CLARITHROMYCIN tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

CLARITHROMYCIN

Sammensetning:

CLARITHROMYCIN 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Clarithromycin tablets USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below: Pharyngitis/Tonsillitis due to Streptococcus pyogenes (The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present). Acute maxillary sinusitis due to Haemophilus influenzae , Moraxella catarrhalis , or Streptococcus pneumoniae . Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae , Haemophilus parainfluenzae , Moraxella catarrhalis , or Streptococcus pneumoniae . Community-Acquired Pneumonia due to Haemophilus influenzae , Mycoplasma pneum

Produkt oppsummering:

Clarithromycin tablets USP are available as follows: 250 mg – yellow, film-coated, oval-shaped tablets, debossed with “93” on one side and “7157” on the other side in bottles of 60 (NDC 0093-7528-06). 500 mg – light-yellow, film-coated, oval-shaped tablets, debossed with “93” on one side and “7158” on the other side in bottles of 60 (NDC 0093-7529-06). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
----------
CLARITHROMYCIN TABLETS USP
7528
7529
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin
tablets USP and other antibacterial drugs, clarithromycin tablets USP
should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Clarithromycin, USP is a semi-synthetic macrolide antibiotic.
Chemically, it is 6-_O_-
methylerythromycin. The structural formula is:
C
H NO M.W. 747.96
Clarithromycin, USP 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.
Clarithromycin is available as immediate-release tablets.
Each yellow, film-coated, oval-shaped clarithromycin tablet USP for
oral administration contains 250
mg of clarithromycin, USP and each light-yellow, film-coated,
oval-shaped clarithromycin tablet for
oral administration contains 500 mg of clarithromycin, USP. Each
tablet of both strengths contains the
following inactive ingredients: colloidal silicon dioxide,
croscarmellose sodium, D&C Yellow #10
aluminum lake, FD&C blue #2 indigo carmine aluminum lake, FD&C red #40
allura red AC aluminum
lake, hypromellose, magnesium hydroxide, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, povidone, sodium starch glycolate, stearic acid,
titanium dioxide, and vanillin.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
38
69
13
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
bioavailabi