amoxicillin + clavulanic acid


Mylan Lab


Full Prescribing Info
Amoxicillin, clavulanic acid.
600 mg-Vial: Each vial contains: Amoxicillin sodium equivalent to Amoxicillin 500 mg and Potassium clavulanate equivalent to Clavulanic acid 100 mg.
1.2 g-Vial: Each vial contains: Amoxicillin sodium equivalent to Amoxicillin 1 g and Potassium clavulanate equivalent to Clavulanic acid 200 mg.
Pharmacology: Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it can act on the pathogen. The clavulanate in Amoxicillin and Clavulanic acid anticipates this defence mechanism by blocking the organisms sensitive to amoxicillin's rapid bactericidal effect at concentrations rapidly attainable in the body.
Clavulanate by itself has little antibacterial activity; however in association with amoxicillin as Amoxicillin and Clavulanic acid, it produces an antibiotic agent of broad spectrum with wide application in hospital and general practice.
Pharmacodynamics: Amoxicillin and Clavulanic acid combination is bactericidal to a wide range of organisms including: Gram-positive: Aerobes: Enterococcus faecalis*, Enterococcus faecium*, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Staphylococcus aureus*, Coagulase negative staphylococci* (including Staphylococcus epidermidis*), Corynebacterium sp, Bacillus anthracis *, Listeria monocytogenes.
Anaerobes: Clostridium sp, Peptococcus sp, Peptostreptococcus.
Gram-negative: Aerobes: Haemophilus influenzae*, Moraxella catarrhalis* (Branhamella catarrhalis), Eschirichia coli*, Proteus mirabilis*, Proteus vulgaris*, Klebsiella sp*, Salmonella sp*, Shigella sp*, Bordetella pertussis, Brucella sp, Neisseria gonorrhoeae*, Neiserria meningitidis*, Vibrio cholerae, Pasteurella multocida.
Anaerobes: Bacteroides sp* including B. fragilis.
* Some members of these species of bacteria produce β-lactamase, rendering them insensitive to amoxicillin alone.
Pharmacokinetics: The pharmacokinetics of the 2 components of Amoxicillin and Clavulanic acid are closely matched. Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of the Amoxicillin and Clavulanic acid approximately doubles the serum levels achieved.
When taken together with amoxicillin (500 mg), absorption of clavulanic acid (250 mg) is approximately the same, with a serum peak of around 6 mg.1-1 and a peak amoxicillin level of 10 mg.1-1, both after 1h. The urinary recovery is about 27-32% after a 250mg dose of clavulanic acid in combination with amoxicillin. The plasma half-life is 0.8-1h and plasma protein binding is 22-30%.
The activity of clavulanic acid is dependent upon the drug achieving concentrations at the site of action above the minimum inhibitory concentration (MIC).
Short term treatment of bacterial infections at the following sites: Upper respiratory tract infections: Recurrent tonsillitis, Sinusitis and otitis media.
Lower respiratory tract infections: Acute and chronic bronchitis, Lobar and bronchopneumonia.
Genitourinary tract infections: Cystitis, urethritis and pyelonephritis.
Skin and soft tissue infections: Boils, abscesses and cellulitis.
Wound infections: Bone and joint infections.
Dosage/Direction for Use
Dosages for the treatment of infection: Adults and children over 12 years: Usually 1.2 g 8 hourly. In more serious infections increase frequency to 6-hourly intervals.
Children 3 months-12 years: 30 mg/kg Amoxicillin and Clavulanic acid 8 hourly. In more serious infections, increase frequency to 6-hourly intervals.
Children 0-3 months: 30 mg/kg Amoxicillin and Clavulanic acid 12 hours in premature infants and in full-term infants during the perinatal period, increasing to 8 hours thereafter.
Dosage in renal impairment: Adults: (See table.)

