Product Description

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

Pharmacology: Dexlansoprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting the H+/K+-ATPase enzyme in gastric parietal cells, thereby blocking the final step of acid production. It is the R-enantiomer of lansoprazole and is formulated as a dual delayed-release system containing two types of enteric-coated granules with different pH-dependent release profiles. This results in two plasma concentration peaks, enhancing acid suppression over time. Dexlansoprazole is extensively metabolized in the liver and excreted mainly via urine.

Dosage & Administration: For healing of erosive esophagitis, the recommended dose is 60 mg once daily for up to 8 weeks. For maintenance of healed erosive esophagitis and relief of heartburn, the dose is 30 mg once daily. For symptomatic non-erosive GERD, 30 mg once daily is recommended for 4 weeks. The capsule should be swallowed whole and may be taken with or without food. Alternatively, the capsule may be opened and the intact granules sprinkled on a tablespoon of 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; double dosing should be avoided.

Interaction: Dexlansoprazole may interact with drugs such as atazanavir, warfarin, tacrolimus, clopidogrel, and methotrexate. No significant interaction with food has 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 well-controlled studies in pregnant and lactating women are lacking; therefore, use should be considered only if clearly needed.

Precautions & Warnings: Long-term use may increase the risk of gastric malignancy masking, Clostridium difficile-associated diarrhea, bone fractures, hypomagnesemia, and potential interaction with methotrexate.

Use in Special Populations: Safety and effectiveness have not been established in children below 12 years of age. No dose adjustment is required in elderly patients or those with renal impairment. In patients with moderate hepatic impairment, the maximum recommended dose is 30 mg daily.

Overdose Effects: No significant overdose cases have been reported. High doses have not resulted in severe adverse outcomes, and management should be supportive if overdose occurs.

Therapeutic Class: Proton pump inhibitor (PPI)

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