CLARITHROMYCIN- clarithromycin tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE, Inc.

INN (International Name):

CLARITHROMYCIN

Composition:

CLARITHROMYCIN 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis , or Streptococcus pneumoniae. Community-Acquired Pneumonia due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Chlamydophila pneumoniae (TWAR), or Mycoplasma pneumoniae. THE EFFICACY AND SAFETY OF CLARITHROMYCIN EXTENDED-RELEASE TABLETS, USP IN TREATING OTHER INFECTIONS FOR WHICH OTHER FORMULATIONS OF CLARITHROMYCIN ARE APPROVED HAVE NOT BEEN ESTABLISHED. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin extended-release tablets, USP and

Product summary:

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 42291-263-60) Store clarithromycin extended-release tablets, USP at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE
AVKARE, INC.
----------
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 concentration-time curve (AUC).
Therefor