LANSODEX 30

Generic Name: Dexlansoprazole

Therapeutic Name: Antiulcerant Drugs

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Dexlansoprazole delayed-release capsule is a Proton Pump Inhibitor (PPI) that inhibits gastric acid secretion. Dexlansoprazole 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. Dexlansoprazole capsule contains a mixture of two types of enteric coated granules with dierent pH-dependent dissolution proles. Dexlansoprazole suppresses gastric acid secretion by specic inhibition of the (H+/K+)- ATPase in the gastric parietal cell. By acting specically on the proton pump, Dexlansoprazole blocks the nal step of acid production. The formulation of Dexlansoprazole utilizing Dual Delayed Release technology results in plasma concentration-time prole with two distinct peaks; the rst peak occurs 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. No accumulation of Dexlansoprazole occurs after multiple once daily doses of 30 mg or 60 mg. After oral administration of Dexlansoprazole 30 mg or 60 mg to healthy subjects, mean Cmax and AUC values of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreted by urine
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