| Suitable for: | Adult |
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| State: | Solid |
| Shape: | Tablet |
| Registration: | Available |
| Transport Package: | 7 Tablets /Box, 14 Tablets / Box |
| Specification: | 1g, 625mg |
| Samples: |
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| Customization: |
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Audited Supplier Amoxicillin And Clavulanate Potassium Tablet
COMPOSITION
Each tablet contains
Amoxicillin Trihydrate equivalent to amoxicillin 875mg
Potassium clavulanate equivalent to clavulanic acid 125mg
PHARMACOLOGICAL ACTION:
Mechanism of action:
Amoxiclan is a combination of amoxicillin and potassium clavulanate. The amoxicillin component of the formulation exerts a bactericidal action against many strains of Gram positive and Gram-nega-tive organisms. The clavulanic acid component has little or no antimicrobial action. It does, however by inactivation of susceptible beta-lactamase protect amoxicillin from degradation by beta-lactamase enzymes produced by penicillin resistant strains of organisms
Antibacterial Activity:
Clavulanic acid is an irreversible inhibitor of beta-lactamases produced by Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Proteus vulgaris, H influenzae, N.gonorrhoeae and B.fraqilis(In-vitro activity does not necessarily imply in-vivo efficacy).Potassium clavulanate does not inactivate the chromosomally mediated (Sykes Type 1 Cephalosporinase) beta-lactamases produced by Acinetobacter species, Citrobacter species, Enterobacter, indole positive Proteus, Providencia species and Serratia marcescens.
INDICATIONS:
Amoxiclan is indicated for the treatment of infections caused by amoxicillin resistant organisms producing beta-lactamases sensitive to clavulanic acid:Upper respiratory tract infections: otitis media, tonsillitis, sinusitis.Lower respiratory tract infections: bronchitis(caused by amoxicillin resistant beta-lactamases producing E.coli, H influenzae and Haemophilus parainfluenzae), pneumonia.
Skin and soft tissue infections.
Urinary tract infections: cystitis, urethritis, pyelonephritis.
Amoxiclan formulations will also be effective in the treatment of infections caused by amoxicillin sensitive organisms at the appropriate amoxicillin dosage since in this situation the clavulanic acid component does not contribute to the therapeutic effect.
CONTRA-INDICATIONS:
Allergy to penicillins and cephalosporins. Safety in pregnancy has not been established. Amoxiclan is contra-indicated in patients with a previous history of amoxicillin and potassium clavulanate associated jaundice/hepatic dysfunction. Amoxiclan is also contraindicated in infectious mononucle-osis, Patients with lymphatic leukemia and patients with hyperuricaemia having been treated with allopurinol may also be at an increased risk of developing skin rashes.
WARNINGS:
Transient hepatitis and cholestatic jaundice has been reported, hence, Amoxiclan should be used with caution in patients with evidence of hepatic dysfunction.
Serious and occasionally fatal hypersensitivity(anaphylactic) reactions have been reported in Patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalo-sporins or other allergens. If an allergic reaction occurs, Amoxiclan should be discontinued and the appropriate therapy instituted: corticosteroids and antihistamines.
DOSAGE AND DIRECTIONS FOR USE
Tablets should be kaken immediately before a meal.
General Information:
For infections caused by amoxicilin sensitive organisms the dosage is that approved for amoxicilin as the clavulanic acid component does not contribute to the therapeutic effect.
Adults
The adult dose for Amoxiclan 1g is one Amoxiclan 1g tablet every 12 hours at the start of a meal.
Impaired renal function
Both amoxicillin and clavulanic acid are excreted by the kidneys and the serum half-life of each increases in patients with renal failure. Therefore, the dose may need to be reduced or the interval extended. Dosage adjustments are based on the maximum recommended level of amoxicillin. The following schedule is proposed.
Amoxiclan 1g should not be used in patients with a glomerular filtration rate of <30 mL /minute .Haemodialysis decreases serum concentrations of both amoxicillin and clavulanic acid and an additional does: should be administered at the end of dialysis.
Dosage guide
| Amoxicillin-Sensitive Organisms | ||||
| Product | Upper Respiratory Tract Infection |
Lower Respiratory Tract Infection |
Urinary Tract Infection |
Skin & Soft Tissue Infections |
| Amoxiclan 1g tablet | 1 tablet 12 hourly | 1 tablet 12 hourly | 1 tablet 12 hourly | 1 tablet 12 hourly |
| Amoxicillin-Resistant Organisms | ||||
| Product | Upper Respiratory Tract Infection (Otitis media) |
Lower Respiratory Tract Infection (bronchitis) |
Urinary Tract Infection |
Skin & Soft Tissue Infections |
| Amoxiclan 1g tablet | 1 tablet 12 hourly | 1 tablet 12 hourly | 1 tablet 12 hourly | 1 tablet 12 hourly |
STORAGE INSTRUCTIONS
Store below 25ºC in the original package, protected from moisture
KEEP OUT OF REACH OF CHILDREN
Production:
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Audited Supplier 
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