Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy, including amoxicillin. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.
Lactation: Not recommended
Indication
H. pylori infection, Peptic ulcer disease, Duodenal Ulcer
Contra Indication
Contraindicated in patients with known severe hypersensitivity to any component. Clarithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin. Clarithromycin should not be given to patients with history of QT prolongation or ventricular cardiac arrhythmia, including torsades de pointes.
A history of severe hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or other beta-lactam antibiotics (e.g., penicillins and cephalosporins) is a contraindication.
Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibiotics.
Clarithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin.
Clarithromycin should not be given to patients with history of QT prolongation or ventricular cardiac arrhythmia, including torsades de pointes.
Amoxicillin/clarithromycin/lansoprazole is not recommended in patients with CrCl less than 30 mL/min.
FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
Lamsoprazole: Proton pump inhibitor; binds to H+/K+-exchanging ATPase (proton pump) in gastric parietal cells resulting in blocking acid secretion.
Amoxicillin: Inhibits bacterial cell wall synthesis by binding to one or more penicillin binding proteins that in turn inhibit the final transpeptidation step of peptoglycan synthesis in cell wall biosynthesis.
Clarithromycin: Inhibits protein synthesis by binding to 50S ribosomal subunit causing antibacterial activity.
Interaction
Amoxicillin: May reduce the efficacy of OC. May increase the effect of anticoagulants. Increased risk of allergic reactions w/ allopurinol. Increased and prolonged blood levels w/ probenecid. Chloramphenicol, macrolides, sulfonamides and tetracyclines may interfere w/ the bactericidal effect of amoxicillin.
Clarithromycin: Serious adverse reactions have been reported in patients taking Clarithromycin concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; and hypotension and acute kidney injury with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem, nifedipine). Most reports of acute kidney injury with calcium channel blockers metabolized by CYP3A4 involved elderly patients 65 years of age or older.
Lansoprazole: 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.
Pregnancy Category Note
Pregnancy
Clarithromycin
No adequate and well-controlled studies in pregnant women; do not use clarithromycin in pregnant women except in circumstances in which no alternative therapy is appropriate
Lansoprazole
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
Amoxicillin
Adverse events not observed in animal reproduction studies; maternal use has not resulted in increased risk of adverse fetal effects; however, possible association with cleft lip with cleft palate observed in some studies; more data needed
Lactation
Caution should be exercised when clarithromycin is administered to nursing women; the development and health benefits of human milk feeding should be considered along with the mother?s clinical need for clarithromycin and any potential adverse effects on human milk- fed child from the drug or from underlying maternal condition
Adult Dose
Oral
Eradication of H. pylori to reduce risk of duodenal ulcer recurrence
Lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg administered together PO twice daily (morning and evening) for 10 or 14 days
Hepatic impairment: No dosage adjustment needed with hepatic impairment
Child Dose
N/A
Renal Dose
CrCl< 30 mL/min: Do not use
Administration
Combination therapy (lansoprazole, amoxicillin, clarithromycin) indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori
To reduce development of drug-resistant bacteria and maintain efficacy of antibacterial drugs, use only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria
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