—30 milligrams (mg) once a day for 4 weeks. Children younger than 12 years of age—Use and dose must be determined by your doctor. Children younger than 2 years of age—Use of Dexilant is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.