CLARITHROMYCIN tablet, film coated, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)

Tilgjengelig fra:

Department of State Health Services, Pharmacy Branch

INN (International Name):

CLARITHROMYCIN

Sammensetning:

CLARITHROMYCIN 500 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin extended-release tablets, USP and other antibacterial drugs, clarithromycin extended-release tablets, USP 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. Clarithromycin extended-release tablets, USP are indicated for the treatment of adults with mild to moderate infection caused by susceptible strains of the designated microorganisms in the conditions listed below: Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis , or Streptococcus pneumoniae. Acute bacterial exacerbation of chronic bronchitis due to

Produkt oppsummering:

Clarithromycin extended-release tablets, USP are supplied as yellow, film coated, oval shaped tablets debossed with and "777" on one side. Bottles of 60 (NDC 0591-2805-60), bottles of 500 (NDC 0591-2805-05), bottles of 1000 (NDC 0591-2805-10). Store clarithromycin extended-release tablets, USP at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE
DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH
----------
CLARITHROMYCIN EXTENDED-RELEASE TABLETS, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin
extended-release tablets and other antibacterial drugs, clarithromycin
tablets should be used only to
treat or prevent infections that are proven or strongly suspected to
be caused by bacteria.
DESCRIPTION
Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically,
it is 6- _0_ -methylerythromycin. The
molecular formula is C
H
NO
, and the molecular weight is 747.96. The structural formula is:
Clarithromycin is a white to off-white crystalline powder. It is
soluble in acetone, slightly soluble in
methanol, ethanol, and acetonitrile, and practically insoluble in
water.
Each yellow oval film-coated clarithromycin extended-release tablet,
for oral administration, contains
500 mg of clarithromycin and the following inactive ingredients:
compressible sugar, D&C yellow #10
Lake, glycerol monostearate, polyethylene glycol 3000, polyvinyl
alcohol, sodium phosphate
monobasic (anhydrous), talc and titanium dioxide.
MEETS USP REQUIREMENTS FOR DISSOLUTION TEST 2.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Clarithromycin is rapidly absorbed from the gastrointestinal tract
after oral administration. The absolute
bioavailability of 250 mg clarithromycin tablets was approximately
50%. For a single 500 mg dose of
clarithromycin, food slightly delays the onset of clarithromycin
absorption, increasing the peak time
from approximately 2 to 2.5 hours. Food also increases the
clarithromycin peak plasma concentration by
about 24%, but does not affect the extent of clarithromycin
bioavailability. Food does not affect the
onset of formation of the antimicrobially active metabolite, 14-OH
clarithromycin or its peak plasma
concentration but does slightly decrease the extent of metabolite
formation, indicated by an 11%
decrease in area under the plasma