Dex-PPI30 mg

Erosive Esophagitis (EE)

Dex-PPI is an established, FDA-approved indication for healing of all grades of erosive esophagitis for up to 8 weeks in adults and adolescents 12 years of age and older. Dex-PPI is also indicated for maintenance of healed erosive esophagitis and relief of heartburn for up to 6 months in adults (up to 16 weeks in patients 12 to 17 years of age).

Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)

Dex-PPI is an established indication for treatment of heartburn associated with symptomatic non-erosive GERD for 4 weeks in adults and adolescents 12 years of age and older.

Each Dexlansoprazole delayed-release capsule contains Dexlansoprazole 30 mg or Dexlansoprazole 60 mg as the active ingredient.

Dex-PPI is a proton pump inhibitor (PPI) medicine used to reduce the amount of acid produced in the stomach. Dex-PPI is commonly prescribed to heal acid-related damage to the food pipe (erosive esophagitis) and to relieve persistent heartburn caused by acid reflux (GERD). Dex-PPI uses a special dual delayed-release capsule technology that releases Dex-PPI in two stages, allowing once-daily dosing to control stomach acid over a longer period. Dex-PPI is taken by mouth, usually once a day, with or without food, and the dose and length of treatment with Dex-PPI depend on the condition being treated. As with all proton pump inhibitors, Dex-PPI should be used at the lowest effective dose for the shortest duration appropriate for the condition.

Proton Pump Inhibitor (PPI)

Dexlansoprazole is the R-enantiomer of lansoprazole and works by irreversibly inhibiting the hydrogen-potassium ATPase (proton pump) enzyme system at the secretory surface of gastric parietal cells, blocking the final step of acid production. Dexlansoprazole is formulated as a Dual Delayed-Release (DDR) capsule containing two types of enteric-coated granules with different pH-dependent release profiles, producing two separate plasma concentration peaks (approximately 1-2 hours and 4-5 hours after dosing) and extending the duration of acid suppression compared with conventional single-release PPIs. Dexlansoprazole is extensively metabolized in the liver, mainly via the CYP2C19 and CYP3A4 enzyme pathways, and has an elimination half-life of approximately 1-2 hours.

• Dex-PPI capsules may be taken with or without food.
• Swallow the Dex-PPI capsule whole; do not crush or chew it.
• If swallowing the capsule whole is difficult, the Dex-PPI capsule may be opened and the granules sprinkled onto a tablespoon of applesauce, then swallowed immediately without chewing; the mixture should not be stored for later use.
• As directed by a healthcare professional, the granules from an opened Dex-PPI capsule may also be mixed with water and given through an oral syringe or a nasogastric tube.
• If a dose of Dex-PPI is missed, take it as soon as remembered; if it is almost time for the next dose, skip the missed dose and continue with the regular schedule. Do not take two doses of Dex-PPI at one time.
• Take Dex-PPI at the same time each day for the best effect.

• Clopidogrel: Dex-PPI may modestly reduce formation of the active metabolite of clopidogrel through CYP2C19 inhibition; in clinical studies with Dex-PPI this reduction was small (about 9%) and was not considered clinically important, but clinical judgment is advised when Dex-PPI is combined with clopidogrel.
• Methotrexate (high-dose): Concomitant use of Dex-PPI with high-dose methotrexate may elevate and/or prolong serum methotrexate levels, increasing the risk of methotrexate toxicity; a temporary interruption of Dex-PPI may be considered by the prescriber.
• Warfarin: Concomitant use with Dex-PPI may increase INR and prothrombin time, raising bleeding risk; INR/PT monitoring is recommended.
• Drugs dependent on gastric pH for absorption (e.g., certain antifungal and antiretroviral drugs such as ketoconazole, itraconazole, atazanavir): Because Dex-PPI reduces stomach acidity, Dex-PPI can lower the absorption and effectiveness of these drugs.
• Rilpivirine-containing products: Concurrent use with Dex-PPI is contraindicated because Dex-PPI significantly decreases rilpivirine plasma concentrations and can cause loss of antiviral effect.
• Tacrolimus: Dex-PPI may increase tacrolimus blood concentrations, particularly in patients who are CYP2C19 intermediate or poor metabolizers; monitoring of tacrolimus levels is advised.
• Digoxin: Dex-PPI may increase digoxin exposure; monitoring for digoxin toxicity is recommended.
• Strong CYP2C19/CYP3A4 inducers (e.g., rifampin, St. John's Wort): These may substantially decrease Dex-PPI concentrations and reduce its effectiveness; concomitant use should generally be avoided.

