Drug Guide

Generic Name

Amoxicillin, Omeprazole Magnesium, Rifabutin

Brand Names Talicia

Classification

Therapeutic: Helicobacter pylori infection eradication, Antibiotic, Proton pump inhibitor

Pharmacological: Amoxicillin: Antibiotic (penicillin type), Omeprazole: Proton pump inhibitor, Rifabutin: Antibiotic (ansamycin)

FDA Approved Indications

  • Treatment of Helicobacter pylori infection in adults

Mechanism of Action

Amoxicillin inhibits bacterial cell wall synthesis, leading to cell lysis; Omeprazole suppresses gastric acid secretion by inhibiting the H+/K+ ATPase enzyme system in the gastric parietal cells; Rifabutin inhibits bacterial DNA-dependent RNA polymerase, suppressing RNA synthesis.

Dosage and Administration

Adult: As prescribed, typically multiple doses per day for 10-14 days

Pediatric: Not generally approved for pediatric use outside specific indications; consult specific guidelines

Geriatric: Adjust dose if renal impairment present; monitor closely

Renal Impairment: Dose adjustment may be necessary, especially for rifabutin

Hepatic Impairment: Caution; dose adjustments may be needed, particularly for omeprazole

Pharmacokinetics

Absorption: Amoxicillin: well absorbed; Omeprazole: absorbed with food, peak 1-2 hrs; Rifabutin: well absorbed

Distribution: Amoxicillin: widespread; Omeprazole: binds to plasma proteins; Rifabutin: highly protein-bound

Metabolism: Rifabutin: hepatic; Omeprazole: hepatic via CYP2C19 and CYP3A4; Amoxicillin: minimal hepatic metabolism

Excretion: Renal (amoxicillin, rifabutin), hepatic (omeprazole)

Half Life: Amoxicillin: 1 hr; Omeprazole: 1 hr; Rifabutin: 45 hrs

Contraindications

  • Hypersensitivity to penicillins, omeprazole, rifamycins

Precautions

  • Liver disease, drug interactions, pregnancy/breastfeeding considerations

Adverse Reactions - Common

  • Diarrhea (Common)
  • Nausea (Common)
  • Headache (Common)

Adverse Reactions - Serious

  • Clostridioides difficile-associated diarrhea (Serious)
  • Hepatotoxicity (Serious)
  • Blood dyscrasias (e.g., leukopenia, thrombocytopenia) (Serious)

Drug-Drug Interactions

  • Increases risk of myopathy/rhabdomyolysis with statins when combined with rifabutin

Drug-Food Interactions

  • Possible reduced absorption with certain antacids for omeprazole

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for allergic reactions, hepatic function, and improvement in symptoms

Diagnoses:

  • Risk for infection, impaired gastrointestinal function

Implementation: Administer with food or as prescribed, monitor for side effects, ensure patient adherence

Evaluation: Assess eradication success via follow-up testing, review lab results

Patient/Family Teaching

  • Take medications as directed, complete the full course, report side effects or allergic reactions, avoid alcohol and certain foods as advised

Special Considerations

Black Box Warnings:

  • Rifabutin: ocular inflammation, mycobacterial resistance

Genetic Factors: CYP2C19 polymorphisms may affect omeprazole metabolism

Lab Test Interference: Potential false-positive urine glucose tests with omeprazole

Overdose Management

Signs/Symptoms: Gastrointestinal distress, toxicity symptoms depending on component

Treatment: Supportive care, activated charcoal if recent ingestion, specific interventions as per symptoms

Storage and Handling

Storage: Store at room temperature, away from moisture and light

Stability: Refer to specific product stability data

This guide is for educational purposes only and is not intended for clinical use.