Description
Indications |
Listed in Dosage. |
Dosage |
Adult : PO Peptic ulcer 30 mg once daily for 2-4 weeks (duodenal ulcer) or for 4-8 weeks (gastric ulcer). Zollinger-Ellison syndrome Initial: 60 mg once daily, may be adjusted up to 180 mg/day according to response. Daily doses >120 mg should be given in 2 divided doses. Gastro-oesophageal reflux disease 15 mg or 30 mg once daily for 4 weeks, may be adjusted according to response. NSAID-associated ulceration 30 mg once daily for 4-8 weeks. Prophylaxis of NSAID-induced ulcers 15-30 mg once daily. Eradication of H. pylori associated with peptic ulcer disease As triple therapy: 30 mg bid for 7-14 days in combination with clarithromycin and with either amoxicillin or metronidazole, or in combination with amoxicillin and metronidazole. As dual therapy: 30 mg tid for 14 days in combination with amoxicillin. Reflux oesophagitis Treatment: 30 mg once daily for 4-8 weeks. Prophylaxis: 15 mg once daily, may be increased up to 30 mg once daily if necessary. IV Erosive oesophagitis 30 mg once daily via infusion over 30 minutes for up to 7 days until oral therapy is possible for a total of 6-8 weeks. |
Dosage Details |
Intravenous Erosive oesophagitis Adult: 30 mg once daily via infusion over 30 minutes for up to 7 days until oral therapy is possible for a total of 6-8 weeks.
Oral Adult: Treatment: 30 mg once daily for 4-8 weeks. Prophylaxis: 15 mg once daily, may be increased up to 30 mg once daily if necessary.
Oral Adult: 15 mg or 30 mg once daily for 4 weeks, may be adjusted according to response.
Oral Adult: 30 mg once daily for 4-8 weeks.
Oral Adult: Initially, 60 mg once daily, may be adjusted up to 180 mg daily according to response. Daily doses >120 mg should be given in 2 divided doses.
Oral Adult: As triple therapy: 30 mg bid for 7-14 days in combination with clarithromycin and with either amoxicillin or metronidazole. As dual therapy: 30 mg tid for 14 days in combination with amoxicillin.
Oral Adult: 15-30 mg once daily.
Oral Adult: 30 mg once daily for 2-4 weeks (duodenal ulcer) or for 4-8 weeks (gastric ulcer). |
Special Patient Group |
Pharmacogenomics
CYP2C19 is the main enzyme responsible in lansoprazole metabolism. CYP2C19 gene variants are known to be associated with increased or decreased response to lansoprazole. The prevalence of CYP2C19 poor metabolisers is estimated in about 2-6% of the population. Gene testing may be considered prior to treatment.
Ultrarapid metabolisers (carriers of 2 increased function alleles *17/*17) |
Hepatic Impairment |
Oral Moderate to severe: Reduce daily dose by 50%. Intravenous |
Administration |
Should be taken on an empty stomach. |
Reconstitution |
IV infusion: Reconstitute vial labelled as 30 mg with 5 mL sterile water for inj to make a final concentration of 6 mg/mL (30 mg/5 mL). Gently mix until the powder is dissolved. Further dilute with either 50 mL of NaCl 0.9%, lactated Ringer’s, or dextrose 5% inj. |
Contraindications |
Concomitant use with rilpivirine and atazanavir. |
Special Precautions |
Patients with gastric malignancy, risk factors for reduced vitamin B12 absorption or reduced body stores; risk of osteoporosis. Moderate to severe hepatic impairment. Elderly. Pregnancy and lactation. CYP2C19 ultrarapid metabolisers. |
Adverse Drug Reactions |
