Dosing & Uses
Dosage Forms & Strengths
- amoxicillin component consists of 2 capsules (500 mg/capsule)
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
Prevpac is clearly labeled for administration of 1 dose (30 mg/1 g/500 mg) PO twice daily
Severe renal impairment (CrCl <30 mL/min): Do not use
Hepatic impairment: Not dosage adjustment required
Safety and efficacy not established
- 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%)
- Fatigue (< 3%)
- Headache (2.5-4.7%)
- Abdominal pain (1.8%)
- Diarrhea (8%)
- Nausea (3.7%)
- 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
- Anaphylaxis, C Diff colitis, Stevens-Johnson syndrome
Frequency Not Defined
- Diarrhea, nausea, vomiting
- AST/ALT elevation
- Acute exanthematous pustulosis
- Exfoliative dermatitis
- Hemorrhagic colitis
- Toxic epidermal necrolysis
- Stevens-Johnson syndrome
- Candidiasis (mucocutaneous), pseudomembranous colitis, serum sickness
- 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
- Acute renal failure
- Reversible hearing loss (hypoacusis)
- Hypersensitivity to lansoprazole or other proton pump inhibitors
- 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)
- 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 extensively metabolized by CYP3A4 (lovastatin or simvastatin); increases risk of myopathy, including rhabdomyolysis
- 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
- PPIs may elevate and prolong methotrexate or its metabolite serum levels, possibly leading to toxicity
- Allergy to cephalosporins, carbapenems
- Endocarditis prophylaxis: use only for high risk pts, per recent AHA Guidelines
- High doses may cause false urine glucose test by some methods
- Caution in severe renal impairment
- Do not refrigerate oral solution
- Endocarditis prophylaxis: use only for high risk patients, per recent AHA Guidelines
- Clarithromycin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia
- Concomitant use of clarithromycin and oral hypoglycemic agents and/or insulin can result in significant hypoglycemia
- There is a risk of serious hemorrhage and significant elevations in INR and prothrombin time when clarithromycin is co-administered with warfarin; monitor INR and prothrombin times
Pregnancy & Lactation
Pregnancy category: C ( based on the pregnancy category for 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
Lactation: Not recommended
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
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
Half-Life: 0.9-1.5 hr
Bioavailability: 81-91% (empty stomach); 50-70% (30 minutes after food)
Clearance Total Body: 0.7 L/hr/kg
Onset of action: 1-3 hr (gastric acid suppression)
Renal: 517 mL/min
Metabolism: Gastric parietal cells: acidic pH converts lansoprazole to its active sulfenamide metabolites
Liver: by hepatic CYP2C19; slow metabolizers are deficient in CPY2C19 enzyme & can have plasma conc can increase 5 times or higher
Metabolites Active: cyclic sulfenamide & disulfide metaboliteInactive: 5-hydroxy-lansoprazole, sulfide metabolite, omeprazole sulfone, sulfone metabolite, hydroxysulfide metabolite, hydroxysulfone metabolite
Excretion: Feces (bile): 77%
Peak Plasma Time: 1.5-3 hr
Protein Bound: 97-99%
Vd: 14-18 L
Enzymes inhibited: CYP2C19
Half-Life: 3.7 hr (neonates, full term); 1-2 hr (infants and children); 0.7-1.4 hr (adults); 7-21 hr (CrCl < 10 mL/min in adults)
Distribution: most body fluids and bone, CSF<1%
Peak Plasma Time: 2hr (capsule); 3.1 hr (extended release tablet); 1 hr (suspension)
Protein Bound: 17-20%
Metabolism: Partially hepatic
Half-Life: 3-7 hr
Peak Plasma Time: 2-3 hr (immediate release); 5-8 hr (extended release)
Absorption: Highly stable in presence of gastric acid (unlike erythromycin); food delays but does not affect extent of absorption
Distribution: Widely into most body tissues except CNS
Protein binding: 42-70%
Metabolism: partially hepatic (P450 enzyme CYP3A4); converted to 14-OH clarithromycin (active metabolite)
Renal Clearance: approximates normal GFR
Excretion: primarily urine
Contains enteric coated granules (acid labile); do not chew or crush
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|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
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