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RiteMED Co-amoxiclav

Amoxicillin + Clavulanic acid




Brand Name, Dosage Format and Strength
RiteMED Co-amoxiclav   875 mg/125 mg  Tablet

Therapeutic Category
Anti-infectives (Systemic)

Sub Therapeutic
Antibacterial, Antifungal, Antituberculosis, Antivirals

Class
Aminoglycoside, Cephalosporin, Chloramphenicol, Lincosamide, Macrolide, Penicillin, Penicillin + Beta lactamase Inhibitor , Penicillinase-resistant isoxazolylpenicillin, Penicillin; Beta-lactam + Beta-lactamase Inhibitor, Quinolone, Sulfonamide + Folate Inhibitor, Tetracycline, Triazole Antibiotic, Immunostimulant, Neuraminidase Inhibitor

Marketing Division





CLINICAL PHARMACOLOGY

Pharmacodynamics

Amoxicillin (an aminopenicillin antibiotic) and potassium clavulanate (a b-lactamase inhibitor) [Co-amoxiclav] is usually bactericidal in action. Concurrent administration of clavulanic acid does not alter the mechanism of action of amoxicillin. However, because clavulanic acid has a high affinity for and binds to certain b-lactamases that generally inactivate amoxicillin by hydrolyzing its b-lactam ring, concurrent administration of the drug with amoxicillin results in synergistic bactericidal effect which expands amoxicillin`s spectrum of activity against many strains of b-lactamase-producing bacteria resistant to amoxicillin alone. 

Antimicrobial Spectrum of Activity 

In vitro and clinical studies have demonstrated the susceptibility of the following microorganisms to Co-amoxiclav:

Aerobic Gram-positive

Aerobic Gram-negative

Staphylococcus aureus*
Streptococcus pneumoniae
Streptococcus pyogenes
Enterococcus faecalis

Haemophilus influenzae* 
Escherichia coli*
Moraxella catarrhalis*
Klebsiella spp. 
Proteus mirabilis*
Neisseria gonorrhoeae*
Eikenella corrodens*

Anaerobic Gram-positive

Anaerobic Gram-negative 

Peptostreptococcus spp

 

Bacteroides spp.* including B. fragilis
Fusobacterium spp.

 

 

*including b-lactamase-producing and non-producing strain 

Although most strains of Enterobacter species are resistant in vitro, clinical efficacy has been demonstrated with Co-amoxiclav in UTI caused by these organisms.

Co-amoxiclav has demonstrated in vitro activity against most strains of the following microorganisms; however, clinical significance is unknown:

Aerobic Gram-positive

Aerobic Gram-negative

Staphylococcus epidermidis*
Staphylococcus saprophyticus*
Streptococcus agalactiae
Streptococcus viridans
Streptococcus bovis
Bacillus anthracis
Corynebacterium spp.
Enterococcus faecium
Listeria monocytogenes
Nocardia asteroides

 

Haemophilus ducreyi
Proteus vulgaris*
Neisseria meningitidis*
Bordetella pertussis
Salmonella spp.*
Shigella spp.*
Brucella spp.
Vibrio cholerae
Helicobacter pylori
Pasteurella multocida
Legionella spp.
Gardnerella vaginalis
Yersinia enterocolitica

Anaerobic Gram-positive

Other Microorganisms

Clostridium spp.
Peptococcus spp.

 

 

Borrelia burgdorferi
Chlamydiae
Leptospira icterohaemorrhagiae
Treponema pallidum

 

*Including b-lactamase-producing and non-producing strains

Pharmacokinetics

Co-amoxiclav is stable in the presence of acidic gastric secretions and is well absorbed following oral administration.

In a single-dose study in healthy male and female subjects, 19 to 44 yrs old, oral administration of Co-amoxiclav 1 g tab resulted in mean peak serum amoxicillin and clavulanic acid concentrations Cmax of 7.787 and 3.078 mcg/mL, respectively. Peak serum concentrations of amoxicillin and of clavulanic acid were generally attained within 1 to 2.5 hrs after oral administration. The AUC0-t for amoxicillin and clavulanic acid were 30.533 and 7.184 mcg/mL•hr, respectively, while AUC0-∞ were 31.615 and 7.487 mcg/mL•hr, respectively.

When a single oral dose of Co-amoxiclav 625 mg tab was administered in adult subjects (fasted state), PK parameters reached were:  Cmax 7.03 mcg/mL, AUC0-t 19.49 mcg/mL•hr, AUC0-∞ 20.91 mcg/mL•hr, and t1/2 1.04 hrs for amoxicillin, and 2.143 mcg/mL, 4.064 mcg/mL•hr, 4.722 mcg/mL•hr and 1.2 hrs, respectively, for clavulanic acid.

Studies in healthy adults using Co-amoxiclav indicate that presence of food in the GI tract does not affect oral absorption of either amoxicillin or clavulanic acid.

Therapeutic concentrations of both amoxicillin and clavulanic acid have been found in the gall bladder, abdominal tissue, skin, fat, and muscle tissues; the synovial and peritoneal fluids, bile and pus. Animal studies show no evidence that either component may accumulate in any organ.

Neither amoxicillin nor clavulanic acid is highly protein-bound; studies show that about 13- 25% of total plasma drug concentration of each compound is protein-bound.

Both Co-amoxiclav components readily cross the placenta. Only small amounts of amoxicillin and clavulanic acid are distributed in human milk.

Serum concentrations of amoxicillin and clavulanic acid both decline in a biphasic manner and their t1/2 are similar.  Approximately 50-73% of amoxicillin and 25-45% of clavulanic acid are excreted unchanged in urine within 6 to 8 hrs following oral administration of a single dose of Co-amoxiclav in adults with normal renal function.

Last Update: Jul 21, 2011


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