Significant: Hypomagnesaemia, osteoporosis-related fractures, fundic gland polyps, carcinoma, subacute cutaneous lupus erythematosus, SLE, interstitial nephritis, Clostridium difficile-associated diarrhoea, gastrointestinal infections (e.g. Salmonella, Campylobacter), vitamin B12 deficiency (long-term therapy). Blood and lymphatic system disorders: Thrombocytopenia, leucopenia, eosinophilia. Eye disorders: Visual disturbances. Gastrointestinal disorders: Diarrhoea, abdominal pain, constipation, nausea, dyspepsia, flatulence, dry mouth or throat. Rarely, colitis, stomatitis. General disorders and admin site conditions: Fatigue, inj site pain and reactions (IV). Hepatobiliary disorders: Increased liver enzymes. Immune system disorders: Urticaria. Metabolism and nutrition disorders: Peripheral oedema. Musculoskeletal and connective tissue disorders: Arthralgia, myalgia. Nervous system disorders: Headache, dizziness, vertigo, somnolence, paraesthesia. Psychiatric disorders: Depression, insomnia, confusion. Reproductive system and breast disorders: Gynaecomastia. Skin and subcutaneous tissue disorders: Rash, pruritus, eczema. |
Pregnancy Category (US FDA) |
PO: B |
Patient Counselling |
This drug may cause dizziness or visual disturbances, if affected, do not drive or operate machinery. |
Monitoring Parameters |
Monitor serum Mg levels at baseline and periodically thereafter; CBC, LFTs, renal function tests, serum gastrin levels. Assess for signs and symptoms of bone fractures and Clostridium difficile-associated diarrhoea (CDAD). |
Overdosage |
Symptoms: IV: Decreased locomotor response, ataxia, ptosis and tonic convulsions. Management: Symptomatic and supportive treatment. |
Drug Interactions |
May decrease plasma concentrations of rilpivirine, atazanavir and nelfinavir. Increased INR and prothrombin time with warfarin. May diminish the therapeutic effect of clopidogrel. May increase exposure of digoxins. May reduce absorption of ketoconazole and itraconazole. May increase risk of hypomagnesaemia with diuretics. May increase plasma concentrations of methotrexate and tacrolimus. May reduce serum concentration of theophylline. Reduced bioavailability with sucralfate and antacids. Increased plasma concentration with CYP2C19 inhibitor (e.g. fluvoxamine). Reduced serum levels with CYP2C19 and CYP3A4 inducers (e.g. rifampicin). |
Food Interaction |
Decreased serum concentrations with St. John’s wort. |
Lab Interference |
May cause a false-positive result in the diagnostic test for neuroendocrine tumours, secretin stimulation test, and urine screening test for tetrahydrocannabinol. |
Mechanism of Action |
Description: Lansoprazole is a substituted benzimidazole gastric antisecretory agent and is also known as a proton pump inhibitor (PPI). It blocks the final step in gastric acid secretion by inhibition of H+/K+-adenosine triphosphatase (ATPase) enzyme system present on the secretory surface of the gastric parietal cells. Onset: Gastric acid suppression: 1-3 hours (oral). Duration: Gastric acid suppression: >24 hours (oral). Pharmacokinetics: Absorption: Rapidly absorbed from the gastrointestinal tract. Food delays absorption and reduces bioavailability (approx 50-70%). Bioavailability: >80%. Time to peak plasma concentration: Approx 1.5-2 hours. Distribution: Volume of distribution: 15.7±1.9 L. Plasma protein binding: Approx 97%. Metabolism: Extensively metabolised in the liver via hydroxylation primarily by CYP2C19 isoenzyme to inactive 5-hydroxyl-lansoprazole; and lesser extent by CYP3A4 isoenzyme to inactive lansoprazole sulfone. Excretion: Mainly via faeces (67%); urine (33%, 14-25% as metabolites; <1% as unchanged drug). Elimination half-life: Approx 1-2 hours. |
Storage |
Store at 25°C. Protect from light and moisture. |
MIMS Class |
Antacids, Antireflux Agents & Antiulcerants |
ATC Classification |
A02BC03 – lansoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD). |
