Product Description

Indications: Regler is indicated for healing all grades of erosive esophagitis (EE) for up to 8 weeks, for maintenance of healed erosive esophagitis and relief of heartburn for up to 6 months, and for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for up to 4 weeks.

Pharmacology: Dexlansoprazole is a proton pump inhibitor that suppresses gastric acid secretion by selectively inhibiting the H+/K+-ATPase enzyme system in gastric parietal cells. It is the R-enantiomer of lansoprazole and is formulated as a dual delayed-release (DDR) system, providing two separate peaks of drug release to prolong acid suppression. After administration, peak plasma concentrations occur in two phases, enhancing sustained therapeutic effect. It is extensively metabolized in the liver and eliminated primarily via urine.

Dosage & Administration: For healing of erosive esophagitis, the recommended dose is 60 mg once daily for up to 8 weeks. For maintenance therapy and relief of heartburn, 30 mg once daily is recommended for up to 6 months. For symptomatic non-erosive GERD, the dose is 30 mg once daily for 4 weeks. The MUPS formulation follows similar dosing, with 30 mg once daily for maintenance and GERD treatment.

Administration: Regler can be taken regardless of meals and should be swallowed whole. Alternatively, capsules may be opened and the intact granules sprinkled onto a spoonful of soft food and swallowed immediately without chewing. If a dose is missed, it should be taken as soon as possible unless it is close to the next scheduled dose, in which case the missed dose should be skipped. Double dosing should be avoided.

Interaction: Concomitant use with drugs such as atazanavir, warfarin, tacrolimus, clopidogrel, and methotrexate may require caution. No significant food-related interactions have been established.

Contraindications: Contraindicated in patients with known hypersensitivity to dexlansoprazole or any component of the formulation.

Side Effects: Common adverse effects include diarrhea, abdominal pain, nausea, vomiting, and flatulence.

Pregnancy & Lactation: Classified as pregnancy category B. Adequate and controlled studies in pregnant or lactating women are not available, so use should be based on clinical necessity and physician guidance.

Precautions & Warnings: Long-term use may mask symptoms of gastric malignancy. There is a risk of Clostridium difficile-associated diarrhea, hypomagnesemia, bone fractures, and interaction with methotrexate. Patients should be monitored appropriately during prolonged therapy.

Use in Special Populations: Safety and efficacy in children below 12 years have not been established. No dose adjustment is required for elderly or patients with renal impairment. In mild hepatic impairment, no adjustment is needed, but in moderate hepatic impairment, the maximum recommended dose is 30 mg daily.

Overdose Effects: No significant overdose cases have been reported. Even high doses have not been associated with serious adverse outcomes. Management should be supportive if overdose occurs.

Therapeutic Class: Proton Pump Inhibitor

Storage Conditions: Store below 30°C in a dry place, protected from light. Keep out of reach of children.