Lansoprazole

Indications

Lansoprazole is used for: Peptic ulcer, H.pylori infection, Gastro-oesophageal reflux disease, Hypersecretory conditions, Acid-related dyspepsia, NSAID-induced ulcers, Erosive oesophagitis

Adult Dose

Oral Peptic ulcer Adult: 30 mg once daily in the morning given for up to 4 wk (duodenal ulcer) or for up to 8 wk (gastric ulcer). Maintenance: 15 mg/day. Zollinger-Ellison syndrome Adult: Initially, 60 mg once daily in the morning and adjust as required. Daily doses >120 mg should be given in 2 divided doses. Acid-related dyspepsia Adult: 15-30 mg once daily in the morning for 2-4 wk. Gastro-oesophageal reflux disease Adult: 15-30 mg once daily in the morning for 4-8 wk. Maintenance: 15-30 mg once daily according to response. Prophylaxis of NSAID-induced ulcers Adult: 15-30 mg once daily in the morning. H.pylori infection Adult: 1-wk triple therapy: 30 mg bid combined w/ clarithromycin 500 mg bid and amoxicillin 1 g bid or combined w/ clarithromycin 250 mg bid and metronidazole 400 mg bid. Erosive oesophagitis Adult: 30 mg once daily in the morning for up to 8 wk, additional 8 wk if not healed. Maintenance: 15 mg once daily. NSAID-associated ulceration Adult: 30 mg once daily in the morning for 4-8 wk. Elderly: No dosage adjustment needed. Hepatic impairment: Severe: Max: 30 mg/day.

Child Dose

Oral Gastro-oesophageal reflux disease 1-11 yr <30 kg: 15 mg once daily in the morning for up to 12 wk; >30 kg: 30 mg once daily in the morning for up to 12 wk. May increase doses up to 30 mg bid if patient is still symptomatic after 2 or more wk of treatment. 12-17 yr 15 mg once daily for up to 8 wk. Erosive oesophagitis 1-11 yr <30 kg: 15 mg once daily in the morning for up to 12 wk; >30 kg: 30 mg once daily in the morning for up to 12 wk. May increase doses up to 30 mg bid if patient is still symptomatic after 2 or more wk of treatment. 12-17 yr 30 mg once daily for up to 8 wk.

Renal Dose

Renal impairment: No dosage adjustment needed.

Administration

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

Contra Indications

Hypersensitivity.

Precautions

Hepatic impairment. Gastric malignancy should be ruled out. Pregnancy and lactation. Lactation Risk Summary There is no information regarding presence of lansoprazole in human milk, effects on breastfed infant, or on milk production; however, lansoprazole and its metabolites are present in rat milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from treatment or from underlying maternal condition.

Pregnancy-Lactation

Pregnancy Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment; estimated background risk of major birth defects and miscarriage for the indicated populations are unknown Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and lansoprazole use; methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy No adverse effects on embryo-fetal development occurred in studies performed in pregnant rats at oral lansoprazole doses up to 150 mg/kg/day (40 times the recommended human dose [30 mg/day] based on body surface area) administered during organogenesis and pregnant rabbits at oral lansoprazole doses up to 0 mg/kg/day (16 times the recommended human dose based on body surface area) administered during organogenesis Lactation There is no information regarding presence of lansoprazole in human milk, effects on breastfed infant, or on milk production; however, lansoprazole and its metabolites are present in rat milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from treatment or from underlying maternal condition

Interactions

Increased risk of hypomagnesaemia w/ diuretics and digoxin. May decrease plasma concentration of erlotinib, dasatinib and lapatinib. May decrease the bioavailability of itraconazole and ketoconazole. May increase plasma concentration of cilostazol and methotrexate. Reduced bioavailability w/ antacids and sucralfate. Potentially Fatal: May decrease serum levels and pharmacological effects of rilpivirine and atazanavir.

Adverse Effects

Side effects of Lansoprazole : 1-10% Headache (3-7%), Diarrhea (1-5%), Constipation (1-5%), Nausea (1-3%), Abdominal pain (1-3%) <1% Anxiety, Angina, Palpitations, Syncope, Edema, Anorexia, Dry mouth, Tenesmus, Flatulence, Melena, Myalgia, Tinnitus, Allergic reaction

Mechanism of Action

Lansoprazole is a substituted benzimidazole, and is also known as PPI due to its property to block the final step of acid secretion by inhibiting H+/K+ ATPase enzyme system in gastric parietal cell. Both basal and stimulated acid are inhibited.