Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)
Sandoz Inc
LANSOPRAZOLE
LANSOPRAZOLE 30 mg
PRESCRIPTION DRUG
The components in lansoprazole delayed-release capsules USP, 30 mg, amoxicillin capsules USP, 500 mg, and clarithromycin tablets USP, 500 mg (lansoprazole, amoxicillin, and clarithromycin) 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 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of lansoprazole delayed-release capsules USP, 30 mg, amoxicillin capsules USP, 500 mg, and clarithromycin tablets USP, 500 mg and other antibacterial drugs, lansoprazole delayed-release capsules USP, 30 mg, amoxicillin capsules USP, 500 mg, and clarithromycin tablets USP, 500 mg should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibil
Lansoprazole Delayed-Release Capsules USP, 30 mg, Amoxicillin Capsules USP, 500 mg, and Clarithromycin Tablets USP, 500 mg are supplied in boxes of 14 daily administration cards, each card containing: Lansoprazole Delayed-Release Capsules USP, 30 mg: Two white hypromellose capsules with GG638 black imprint on cap and body of the capsule, containing white to off-white pellets. Amoxicillin Capsules USP, 500 mg: Four yellow, opaque, hard gelatin amoxicillin 500 mg capsules, USP, imprinted AMOX 500 on one side and GG 849 on the other side. Clarithromycin Tablets USP, 500 mg: Two white oval film-coated tablets, debossed GG C9 on one side and plain on the reverse side. NDC 0781-4054-42 Carton containing 14 daily administration cards NDC 0781-4054-32 Daily administration card Store between 20°C and 25°C (68°F and 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.
Abbreviated New Drug Application
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN- LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN SANDOZ INC ---------- _TRIPLE THERAPY_ LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP, 30 MG AMOXICILLIN CAPSULES USP, 500 MG CLARITHROMYCIN TABLETS USP, 500 MG RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of lansoprazole delayed-release capsules USP, 30 mg, amoxicillin capsules USP, 500 mg, and clarithromycin tablets USP, 500 mg and other antibacterial drugs, lansoprazole delayed-release capsules USP, 30 mg, amoxicillin capsules USP, 500 mg, and clarithromycin tablets USP, 500 mg should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. THESE PRODUCTS ARE INTENDED ONLY FOR USE AS DESCRIBED. The individual products contained in this package should not be used alone or in combination for other purposes. The information described in this labeling concerns only the use of these products as indicated in this daily administration pack. For information on use of the individual components when dispensed as individual medications outside this combined use for treating _Helicobacter pylori (H. pylori),_ please see the package inserts for each individual product. DESCRIPTION _triple therapy_ Lansoprazole Delayed-Release Capsules USP, 30 mg, Amoxicillin Capsules USP, 500 mg, and Clarithromycin Tablets USP, 500 mg consists 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. LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a proton pump inhibitor. Its molecular formula is C H F N O S with a molecular weight of 369.37. Lansoprazole has the following structure: 16 14 3 3 2 Lansoprazole is a white to brownish- Soma hati kamili