Dexlansoprazole

Dexlansoprazole is a prescription medication used to treat the symptoms of erosive esophagitis and gastroesophageal reflux disease. 

• Dexlansoprazole is available under the following different brand names: Dexilant, Kapidex, Dexilant SoluTab

Adult and pediatric dosage

Delayed-release capsule

• 30 mg
• 60 mg

Delayed-release oral disintegrating tablet (ODT)

• 30 mg

Erosive Esophagitis

Adult dosage

• Healing (capsule): 60 mg orally once a day for up to 8 weeks
• Maintenance (capsule or ODT): 30 mg orally once a day for up to 6 months

Pediatric dosage

Children below 12 years

• Safety and efficacy not established

Children above12 years

• Healing (capsule): 60 mg orally once a day for up to 8 weeks
• Maintenance (capsule or ODT): 30 mg orally once a day for up to 6 months

Gastroesophageal Reflux Disease

Adult dosage

• Capsule or orally disintegrating: 30 mg orally once a day for 4 weeks

Pediatric dosage

Children below 12 years

• Safety and efficacy not established

Children above 12 years

• Capsule or orally disintegrating tablet: 30 mg orally once a day for 4 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Dexlansoprazole include:

• diarrhea
• stomach pain
• nausea
• common cold
• vomiting
• gas
• headache
• stomach pain
• diarrhea
• pain or swelling (inflammation) in the mouth, nose, or throat

Serious side effects of Dexlansoprazole include:

• bone fracture
• allergic reaction
• acute nephritis (sudden swelling in the kidneys)
• low level of magnesium
• low level of vitamin B12
• lupus (an autoimmune disease that causes pain and inflammation throughout the body)
• polyps (abnormal growths of tissue) in the upper area of the stomach
• severe diarrhea related to Clostridium difficile, which is a type of bacterial infection that causes the colon to swell

Rare side effects of Dexlansoprazole include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Dexlansoprazole has severe interactions with the following drugs:
  • erlotinib
  • mavacamten
  • nelfinavir
  • rilpivirine
• Dexlansoprazole has serious interactions with at least 30 other drugs.
• Dexlansoprazole has serious interactions with at least 63 other drugs.
• Dexlansoprazole has minor interactions with the following drugs:
  • axitinib
  • blessed thistle
  • cyanocobalamin
  • devil's claw
  • elvitegravir/cobicistat/emtricitabine/tenofovir DF
  • ferric carboxymaltose
  • levoketoconazole
  • levothyroxine
  • liothyronine
  • liotrix
  • lisdexamfetamine
  • methamphetamine
  • phytoestrogens
  • ribociclib
  • risedronate
  • ruxolitinib topical
  • theophylline
  • thyroid desiccated

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity reactions, including anaphylaxis and acute interstitial nephritis, reported
• PPIs are contraindicated with rilpivirine-containing products

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dexlansoprazole?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dexlansoprazole?”

Cautions

• Proton pump inhibitors (PPIs) are possibly associated with an increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider the diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve
• May interfere with absorption of drugs for which pH is a determinant of oral bioavailability (e.g., atazanavir)
• Proton pump inhibitors may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite
• Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to a specialist; most patients improve with discontinuation of PPI alone in 4- 12 weeks; serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations
• Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthemata’s pustulosis (AGEP) reported in association with the use of PPIs; discontinue therapy at first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation
• Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine; particularly with prolonged (above1 year), high-dose therapy
• Relief of symptoms does not eliminate the possibility of a gastric malignancy; consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or early symptomatic relapse after completing treatment with a PPI
• Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels
• Therapy increases the risk of Salmonella, Campylobacter, and other infections
• Brand name changed from Kapidex to Dexilant
• Daily long-term use (e.g., above 3 years) may lead to malabsorption or a deficiency of cyanocobalamin
• Acute interstitial nephritis was reported in patients taking proton pump inhibitors (see Contraindications)
• Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity; increased CgA level may cause false-positive results in diagnostic investigations for neuroendocrine tumors; temporarily stop dexlansoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high
• May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered concomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of dexlansoprazole therapy with high dose methotrexate administration
• A significant increase in systemic exposure to dexlansoprazole was reported in patients with moderate hepatic impairment (Child-Pugh Class B) who received a single dose of 60 mg compared to healthy subjects with normal hepatic function
• PPI therapy is associated with an increased risk of fundic gland polyp; risk increases with long-term use above1 year; the patient may be asymptomatic; the problem is usually identified incidentally on endoscopy; use the shortest duration of therapy appropriate to the condition being treated
• Not recommended in pediatric patients below 2 years; nonclinical studies in juvenile rats with lansoprazole have demonstrated the adverse effects of heart valve thickening
• Acute tubulointerstitial nephritis (TIN) reported in patients taking PPIs; may occur at any point during PPI therapy; patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia); in reported case series, some patients were diagnosed on biopsy and in absence of extra-renal manifestations (e.g., fever, rash or arthralgia); discontinue therapy and evaluate patients with suspected acute TIN
• Hypomagnesemia and mineral metabolism
  • Hypomagnesemia may occur with prolonged use (i.e., above 1 year); adverse effects may result and include tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued; consider monitoring magnesium levels before initiation of PPI treatment and periodically
  • Hypomagnesemia may lead to hypocalcemia and/or hypokalaemia and may exacerbate underlying hypocalcemia in at-risk patients; in most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI
  • Consider monitoring magnesium and calcium levels before initiation of therapy and periodically while on treatment in patients with a pre-existing risk of hypocalcemia (e.g., hypoparathyroidism); supplement with magnesium and/or calcium as necessary. If hypocalcemia is refractory to treatment, consider discontinuing the PPI

Pregnancy & Lactation

• There are no studies on dexlansoprazole use in pregnant women to inform a drug-associated risk; dexlansoprazole is an 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.
• In animal reproduction studies, oral administration of lansoprazole to rats during organogenesis through lactation at 1.8 times the maximum recommended human dexlansoprazole dose; produced reductions in the offspring in femur weight, femur length, crown-rump length, and growth plate thickness (males only) on postnatal day 21; these effects were associated with a reduction in body weight gain; advise pregnant women of the potential risk to the fetus
• Lactation
  • There is no information regarding the presence of dexlansoprazole in human milk, effects on the breastfed infant, or milk production; however, lansoprazole and its metabolites are present in rat milk; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and potential adverse effects on the breastfed child from therapy or the underlying maternal condition