Amoxicillin trihydrate - Potassium clavulanate

Mixtures in ratios: 2:1, 4:1 and 7:1

Amoxicillin trihydrate

CHEMICAL NAME
(2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino] -3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane -2-carboxylic acid trihydrate

FORMULA
C₁₆H₁₉N₃O₅S.3H₂O

Potassium clavulanate

CHEMICAL NAME
Potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene) -7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate

FORMULA
C₈H₈NO₅K

DESCRIPTION
White to slightly yellowish powder.

SPECIFICATIONS
The product meets Lek's specification.
Amoxicillin Trihydrate meets Ph. Eur. and USP requirements,
Potassium Clavulanate meets Ph. Eur. and USP requirements.

PHARMACOLOGICAL PROPERTIES
The combination of amoxicillin, a bactericidal penicillin antibiotics with a broad spectrum of activity, and clavulanic acid, an irreversible beta-lactamase inhibitor forming stable, inactive complexes with the enzymes, thereby protecting amoxicillin from degradation, possesses a broad spectrum of activity. The activity of the combination is extended from microorganisms susceptible to amoxicillin alone to also include amoxicillin-resistant beta-lactamase producing organisms:

Gram-positive aerobes (S. pneumoniae, S. pyogenes, S. viridans, S. bovis, S. aureus, S. epidermidis, Listeria sp., Enterococcus sp.),
Gram-negative aerobes (H. influenzae, M. catarrhalis, E. coli, Proteus sp., Klebsiella sp., N. gonorrhoeae, N. meningitidis, Pasteurella multocida),
Anaerobes (Peptococcus sp., Peptostreptococcus sp., Clostridium sp., Bacteroides sp., Actinomyces israellii).

Amoxicillin and clavulanic acid have similar principal pharmacokinetic properties. The two substances are well absorbed from the gastrointestinal tract and readily diffuse into various body tissues and fluids.

USES
The combination of amoxicillin trihydrate and clavulanic acid potassium salt in the form of tablets and/or suspension is indicated for the treatment of conditions listed below:

Upper and lower respiratory tract infections
Acute and chronic otitis media
Genitourinary tract infections
Gonorrhea
Animal/human bites
Skin and soft tissue infections
Bone and joint tissue infections
Chancroid
Odontogenic infections
Mixed infections due to Gram-negative, Gram-positive microorganisms and anaerobes
Biliary tract infections
Postoperative intra-abdominal complications

PRESENTATION
Double polyethylene bags inserted in multi-layer bags and drums.

Product protected by patent in a country are not offered or supplied to that country.

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Lek d.d., tel: +386 1 580 2737, fax: +386 1 568 1325

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