LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN kit

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Rising Pharma Holdings, Inc.

INN (Jina la Kimataifa):

LANSOPRAZOLE

Tungo:

LANSOPRAZOLE 30 mg

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of lansoprazole delayed-release capsules, amoxicillin capsules, and clarithromycin tablets and other antibacterial drugs, lansoprazole delayed-release capsules, amoxicillin capsules, and clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecti

Bidhaa muhtasari:

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 Two size '1' capsules with dark blue color body and pink color cap, printed NATCO on cap and 30 on body with white ink are filled with white to off white colored spherical shaped pellets. Amoxicillin Capsules USP Four blue/pink size "0EL" hard gelatin capsules filled with white to off white granular powder and imprinted with "A45" on pink body with black ink. Clarithromycin Tablets USP Two light yellow colored, oval shaped, biconvex film-coated tablets, with 'D' debossed on one side and '63' on the other side.                 NDC 57237-001-14            Carton containing 14 daily administration cards                 NDC 57237-001-01            Daily administration card Store between 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from light and moisture.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

LANSOPRAZOLE, AMOXICILLIN, CLARITHROMYCIN- LANSOPRAZOLE, AMOXICILLIN,
CLARITHROMYCIN
RISING PHARMA HOLDINGS, INC.
----------
LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP, 30 MG, AMOXICILLIN CAPSULES
USP, 500 MG, AND CLARITHROMYCIN TABLETS USP, 500 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
lansoprazole delayed-release capsules, amoxicillin capsules, and
clarithromycin tablets
and other antibacterial drugs, lansoprazole delayed-release capsules,
amoxicillin
capsules, and clarithromycin tablets 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
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.
LANSOPRAZOLE DELAYED-RELEASE CAPSULES, USP
The active ingredient in lansoprazole delayed-release capsules USP is
lansoprazole, a
proton pump inhibitor. Its empirical formula is C
H
F N O S with a molecular weight of
369.37. Lansoprazole has the following structure:
Lansoprazole USP is a white to brownish-white odorless crystalline
powder which melts
with decomposition at approximately 166°C. Lansoprazole is freely
soluble in
dimethylformamide; soluble in methanol; sparingly soluble in ethanol;
slightly soluble in
ethyl acetate, d