CLARITHROMYCIN tablet, film coated, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

RedPharm Drug, Inc.

INN (Medzinárodný Name):

CLARITHROMYCIN

Zloženie:

CLARITHROMYCIN 500 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Adults (Clarithromycin Extended-Release Tablets, USP) 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 clarit

Prehľad produktov:

Clarithromycin extended-release tablets, USP are supplied as yellow, film coated, oval shaped tablets debossed with [Company Logo] and "777" on one side. Bottles of 60 (NDC 0591-2805-60), bottles of 500 (NDC 0591-2805-05), bottles of 1000 (NDC 0591-2805-10). Store clarithromycin extended-release tablets, USP at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE
REDPHARM DRUG, INC.
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SPL UNCLASSIFIED SECTION
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 C38H69NO13, and the
molecular weight is
747.96. The structural formula is:
[Clarithromycin structural formula]
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-t