Lansoprazole/Amoxicillin/Clarithromycin

DEA Class; Rx

Common Brand Names; Prevpac

Indicated for the treatment of Helicobacter pylori (H. pylori) eradication.

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

Lansoprazole

• Fatigue (< 3%)

• Headache (2.5-4.7%)

• Abdominal pain (1.8%)

• Diarrhea (8%)

• Nausea (3.7%)

Clarithromycin

• GI effects, general (13%)

• 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%)

• 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

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

Anaphylaxis has been reported rarely but is more likely to occur following parenteral therapy with penicillins

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents; severity may range from mild diarrhea to fatal colitis; CDAD may occur over 2 months after discontinuation of therapy; if CDAD is suspected or confirmed, discontinue immediately and begin appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difficile, and surgical evaluation

Do not administer in patients with infectious mononucleosis because of risk of development of erythematous skin rash

Do not administer to patients in the absence of a proven or suspected bacterial infection because of risk of development of drug-resistant bacteria

Superinfections with bacterial or fungal pathogens may occur during therapy; if suspected, discontinue immediately and begin appropriate treatment

Chewable tablets contain aspartame, which contains phenylalanine

Use caution in patients with allergy to cephalosporins, carbapenems

Endocarditis prophylaxis: use for only high-risk patients, as per recent AHA guidelines

High doses may cause false urine glucose test by some methods

May cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP); if patients develop a skin rash they should be monitored closely and therapy discontinued if lesions progress

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

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