CLARITHROMYCIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

CLARITHROMYCIN

Composition:

CLARITHROMYCIN 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 pneumo

Product summary:

Clarithromycin Tablets USP, 500 mg are light yellow colored, oval shaped, biconvex film-coated tablets, with 'D' debossed on one side and '63' on the other side.         Bottles of 14                                                      NDC 63187-625-14         Bottles of 28                                                      NDC 63187-625-28         Bottles of 30                                                      NDC 63187-625-30         Bottles of 60                                                      NDC 63187-625-60         Bottles of 90                                                      NDC 63187-625-90 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED
PROFICIENT RX LP
----------
CLARITHROMYCIN TABLETS, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin
and other antibacterial drugs, clarithromycin 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 or almost white, crystalline powder. It is
soluble in acetone, slightly soluble
in methanol, ethanol, and acetonitrile, and practically insoluble in
water.
Clarithromycin tablets, USP are available as immediate-release
tablets.
Each film-coated tablet contains 250 mg or 500 mg of clarithromycin
and the following inactive
ingredients: microcrystalline cellulose, croscarmellose sodium,
colloidal silicon dioxide, magnesium
stearate, povidone, hypromellose, titanium dioxide, hydroxypropyl
cellulose, iron oxide yellow,
propylene glycol, vanillin, and sorbic acid.
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 concentration-time curve (AUC).
Therefore, clarithromycin tablets
38
69
13
may be gi