Common Side Effects

Diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence are the most commonly reported side effects of Dex-PPI. In adolescents (12-17 years), headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain have also been reported with Dex-PPI.

Serious Side Effects - Seek Medical Attention

• Signs of a severe allergic reaction (anaphylaxis) such as swelling of the face or throat, severe rash, or difficulty breathing.
• Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis (blistering or peeling skin).
• Signs of kidney problems (acute tubulointerstitial nephritis), such as decreased urination, blood in urine, or swelling.
• Persistent, watery, or bloody diarrhea, which may indicate Clostridioides difficile-associated diarrhea (see Precautions and Warnings).
• Signs of liver problems, such as yellowing of the skin or eyes, dark urine, or severe abdominal pain.
• New or worsening joint pain with a rash on the cheeks or arms that worsens in sunlight (possible cutaneous or systemic lupus erythematosus).
• Signs of low magnesium, such as seizures, irregular heartbeat, tremors, or muscle spasms, particularly with long-term Dex-PPI use (see Precautions and Warnings).
• A bone fracture, particularly of the hip, wrist, or spine, associated with long-term Dex-PPI use (see Precautions and Warnings).

Pregnancy

There are no adequate, well-controlled studies of Dex-PPI use in pregnant women. Animal reproduction studies with Dex-PPI showed effects on fetal/offspring bone development (reduced femur weight, femur length, and growth plate thickness) at maternal exposures around 1.8 times the recommended human dose. Dex-PPI should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and pregnant women should discuss the use of Dex-PPI with their healthcare provider.

Breastfeeding

It is not known whether Dex-PPI passes into human breast milk; related lansoprazole metabolites have been detected in the milk of lactating rats. The decision to use Dex-PPI while breastfeeding should weigh the benefits of breastfeeding and the mother's clinical need for Dex-PPI against any potential risk to the infant, and should be made in consultation with a healthcare professional.

• Gastric malignancy: A symptomatic response to Dex-PPI does not exclude the presence of gastric cancer; consider further evaluation, especially in older patients or those with alarm symptoms such as unexplained weight loss or persistent vomiting.
• Acute tubulointerstitial nephritis: This kidney condition may occur at any point during treatment with Dex-PPI; discontinue promptly if it is suspected.
• Clostridioides difficile-associated diarrhea: Proton pump inhibitors such as Dex-PPI may be associated with an increased risk of C. difficile infection, particularly in hospitalized patients; use Dex-PPI at the lowest effective dose for the shortest duration needed.
• Bone fracture risk: Long-term use of Dex-PPI, especially at high doses and for a year or longer, has been associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine; at-risk patients should follow guidance on adequate calcium and vitamin D intake and use the lowest effective Dex-PPI dose.
• Hypomagnesemia: Low blood magnesium has been reported with prolonged Dex-PPI use, generally after 3 months or more and most often after a year; healthcare providers may consider checking magnesium levels before and periodically during long-term Dex-PPI therapy.
• Vitamin B12 (cyanocobalamin) deficiency: Long-term use of Dex-PPI, generally longer than 3 years, may reduce absorption of vitamin B12; monitor for signs of deficiency if long-term Dex-PPI use is required.
• Cutaneous and systemic lupus erythematosus: New-onset or worsening lupus has been reported with PPI use, including Dex-PPI; discontinue Dex-PPI and refer to a specialist if manifestations occur.
• Fundic gland polyps: Long-term use of Dex-PPI, especially beyond 1 year, is associated with an increased risk of benign fundic gland polyps; use the shortest duration of Dex-PPI appropriate for the condition.
• Interference with diagnostic testing: Dex-PPI can cause false-positive results in tests for neuroendocrine tumors (chromogranin A) and in secretin stimulation tests; Dex-PPI should be temporarily stopped before these tests as advised by the prescriber.
• Methotrexate co-administration: See Drug Interactions; high-dose methotrexate combined with Dex-PPI may require temporary interruption of Dex-PPI.

