Protolan 30

Generic

Lansoprazole

 

Indications

Lansoprazole is used to treat the following conditions:

• Treatment of an active duodenal ulcer on a short-term basis
• Maintenance of duodenal ulcers that have healed
• Treatment of active benign gastric ulcers in the short term
• Treatment of active erosive esophagitis in the short term
• Maintenance of erosive esophagitis healing
• The Zollinger- Ellison Syndrome is a pathological hypersecretory disease.
• Eradication of Helicobacter pylori to decrease the incidence of duodenal ulcer recurrence

 

Pharmacology

Lansoprazole is a substituted benzimidazole that is also known as a proton pump inhibitor (PPI) because it inhibits the H+/K+ ATPase enzyme system in the gastric parietal cell, blocking the final stage of acid secretion. Acid is blocked at both the baseline and stimulated levels.

 

Dosage & Administration

Benign gastric ulcer: 30 mg daily in the morning for 8 weeks.

Duodenal ulcer: 30 mg daily in the morning for 4 weeks; maintenance 15 mg.

NSAID-associated duodenal or gastric ulcer: 15-30 mg daily for 4 weeks, followed by a further 4 weeks if not fully healed.

Zollinger-Ellison syndrome (and other hypersecretory conditions): Initially 60 mg once daily adjusted according to response; daily doses of 120 mg or more is given in two divided doses.

Gastroesophageal reflux disease: 30 mg daily in the morning for 4 weeks, followed by a further 4 weeks if not fully healed; maintenance 15-30 mg daily.

Acid-related dyspepsia: 15-30 mg daily in the morning for 2-4 weeks.

 

Interaction

Lansoprazole appears to be a selective inhibitor of the cytochrome P-450 monooxygenase system; it may affect hepatic clearance, although no clinically significant interactions have been reported to yet. The impact of Lansoprazole on the oral combination contraceptive pill is still unknown. A more thorough investigation is now ongoing. 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.

 

Contraindications

Patients with known hypersensitivity to any component of the formulation should avoid using lansoprazole.

 

Side Effects

Severe or permanent side effects include the possibility of carcinoid tumors being induced by severe acid suppression, as well as an increase in serum gastrin. Serum gastrin levels rise over the first three months of therapy and subsequently remain stable, but at a lower level than in pernicious anemia. In individuals with Helicobacter pylori infection, long-term therapy with a proton pump inhibitor may hasten the onset of atrophic gastritis.

Symptomatic side effect: At 30 mg per day, the incidence of dose-dependent diarrhoea is around 4%, increasing to 8% at 60 mg per day. Headache affects 2% to 3% of individuals who are being treated.

 

Pregnancy & Lactation

Unless there are strong reasons, lansoprazole should be avoided during pregnancy.

 

Precautions & Warnings

Malignancy of the stomach should be checked out. Hepatic dysfunction. Lactation and pregnancy.

 

Therapeutic Class

Proton Pump Inhibitor

 

Storage Conditions

Keep at a temperature of 25° C.

 

Pharmaceutical Name

Beximco Pharmaceuticals Ltd.