PENBRITIN Capsules Ref.[6182] Active ingredients: Ampicillin

Before initiating therapy with ampicillin, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.

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

Ampicillin 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.

Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

Dosage should be adjusted in patients with renal impairment (see section 4.2).

Bacteriostatic drugs may interfere with the bactericidal action of ampicillin.

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

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

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

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

Pregnancy

Animal studies with Ampicillin have shown no teratogenic effects. The product has been in extensive clinical use since 1961 and its use in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Ampicillin may be considered appropriate.

Lactation

During lactation, trace quantities of penicillins can be detected in breast milk.

Adequate human and animal data on use of Ampicillin during lactation are not available.

Adverse effects on the ability to drive or operate machinery have not been observed.

Hypersensitivity reactions

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

Skin rash, pruritis and urticaria have been reported occasionally. The incidence is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura has also been reported. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.

As with other antibiotics, anaphylaxis (see Item 4.4 – Warnings) has been reported rarely.

Renal effects

Interstitial nephritis can occur rarely.

Gastrointestinal reactions

Effects include nausea, vomiting and diarrhoea. Pseudomembraneous colitis and haemorrhagic colitis have been reported rarely.

Hepatic effects

As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely. As with most other antibiotics, a moderate and transient increase in transaminases has been reported.

Haematological effects

As with other beta-lactams, haematological effects including transient leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely. Prolongation of bleeding time and prothrombin have also been reported rarely.

Reporting of suspected adverse reactions

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.

None.