COMPOSITION :- AMOXICILLIN 500 MG CLAVULANATE 125 MG
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- Product Description
ACUTE OTITIS MEDIA, BITE WOUNDS, CHANCROID CHRONIC OBSTRUCTIVE PULMONARY DISEASE, COMMUNITY-ACQUIRED PNEUMONIA, DIABETIC FOOT, DIVERTICULITIS, ERYSIPELAS, FEBRILE NEUTROPENIA, GONORRHEA, LOWER RESPIRATORY TRACT INFECTION
Amoxicillin and Clavulanic Acid:
An oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor clavulanic acid.
MECHANISM OF ACTION:
Amoxicillin: Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus 6-aminopenicillanic acid. It inhibits cross-linkage between the linear peptidoglycan polymer chains that make up a major component of the cell walls of both Gram-positive and Gram-negative bacteria. Amoxicillin inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Clavulanic acid is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferring drug resistance to penicillins and cephalosporins.
Rationale for combination:
Amoxicillin is susceptible to degradation by β-lactamases. The clavulanic acid component of Amoxy-Clav protects amoxicillin from degradation by β-lactamase enzymes and effectively extends the antibiotic spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other β-lactam antibiotics.
Indicated for the treatment of patients with community-acquired pneumonia or acute bacterial sinusitisdue to confirmed, or suspected β-lactamase−producing pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae, or methicillin-susceptible S. aureus) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs = 2 mcg/mL).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
The majority of side effects observed were of a mild and transient nature. The most frequently reported adverse effects which were suspected or probably drug-related were diarrhea (14.5%), vaginal mycosis (3.3%) nausea (2.1%), and loose stools (1.6%).
Other adverse effects that are common for the ampicillin group of antibiotics and may occur during use of amoxicillin are: GI effects like diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudo-membranous colitis; Hypersensitivity reactions like skin rashes, pruritus, urticaria, angioedema, serum sickness-like reactions; A moderate rise in AST (SGOT) and/or ALT (SGPT), interstitial nephritis and hematuria; CNS effects like agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, headache, insomnia.
WARNINGS / PRECAUTIONS:
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
Prolonged use may result in fungal or bacterial super infection, including C. difficile-associated diarrhea (CDAD) and pseudo-membranous colitis; CDAD has been observed >2 months post antibiotic treatment.
While amoxicillin/clavulanate potassium combination possesses the characteristic low toxicity of the penicillin group of antibiotics, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic function, is advisable if therapy is for longer than the drug is approved for administration.