CLARITHROMYCIN tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Aidarex Pharmaceuticals LLC

INN (Nama Internasional):

CLARITHROMYCIN

Komposisi:

CLARITHROMYCIN 250 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablet and other antibacterial drugs, clarithromycin tablet 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 tablet is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms 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

Ringkasan produk:

Clarithromycin tablet, USP 250 mg are supplied as white oval film-coated tablets debossed with W954 on one side and other side plain. Bottles of 20 Tablets (NDC 33261-0631-20) Clarithromycin tablet, USP 500 mg are supplied as white oval film-coated tablets debossed with W949 on one side and other side plain. Bottles of 10 Tablets (NDC 33261-0618-10) Bottles of 14 Tablets (NDC 33261-0618-14) Bottles of 20 Tablets (NDC 33261-0618-20) Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
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CLARITHROMYCIN TABLETS, USP
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin
tablet and other antibacterial drugs, clarithromycin tablet 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 747.95. 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.
Clarithromycin tablet are available as immediate-release tablets.
Each white oval film-coated immediate-release clarithromycin tablet
contains 250 mg or 500 mg of
clarithromycin and the following inactive ingredients:
250 mg tablets: microcrystalline cellulose, lactose monohydrate,
hydroxypropyl cellulose, sodium
starch glycolate, colloidal silicon dioxide, talc, magnesium stearate,
hypromellose, titanium dioxide,
and polyethylene glycol.
500 mg tablets: microcrystalline cellulose, lactose monohydrate,
hydroxypropyl cellulose, sodium
starch glycolate, colloidal silicon dioxide, talc, magnesium stearate,
hypromellose, titanium dioxide,
and polyethylene glycol.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Clarithromycin is rapidly absorbed from the gastrointestinal tract
after oral administration. The absolute
38
69
13
bioavailability of 250 mg clarithromycin tablet 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 an