Overview
DESCRIPTION Lansoprazole delayed-release capsules USP, amoxicillin capsules USP, and clarithromycin tablets USP consist of a daily administration card containing two lansoprazole 30 mg delayed-release capsules USP, four amoxicillin 500 mg capsules USP, and two clarithromycin 500 mg tablets USP, for oral administration.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetics Pharmacokinetics when all three components of the lansoprazole delayed-release capsules, amoxicillin capsules, and clarithromycin tablets were coadministered has not been studied. Studies have shown no clinically significant interactions of lansoprazole delayed-release capsules and amoxicillin or lansoprazole delayed-release capsules and clarithromycin when administered together. There is no information about the gastric mucosal concentrations of lansoprazole delayed-release capsules, amoxicillin and clarithromycin after administration of these agents concomitantly. The systemic pharmacokinetic information presented below is based on studies in which each product was administered alone.
Indications
- INDICATIONS AND USAGE H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence The components in lansoprazole delayed-release capsules, amoxicillin capsules, and clarithromycin tablets are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence (see CLINICAL STUDIES and DOSAGE AND ADMINISTRATION ).
Common Doses
- 30 mg
- 1 g
- 500 mg
- 30 mL
Dosage
DOSAGE AND ADMINISTRATION H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence The recommended adult oral dose is 30 mg lansoprazole delayed-release capsules, 1 g amoxicillin, and 500 mg clarithromycin administered together twice daily (morning and evening) for 10 or 14 days (see INDICATIONS AND USAGE ). Lansoprazole delayed-release capsules, 30 mg, amoxicillin capsules, 500 mg, and clarithromycin tablets, 500 mg are not recommended in patients with creatinine clearance less than 30 mL/min.
Contraindications
- CONTRAINDICATIONS Lansoprazole delayed-release capsules, amoxicillin capsules, and clarithromycin tablets are contraindicated in patients with known severe hypersensitivity to any component of the formulation of lansoprazole delayed-release capsules. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria (see ADVERSE REACTIONS ). Proton Pump Inhibitors (PPIs), including lansoprazole delayed-release capsules, are contraindicated with rilpivirine-containing products (see CLINICAL PHARMACOLOGY , Drug...
Side Effects
- ADVERSE REACTIONS LANSOPRAZOLE DELAYED-RELEASE CAPSULES, AMOXICILLIN CAPSULES, AND CLARITHROMYCIN TABLETS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most common adverse reactions (≥3%) reported in clinical trials when all three components of this therapy were given concomitantly for 14 days are listed in Table 8.
Interactions
- Drug Interactions No drug interaction studies have been conducted specifically with lansoprazole delayed-release capsules, amoxicillin capsules, and clarithromycin tablets. The following drug interactions are for the individual drug components: lansoprazole, amoxicillin, and clarithromycin. Therefore, the decision to adjust dosage should depend on the clinician’s assessment of among other things, the cumulative or net effect of the drug components of lansoprazole delayed-release capsules, amoxicillin capsules, and clarithromycin tablets.