LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN kit

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)

Prieinama:

Sandoz Inc

INN (Tarptautinis Pavadinimas):

LANSOPRAZOLE

Sudėtis:

LANSOPRAZOLE 30 mg

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

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.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

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-