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 Cmax and AUC value of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreated by urine.
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Dosage
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
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Administration
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.
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Interaction
With medicine: Atazanavir, Warfarin, Tacrolimus, Clopidogrel & Methotrexate. With food & others: No data available.
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 Dexilend with Methotrexate.
Use in Special Populations
Use in children & adolescents: Safety and effectiveness of Dexilend in patients below 12 years age have not been established.

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

Renal impairment: No dose adjustment of Dexilend is necessary for patients with renal
impairment.

Hepatic impairment: No dose adjustment for Dexilend is necessary for patients with mild hepatic impairment. A maximum daily dose of Dexilend 30 mg should be considered for patients with moderate hepatic impairment.
Overdose Effects
There have been no reports of a significant overdose of Dexilend. Multiple doses of Dexilend 120 mg and a single dose of Dexilend 300 mg did not result in death or other severe adverse events.
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.