IBN SINA PHARMACEUTICALS LTD.
Dexlansoprazole is indicated for- Healing of all grades of Erosive Esophagitis (EE) for up to 8 weeks. Maintain healing of Erosive Esophagitis and relief of heartburn for up to 6 month. Treatment of heartburn associated with symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks.
Proton Pump Inhibitor
Dexlansoprazole delayed-release capsule is a Proton Pump Inhibitor (PPI), that inhibits gastric acid secretion. It is the R-enantiomer of lansoprazole (A racemic mixture of the R- and S-enantiomers). This 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 different pH-dependent dissolution profiles. Dexlansoprazole is a PPI that 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.
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. Administration Dexlansoprazole can be taken without regard to food or the timing of food. It should be swallowed whole. 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.
Lansoprazole appears to be a selective inhibitor of the cytochrome P-450 monooxygenase system; there may be an effect on hepatic clearance, but there have been no reports to date of clinically relevant interactions. There is some uncertainty over the effect of Lansoprazole on the oral combined contraceptive pill. Further assessment is currently underway. Physiological changes similar to those found with Omeprazole are likely to take place because of the reduction in gastric acid, which is likely to influence the bacterial colonization of the stomach and duodenum and also vitamin B12 absorption.
Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
Common side effects are Diarrhea, abdominal pain, nausea, upper respiratory tract Infection, vomiting & flatulence.
There are no adequate or well-controlled studies in pregnant women with Dexlansoprazole. Exposure in clinical trials was very limited. Dexlansoprazole should not be administered to pregnant women unless the expected benefits outweigh the potential risks. It is not known whether dexlansoprazole is excreted in human milk. However, Dexlansoprazole and its metabolites are excreted in the milk of rats. As many drugs are excreted in human milk, Dexlansoprazole should not be given to nursing mothers unless its use is considered
There have been no reports of significant overdose of Dexlansoprazole. Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in any severe adverse events.
Gastric malignancy, Clostridium difficile associated diarrhea, bone fracture, hypomagnesemia, concomitant use of Dexlansoprazole with Methotrexate.
Store at temperature not exceeding 308C in a dry place. Protect from light & moisture.