AUGMENTIN 1GM TAB 14’S *

Composition
Tablets containing different ratios of Amoxycillin trihydrate to Potassium Calvulanate:
 
375 mg (2:1)
625 mg (4:1)
1 g (7:1)
Suspensions containing different ratios of Amoxycillin trihydrate to Potassium Calvulanate:
156.25 mg / 5 mL (4:1)
312.5 mg / 5 mL (4:1)
457 mg / 5 mL (7:1)
Description
Properties/Actions
Augmentin (beta-lactam antibacterial penicillin co-formualted with a beta-lactamase inhibitor) is an antibiotic agent with a notably broad spectrum of activity against commonly occuring bacetrial pathogens in general practice and hospital. The beta-lactamase inhibitory action of Clavulante extends the spectrum of amoxycillin to embrace a wider range of organisms, including many resistant to other beta-lactam antibiotics. Amoxycillin is a semisynthetic antibiotic with a broad spectrum of antibacterial activity against many gram-positive and gram-negative microogranisms. Amoxycillin is, however, susceptible to degradation by beta-lactamases and therefore the spectrum of acitivity of amoxycillin alone does not include organisms which produce these enzymes.Clavulanic acid is a beta-lactam, structurally related to the penicillins, which possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in micro-organisms resistant to penicillins and cephalosporins. In particular, it has good activity the clinically important plasmid mediated beta-lactamases frequently responsible for transferred drug resistance. It is generally less effective against chromosomally-meditated type 1 beta-lactamases.The presence of clavulanic acid in Augmentin formulations protects amoxycillin from degradation by beta-lactamase enzymes and effectively extends the antibacterial spectrum of amoxycillin to include many bacteria normally resistant to amoxycillin and other penicillins and cephalosporins.Thus Augmentin possesses the distinctive properties of a broad spectrum antibiotic and a beta-lactamase inhibitor. Augmentin is bactericidal to a wide range of organisms.
Indications
Short term treatment of bacetrial infections at the following sites when caused by Augmentin sensitive organisms:
 
Upper Respiratory Tract infections (including ENT): recurrent tonsilitis, sinusitis, otitis media typically caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
Lower Respiratory Tract infections: acute exacerbations of chronic bronchitis, lobar and bronchopneumonia typically caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis.
Gentio-urinary Tract infections: cystitis, urethritis, pyelonephritis, female genital infections typically caused by Enterobacteriaceae (mainly Escheria coli), Stayphylococcus saprophyticus and Enterococcus species; and gonorrhoea caused by Neisseria gonorrhoeae.
Skin and soft tissue infections: typically caused by Staphylococcus aureus, Streptococcus pyogenes and Bacteriodes species.
The paediatric t.i.d. dosing regimen is also indicated for the following infections:
Other infections: septic abortion, puerperal sepsis, intra-abdominal sepsis.
Some members of these species of bacteria produce beta-lactamase, rendering them insensitive to amoxycillin alone.
Infections caused by amoxycillin-susceptible organisms are amenable to Augmentin treatment due to its amoxycillin content. Mixed infections caused by amoxycillin-susceptible organisms in conjunction with Augmentin-susceptible beta-lactamase-producing organisms may therefore be treated by Augmentin.
Warnings
Before inititating therapy with Augmentin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.Serious and occasionally fatal hypersensitivity (anaphyalactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivty. If an allergic reaction occurs, Augmentin therapy should be dicontinued and appropriate alternative therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation may also be required. Agumentin should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this conditon following the use of amoxycillin.Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.In general, Augmentin is well tolerated and possesses the characteristic low toxicity of the penicillin group of antibiotics. Periodic assessement of organ system functions; including renal, hepatic and haematopoietic function is advisable during prolonged therapy. Prolongation of prothrombin time has been reported rarely in patients receiving Augmentin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Agumentin should be used with caution in patients with evidence of hepatic dysfunction.In patients with renal impairment, dosage should be adjusted according to the degree of impairment. In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxycillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxycillin crystalluria. Agumentin suspensions containing aspartame, which is a source of phenylalanine and so should be used with caution in patients with phenylketonuria.