Helicon KIT

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

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.

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

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.

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

H. pylori infection, Peptic ulcer disease, Duodenal Ulcer

CrCl< 30 mL/min: Do not use

>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)

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.