Delpraz 30 Capsule

Dexlansoprazole delayed-release capsule is a Proton Pump Inhibitor (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. 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 shows a 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 values of Dexlansoprazole increased approximately dose-proportionally. Dexlansoprazole is extensively metabolized in the liver and excreted in urine.

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.

1. Use in children & adolescents: Safety and effectiveness of Delpraz in patients below 12 years age have not been established.
2. Geriatric use: No dose adjustment is necessary for elderly patients.
3. Renal impairment: No dose adjustment of Delpraz is necessary for patients with renal
   impairment.
4. Hepatic impairment: No dose adjustment for Delpraz is necessary for patients with mild hepatic impairment. A maximum daily dose of Delpraz 30 mg should be considered for patients with moderate hepatic impairment.

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.

1. 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.
2. With medicine: Atazanavir, Warfarin, Tacrolimus, Clopidogrel & Methotrexate. With food & others: No data available.
3. Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
4. Common side effects: Diarrhea, abdominal pain, nausea, vomiting & flatulence.
5. Pregnancy Category B. There are no adequate and well-controlled studies with Dexlansoprazole in pregnant women. There are no adequate and well-controlled studies with Dexlansoprazole in lactating mothers.
6. Gastric Malignancy, Clostridium difficile-associated diarrhea, Bone fracture, Hypomagnesemia, and concomitant use of Delpraz with Methotrexate.
7. Store below 30°C temperature & in a dry place, protected from light. Keep all medicines out of reach of children.