What is Dexilant (dexlansoprazole), and how does it work?
Dexilant is a prescription medicine called a proton pump inhibitor (PPI). Dexilant reduces the amount of acid in your stomach.
Dexilant capsules are used in people 12 years of age and older:
- 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)
GERD happens when acid from your stomach enters the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste or burping.
It is not known if Dexilant is safe and effective in children under 12 years of age.
Dexilant is not effective for symptoms of GERD in children under 1 year of age.
What are the side effects of Dexilant?
Dexilant may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
Dexilant can cause serious side effects, including:
- A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Dexilant, may develop a kidney problem called acute interstitial nephritis, that can happen at any time during treatment with PPI medicines. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.
- Diarrhea. Dexilant 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 PPI 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 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.
- Certain types of lupuserythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.
- Vitamin B12 deficiency. Dexilant reduces the amount of acid in your stomach. Stomach acid is needed to absorb Vitamin B12 properly. Talk with your doctor about the possibility of Vitamin B12 deficiency if you have been on Dexilant 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 PPI 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:
Your doctor may check the level of magnesium in your body before you start taking Dexilant, or during treatment, if you will be taking Dexilant for a long period of time.
The most common side effects of Dexilant in adults include:
The most common side effects of Dexilant in children 12 to 17 years of age include:
Other side effects:
Serious allergic reactions. Tell your doctor if you get any of the following symptoms with Dexilant:
Your doctor may stop Dexilant 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. 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.
What is the dosage for Dexilant?
- Take Dexilant exactly as prescribed by your doctor.
- Do not change your dose or stop taking Dexilant without talking to your doctor first.
- Take Dexilant capsules with or without food.
- Swallow Dexilant capsules whole. Do not chew Dexilant capsules or the granules that are in the capsules.
- If you have trouble swallowing a whole capsule, you can open the capsule and take the contents in applesauce. See the "Instructions for Use" at the end of this Medication Guide for instructions on how to take Dexilant capsules with applesauce.
- See the "Instructions for Use" at the end of this Medication Guide for instructions on how to mix and give Dexilant capsules with water using an oral syringe or through a nasogastric tube.
- If you miss a dose of Dexilant, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take your next dose at your regular time. Do not take 2 doses at the same time to make up for the missed dose.
- If you take too much Dexilant, call your doctor or your poison control center at 1-800-222- 1222 right away or go to the nearest hospital emergency room.
Taking Dexilant 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.
Giving Dexilant capsules with water using an oral 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 oral syringe to keep the granules from settling.
- Place the tip of the oral syringe in your mouth. Give the medicine right away. Do not save the water and granule mixture for later use.
- Refill the syringe with 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 step 6.
Giving Dexilant capsules with water through a nasogastrictube (NG tube):
For people who have an NG tube that is size 16 French or larger, Dexilant 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 catheter-tip syringe to keep the granules 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 water and granule mixture for later use.
- Refill the catheter-tip syringe with 10 mL of water and swirl gently. Flush the NG tube with the water.
- Repeat step 7.
What drugs interact with Dexilant?
Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with Dexilant and instructions for preventing or managing them.
Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
Table 3: Clinically Relevant Interactions Affecting Drugs Co-Administered with Dexilant and Interactions with Diagnostics
|Clinical Impact:||The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.|
Concomitant use with Dexilant is contraindicated. See prescribing information.|
Atazanavir: See prescribing information for atazanavir for dosing information.
Nelfinavir: Avoid concomitant use with Dexilant. See prescribing information for nelfinavir.
Saquinavir: See the prescribing information for saquinavir and monitor for potential saquinavir toxicities.
Other antiretrovirals: See prescribing information.
|Clinical Impact:||Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.|
|Intervention:||Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin.|
|Clinical Impact:||Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted.|
|Intervention:||A temporary withdrawal of Dexilant may be considered in some patients receiving high-dose methotrexate.|
|Clinical Impact:||Potential for increased exposure of digoxin.|
|Intervention:||Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. See prescribing information for digoxin.|
|Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole)|
|Clinical Impact:||Dexlansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.|
|Intervention:||Mycophenolate mofetil (MMF): Co-administration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving Dexilant and MMF. Use DEXiLaNT with caution in transplant patients receiving MMF. See the prescribing information for other drugs dependent on gastric pH for absorption.|
|Clinical Impact:||Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.|
|Intervention:||Monitor tacrolimus whole blood trough concentrations. Dose adjustment of tacrolimus may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus.|
|Interactions with Investigations of Neuroendocrine Tumors|
|Clinical Impact:||CgA levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors.|
|Intervention:||Temporarily stop Dexilant treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.|
|Interaction with Secretin Stimulation Test|
|Clinical Impact:||Hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma.|
|Intervention:||Temporarily stop Dexilant treatment at least 30 days before assessing to allow gastrin levels to return to baseline.|
|False Positive Urine Tests for THC|
|Clinical Impact:||There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs.|
|Intervention:||An alternative confirmatory method should be considered to verify positive results.|
Table 4: Clinically Relevant Interactions Affecting Dexilant When Co-Administered with Other Drugs and Substances
|CYP2C19 or CYP3A4 Inducers|
|Clinical Impact:||Decreased exposure of dexlansoprazole when used concomitantly with strong inducers.|
|Intervention:||St. John's Wort, rifampin: Avoid concomitant use with Dexilant.|
|Ritonavir-containing products: See prescribing information.|
|CYP2C19 or CYP3A4 Inhibitors|
|Clinical Impact:||Increased exposure of dexlansoprazole is expected when used concomitantly with strong inhibitors.|
|Intervention:||Voriconazole: See prescribing information.|
Is Dexilant safe to take while pregnant or breastfeeding?
Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and lansoprazole use. There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk. Dexlansoprazole is the R-enantiomer of lansoprazole, and published observational studies of lansoprazole use during pregnancy did not demonstrate an association of adverse pregnancy-related outcomes with lansoprazole
There is no information regarding the presence of dexlansoprazole in human milk, the effects on the breastfed infant, or the effects on milk production. However, lansoprazole and its metabolites are present in rat milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Dexilant and any potential adverse effects on the breastfed child from Dexilant or from the underlying maternal condition.
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GERD (gastroesophageal reflux disease) is the upward movement of stomach content, including acid, into the esophagus and sometimes into or out of the mouth. Common symptoms of GERD in children include colic, feeding problems, poor growth, frequent vomiting or coughing, heartburn, regurgitation, recurrent wheezing, pneumonia, choking, or gagging. Treatment may involve elevating the child's bed, keeping the child upright after eating, limiting foods that seem to make the reflux worse, encouraging your child to exercise, and serving several small meals a day.
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