Dexlansoprazole

Dexlansoprazole is a PPI which suppresses gastric acid secretion by specific inhibition of the (H+/K+)-ATPase in the gastric parietal cell. It is the R-enantiomer of lansoprazole and is supplied as a Dual Delayed Release (DDR) formulation, which produces two distinct plasma concentration peaks; the first peak occurs 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours.

• Healing of erosive esophagitis (up to 8 weeks)
• Maintenance of healed erosive esophagitis (up to 6 months)
• Treatment of heartburn associated with symptomatic non-erosive GERD (4 weeks)

Dexlansoprazole delayed-release capsule is a PPI which suppresses gastric acid secretion by specific inhibition of the (H+/K+)-ATPase in the gastric parietal cell. It is the R-enantiomer of lansoprazole and is supplied as a Dual Delayed Release (DDR) formulation.

Dexlansoprazole blocks the proton pump (H+/K+ ATPase) in gastric parietal cells, inhibiting the final step of acid production, thereby reducing stomach acid.

Healing of erosive esophagitis: 60 mg once daily (up to 8 weeks).
Maintenance of healed erosive esophagitis: 30 mg once daily (up to 6 months).
Non-erosive GERD: 30 mg once daily (4 weeks).
Moderate hepatic impairment (Child-Pugh B): Not to exceed 30 mg/day.
Children (12-17 years): Maintenance 30 mg once daily (16 weeks).

May be taken with or without food. Swallow the capsule whole, do not chew, crush or break. Alternatively, open the capsule, sprinkle intact granules on one tablespoon, and swallow immediately (do not chew the granules).

If you miss a dose of Dexlansoprazole, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not double the dose.

Common: Diarrhea, abdominal pain, nausea, vomiting, flatulence.
Other: Headache, constipation, dry mouth.

Gastric malignancy, Clostridium difficile-associated diarrhea, bone fracture (with long-term use), hypomagnesemia, and concomitant use with methotrexate. Inform doctor if no improvement within 14 days. With long-term use, take calcium and vitamin D supplements.

Hypersensitivity to any component of the formulation.

Diuretics, digoxin: Increased risk of hypomagnesemia.
Erlotinib, dasatinib, lapatinib: May decrease plasma concentration.
Itraconazole, ketoconazole: May decrease bioavailability.
Cilostazol, methotrexate: May increase plasma concentration.
Antacids, sucralfate: Reduced bioavailability.
Atazanavir, rilpivirine: May decrease serum levels and pharmacological effects (potentially fatal).

Caution is advised when consuming alcohol with Dexlansoprazole. Please consult your doctor.

Pregnancy Category B. Dexlansoprazole is generally considered safe during pregnancy. Animal studies have shown low or no adverse effects; however, there are limited human studies.

Dexlansoprazole is probably safe during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.

Safety and effectiveness in patients below 12 years of age have not been established.

No dose adjustment is necessary for elderly patients.

Renal impairment: No dose adjustment is necessary for patients with renal impairment.
Hepatic impairment: No dose adjustment for mild impairment. A maximum daily dose of 30 mg should be considered for patients with moderate hepatic impairment. Not recommended in severe hepatic impairment.

There have been no reports of a significant overdose. Multiple doses of 120 mg and a single dose of 300 mg did not result in death or other severe adverse events.

Store below 30°C temperature & in a dry place, protected from light. Keep out of reach of children.

Dexlansoprazole