Lansoprazole

What it is and how it works

Mechanism of Action Lansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.

Mechanism class: Proton Pump Inhibitors

Indications

Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the: • Treatment of active duodenal ulcer in adults. • Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. • Maintenance of healed duodenal ulcers in adults. • Treatment of active benign gastric ulcer in adults. • Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. • Risk reduction of NSAID-associated gastric ulcer in adults. • Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. • Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. • Maintenance of healing of EE in adults. • Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. Treatment of Active Duodenal Ulcer Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer .

Dosage and administration (summary)

Recommended Dosage: • See full prescribing information for complete dosing information for lansoprazole delayed-release capsule by indication and age group and dosage adjustment in patients with severe hepatic impairment. ( 2.1 , 2.2 , 2.3 ) Administration Instructions Lansoprazole delayed-release capsules • Should be swallowed whole. • See full prescribing information for alternative administration options. Recommended Adult Dosage by Indication Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment Maintenance of Healed 15 mg 15 mg Once daily for 4 weeks Once daily Eradicationof H.

Contraindications

Lansoprazole delayed-release capsules are contraindicated in patients with known severe hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria . Proton Pump Inhibitors (PPIs), including lansoprazole delayed-release capsules are contraindicated with rilpivirine-containing products .

Warnings and precautions

Gastric Malignancy: In adults, symptomatic response with lansoprazole delayed-release capsules does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk of Clostridium-difficile associated diarrhea. Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.

Pregnancy

Pregnancy Risk Summary Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment (see Data).

Storage and supply

Product: 50090-6830 NDC: 50090-6830-0 90 CAPSULE, DELAYED RELEASE in a BOTTLE

Source: Lansoprazole (Lansoprazole) — US FDA prescribing information, 2023-11-28, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.