Dexlansoprazole

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 a delayed-release capsule form and is taken once a day, with or without food. It also comes as a delayed-release orally disintegrating tablet form and is taken once a day on an empty stomach, 30 minutes before a meal. 

Do not chew, divide, or break dexlansoprazole capsules and orally disintegrating tablets. Allow tablet to melt on the tongue and swallow without chewing, or swallow tablets or capsules whole.

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

CYP2C19 is an enzyme in the blood that is responsible for breaking down dexlansoprazole and other drugs in the body. Some patients have less of this protein in their bodies, affecting how much of the drug gets eliminated. Levels of CYP2C19 can vary greatly between individuals, and those having less of this protein are known as "poor metabolizers." 

CYP2C19 testing is done to determine whether you are a poor metabolizer. If you are a poor metabolizer, the levels of dexlansoprazole in your blood can become too high. As a result you may be at an increased risk of having more side effects from dexlansoprazole. 

Your doctor may adjust your dose of dexlansoprazole if you are a poor metabolizer.

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 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).

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

Dexlansoprazole may be found in some form under the following brand names:

• Dexilant

• Dexilant SoluTab

• Kapidex

Dexlansoprazole may cause serious side effects, including:

• See “Drug Precautions”
• Vitamin B-12 deficiency. Dexlansoprazole reduces the amount of acid in your stomach. Stomach acid is needed to absorb Vitamin B-12 properly. Talk with your doctor about the possibility of Vitamin B-12 deficiency if you have been on dexlansoprazole for a long time (more than 3 years). 
• 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

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

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

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.

Dexlansoprazole orally disintegrating tablets should not be taken with alcohol. Alcohol may may affect how dexlansoprazole orally disintegrating tablets works. 

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.

Dexlansoprazole capsules

• You can take dexlansoprazole capsules with or without food.
• Swallow dexlansoprazole capsules whole.

Dexlansoprazole orally disintegrating tablets

• Take dexlansoprazole orally disintegrating tablets on an empty stomach, 30 minutes before a meal. 
• Place the tablet on the tongue, allow to disintegrate and swallow without water.
• Do not chew microgranules.
• May also be swallowed whole with water.
• Avoid use of alcohol when taking dexlansoprazole orally disintegrating tablets.

If you have trouble swallowing dexlansoprazole capsules or tablets whole, you may take or give them as follows:

Dexlansoprazole capsules:

1. Take dexlansoprazole capsules 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 capsules 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 capsules 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 the previous step.

Dexlansoprazole orally disintegrating tablet:

1. Dexlansoprazole orally disintegrating tablet with water using an oral syringe: 

• Put 1 tablet in an oral syringe and draw up 20 mL of water into the oral syringe.
• Gently swirl the oral syringe to mix the tablet and the water. 
• After the tablet is mixed in the water, place the tip of the oral syringe in your mouth. Give the medicine right away. Do not save the tablet and water mixture for later use. 
• Refill the syringe with about 10 mL of water and swirl gently. Place the tip of the oral syringe in your mouth and give the medicine that is left in the syringe. 
• Repeat the previous step. 

2. Administration with Water via a NG Tube (≥8 French):

• Put 1 tablet in a catheter-tip syringe and draw up 20 mL of water.
• Gently swirl the catheter-tip syringe to mix the tablet and the water.
• After the tablet is mixed in the water, swirl the catheter-tip syringe gently in order to keep the particles from settling.
• Connect the catheter-tip syringe to the NG tube. 
• Give the mixture right away through the NG tube that goes into the stomach. Do not save the tablet and water mixture for later use. 
• Refill the catheter-tip syringe with about 10 mL of water and swirl gently. Flush the NG tube with water. 
• 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.

Take dexlansoprazole exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. 

The dose will be based on the condition being treated. 

Heal Erosive Esophagitis:

• The recommended dose of Dexilant (dexlansoprazole) capsules is 60 mg once daily for up to eight weeks.

Dexlansoprazole orally disintegrating tablets are not recommended for the initial treatment of erosive esophagitis. 

Maintenance of Erosive Esophagitis:

• After erosive esophagitis is healed, the recommended dose is Dexilant capsules and Dexilant Solutab (dexlansoprazole) 30 mg once daily. 

Heartburn Related to Gastroesophageal Reflux Disease (GERD):

• The recommended dose of Dexilant capsules and Dexilant Solutab (dexlansoprazole) is 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 an 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.