Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK
Allergy to penicillins. Hypersensitivity to any ingredient of the preparation.
Cross allergy to other beta-lactams such as cephalosporins should be taken into account.
600 mg benzylpenicillin contains 1.68 mmol of sodium. Massive doses of Benzylpenicillin Sodium can cause hypokalaemia and sometimes hypernatraemia. Use of a potassium-sparing diuretic may be helpful. In patients undergoing high-dose treatment for more than 5 days, electrolyte balance, blood counts and renal functions should be monitored.
In the presence of impaired renal function, large doses of penicillin can cause cerebral irritation, convulsions and coma.
Skin sensitisation may occur in persons handling the antibiotic and care should be taken to avoid contact with the substance.
It should be recognised that any patient with a history of allergy, especially to drugs, is more likely to develop a hypersensitivity reaction to penicillin. Patients should be observed for 30 minutes after administration and if an allergic reaction occurs the drug should be withdrawn and appropriate treatment given.
Delayed absorption from the intramuscular depot may occur in diabetics.
Prolonged use of benzylpenicillin may occasionally result in an overgrowth of non-susceptible organisms or yeast and patients should be observed carefully for superinfections.
Pseudomembranous colitis should be considered in patients who develop severe and persistent diarrhoea during or after receiving benzylpenicillin. In this situation, even if Clostridium difficile is only suspected, administration of benzylpenicillin should be discontinued and appropriate treatment given.
The efficacy of oral contraceptives may be impaired under concomitant administration of benzylpenicillin sodium, which may result in unwanted pregnancy. Women taking oral contraceptives should be aware of this and should be informed about alternative methods of contraception.
There is reduced excretion of methotrexate (and therefore increased risk of methotrexate toxicity) when used with benzylpenicillin sodium.
Probenecid inhibits tubular secretion of benzylpenicillin sodium and so may be given to increase the plasma concentrations.
Penicillins may interfere with:
Benzylpenicillin sodium has been taken by a large number of pregnant women and women of childbearing age without an increase in malformations or other direct or indirect harmful effects on the foetus having been observed.
Although it is not known if benzylpenicillin sodium may be excreted into the breast milk of nursing mothers, it is actively transported from the blood to milk in animals and trace amounts of other penicillins in human milk have been detected.
None.
Rare (0.01%-0.1%): Haemolytic anaemia and granulocytopenia (neutropenia), agranulocytosis, leucopenia and thrombocytopenia, have been reported in patients receiving prolonged high doses of benzylpenicillin sodium (eg. Subacute bacterial endocarditis).
Very Common (>10%): Patients undergoing treatment for syphilis or neurosyphilis with benzylpenicillin may develop a Jarisch-Herxheimer reaction.
Common (1-10%): Hypersensitivity to penicillin in the form of rashes (all types), fever, and serum sickness may occur (1-10% treated patients). These may be treated with antihistamine drugs.
Rare (0.01%-0.1%): More rarely, anaphylactic reactions have been reported (<0.05% treated patients).
Rare (0.01%-.01%): Central nervous system toxicity, including convulsions, has been reported with massive doses over 60 g per day and in patients with severe renal impairment.
Rare (0.01%-0.1%): Interstitial nephritis has been reported after intravenous benzylpenicillin sodium at doses of more than 12 g per day.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Benzylpenicillin sodium and solutions that contain metal ions should be administered separately.
Benzylpenicillin sodium should not be administered in the same syringe/giving set as amphotericin B, cimetidine, cytarabine, flucloxacillin, hydroxyzine, methylprednisolone, or promethazine since it is incompatible with these drugs.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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