Amoxicillin + Clarithromycin + Lansoprazole Kit

Indications

Amoxicillin + Clarithromycin + Lansoprazole Kit is used for: H. pylori infection, Peptic ulcer disease, Duodenal Ulcer

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

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

Contra Indications

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.

Precautions

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

Pregnancy-Lactation

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

Interactions

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.

Adverse Effects

Side effects of Amoxicillin + Clarithromycin + Lansoprazole Kit : >10% Clarithromycin GI effects, general (13%) 1-10% Clarithromycin Headache (6%), Rash (children 3%), Abdominal pain (adults 2%, children 3%), Abnormal taste (adults 3-7%), Diarrhea (3-6%), Dyspepsia (2%), Heartburn (adults 2%), GI intolerance (oral-dose related), Nausea (adults 3-6%), Vomiting (adults 1%; children 6%), Decreased WBC, elevated BUN (4%), elevated PT (1%) Lansoprazole Fatigue (< 3%), Headache (2.5-4.7%), Abdominal pain (1.8%), Diarrhea (8%), Nausea (3.7%) <1% Clarithromycin QT prolongation, Anxiety, dizziness, hallucinations, manic behavior, neuromuscular blockade, psychosis, seizures, Anorexia, glossitis, pancreatitis, AST increased, bilirubin increased, elevated LFTs, hepatic dysfunction, hepatitis, increased alkaline phosphate, jaundice, Hypoglycemia, leukopenia, neutropenia, thrombocytopenia, Increased serum creatinine, Dyspnea, Anaphylaxis, C Diff colitis, Stevens-Johnson syndrome Frequency Not Defined Amoxicillin Headache, Rash, Diarrhea, nausea, vomiting, Anemia, AST/ALT elevation, Acute exanthematous pustulosis, Exfoliative dermatitis Seizure, Insomnia, Hemorrhagic colitis, Toxic epidermal necrolysis, Urticaria, Stevens-Johnson syndrome, Anaphylaxis, Candidiasis (mucocutaneous), pseudomembranous colitis, serum sickness Clarithromycin Torsade de pointes (rare), Allergic reactions: urticaria & skin eruptions, leukocytoclastic vasculitis, toxic epidermal necrolysis, pruritus, rash Transient CNS effects: psychosis, anxiety, behavioral changes, confusional states, depersonalization, disorientation, hallucinations, insomnia, nightmares, tinnitus, tremor, and vertigo, Hepatic failure, Stomatitis, Acute renal failure, Reversible hearing loss (hypoacusis)

Mechanism 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.