CLARITHROMYCIN for suspension

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Physicians Total Care, Inc.

INN (Nama Antarabangsa):

CLARITHROMYCIN

Komposisi:

CLARITHROMYCIN 250 mg in 5 mL

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Clarithromycin for oral suspension, USP is indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below: Adults 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 i

Ringkasan produk:

Clarithromycin for oral suspension, USP is supplied in the following strengths and sizes: Total volume after constitution Clarithromycin concentration after constitution Clarithromycin contents per bottle NDC 50 mL 125 mg/5 mL 1250 mg 100 mL 125 mg/5 mL 2500 mg 50 mL 250 mg/5 mL 2500 mg 54868-0654-1 100 mL 250 mg/5 mL 5000 mg 54868-0654-0 Store clarithromycin granules for oral suspension, USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in a well-closed container. Do not refrigerate clarithromycin suspension..

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

CLARITHROMYCIN - CLARITHROMYCIN FOR SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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CLARITHROMYCIN FOR ORAL SUSPENSION, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin
and other antibacterial drugs, clarithromycin for oral suspension
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 is available as granules for oral suspension.
After constitution, each 5 mL of clarithromycin for oral suspension,
USP contains 125 mg or 250 mg of
clarithromycin. Each bottle of clarithromycin granules for oral
suspension contains 1250 mg (50 mL
size), 2500 mg (50 and 100 mL sizes) or 5000 mg (100 mL size) of
clarithromycin. In addition, each 5
mL of reconstituted clarithromycin for oral suspension USP contains
the following inactive ingredients:
citric acid (anhydrous), colloidal silicon dioxide, confectioner’s
sugar, fruit punch flavor, glyceryl
monostearate, hypromellose, maltodextrin, methacrylic acid copolymer
dispersion, poloxamer,
polyethylene glycol, polysorbate 80, potassium sorbate, povidone,
titanium dioxide, triethyl citrate, and
xanthan gum.
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 do