Indications

Healing of Erosive Esophagitis : Dexlansoprazole is indicated for the healing of all grades of erosive esophagitis (EE) for up to 8 weeks. Maintenance of Healed Erosive Esophagitis : Dexlansoprazole is indicated to maintain healing of EE and relief of heartburn for up to 6 months. Symptomatic Non-Erosive Gastroesophageal Reflux Disease : Dexlansoprazole is indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks.

Composition

Pharmacology

Dexlansoprazole delayed-release capsule is a Proton Pump Inhibitor (PPI) which suppresses gastric acid secretion by specific inhibition of the (H + /K + )-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Dexlansoprazole blocks the final step of acid production. It is the R-enantiomer of lansoprazole (A racemic mixture of the R- and S-enantiomers). Dexlansoprazole is supplied as a Dual Delayed Release (DDR) formulation in a capsule for oral administration. This capsule contains a mixture of two types of enteric coated granules with different pH-dependent dissolution profiles. The dual delayed release formulation in dexlansoprazole, plasma concentration-time profile with two distinct peaks; the first peak occurs 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. After oral administration, mean C max and AUC value of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreated by urine.

Dosage & Administration

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

Contraindications

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

Side Effects

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

Pregnancy & Lactation

Pregnancy Category B. There is no adequate and well-controlled studies with Dexlansoprazole in pregnant women. There is no adequate and well-controlled studies with Dexlansoprazole in Lactating mother.

Precautions & Warnings

Gastric Malignancy, Clostridium difficile Associated Diarrhea, Bone fracture, Hypomagnesemia, and concomitant use of Dexlansoprazole with Methotrexate.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

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