Lansoprazole


Generic Medicine Info
Indications and Dosage
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
Reflux oesophagitis
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.
Elderly: Max: 30 mg daily.

Oral
Gastro-oesophageal reflux disease
Adult: 15 mg or 30 mg once daily for 4 weeks, may be adjusted according to response.
Elderly: Max: 30 mg daily.

Oral
NSAID-associated ulceration
Adult: 30 mg once daily for 4-8 weeks.
Elderly: Max: 30 mg daily.

Oral
Zollinger-Ellison syndrome
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.
Elderly: Max: 30 mg daily.

Oral
Eradication of H. pylori associated with peptic ulcer disease
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.
Elderly: Max: 30 mg daily.

Oral
Prophylaxis of NSAID-induced ulcers
Adult: 15-30 mg once daily.
Elderly: Max: 30 mg daily.

Oral
Peptic ulcer
Adult: 30 mg once daily for 2-4 weeks (duodenal ulcer) or for 4-8 weeks (gastric ulcer).
Elderly: Max: 30 mg daily.
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)
Eradication of H. pylori: Increase dose by 200%. Monitor for risks of insufficient therapeutic response.
Hepatic Impairment
Oral
Moderate to severe: Reduce daily dose by 50%.

Intravenous
Erosive oesophagitis: Dose reduction may be necessary.
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 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.
Patient Counseling Information
This drug may cause dizziness or visual disturbances, if affected, do not drive or operate machinery.
MonitoringParameters
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.
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.
Chemical Structure

Chemical Structure Image
Lansoprazole

Source: National Center for Biotechnology Information. PubChem Database. Lansoprazole, CID=3883, https://pubchem.ncbi.nlm.nih.gov/compound/Lansoprazole (accessed on Jan. 22, 2020)

Storage
Store at 25°C. Protect from light and moisture.
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).
References
Annotation of DPWG Label for Lansoprazole and CYP2C19. Pharmacogenomics Knowledgebase (PharmGKB). https://www.pharmgkb.org/. Accessed 23/05/2019.

Annotation of FDA Label for Lansoprazole and CYP2C19. Pharmacogenomics Knowledgebase (PharmGKB). https://www.pharmgkb.org/. Accessed 23/05/2019.

Anon. Lansoprazole. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 23/05/2019.

Anon. Lansoprazole. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 23/05/2019.

Buckingham R (ed). Lansoprazole. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/05/2019.

Joint Formulary Committee. Lansoprazole. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/05/2019.

Lansoprazole 30 mg Gastro-Resistant Capsules, Hard (Teva UK Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 23/05/2019.

Prevacid Capsule, Delayed Release and Prevacid Solutab Tablet, Orally Disintegrating, Delayed Release (Takeda Pharmaceuticals America, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 23/05/2019.

Prevacid FDT/IV (Takeda). MIMS Thailand. http://www.mims.com/thailand. Accessed 23/05/2019.

Prevacid FDT/Prevacid IV (Takeda). MIMS Philippines. http://www.mims.com/philippines. Accessed 23/05/2019.

Prevacid IV (Takeda Pharmaceuticals America, Inc.). U.S. FDA. https://www.fda.gov/. Accessed 23/05/2019.

Disclaimer: This information is independently developed by MIMS based on Lansoprazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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