Amoxicillin/Omeprazole/Rifabutin

DEA Class; Rx

Common Brand Names; Talicia

Indicated for Helicobacter Pylori Infection

Hypersensitivity to drug components or excipients

Concomitant administration with rilpivirine containing products (due to omeprazole, a drug component)

Concomitant administration with delavirdine or voriconazole (due to rifabutin, a drug component)

Rifabutin

• Discoloration of urine (30%)

• Neutropenia (25%)

• Leukopenia (17%)

• Rash (11%)

• Incr AST/ALT (7-9%)

• Thrombocytopenia (5%)

• Abdominal pain (4%)

• Diarrhea (3%)

• Eructation (3%)

• Headache (3%)

• Nausea/vomiting (3%)

• Anorexia (2%)

• Flatulence (2%)

• Anemia

• Myalgia

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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%)

Amoxicillin

• Headache

• Rash

• Diarrhea, nausea, vomiting

• Anemia

• AST/ALT elevation

• Anaphylaxis

• Candidiasis (mucocutaneous), pseudomembranous colitis, serum sickness

Serious and fatal hypersensitivity reactions reported with all the drug components; inquire about history of hypersensitivity reactions to drug components before initiating therapy; institute immediate therapy, if hypersensitivity reactions occur

Clostridioides difficile-associated diarrhea (CDAD) ranging in severity from mild diarrhea to fatal colitis reported with all drug components; may occur over two months after initiating therapy; assess for CDAD all patients who present with diarrhea following therapy administration; discontinue if confirmed; institute appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile as clinically indicated

Therapy may reduce efficacy of hormonal contraceptives; additional non-hormonal highly effective method of contraception should be used while receiving therapy

Acute tubulointerstitial nephritis (TIN) reported in patients taking PPIs; TIN may occur at any point during PPI therapy; patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions, to non-specific symptoms of decreased renal function (eg, malaise, nausea, anorexia); in reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (eg, fever, rash or arthralgia); discontinue drug and evaluate patients with suspected acute TIN

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported in patients taking PPIs; reported as both new onset and an exacerbation of existing autoimmune disease; discontinue therapy and evaluate as appropriate if symptoms consistent with CLE or SLE develop while administering therapy

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) reported with components of the drug rifabutin, amoxicillin, and omeprazole; in addition, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin, a component of the drug combination; monitor closely and discontinue the drug at first signs of SCAR

A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash; avoid therapy in patients with mononucleosis

Based on animal reproduction studies, therapy may cause fetal harm when administered to pregnant women; there are no adequate and well controlled studies of amoxicillin, omeprazole, or rifabutin (used separately or together) in pregnant women; therapy is generally not recommended for use in pregnancy; if therapy administered during pregnancy, advise pregnant women of potential risk to fetus

The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breast-fed child from drug or from the underlying condition