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KlacidKlacid
 

PRODUCT NAME

Clarithromycin Tablets


DESCRIPTION
Clarithromycin is a semi-synthetic macrolide antibiotic obtained by substitution of the hydroxyl group in position 6 by a CH30 group in the erythromycin lactonic ring. Specifically clarithromycin is 6-0-Methyl Erythromycin A. The white to off-white antibiotic powder is bitter, practically odorless, essentially insoluble in water, and slightly soluble in ethanol, methanol, and acetonitrile. Its molecular weight is 747.96 and the structural formula is as follows:

Klacid

Clarithromycin is available in Filmtab tablets, containing 500 mg of the active antibiotic. The tablets may also contain a number of inactive ingredients such as dyes, coatings, lubricants, fillers, etc.


PHARMACEUTICAL FORM
A yellow, ovaloid film-coated tablet containing 500mg of Clarithromycin.


CLINICAL PHARMACOLOGY
Microbiology
Clarithromycin exerts its antibacterial action by binding to the 5OS ribosomal subunits of susceptible bacteria and suppressing protein synthesis.


Clarithromycin has demonstrated excellent in vitro activity against both standard strains of bacteria and clinical isolates. It is highly potent against a wide variety of aerobic and anaerobic Gram-positive and Gram-negative organisms. The minimum inhibitory concentrations (MIC's) of clarithromycin are generally one log2 dilution more potent than the MIC's of erythromycin.


In vitro data also indicate clarithromycin has excellent activity against Legionella pneumophila, and Mycoplasma pneumoniae. It is bactericidal to Helicobacter pylori; this activity of clarithromycin is greater at neutral pH than at acid pH. In vitro and in vivo data show this antibiotic has activity against clinically significant mycobacterial species. The in vitro data indicate Enterobacteriaceae, pseudomonas species and other non-lactose fermenting gram negative bacilli are not sensitive to clarithromycin.

 

Clarithromycin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the Indications and Usage section:


Aerobic Gram-Positive microorganisms

Staphylococcus aureus
Streptococcus pneumoniae

Streptococcus pyogenes

Listeria monocytogenes


Aerobic Gram-negative microorganisms

Haemophilus influenzae

Haemophilus parainfluenzae

Moraxella catarrhalis

Neisseria gonorrhoeae

Legionella pneumophila


Other microorganisms

Mycoplasma pneumoniae

Chlamydia pneumoniae (TWAR)


Mycobacteria
Mycobacterium leprae

Mycobacterium kansasii

Mycobacterium chelonae

Mycobacterium fortuitum
Mycobacterium avium complex (MAC) consisting of: Mycobacterium avium, Mycobacterium Intracellulare


Beta-lactamase production should have no effect on clarithromycin activity.
NOTE: Most strains of methicillin-resistant and oxacillin-resistant staphylococci are resistant to clarithromycin.


Helicobacter
Helicobacter pylori
In cultures performed prior to therapy, H. pylon was isolated and clarithromycin MIC's were determined pre-treatment in 104 patients. Of these, four patients had resistant strains, two patients had strains with intermediate susceptibility, and 98 patients had susceptible strains.


The following in vitro data are available, but their clinical significance is unknown. Clarithromycin exhibits in vitro activity against most strains of the following microorganisms; however, the safety and effectiveness of clarithromycin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.


Aerobic Gram-positive microorganisms

Streptococcus agalactiae

Streptococci (Group C,F,G)

Viridans group streptococci


Aerobic Gram-negative microorganisms

Bordetella pertussis
Pasteurella multocida


Anaerobic Gram-positive microorganisms

Clostridium perfringens

Peptococcus niger
Propionibactenum acnes


Anaerobic Gram-negative microorganisms

Bacteroides melaninogenicus


Spirochetes

Borrelia burgdorferi

Treponema pallidum


Campylobacter

Campylobacter jejuni


The principal metabolite of clarithromycin in man and other primates is a microbiologicallyactive metabolite, 14-OH-clarithromycin. This metabolite is as active or 1- to 2-fold less active than the parent compound for most organisms, except for H. influenzae against which it is twice as active. The parent compound and the 14-OH metabolite exert either an additive or synergistic effect on H. influenzae in vitro and in vivo, depending on bacterial strains.


Clarithromycin was found to be two to ten times more active than erythromycin in several experimental animal infection models. It was shown, for example, to be more effective than erythromycin in mouse systemic infection, mouse subcutaneous abscess, and mouse respiratory tract infections caused by S. pneumoniae, S. aureus, S. pyogenes, and H. influenzae. In guinea pigs with Legionella infection this effect was more pronounced; an intraperitoneal dose of 1.6 mg/kg/day of clarithromycin was more effective than 50 mg/kg/day of erythromycin.


Susceptibility Tests
Quantitative methods that require measurement of zone diameters give the most precise estimates of susceptibility of bacteria to antimicrobial agents. One recommended procedure uses discs impregnated with 15 mcg of clarithromycin for testing susceptibility (Kirby-Bauer diffusion test); interpretations correlate inhibition zone diameters of this disc test with MIC values for clarithromycin. The MIC's are determined by the broth or agar dilution method.


With these precedes, a report from the laboratory of "susceptible" indicates the infecting organism is likely to respond to therapy. A report of "resistant" indicates the infective organism is not likely to respond to therapy A report of "Intermediate Susceptibility" suggests the therapeutic effect of the drug may be equivocal or the organism would be susceptible if higher doses were used. (Intermediate susceptibility is also referred to as moderately susceptible.)

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