Amoxicillin + Clarithromycin + Lansoprazole Kit

H. pylori infection, Peptic ulcer disease, Duodenal Ulcer

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 Each dose of this combination therapy contains 4 pills: 1 capsule lansoprazole 30 mg, 2 capsules amoxicillin 500 mg, and 1 tablet clarithromycin 500 mg

Severe renal impairment (CrCl <30 mL/min): Do not use

Elderly patients may suffer from asymptomatic renal and hepatic dysfunction. Care should be taken when administering Amoxicillin to this patient population. Amoxicillin is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Hepatic impairment: Not dosage adjustment required

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

Lansoprazole Hypersensitivity to lansoprazole or other proton pump inhibitors Coadministration with rilpivirine containing products Amoxicillin History of severe hypersensitivity reactions (eg, anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or other beta-lactam antibiotics (eg, penicillins and cephalosporins) Infectious mononucleosis (relative) Clarithromycin Documented hypersensitivity Clarithromycin/ranitidine bicitrate contraindicated in: severe renal impairment (CrCl<25 mL/min); history of acute porphyria QT prolongation or ventricular cardiac arrhythmia, including torsades de pointes Concomitant administration with HMG-CoA reductase inhibitors History of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin Coadministration with colchicine in patients with renal or hepatic impairment

Consider possibility of superinfections with fungal or bacterial pathogens during therapy; if superinfections occur, discontinue therapy and institute appropriate therapy; prescribing therapy either in absence of proven or strongly suspected bacterial infection is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria Lansoprazole Liver disease may require dosage reduction Published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine; particularly with prolonged (>1 yr), high-dose therapy Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to specialist Hypomagnesemia may occur with prolonged use (ie, >1 year); adverse effects may result and include tetany, arrhythmias, or seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued PPIs possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs with diarrhea that does not improve Symptomatic response to therapy with lansoprazole does not preclude the presence of gastric malignancy; consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI; in older patients, also consider endoscopy PPIs may elevate and prolong methotrexate or its metabolite serum levels, possibly leading to toxicity PPI therapy is associated with increased risk of fundic gland polyp; risk increases with long-term use >1 year; patient may be asymptomatic; problem usually identified incidentally on endoscopy; use short

Not Classi 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 If pregnancy occurs while taking clarithromycin, inform patient of paotential hazard to fetus; drug has demonstrated adverse effects of prengnacy outcome and/or embryofetal development in monkeys, rats, mice, and rabbits at doses that produced plasma levels 2 to 17 times serum levels achieved in humans treated at maximum recommended human doses 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

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.

>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)

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.