PAMECIL Powder for solution for injection or infusion Ref.[28317] 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 panicillins. 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).

Pamecil contains sodium.

Pamecil 250mg contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

Pamecil 500mg contains 33.01mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Pamecil 1g contains 66.03mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Drug interactions

Aminoglycosides: If Pamecil is prescribed concurrently with an aminoglycoside the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur under these conditions.

Bacteriostatic antibiotics may interfere with the bactericidal effect of ampicillin.

Oral contraceptives: In common with other oral broad-spectrum antibiotics ampicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly (oral contraceptives may be less effective and increased breakthrough bleeding may occur. Additional non-hormonal contraception should be used).

Probenecid: Probenecid decreases renal tubular secretion of ampicillin resulting in increased and prolonged blood levels of ampicillin (ampicillin toxicity).

Allopurinol: Increased possibility of allergic skin reactions, may occur with concurrent administration.

Laboratory Test Interactions

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

In animal studies ampicillin has shown no teratogenic effects. Ampicillin has been in extensive worldwide use since about 1961 and use in pregnancy has been well documented. Ampicillin may be considered appropriate for use should antibiotic therapy be required during pregnancy.

Breast-feeding

Traces of penicillin are found in breast milk which may induce allergic sensitivity in the infant and it is recommended to stop breast-feeding during ampicillin therapy.

There are no reported effects of ampicillin on the ability to drive or operate machinery.

As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever or urticaria.

The following adverse reactions have been reported as associated with the use of ampicillin:

Gastrointestinal disorders: glossitis, stomatitis, nausea, vomiting, enterocolitis, pseudomembranous colitis and diarrhoea.

Blood and Lymphatic Systems: Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leucopenia and agranulosytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Hepatobiliar disorders: A moderate elevation in the serum glutamic-oxaloacetic transaminase (SGOT) has been noted, but the significance of this finding is unknown. Isolated report of cholestasis and jaundice in association with severe Stevens-Johnson syndrome.

Immune system disorders: an erythematous, mildly pruritic, maculopapular skin rash has been reported fairly frequently. The rash which usually does not develop within the first week of therapy, may cover the entire body including the soles, palms, and oral mucosa. The eruption usually disappears in three to seven days. Other reported hypersensitivity reactions are skin rash, pruritus, urticaria, erythema multiforme and rarely exfoliative dermatitis. Anaphylaxis is the most serious reactions experienced and has usually been associated with the parenteral dosage form of the drug.

Musculoskeletal and connective tissue disorders: Intramuscular administration of ampicillin is reported to increase serum CPK levels due to local skeletal muscle injury. CPK elevation is not seen when other routes of administration are used. Renal and urinary disorders: Creatinine clearance rate may be reduced. Interstitial nephritis has been reported it is believed to be caused by hypersensitivity.

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 to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649

Pamecil should not be mixed with aminoglycosides as loss of aminoglycoside activity will result.

Pamecil should not be mixed with blood products, protein hydrolysates or intravenous lipid emulsions.