Dexlansoprazole (dex-lan-SOE-pra-zole)

Treats heartburn, gastroesophageal reflux disease (GERD), or a damaged esophagus, conditions that cause your stomach to make too much acid. This medicine is a proton pump inhibitor (PPI). On October 17, 2017, Dexilant Solutab® (delayed-release disintegrating tablets) was withdrawn from the US market. Dexilant® and Kapidex® (delayed-release capsules) are still available.

Brand Name(s):

Dexilant

When This Medicine Should Not Be Used:

How to Use This Medicine:

Delayed Release Capsule, Tablet Disintegrating, Delayed Release

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Delayed-release capsule:
  • Swallow it whole. If you cannot swallow the capsule whole, you may open it and pour the medicine into a tablespoon of applesauce. Swallow the mixture right away without chewing. Do not store the mixed medicine for later use.
  • If a capsule is given through an oral syringe:
    • Open the capsule and mix the contents with 20 milliliters (mL) of water.
    • Use an oral syringe to draw up all of the mixture and swirl gently.
    • Give the mixture right away. Do not chew.
    • Refill the syringe with 10 mL of water. Swirl gently. Swallow the water.
    • Refill the syringe with another 10 mL of water and swallow it right away. This will make sure you get your whole dose.
  • If a capsule is given through a feeding tube:
    • Open the capsule and combine the medicine with 20 milliliters (mL) of water.
    • Use a catheter-tip syringe to draw up the mixture and swirl gently.
    • Inject the medicine into the feeding tube right away.
    • Refill the syringe with 10 mL of water. Swirl it gently. Inject the water into the tube.
    • Refill with another 10 mL of water and inject this into the tube. This will make sure the full dose is given.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also using products containing rilpivirine.
• Some medicines can affect how dexlansoprazole works. Tell your doctor if you are using any of the following:
  • Ampicillin, atazanavir, dasatinib, digoxin, erlotinib, itraconazole, ketoconazole, methotrexate, mycophenolate mofetil, nelfinavir, nilotinib, rifampin, ritonavir, saquinavir, St John's wort, tacrolimus, voriconazole
  • Blood thinner (including warfarin)
  • Diuretic (water pill)
  • Iron supplements

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, lupus, or osteoporosis.
• This medicine may cause the following problems:
  • Kidney problems, including acute tubulointerstitial nephritis
  • Increased risk of broken bones in the hip, wrist, or spine (more likely if used several times per day or longer than 1 year)
  • Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Lupus
  • Fundic gland polyps (abnormal growth in the upper part of your stomach)
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Dry mouth, increased thirst, confusion, numbness and tingling around the mouth, fingertips, or feet
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Joint pain, rash on your cheeks or arms that gets worse in the sun
• Seizures, dizziness, fast or uneven heartbeat, muscle cramps or twitching
• Severe diarrhea that does not go away, stomach cramps or pain, nausea, vomiting, loss of appetite, weight loss
• Swelling in your body, unusual weight gain, changes in how much or how often you urinate
• Unusual bleeding, bruising, tiredness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Stomach upset
• Trouble having an erection

If you notice other side effects that you think are caused by this medicine, tell your doctor

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