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.

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.

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.

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.

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.