Click on icon to see table/diagram/image

Children: Similar reductions in dosage should be made for children.
Dosage in hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.
There are, as yet, insufficient data on which to base a dosage recommendation.
Each 1.2g vial of Amoxicillin and Clavulanic acid contains 1.0 mmol of potassium and 2.7 mmol of sodium (approx).
Route of administration: Intravenous route only.
Duration of therapy should be appropriate to the indication and should not exceed 14 days without review.
Symptoms: Cases of overdosage with Amoxicillin and Clavulanic acid are usually asymptomatic. If encountered gastrointestinal symptoms and disturbances of the fluid and electrolyte balances may be evident.
Treatment: They may be treated symptomatically with attention to the water electrolyte balance. Amoxicillin and Clavulanic acid can be removed from the circulation by haemodialysis. During the administration of high doses of Amoxicillin and Clavulanic acid adequate fluid intake and urinary output should be maintained to minimize the possibility of amoxicillin crystalluria.
Penicillin hypersensitivity. Attention should be paid to possible sensitivity with other β-lactam antibiotics, e.g. Cephalosporin. A previous history of Amoxicillin and Clavulanic acid or penicillin associated jaundice / hepatic dysfunction.
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. If an allergic reaction occurs, the amoxicillin and clavulanic acid combination should be discontinued and the appropriate therapy instituted.
Special Precautions
Changes in liver function tests have been observed in some patients receiving Amoxicillin and Clavulanic acid. The clinical significance of these changes is uncertain but Amoxicillin and Clavulanic acid should be used with caution in patients with evidence of severe hepatic dysfunction. Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent for several weeks after treatment has ceased. Dosage should be adjusted in patients with renal impairment.
The sodium content must be taken into account in patients on a sodium restricted diet if the parenteral administration of high doses is necessary.
Crystalluria has been observed very rarely in patients with reduced urine output, predominantly with parenteral therapy. During administration of high doses of amoxicillin it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria. Amoxicillin has been reported to precipitate in bladder catheters after intravenous administration of large doses. A regular check of potency should be maintained.
Erythematous rashes have been associated with glandular fever in patients receiving amoxicillin.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
Effects on ability to drive and use machines: None known.
Use in Elderly: No special precautions have to be taken when prescribing for elderly.
Use In Pregnancy & Lactation
Pregnancy: Reproduction studies in animals (mice and rats) with orally and parenterally administered Amoxicillin and Clavulanic acid have shown no teratogenic effects. In a single study in women with preterm, premature rupture of the foetal membrane (pPROM), it was reported that prophylactic treatment with Amoxicillin and Clavulanic acid may be associated with an increased risk of necrotising enterocolitis in neonates. As with all medicines, use should be avoided in pregnancy, especially during the 1st trimester, unless considered essential by the physician.
Nursing mothers: Amoxicillin and Clavulanic acid may be administered during the period of lactation. With the exception of the risk of sensitisation, associated with the excretion of trace quantities in breast milk, there are no known detrimental effects on the breast-fed infant.
Adverse Reactions
Side effects are uncommon and mainly of a mild and transitory nature.
Gastrointestinal reactions: Side effects include diarrhoea, indigestion, nausea, vomiting, and mucocutaneous candidiasis have been reported. Antibiotic associated colitis (including pseudomembranous colitis and haemorrhagic colitis) has been reported rarely. Nausea, although uncommon, is more often associated with higher oral dosages.
Renal and urinary tract disorders: Crystalluria has been reported very rarely.
Genito-urinary effects: Vaginal itching, soreness and discharge may occur.
Hepatic effects: Moderate and asymptomatic rises in AST and/or ALT and alkaline phosphatase have been reported occasionally. Hepatitis and cholestatic jaundice have been reported rarely. It has been reported more commonly in the elderly, in males, or in patients with duration of treatment longer than 14 days. Signs and symptoms usually occur during or shortly after treatment but in some cases may not occur until several weeks after treatment has ended. Hepatic reactions are usually reversible but they may be severe and, very rarely, deaths have been reported.
Hypersensitivity reactions: Urticarial and erythematous skin rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP), serum sickness-like syndrome and hypersensitivity vasculitis have been reported. Whenever such disorders occur, treatment should be discontinued. In common with other β-lactam antibiotics angioedema and anaphylaxis have been reported. Intestinal nephritis can occur rarely.
Hematological effects: As with other β-lactams transient leucopenia (including neutropenia and agranulocytosis), thrombocytopenia and haemolytic anaemia have been reported rarely. Prolongation of bleeding time and prothrombin time has also been reported rarely.
CNS effects: CNS effects have been very rarely. These include reversible hyperactivity, dizziness, headache and convulsions. Convulsions may occur with impaired renal function or in those receiving high doses.
Local: Thrombophlebitis at the site of injection has been reported occasionally.
Drug Interactions
Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Amoxicillin and Clavulanic acid. It should be used with care in patients on anticoagulation therapy. In common with other broad-spectrum antibiotics, Amoxicillin and Clavulanic acid may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with Amoxicillin and Clavulanic acid may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid.
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of Amoxicillin and Clavulanic acid and allopurinol.
Caution For Usage
Instructions for use and handling: 600mg vial: To reconstitute dissolve in 10ml Water for Injections.
(Final volume 10.5ml.)
1.2g vial: To reconstitute dissolve in 20ml Water for Injections.
(Final volume 20.9ml.)
The solution should be given by slow intravenous injection over a period of three to four minutes and used within 20 minutes of reconstitution. It may be injected directly into a vein or via drip tube. Any residual antibiotic solutions should be discarded.
Amoxicillin and Clavulanic acid should not be mixed with blood products, other proteinaceous fluids such as protein hydrolysates or with intravenous lipid emulsions.
If Amoxicillin and Clavulanic acid combination is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur under these conditions.
Store at controlled room temperature not exceeding 25°C. Protect from light.
Shelf-Life: 2 years.
MIMS Class
ATC Classification
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Powd for inj (white to off white in vial) 600 mg x 1's, 10's, 50's. 1.2 g x 1's, 10's, 50's.
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