Drug Class: H. pylori eradication agents
Usual Adult Dose for Helicobacter pylori Infection
Amoxicillin 1000 mg-clarithromycin 500 mg-lansoprazole 30 mg orally 2 times a day
- Duration of therapy: 10 to 14 days
Comment: This drug should be taken in the morning and evening.
Use: Treatment of patients with Helicobacter pylori infection and duodenal ulcer disease to eradicate H pylori
Renal Dose Adjustments
Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended.
Acute interstitial nephritis (AIN): Discontinue treatment in patients who develop AIN.
Liver Dose Adjustments
Liver dysfunction and normal renal function: No adjustment recommended.
Liver dysfunction with severe renal dysfunction (CrCl less than 30 mL/min): Not recommended.
Signs/symptoms of hepatitis: Discontinue clarithromycin immediately
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to the active components, erythromycin, any macrolide antibiotic, or any of the ingredients
- Patients using astemizole, cisapride, ergotamine/dihydroergotamine, HMG-CoA reductase inhibitors extensively metabolized by CYP450 3A4 (e.g. lovastatin, simvastatin), pimozide, and/or terfenadine concomitantly
- Patients with a history of clarithromycin-associated cholestatic jaundice/hepatic dysfunction
- Patients with a history of QT prolongation or ventricular cardiac arrhythmia, including Torsade de pointes
- Patients with a history of severe hypersensitivity reactions to beta-lactam antibiotics (e.g., penicillins, cephalosporins)
- Patients with liver/renal dysfunction who are receiving concomitant administration of colchicine
- Use with rilpivirine-containing products
Safety and efficacy have not been established in pediatric patients.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Patients should take each dose before meals.
- This drug combination should be swallowed whole.
Storage requirements:
- Protect from light and moisture.
General:
- Eradication of H pylori reduces the risk of duodenal ulcer recurrence.
- This drug may be used in patients with active or a one-year history of duodenal ulcer.
- LIMITATION OF USE: Some manufacturers recommend limiting use of combination products to their intended use; the use of the individual products to treat other conditions alone or in combination should be avoided.
Monitoring:
- HEPATIC: Hepatic function tests
- HEMATOLOGIC: Hematopoietic function tests
- RENAL: Renal function tests
Patient advice:
- Patients should be advised to avoid missing doses and to complete the entire course of therapy.
- Instruct patients to seek medical attention if signs/symptoms of hypersensitivity, Clostridium difficile-associated diarrhea, hypomagnesemia, or systemic cutaneous lupus erythematosus occur.
- Inform patients that this drug may cause drowsiness, dizziness, vertigo, and/or visual disturbances. They should avoid driving or operating machinery until the full effects of the drug are seen.
- Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
