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Clamentin

 

Ingredient(s)
Clamentin Film Coated Tablet 375 mg

Each film-coated tablet contains:

Amoxicillin (as Trihydrate) .............................250mg

Clavulanic Acid (as Potassium Salt) ...............125mg


Clamentin Film Coated Tablet 625 mg
Each film-coated tablet contains:

Amoxicillin (as Trihydrate) ..............................500mg

Clavulanic Acid (as Potassium Salt) ................125mg

Pharmacology (Summary of Pharmacodynamic and Pharmacokinetics)
Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it can act on the pathogen. The clavulanate in Clamentin anticipates this defense mechanism by blocking the β-lactamase enzymes, thus rendering the organisms sensitive to amoxicillin's rapid bactericidal effect at concentrations readily attainable in the body. Clamentin is bactericidal to a wide range of organisms including:
Gram-positive:
Aerobes: *Enterococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, *Staphylococcus aureus, *Coagulase-negative staphylococci (including Staphylococcus epidermidis), Corynebacterium sp, *Bacillus anthracis, Listeria monocytogenes, Enterococcus faecium, Streptococcus agalactiae, Streptococcus sp.
Anaerobes: Clostridium, Peptococcus spp, Peptostreptococcus.

Gram-negative:
Aerobes: *Haemophilus influenzae, *Escherichia coli, *Proteus marabilis, *Proteus vulgaris, *Klebsaella sp, *Moraxella catarrhalis (Branhamella catharralas), *Salmonella sp, *Shigella sp, Bordetella pertussis, Brucella sp, *Neisseria gonorrhoeae, *Neisseria meningitidis, Vibrio cholerae, *Yersinia enterocolitica, Pasteurella multocida, Gardnerella vaginalis, Helicobacter pylori, Legionella sp.

Anaerobes: *Bacteroides sp (including Bacteroides fragilis), *Fusobacterium sp.
*Including β-lactamase producing strains resistant to ampicillin and amoxicillin.

Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While Clamentin can be given without regard to meals, absorption of clavulanic acid when taken with food is greater relative to the fasted state.

Amoxicillin serum concentrations achieved with Clamentin are similar to those produced by the oral administration of equivalent doses of amoxicillin alone. The half-life of amoxicillin after oral administration is 1.3 hours and that of clavulanic acid is 1.0 hour.

Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.

Clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound.

Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues.

Indication(s)
Clamentin are indicated for short-term treatment of bacterial infections at the following sites:
Upper respiratory tract infections (including ENT) e.g. tonsillitis, sinusitis, otitis media.
Lower respiratory tract infections e.g. acute and chronic bronchitis, lobar and bronchopneumonia.

Genito-urinary tract infection e.g. cystitis, urethritis, pyelonephritis.
Skin and soft tissue infections e.g. boils, abscesses, cellulites, wound infections.
Bone and joint infections e.g. osteomyelitis.
Dental infections e.g. dentoalveolar abscess.
Other infections e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis.

Clamentin is bactericidal to a wide range of organisms including:
Gram positive
Aerobes: Enterococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, *Staphylococcus aureus, *Coagulase negative staphylococci (including Staphylococcus epidermidis), Corynebacterium species, Bacillus anthracis, Listeria monocytogenes..
Anaerobes: Clostridium species, Peptococcus species, Peptostreptococcus.

Gram Negative
Aerobes: *Haemophilus influenzae, *Escherichia coli, *Proteus marabilis, *Proteus vulgaris, *Klebsiella species, *Moraxella catarrhalis, *Salmonella species, *Shigella species, Bordetella pertussis, Brucella species, *Neisseria gonorrhoeae, Neisseria meningitidis, Vibrio cholerae, Pasteurella multocida.
Anaerobes: *Bacteroides spp. Including B. fragilis.
*including β-lactamase producing strains resistant to ampicillin and amoxicillin.

Dosage and Administration
Usual dosages for the treatment of infection

Adults and children over 12 years
Mild Moderate infections:

One Clamentin Film Coated Tablet 625 mg two times a day.
One Clamentin Film Coated Tablet 375 mg three times a day.

Therapy can be started parenterally and continued with an oral preparation.

Dosage in dental infections (e.g. dentoalveolar abscess)
Adult and children over 12 years: One Clamentin Film Coated Tablet 625 mg two times a day for five days. Clamentin Film Coated Tablet 625 tug is not recommended in children of 12 years and under

Dosage in renal impairment
Adult:
Mild impairment (Creatinine clearance >30 mL/min) : No change in dosage.

Moderate impairment (Creatinine clearance 10-30 mL/min) : One Clamentin 625 mg or 375 mg two times a day.
(Depending on severity of infection)

Severe impairment (Creatinine clearance <10 mL/min) : Not more than one Clamentin 625 mg or 375 mg every 24 hours.
(Depending on severity of infection).

Dosage in hepatic impairment
Dose with caution; monitor hepatic at regular intervals.

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