Healing of erosive esophagitis: Dexlansoprazole is indicated for the treatment and healing of all grades of erosive esophagitis for up to 8 weeks.

Maintenance of healed erosive esophagitis: It is used to maintain healing of erosive esophagitis and provide relief from heartburn for up to 6 months.

Symptomatic non-erosive gastroesophageal reflux disease (GERD): Dexlansoprazole is indicated for the treatment of heartburn associated with symptomatic non-erosive GERD for up to 4 weeks.

Dexlansoprazole delayed-release capsules are proton pump inhibitors (PPIs) that reduce gastric acid secretion by selectively inhibiting the (H⁺/K⁺)-ATPase enzyme in gastric parietal cells. By targeting the proton pump, Dexlansoprazole blocks the final step of acid production. It is the R-enantiomer of lansoprazole, which is a racemic mixture of R- and S-enantiomers. Dexlansoprazole is formulated as a Dual Delayed Release (DDR) capsule for oral use. It contains two types of enteric-coated granules with different pH-dependent release properties. This formulation produces a plasma concentration-time profile with two peaks: the first occurs 1–2 hours after administration, and the second occurs 4–5 hours later. After oral administration, the mean maximum plasma concentration (Cmax) and area under the curve (AUC) increase in a dose-proportional manner. Dexlansoprazole is extensively metabolized in the liver and eliminated primarily through urine.

Dexlansoprazole dosing recommendations-

• Maintenance of Healed erosive esophagitis and relief of heartburn: 30 mg Once daily
• Symptomatic Non-Erosive GERD: 30 mg Once daily for 4 weeks
• Healing of erosive esophagitis: 60 mg Once daily for up to 8 weeks

Dexlansoprazole MUPS dosing recommendations-

• Maintenance of healed erosive esophagitis and relief of heartburn: One 30 mg tablet once daily for 6 months in adults and 16 weeks in patients 12 to 17 years of age
• Symptomatic Non-Erosive GERD: One 30 mg tablet once daily for 4 weeks

Dexlansoprazole can be taken without regard to food. It should be swallowed whole

Alternatively, Dexlansoprazole capsules can be administered as follows:

• Open capsule
• Sprinkle intact granules on one tablespoon
• Swallow immediately

Granules should not be chewed.

If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.

With medicines: Atazanavir, warfarin, tacrolimus, clopidogrel, and methotrexate. With food and others: No data available.

Dexlansoprazole is contraindicated in patients with a known hypersensitivity to any of the ingredients of the formulation.

Common side effects: Diarrhea, abdominal pain, nausea, vomiting, and flatulence.

Pregnancy Category B. There are no adequate and well-controlled studies of Dexlansoprazole in pregnant women. There are also no adequate and well-controlled studies in breastfeeding mothers.

Gastric malignancy, Clostridium difficile–associated diarrhea, bone fractures, hypomagnesemia, and concomitant use of dexlansoprazole with methotrexate.

Use in children & adolescents: Safety and effectiveness of Dexlansoprazole in patients under 12 years of age have not been established.

Geriatric use: No dose adjustment is required for elderly patients.

Renal impairment: No dose adjustment of Dexlansoprazole is necessary in patients with renal impairment.

Hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment. In patients with moderate hepatic impairment, a maximum daily dose of Dexlansoprazole 30 mg should be considered.

There are no reports of significant overdose with Dexlansoprazole. Administration of multiple doses of 120 mg or a single dose of 300 mg did not result in death or serious adverse effects.

Proton Pump Inhibitor

Store below 30°C in a dry place, protected from light. Keep all medicines out of reach of children.