Generic

Dexlansoprazole

Indications

Healing of Erosive Esophagitis: Dexlansoprazole is used to treat erosive esophagitis (EE) of all grades for up to 8 weeks.

Maintenance of Healed Erosive Esophagitis: Dexlansoprazole is prescribed for up to 6 months to keep EE healed and relieve heartburn.

Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD): Dexlansoprazole is used to treat heartburn caused by symptomatic non-erosive gastroesophageal reflux disease (GERD) for a period of four weeks.

Pharmacology

Dexlansoprazole delayed-release capsule is a proton pump inhibitor (PPI) that inhibits the (H+/K+)-ATPase in the gastric parietal cell, suppressing gastric acid output. Dexlansoprazole works by blocking the final step of acid generation by acting on the proton pump. It's lansoprazole's R-enantiomer (A racemic mixture of the R- and S-enantiomers). Dexlansoprazole is available in a capsule form with a Dual Delayed Release (DDR) formulation for oral consumption. This capsule comprises a blend of two types of enteric coated granules with pH-dependent dissolving characteristics that differ. Plasma concentration-time profile exhibiting two separate peaks in dexlansoprazole's dual delayed release formulation; the first peak occurs 1 to 2 hours after delivery, followed by a second peak within 4 to 5 hours. The mean Cmax and AUC values of Dexlansoprazole increased dosage proportionately after oral delivery. Dexlansoprazole is processed extensively in the liver and excreted in the urine.

Dosage & Administration

• 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 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.

Interaction

Atazanavir, Warfarin, Tacrolimus, Clopidogrel, and Methotrexate are some of the medications used. With regard to food and other items, there is no information accessible.

Contraindications

Patients with known hypersensitivity to any component of the formulation should not use dexlansoprazole.

Side Effects

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

Pregnancy & Lactation

Dexlansoprazole has not been studied in pregnant women in sufficient and well-controlled research. There are no adequate and well-controlled Dexlansoprazole studies in lactating mothers.

Precautions & Warnings

Gastric cancer, Clostridium difficile-associated diarrhea, bone fractures, hypomagnesemia, and Dexlansoprazole-Methotrexate concurrent usage.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

Keep the temperature below 30°C and away from light and moisture. Keep out of children's reach.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.