LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN- lansoprazole, amoxicillin and clarithromycin

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

lansoprazole (UNII: 0K5C5T2QPG) (lansoprazole - UNII:0K5C5T2QPG)

Beschikbaar vanaf:

Prasco Laboratories

INN (Algemene Internationale Benaming):

lansoprazole

Samenstelling:

lansoprazole 30 mg

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

The components in lansoprazole/amoxicillin/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/amoxicillin/clarithromycin and other antibacterial drugs, lansoprazole/amoxicillin/clarithromycin 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 selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Lansoprazole/amoxicillin/clarithromycin is contraindicated in p

Product samenvatting:

Lansoprazole/amoxicillin/clarithromycin is supplied as an individual daily administration card, each containing: Store between 20°C and 25°C (68°F and 77°F)[see USP Controlled Room Temperature]. Protect from light and moisture.

Autorisatie-status:

New Drug Application Authorized Generic

Productkenmerken

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN- LANSOPRAZOLE,
AMOXICILLIN AND
CLARITHROMYCIN
PRASCO LABORATORIES
----------
LANSOPRAZOLE DELAYED-RELEASE CAPSULES, 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/amoxicillin/clarithromycin and other antibacterial drugs,
lansoprazole/amoxicillin/clarithromycin 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/amoxicillin/clarithromycin consists of a daily
administration card containing two
lansoprazole delayed-release 30 mg capsules, four amoxicillin 500 mg
capsules, USP, and two
clarithromycin 500 mg tablets, USP, for oral administration.
LANSOPRAZOLE DELAYED-RELEASE CAPSULES
The active ingredient in lansoprazole delayed-release capsules is
lansoprazole, a substituted
benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]
methyl] sulfinyl] benzimidazole, a
compound that inhibits gastric acid secretion. Its empirical formula
is C
H F N O S with a
molecular weight of 369.37. Lansoprazole has the following structure:
Lansoprazole 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, dichloromethane and
acetonitrile; very slight