Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Co-fluampicil is indicated for the treatment of severe infections where the causative organism is unknown, and for mixed infections involving ?-lactamase-producing staphylococci.

Typical indications include:

In general practice: Chest infections, ENT infections, skin and soft tissue infections, and infections in patients whose underlying pathology places them at special risk.

In hospital (prior to laboratory results being available): severe respiratory tract infections, post-operative chest and wound infections, septic abortion, puerperal fever; septicaemia, prophylaxis in major surgery, infections in patients receiving immuno-suppressive therapy.

The spectrum of activity of co-fluampicil also makes it suitable for the treatment of many mixed infections, particularly those where ?-lactamase-producing staphylococci are suspected or confirmed. Parenteral usage is indicated where oral dosage is inappropriate.

Adult Dosage

Usual adult dosage (including elderly patients and children over ten years):

Intramuscular/Intravenous: 500mg four times a day.

Usual children's dosage:

Intramuscular/Intravenous: Under 2 years: quarter adult dose, four times a day.

2-10 years: half adult dose, four times a day.

The above dosages for adults and children may be doubled where necessary.

Therapy may be continued for as long as it is indicated by the nature of infection.

Administration:

Intramuscular: Add 1.5ml Water for Injections BP to vial contents.

Intravenous: Dissolve 500mg in 10ml Water for Injections BP.

Administer by slow intravenous injection.

Co-fluampicil Injection may be added to infusion fluids or injected, suitably diluted into the drip tube over a period of 3-4 minutes.

Child Dosage

Contra Indications

Co--fluampicil contains ampicillin and flucloxacillin which are penicillins, and should not be given to patients with a history of hypersensitivity to β-lactam antibiotics (e.g. penicillins, cephalosporins).

Co-fluampicil is contraindicated in patients with a history of flucloxacillin-associated jaundice/hepatic dysfunction.

Ocular administration

Special Precautions

Before initiating therapy with co-fluampicil careful enquiries should be made concerning previous hypersensitivity reactions to β-lactam antibiotics.

Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving β-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. These reactions are more likely to occur in individuals with hypersensitivity to β-lactam antibiotics.

Co-fluampicil contains ampicillin and should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin.

Co-fluampicil should be used with caution in patients with evidence of hepatic dysfunction.

Special caution is essential in the newborn because of the risk of hyperbilirubinemia. Studies have shown that, at high dose following parenteral administration, flucloxacillin can displace bilirubin from plasma protein binding sites, and may therefore predispose to kernicterus in a jaundiced baby. In addition, special caution is essential in the newborn because of the potential for high serum levels of flucloxacillin due to a reduced rate of renal excretion.

During prolonged treatments (e.g osteomyelitis, endocarditis), regular monitoring of hepatic and renal functions is recommended.

Prolonged use may occasionally result in the selection of resistant strains of organisms.

Sodium Content: Co-fluampicil 500mg vials contains 29.9mg sodium per vial. This should be included in the daily allowance of patients on sodium restricted diets.

Interactions

Bacteriostatic drugs may interfere with the bactericidal action of ampicillin and flucloxacillin.

In common with other oral broad-spectrum antibiotics, co-fluampicil may reduce the efficacy of oral contraceptives and patients should be warned accordingly.

Probenecid decreases the renal tubular secretion of co-fluampicil. Concurrent use with co-fluampicil may result in increased and prolonged blood levels of both ampicillin and flucloxacillin.

Concurrent administration of allopurinol during treatment with ampicillin can increase the likelihood of allergic skin reactions.

Co-fluampicil contains ampicillin. It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used, because false positive readings are common with chemical methods due to the high urinary concentrations of ampicillin.

Adverse Reactions

Hypersensitivity reactions:

If any hypersensitivity reaction occurs, the treatment should be discontinued.

Skin rash, puritis and urticaria have been reported occasionally. The incidence of rash is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura, fever, eosinophilia and sometimes angioneurotic oedema have also been reported. Rarely, skin reactions such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. Reactions such as fever, arthralgia, and myalgia can develop more than 48 hours after the start of the treatment.

Anaphylaxis has been reported rarely.

Gastrointestinal reactions:

Minor gastrointestinal disturbances, including occasionally nausea, vomiting and diarrhoea may occur during treatment. Pseudomembranous colitis has been reported rarely.

Hepatic effects:

Hepatitis and cholestatic jaundice have been reported rarely. These may be delayed for up to two months after withdrawal of treatment. In some cases the course of these conditions has been protracted and lasted for several months. Very rarely deaths have been reported from hepatic effects but are mostly limited to patients with serious underlying disease.

As with most other antibiotics, a moderate transient increase in transaminases has been reported.

Renal effects:

Interstitial nephritis may occur.

Neurological effects:

Convulsions may be associated with IV administration of high doses to patients with underlying renal failure.

Haematological effects:

As with other β-lactam antibiotics haematological effects including reversible leucopenia, reversible thrombocytopenia and haemolytic anaemia have been reported rarely.

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