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Dexlansoprazole is a prescription medication used to treat acid-related damage to the lining of the esophagus (erosive esophagitis, or EE) and heartburn related to gastroesophageal reflux disease (GERD) in adults. Dexlansoprazole belongs to a group of drugs called proton pump inhibitors (PPI), which reduce the amount of acid in the stomach.

This medication comes in capsule form and is taken once a day, with or without food.

Common side effects of dexlansoprazole include diarrhea, stomach pain, and nausea.

Dexlansoprazole is a prescription medication used in adults:

• 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 to continue healing of erosive esophagitis and relief of heartburn.
• for 4 weeks to treat heartburn related to gastroesophageal reflux disease (GERD).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Quality Care Products, LLC

• Takeda Pharmaceuticals America, Inc.

Dexlansoprazole may cause serious side effects, including:

• See “Drug Precautions”
• Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away if you develop any of these symptoms:

• seizures
• dizziness
• abnormal or fast heartbeat
• jitteriness
• jerking movements or shaking (tremors)
• muscle weakness
• spasms of the hands and feet
• cramps or muscle aches
• spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking dexlansoprazole, or during treatment, if you will be taking dexlansoprazole for a long period of time.

The most common side effects of dexlansoprazole include:

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

Serious allergic reactions may occur. Tell your doctor if you get any of the following symptoms with dexlansoprazole:

• rash
• face swelling
• throat tightness
• difficulty breathing

Your doctor may stop dexlansoprazole if these symptoms happen.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of dexlansoprazole. For more information, ask your doctor or pharmacist.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Dexlansoprazole may affect how other medicines work, and other medicines may affect how dexlansoprazole works.

Especially tell your doctor if you take:

• an antibiotic that contains ampicillin
• atazanavir (Reyataz)
• digoxin (Lanoxin)
• a product that contains iron
• ketoconazole (Nizoral)
• warfarin (Coumadin, Jantoven)
• tacrolimus (Prograf)
• methotrexate
• erlotinib
• medications that contain iron including Feosol, Ferra-TD, Fer-in-Sol, and ferrous sulfate

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Do not take dexlansoprazole if you are allergic to dexlansoprazole or any of the other ingredients in dexlansoprazole.

Dexlansoprazole may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Dexlansoprazole can cause serious side effects, including:

• Diarrhea. Dexlansoprazole may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines.

Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.

• Bone fractures. People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take dexlansoprazole exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take dexlansoprazole.

Dexlansoprazole can have other serious side effects. See "Side Effects" section.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of dexlansoprazole there are no specific foods that you must exclude from your diet when receiving dexlansoprazole.

Before you take dexlansoprazole, tell your doctor if you:

• have been told that you have low magnesium levels in your blood
• have liver problems
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if dexlansoprazole will harm your unborn baby.
• are breastfeeding or planning to breastfeed. It is not known if dexlansoprazole passes into your breast milk. You and your doctor should decide if you will take dexlansoprazole or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take dexlansoprazole.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. There are no well-done studies that have been done in humans with dexlansoprazole. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if dexlansoprazole passes into your breast milk. You and your doctor should decide if you will take dexlansoprazole or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take dexlansoprazole.

• Take dexlansoprazole exactly as prescribed by your doctor.
• Do not change your dose or stop taking dexlansoprazole without talking to your doctor first.
• You can take dexlansoprazole with or without food.
• Swallow dexlansoprazole capsules whole.
• If you have trouble swallowing dexlansoprazole capsules whole, you may take or give them as follows:

1. Take dexlansoprazole with applesauce
   • Place 1 tablespoon of applesauce into a clean container.
   • Carefully open the capsule and sprinkle the granules onto the applesauce.
   • Swallow the applesauce and granules right away. Do not chew the granules. Do not save the applesauce and granules for later use.
2. Take dexlansoprazole with water using an oral (by mouth) syringe
   • Place 20 mL of water into a clean container.
   • Carefully open the capsule and empty the granules into the container of water.
   • Use an oral syringe to draw up the water and granule mixture.
   • Gently swirl the syringe to keep the granules from settling.
   • Give the mixture into the mouth right away. Do not save the water and granule mixture for later use.
   • Refill the syringe with 10 mL of water and swirl gently. Give the water into the mouth.
   • Repeat the previous step.
3. For people who have a nasogastric (NG) tube that is size 16 French or larger, dexlansoprazole may be given as follows:
   • Place 20 mL of water into a clean container.
   • Carefully open the capsule and empty the granules into the container of water.
   • Use a 60 mL catheter-tip syringe to draw up the water and granule mixture.
   • Gently swirl the syringe to keep the granules from settling.
   • Connect the catheter-tip syringe to the nasogastric tube.
   • Give the mixture right away through the nasogastric tube into the stomach. Do not save the water and granule mixture for later use.
   • Refill the syringe with 10 mL of water and swirl gently. Flush the nasogastric tube with the water.
   • Repeat repeat the previous step.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of dexlansoprazole at the same time.

Dexlansoprazole Dosing Recommendations for Erosive Esophagitis (EE)

The recommended dexlansoprazole dosage to heal erosive esophagitis is 60 mg once daily for up to eight weeks.

After erosive esophagitis is healed, the recommended dose is dexlansoprazole 30 mg once daily. 

Dexlansoprazole Dosing Recommendations for Heartburn related to Gastroesophageal Reflux Disease (GERD)

Dexlansoprazole 30 mg once daily for four weeks.

If you take too much dexlansoprazole call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If dexlansoprazole is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store dexlansoprazole at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep dexlansoprazole and all medicines out of the reach of children.