Classes
DEA Class; Rx
Common Brand Names; Prevpac
- H pylori Agents;
- PUD Combos
Description
A triple-drug regimen pack containing an aminopenicillin (amoxicillin), a macrolide (clarithromycin), and a PPI (lansoprazole)
Used for the eradication of H. pylori in adults
Triple-drug regimens are usually recommended by the American College of Gastroenterology (ACG) guidelines for managing H. pylori infection
Indications
Indicated for the treatment of Helicobacter pylori (H. pylori) eradication.
Eradication of H. pylori to reduce risk of duodenal ulcer recurrence
Contraindications
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
Adverse Effects
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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
Lansoprazole 60 mg/day PO; amoxicillin 2 g/day PO; clarithromycin 1 g/day PO.
Lansoprazole 60 mg/day PO; amoxicillin 2 g/day PO; clarithromycin 1 g/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Lansoprazole/amoxicillin/clarithromycin
capsule/capsule/tablet prepack
- 30mg/500mg/500mg
- amoxicillin component consists of 2 capsules (500 mg/capsule)