Lansoprazole inhibits gastric acid secretion by inhibiting the H+/K+ ATPase, which is also known as the proton pump. Both basal and stimulated acid are inhibited.

Absorption
Rapidly absorbed from the GIT (oral); peak plasma concentrations after 1.5 hours.

Distribution
Protein-binding: 97%.

Metabolism
Extensively hepatic; converted to 5-hydroxyl-lansoprazole and lansoprazole sulfone.

Excretion
Via faeces (main) and urine (15-30% of a dose); 1-2 hours (elimination half-life).

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Diarrhoea, abdominal pain, nausea, constipation, headache, dizziness, eosinophilia, myalgia, glossitis, stomatitis, rash.

Symptomatic response to therapy with Lansoprazole does not preclude the presence of gastric malignancy.

Hepatic impairment. Gastric malignancy should be ruled out. Pregnancy and lactation.

Reduced bioavailability with antacids and sucralfate. May decrease the absorption of atazanavir, itraconazole and ketoconazole. May increase plasma concentration of cilostazol.

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Oral
Peptic ulcer
Adult: 30 mg once daily in the morning given for 4 weeks (duodenal ulcer) or for 8 weeks (gastric ulcer).

Hepatic impairment: Severe impairment: Max dose: 30 mg/day.

Oral
Hypersecretory conditions
Adult: Initially, 60 mg daily and adjust as required. Daily doses >120 mg should be given in 2 divided doses.

Hepatic impairment: Severe impairment: Max dose: 30 mg/day.

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

Hepatic impairment: Severe impairment: Max dose: 30 mg/day.

Oral
Gastro-oesophageal reflux disease
Adult: 30 mg once daily in the morning for 4-8 weeks. Maintenance: 15-30 mg once daily according to response.
Child: and erosive oesophagitis: 1-11 years: ≤30 kg: 15 mg once daily; >30 kg: 30 mg once daily. May increase doses up to 30 mg bid if patient is still symptomatic after 2 or more weeks of treatment. 12-17 years: For erosive oesophagitis: 30 mg once daily for up to 8 weeks; For nonerosive gastro-oesophageal reflux disease: 15 mg once daily for up to 8 weeks.

Hepatic impairment: Severe impairment: Max dose: 30 mg/day.

Oral
NSAID-associated ulceration
Adult: 15-30 mg daily for 4-8 weeks.

Hepatic impairment: Severe impairment: Max dose: 30 mg/day.

Oral
Prophylaxis of NSAID-induced ulcers
Adult: 15-30 mg daily for 4-8 weeks.

Hepatic impairment: Severe impairment: Max dose: 30 mg/day.

Oral
H.pylori infection
Adult: 1-weeks triple therapy: 30 mg bid combined with clarithromycin 500 mg bid and either amoxicillin 1 g bid or metronidazole 400 mg bid.

Hepatic impairment: Severe impairment: Max dose: 30 mg/day.

Intravenous
Erosive oesophagitis
Adult: 30 mg over 30 minutes daily for up to 7 days.

Hepatic impairment: Consider dose adjustment.

Should be taken on an empty stomach. (Take before meals.)

Caution when used during pregnancy

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Caution when used during lactation

Safety and efficacy not established in children younger than 1 years of age. Safety and efficacy of lansoprazole IV has not been established in pediatric patients.

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Intravenous
Store at 25°C (77°F).

Oral
Store at 25°C (77°F).

Information Not Available