There is limited experience with Dex-PPI overdose, and no cases involving serious harm or death have been reported. If an overdose of Dex-PPI is suspected, do not induce vomiting unless specifically directed to do so by a doctor or a poison control center. Seek immediate medical attention or contact an emergency or poison control service. Treatment of Dex-PPI overdose is symptomatic and supportive; Dex-PPI is not effectively removed by hemodialysis.

Store Dex-PPI according to the instructions on the product label, and keep Dex-PPI out of the reach of children.

Children

The safety and effectiveness of Dex-PPI have been established only in patients 12 years of age and older. Dex-PPI is not recommended in children younger than 2 years of age because of a potential risk of heart valve (mitral valve) thickening observed in animal studies, and Dex-PPI has not been shown to be effective for symptomatic GERD in infants 1 month to less than 1 year of age. Use of Dex-PPI in children below 12 years of age should only occur under specialist guidance.

Elderly

No overall differences in the safety or effectiveness of Dex-PPI were observed between elderly and younger patients in clinical trials, although elimination of Dex-PPI may be slower and drug exposure somewhat higher in older adults. No dose adjustment of Dex-PPI is required based on age alone, but elderly patients using Dex-PPI long-term should be monitored for bone, magnesium, and vitamin B12-related risks (see Precautions and Warnings).

Renal Impairment

No dosage adjustment of Dex-PPI is required in patients with renal impairment, as Dex-PPI is primarily eliminated through the liver rather than the kidneys.

Hepatic Impairment

No dose adjustment of Dex-PPI is needed in mild hepatic impairment (Child-Pugh Class A). In moderate hepatic impairment (Child-Pugh Class B), the recommended dose of Dex-PPI for healing erosive esophagitis is reduced to 30 mg once daily. Dex-PPI is not recommended in patients with severe hepatic impairment (Child-Pugh Class C), as Dex-PPI has not been studied in this population.

The duration of Dex-PPI treatment depends on the indication: healing of erosive esophagitis is typically treated with Dex-PPI for up to 8 weeks; maintenance therapy after healing, to keep the esophagitis healed and control heartburn, may continue with Dex-PPI for up to 6 months in adults (up to 16 weeks in patients 12-17 years); and symptomatic non-erosive GERD is generally treated with Dex-PPI for 4 weeks. Long-term or repeated courses of Dex-PPI should be reviewed periodically by a healthcare professional, given the risks associated with prolonged PPI use (see Precautions and Warnings).

Proton Pump Inhibitor (PPI); Antisecretory / Antiulcer agent

Dexlansoprazole irreversibly binds to and inhibits the hydrogen-potassium ATPase (H+/K+-ATPase) enzyme, or proton pump, located on the surface of gastric parietal cells, thereby blocking the final step of gastric acid secretion regardless of the stimulus.

Dex-PPI is approved for use only in patients 12 years of age and older for the labeled indications. The safety and effectiveness of Dex-PPI have not been established in children below 12 years of age. Dex-PPI is not recommended in children under 2 years of age because of a possible risk of heart valve thickening seen in animal studies, and studies have not shown Dex-PPI (or its parent compound lansoprazole) to be effective for symptomatic GERD in infants aged 1 month to less than 1 year.