Indications & Dose:
Treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below. Bone and joint infections caused by betalactamase producing strains of Staphylococcus aureus.
Gynaecologic infections, endometritis caused by beta-lactamase producing strains of Bacteroides melaninogenicus, Enterobacter species (including E. cloacae), Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus and Staphylococcus epidermidis.
Intra-abdominal infections, peritonitis caused by beta-lactamase producing strains of Escherichia coli, Klebsiella pneumoniae and Bacteroides fragilis group.
Lower respiratory infections caused by betalactamase producing strains of Staphylococcus aureus, Haemophilus influenzae and Klebsiella species
Septicaemia including bacteraemia, caused by beta-lactamase producing strains of Klebsiella species, E. coli, Staphylococcus aureus and Pseudomonas aeruginosa (and other Pseudomonas species).
Skin and skin structure infections caused by betalactamase producing strains of Staphylococcus aureus, Klebsiella species and E. coli.
Urinary tract infections (complicated and uncomplicated) caused by beta-lactamase producing strains of E. coli, Klebsiella species, Pseudomonas aeruginosa (and other Pseudomonas species, Citrobacter species, Enterobacter cloacae, Serratia marcescens, and Staphylococcus aureus.
- Severe infections in hospitalised patients and proven or suspected infections in patients with impaired or suppressed host defences including :septicaemia, bacteraemia, peritonitis, intraabdominal sepsis, post - surgical infections, bone and joint infections, skin and soft tissue infections, respiratory tract infections, serious or complicated renal infections (e.g. pyelonephritis), ear, nose and throat infections.
While ticarcillin-clavulanate is indicated only for the conditions listed above, infections caused by ticarcillin susceptible organisms are also amenable to ticarcillin-clavulanate treatment due to its ticarcillin content. Therefore, mixed infections caused by ticarcillin susceptible organisms and beta-lactamase producing organisms susceptible to ticarcillin-clavulanate should not require the addition of another antibiotic.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ticarcillinclavulanate. Because of its broad spectrum of bactericidal activity against Gram-positive and Gram-negative bacteria, ticarcillin-clavulanate is particularly useful for the treatment of mixed infections and for presumptive therapy prior to the identification of the causative organisms. Ticarcillinclavulanate has been shown to be effective as single drug therapy in the treatment of some serious infections where normally combination antibiotic therapy might be employed. Therapy with ticarcillin-clavulanate may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above; however, once these results become available, appropriate therapy should be continued. Based on the in vitro synergism between ticarcillinclavulanate and aminoglycosides against certain strains of Pseudomonas aeruginosa, combined therapy has been successful, especially in patients with impaired host defences. Both drugs should be used in full therapeutic doses. As soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted as indicated
DOSAGE AND ADMINISTRATION
The usual dosage is 3.2 g Timentin given six to eight hourly. The maximum recommended dosage is 3.2 g four hourly.
Children under 40kg
– Usual daily dosage: 80mg/kg every 8hr
– Maximum recommended dosage frequency:
80mg/kg every 6hr
– Weighing less than 2kg:80mg/kg every 12hr.
– Weighing greater than 2kg:80mg/kg every 8hr
An initial loading dose of 3g should be followed by doses based on creatinine clearance rate and type of dialysis as indicated below.
Mild Moderate Severe
impairment impairment impairment
(Creatinine (Creatinine (Creatinine
Clearance Clearance Clearance
>30 ml/min) <10 ml/min) 10-30 ml/min)
1.6 g 8 hourly 1.6 g 12 hourly 3.2 g 8 hourly
– Patients on peritoneal dialysis: as for creatinine clearance less than 10ml/min
– Patients on haemodialysis:as for creatinine clearance less than 10ml/min supplemented with 3g after each dialysis.
Renal impairment - Children under 40 kg
Similar dosage adjustment as for adults, e.g. an initial loading dose of 80mg/kg should be followed by doses based on creatinine clearance and type of dialysis as indicated below.
Greater than 30ml/min80mg/kg every 8hr
10 to 30ml/min 40mg/kg every 8hr
Less than 10ml/min 40mg/kg every 12hr
Renal impairment h Premature infants
No dosage recommendation can be made for this category.
Hepatic impairment
There is insufficient evidence on which to base a dosage recommendation.
Contraindications:
Should not be given to patients with a history of hypersensitivity to betalactam antibiotics (e.g. penicillins and cephalosporins).
Side Effects:
Cautions:
Precautions:
Interaction:
Co-administration of probenecid cannot be recommended. Probenecid decreases the renal tubular secretion of ticarcillin. Concurrent administration of probenecid delays ticarcillin renal excretion but does not delay the excretion of clavulanic acid.
The presence of clavulanic acid may cause a nonspecific binding of IgG and albumin by red cell membranes leading to a false positive Coombs test.
In common with other antibiotics, may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
Pregnancy and Lactation
Should only be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.
Trace quantities are excreted in breast milk, may be administered during the period of lactation. With the exception of the risk of sensitisation, there are no detrimental effects for the breast-fed infant.
Effects on Ability to Drive and Use Machines Adverse effects on the ability to drive or operate machinery have not been observed
Warnings:
Before initiating therapy with careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactams (e.g. penicillins and cephalosporins). If an allergic reaction occurs, the drug should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, i.v. steroids, and airway management, including intubation, may also be required. Bleeding manifestations have occurred in some patients receiving beta-lactam antibiotics. These reactions have been associated with abnormalities of coagulation tests such as clotting time, platelet aggregation and prothrombin time and are more likely to occur in patients with renal impairment. If bleeding manifestations appear, treatment should be discontinued and appropriate therapy instituted. Rarely been reported to cause hypokalemia; however, the possibility of this occurring should be kept in mind particularly when treating patients with fluid and electrolyte imbalance. Periodic monitoring of serum potassium may be advisable in patients receiving prolonged therapy. The presence of clavulanic acid in may cause a non-specific binding of IgG and albumin by red cell membranes leading to a false positive Coombs test.
Sodium content: These formulation of contain the amounts of sodium (mg per g) outlined in the following table. This should be included in the daily allowance of patients on sodium restricted diets. Product Sodium content (mg per g) 3.2 g 107
Prolonged use may occasionally result in overgrowth of non-susceptible organisms. In patients with renal impairment, dosage should be adjusted according to the degree of impairment (see Dosage and Administration, Renal Impairment).
Adverse Effects:
Lactations:
Special Precautions:
Counselling:
Side Effects Or Adverse Reactions:
Hypersensitivity reactions:
Hypersensitivity effects, including skin rashes: Skin rashes, pruritus, urticaria, and anaphylactic reactions.
Bullous reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported very rarely.
Gastrointestinal effects: Nausea, vomiting and diarrhoea have been reported. Pseudomembranous colitis has been reported rarely.
Hepatic effects: A moderate rise in AST and/or ALT has been noted in patients receiving ampicillin class antibiotics. Hepatitis and cholestatic jaundice have been reported very rarely. These events have been noted with other penicillins and cephalosporins.
Renal effects: Hypokalaemia has been reported rarely.
Central Nervous System effects: Convulsions may occur rarely, particularly in patients with impaired renal function or in those receiving high doses.
Haematological effects: Thrombocytopenia, leucopenia, eosinophilia have been reported rarely and reduction of haemoglobin. Prolongation of prothrombin time and bleeding time. Bleeding manifestations have occurred.
Local effects: Pain, burning, swelling and induration at the injection site and thrombophlebitis with i.v. administration.
Patient And Carer Advice:
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