Chemical formula: C₁₆H₁₄F₃N₃O₂S Molecular mass: 369.361 g/mol PubChem compound: 3883
Lansoprazole interacts in the following cases:
A dose reduction may be considered when combining lansoprazole with the CYP2C19 inhibitor fluvoxamine. The plasma concentrations of lansoprazole increase up to 4-fold.
Lansoprazole has been observed to inhibit the transport protein, P-glycoprotein (P-gp) in vitro. The clinical relevance of this is unknown.
Patients with moderate or severe liver disease should be kept under regular supervision and a 50% reduction of the daily dose is recommended.
Co-administration of lansoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH, such as atazanavir and nelfinavir, due to significant reduction in their bioavailability.
Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin, and St. John’s wort (Hypericum perforatum) can markedly reduce the plasma concentrations of lansoprazole.
Lansoprazole may increase plasma concentrations of medicinal products that are metabolised by CYP3A4. Caution is advised when combining lansoprazole with medicinal products which are metabolised by this enzyme and have a narrow therapeutic window.
A study has shown that co-administration of lansoprazole (60 mg once daily) with atazanavir 400 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 90% decrease in AUC and Cmax).
Co-administration of lansoprazole and digoxin may lead to increased digoxin plasma levels. The plasma levels of digoxin should therefore be monitored and the dose of digoxin adjusted if necessary when initiating and ending lansoprazole treatment.
The absorption of ketoconazole and itraconazole from the gastrointestinal tract is enhanced by the presence of gastric acid. Administration of lansoprazole may result in sub-therapeutic concentrations of ketoconazole and itraconazole and the combination should be avoided.
Concomitant useof lansoprazole with high-dose methotrexate may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities.
Sucralfate, antacids may decrease the bioavailability of lansoprazole. Therefore lansoprazole should be taken at least 1 hour after taking these medicinal products.
Co-administration of lansoprazole increases the plasma concentrations of tacrolimus (a CYP3A and P-gp substrate). Lansoprazole exposure increased the mean exposure of tacrolimus by up to 81%. Monitoring of tacrolimus plasma concentrations is advised when concomitant treatment with lansoprazole is initiated or ended.
Lansoprazole reduces the plasma concentration of theophylline, which may decrease the expected clinical effect at the dose. Patient monitoring should be taken in co-administration of lansoprazole with theophylline.
Daily treatment with any acid-suppressing medications over a prolonged period of time (several years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria. Cyanocobalamin deficiency should be considered in patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long- term treatment, individuals with reduced body stores or risk factors for reduced vitamin B12 absorption (such as the elderly) on long-term therapy or if relevant clinical symptoms are observed.
There have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with lansoprazole and warfarin concomitantly may need to be monitored for increase in INR and prothrombin time.
Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in the presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
Severe hypomagnesaemia has been reported in patients treated with PPIs like lansoprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.
Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Lansoprazole capsules. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
For lansoprazole no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Therefore, the use of lansoprazole during pregnancy is not recommended.
It is not known whether lansoprazole is excreted in human breast milk. Animal studies have shown excretion of lansoprazole in milk.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with lansoprazole should be made taking into account the benefit of breastfeeding for the child and the benefit of lansoprazole therapy for the woman.
No human data on the effect of lansoprazole on fertility are available. Reproductive studies in pregnant rats and rabbits revealed no lansoprazole-related impairment of fertility.
Adverse drug reactions such as dizziness, vertigo, visual disturbances and somnolence may occur. Under these conditions the ability to react may be decreased.
Frequencies are defined as common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Uncommon: leucopenia, thrombocyto-penia, eosinophilia
Rare: anaemia
Very rare: pancytopenia, agranulocytosis
Very rare: anaphylactic shock
Not known: hypomagnesaemia
Uncommon: depression
Rare: hallucination, insomnia, confusion
Not known: visual hallucinations
Common: headache, dizziness
Rare: paresthesia, vertigo, restlessness, somnolence, tremor
Rare: visual disturbances.
Common: vomiting nausea, diarrhoea, stomach ache, constipation, flatulence, dry mouth or throat, fundic gland polyps (benign)
Rare: pancreatitis, candidiasis of the oesophagus, glossitis, taste disturbances
Very rare: colitis, stomatitis
Common: increase in liver enzyme levels
Rare: hepatitis, jaundice
Common: urticaria, itching, rash
Rare: petechiae, purpura, erythema multiforme, photosensitivity, hair loss
Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis
Not known: subacute cutaneous lupus erythematosus
Uncommon: fracture of the hip, wrist or spine, arthralgia, myalgia
Rare: interstitial nephritis
Rare: gynaecomastia
Common: fatigue
Uncommon: oedema
Rare: angioedema, fever, hyperhidrosis, anorexia, impotence
Very rare: increase in cholesterol and triglyceride levels, hyponatremia
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