Broad-spectrum penicillins / beta-lactamase inhibitors.

Generic

Amoxicillin Sodium for Injection BP 250mg Amoxicillin Sodium for Injection BP 500mg Amoxicillin Sodium for Injection BP 1g

Powder for solution for injection.

Amoxicillin is a broad-spectrum aminopenicillin and is indicated in the treatment of bacterial infections such as actinomycosis, biliary-tract infections, bone and joint infections, acute exacerbations of chronic bronchitis, gastroenteritis, (including Escherichia coli enteritis and Salmonella enteritis, but not shigellosis), gonorrhoea, mouth infections, sinusitis, otitis media, pneumonia (except where Mycoplasma suspected), typhoid and paratyphoid fever, urinary-tract infections, bacterial meningitis and the prophylaxis of endocarditis. It is also used in the treatment of Lyme disease.

Treatment of Infections in Adults and the Elderly

Treatment of Infection in Children up to 10 years

Renal impairment

It may be necessary to reduce the total daily dosage depending on the degree of renal impairment.

As amoxicillin is removed by haemodialysis, patients receiving haemodialysis may require another dose of amoxicillin at the end of their dialysis.

Endocarditis prophylaxis

Method of Administration

Amoxicillin Sodium for Injection BP, when diluted may be injected slowly into a vein or infusion line over three to four minutes.

Intravenous Infusion:

Prepare as above and add to an iv solution in a minibag or in-line burette. Administer over 30 to 60 minutes. Alternatively the appropriate volume of iv fluid may be transferred from the infusion bag into the vial, using a suitable reconstitution device, and drawn back into the bag after dissolution.

Suspension, 250/62: Under 15 kg, 25 mg/kg daily using the syringe measure; 6 - 12 years, 5 mL three times daily before meals for up to 14 days, then review. Suspension, 125/31: Under 1 year, 25 mg/kg daily; 1 - 6 years, 5 mL three times daily before meals. All for up to 14 days, then review.

Penicillin hypersensitivity.

Glandular fever and lymphatic lymphoma.

Bacterial resistance to amoxicillin or ampicillin

Amoxicillin should be given with caution to patients with a history of allergy, especially to drugs. Desensitisation may be necessary if treatment is essential.

Amoxicillin should not be used in patients with underlying defects of the urinary tract or for long-term treatment of recurrent urinary tract infection, as resistance may develop in the enteric flora.

Care is necessary if very high doses of amoxicillin are given, especially if renal function is poor, because of the risk of nephrotoxicity. The intrathecal route should be avoided. Care is also necessary if large doses of sodium (as amoxicillin sodium) are given to patients with impaired renal function or heart failure. Renal and haematological status should be monitored during prolonged and high-dose therapy.

Care is required when treating some patients with syphilis because of the Jarisch- Herxheimer reaction.

Contact with amoxicillin should be avoided since skin sensitisation may occur.

Amoxicillin should preferably not be given to patients with undiagnosed pharyngitis (who may have mononucleosis) or patients with lymphatic leukaemia or possibly HIV infection who may also be at increased risk of developing skin rashes with amoxicillin.

Amoxicillin may decrease the efficacy of oestrogen-containing oral contraceptives. Plasma concentrations of amoxicillin are enhanced if probenecid is given concurrently. There is reduced excretion of methotrexate (increased risk of toxicity).

There may be antagonism between amoxicillin and bacteriostatic agents such as chloramphenicol. An increased frequency of skin rashes has been reported in patients receiving amoxicillin together with allopurinol, compared to those receiving amoxicillin alone.

The most common adverse effects are sensitivity reactions including urticaria, maculo- papular rashes (often appearing more than seven days after commencing treatment), fever, joint pains and angioedema. Anaphylaxis occasionally occurs and has sometimes been fatal. Late sensitivity reactions may include serum sickness-like reactions, haemolytic anaemia and acute interstitial nephritis.

Other adverse effects are generally associated with large intravenous doses of amoxicillin or impaired renal function. These include transient leucopenia and thrombocytopenia, haemolytic anaemia and neutropenia (which might have some immunological basis); prolongation of bleeding time and defective platelet function; convulsions and other signs of central nervous system toxicity (encephalopathy has been reported following intrathecal administration and can be fatal); electrolyte disturbances due to administration of large amounts of sodium.

Most patients with infectious mononucleosis develop a maculopapular rash when treated with amoxicillin, and patients with other lymphoid disorders such as lymphatic leukaemia also appear to be at higher risk.

Some patients with syphilis may experience a Jarisch-Herxheimer reaction shortly after treatment is started. Symptoms include fever, chills, headache and reaction at the site of lesions. The reaction can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as with optic atrophy.

Gastrointestinal effects (diarrhoea and nausea) reported with amoxicillin commonly occur after oral administration, not parenteral administration. Pseudomembranous colitis has been reported with most antibiotics.

Erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, hepatitis and cholestatic jaundice have been reported with combined amoxicillin and clavulanic acid therapy.

Wockhardt UK Ltd

(POM)

04 June 2009