Dexilant SoluTab

Dexilant SoluTab 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. Dexilant SoluTab 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 orally disintegrating tablet form that melts in your mouth without water and is then swallowed. Care should be taken not to chew the granules after the tablet melts. Alternatively, tablets can be swallowed whole with a glass of water. Do not break or cut Dexilant SoluTab. Dexilant SoluTab is usually taken once a day on an empty stomach, at least 30 minutes before a meal.

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

Dexilant SoluTab is a prescription medication used in people 12 years of age or older:

• for up to 6 months in adults and up to 16 weeks in children 12 to 17 years of age to continue healing of EE 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.

• Takeda Pharmaceuticals America, Inc.

Dexilant SoluTab may cause serious side effects, including:

• See “Drug Precautions”
• Vitamin B-12 deficieny. Dexilant SoluTab reduces the amount of acid in your stomach. Stomach acid is needed to absorb Vitamin B-12 properly. Talk to your doctor about the possibility of Vitamin B-12 deficiency if you have been on Delixant SoluTab for a long time. This usually occurs after 3 or more years of treatment. 
• 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 Dexilant SoluTab, or during treatment, if you will be taking Dexilant SoluTab for a long period of time.

The most common side effects of Dexilant SoluTab include:

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

The most common side effects of Dexilant SoluTab 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 Dexilant SoluTab:

• rash
• face swelling
• throat tightness
• difficulty breathing

Your doctor may stop Dexilant SoluTab 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 Dexilant SoluTab. 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. Dexilant SoluTab may affect how other medicines work, and other medicines may affect how Dexilant SoluTab 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 Dexilant SoluTab if you are allergic to Dexilant SoluTab or any of the other ingredients in Dexilant SoluTab.

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

Dexilant SoluTab can cause serious side effects, including:

• Diarrhea. Dexilant SoluTab 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 Dexilant SoluTab 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 Dexilant SoluTab.

Dexilant SoluTab 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 Dexilant SoluTab there are no specific foods that you must exclude from your diet when receiving Dexilant SoluTab.

Avoid taking Dexilant SoluTab with alcohol. Taking Dexilant SoluTab with alcohol may affect how Dexilant SoluTab works. 

Before you take Dexilant SoluTab, 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 Dexilant SoluTab will harm your unborn baby.
• are breastfeeding or planning to breastfeed. It is not known if Dexilant SoluTab passes into your breast milk. You and your doctor should decide if you will take Dexilant SoluTab or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take Dexilant SoluTab.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Dexilant SoluTab may affect how other medications work. Especially tell your doctor if you take methotrexate. 

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 Dexilant SoluTab. 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 Dexilant SoluTab passes into your breast milk. You and your doctor should decide if you will take Dexilant SoluTab or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take Dexilant SoluTab.

• Take Dexilant SoluTab exactly as prescribed by your doctor.
• Do not change your dose or stop taking Dexilant SoluTab without talking to your doctor first.
• You should take Dexilant SoluTab without food, at least 30 minutes before a meal.
• You may swallow Dexilant SoluTab whole with a full glass of water.
• If you have trouble swallowing Dexilant SoluTab whole, you may take or give them as follows:

1. Take Dexilant SoluTab with water using an oral (by mouth) 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. For people who have a nasogastric (NG) tube that is size 8 French or larger, Dexilant SoluTab may be given as follows:

• 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 Dexilant SoluTab at the same time.

Dexilant SoluTab Dosing Recommendations for Maintenance of Erosive Esophagitis (EE) and Relief of Pyrosis (Heartburn)

Dexilant Solutab is not recommended for the initial treatment of erosive esophagitis.

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

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

Dexilant SoluTab 30 mg once daily for four weeks.

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

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