Omeprazole/Amoxicillin/Clarithromycin

DEA Class; Rx

Common Brand Names; Omeclamox-Pak

Indicated for eradication of H pylori to reduce risk of duodenal ulcer recurrence

Coadministration with pimozide, ergotamine or dihydroergotamine

Omeprazole

• • Hypersensitivity to omeprazole, benzimidazoles or other proton pump inhibitors

Amoxicillin

• Allergy to penicillins, cephalosporins, imipenem

• Infectious mononucleosis (relative)

• Concomitant live bacterial vaccines

Clarithromycin

• Clarithromycin/ranitidine bicitrate contraindicated in: severe renal impairment (CrCl<25 mL/min); history of acute porphyria

Clarithromycin

• GI effects, general (13%)
• Headache (2%)
• Abdominal pain (2%)
• Abnormal taste (3-7%)
• Diarrhea (3-6%)
• Dyspepsia (2%)
• Heartburn (2%)
• Nausea (3-6%)
• Increased BUN (4%)
• Increased PT (1%)
• Vomiting (1%)
• GI intolerance
• Decrease WBC Rash
• QT prolongation
• Neurology/Psychiatric: Anxiety, dizziness, hallucinations, manic behavior, neuromuscular blockade, psychosis, seizures
• Gastrointestinal: Anorexia, glossitis, pancreatitis, jaundice, hepatitis/hepatic dysfunction, C difficile colitis
• Laboratory: Bilirubin increased, elevated AST, LFTs, alkaline phosphate, serum creatinine; hypoglycemia, leukopenia, neutropenia, thrombocytopenia
• Anaphylaxis, dyspnea, Stevens-Johnson syndrome

Omeprazole

• Acid regurgitation (1.9%)
• Upper respiratory infection (1.9%)
• Constipation (1.5%)
• Dizziness (1.5%)
• Rash (1.5%)
• Asthenia (1.3%)
• Back pain (1.1%)
• Cough (1.1%)

• Fracture of bone, osteoporosis-related
• Hepatotoxicity (rare)
• Hip fracture
• Interstitial nephritis (rare)
• Pancreatitis (rare)
• Rhabdomyolysis
• Toxic epidermal necrolysis (rare)

Amoxicillin

• Headache
• Rash
• Diarrhea, nausea, vomiting
• Anemia
• AST/ALT elevation
• Anaphylaxis
• Candidiasis (mucocutaneous), pseudomembranous colitis, serum sickness

Omeprazole

• 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

Amoxicillin

• Allergy to cephalosporins, carbapenems

• Endocarditis prophylaxis: use only for high-risk patients, per recent AHA Guidelines

• High doses may cause false urine glucose test by some methods

Clarithromycin

• Severe renal impairment

• Do not refrigerate oral solution

• Endocarditis prophylaxis: use only for high-risk patients, per recent AHA Guidelines

Pregnancy

Based on findings in animal studies for omeprazole and clarithromycin during pregnancy may cause fetal harm; therapy is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate

Based on limited human data, clarithromycin and its active metabolite 14-OH clarithromycin are present in human milk at less than 2% of maternal weight-adjusted dose