Ampicillin 500mg Vials for Injection

(Ampicillin Sodium BP for injection): Each vial contains 500mg ampicillin as Ampicillin Sodium EP.

Vials containing sterile powder for injection.

Ampicillin is a broad-spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin-sensitive organisms. Typical indications include: ear, nose and throat infections, bronchitis, pneumonia, urinary tract infections, gonorrhoea, gynaecological infections, septicaemia, peritonitis, endocarditis, meningitis, enteric fever, gastro-intestinal infections.

Extraperitoneal application of Ampicillin to wounds can be used to prevent infection following abdominal surgery.

Parenteral usage is indicated where oral dosage is inappropriate.

Routes of administration: Intramuscular, intravenous, intraperitoneal, intrapleural, intra-articular, extraperitoneal.

Usual adult dosage (including elderly patients):

Septicaemia, endocarditis, osteomyelitis: 500 mg four to six times a day IM or IV for one to six weeks.

Peritonitis, intra-abdominal sepsis: 500mg four times a day IM or IV.

Ampicillin may also be administered by other routes of conjunction with systemic therapy.

Intraperitoneal: 500 mg daily in up to 10 ml Water for Injections BP.

Intrapleural: 500 mg daily in 5-10 ml Water for Injections BP.

Intra-articular: 500 mg daily, in up to 5 ml Water for Injections BP or sterile 0.5% procaine hydrochloride solution.

Local use in abdominal surgery: 1 g sterile powder sprinkled into the wound extraperitoneally or into muscle layers to prevent wound infection post operatively.

Usual children's dosage (under 10 years)

Half adult routine dosage.

All recommended dosages are a guide only. In severe infections the above dosages may be increased.

Renal Impairment

In the presence of severe renal impairment (creatinine clearance <10ml/min) a reduction in dose or extension of dose interval should be considered. In cases of dialysis, an additional dose should be administered after the procedure.

Administration:

Intramuscular: Add 1.5 ml Water for Injections BP to 500mg vial contents.

Intravenous: Dissolve 500 mg in 10 ml Water for Injections BP. Administer by slow injection (three to four minutes). Ampicillin may also be added to infusion fluids or injected, suitably diluted, into the drip tube over a period of three to four minutes.

Ampicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. ampicillin, penicillins, cephalosporins) or excipients.

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).

Sodium content: One vial contains 33.7 mg of sodium. This sodium content should be included in the daily allowance of patients on sodium restricted diets.

If Ampicillin 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 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, pruritus 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 has 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.

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.

Ampicillin may be removed from circulation by haemodialysis.

Ampicillin is a broad spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin sensitive organisms.

Ampicillin is excreted mainly in the bile and urine with a plasma half life of 1 – 2 hours.

No further information of relevance.

None

Ampicillin should not be mixed with blood products or other proteinaceous fluids (e.g. protein hydrolysates) or with intravenous lipid emulsions.

36 months

Ampicillin should not be stored above 25°C. Ampicillin Solutions for injection should be stored at 2-8°C in a refrigerator and used within 24 hours.

Clear glass vial (Ph.Eur Type 1) fitted with a butyl rubber plug and an aluminium seal – 10.

Ampicillin vials are not suitable for multidose use. Any residual Ampicillin solution should be discarded.

Essential Generics,

7, Egham Business Village,

Crabtree Road,

Egham,

Surrey,

TW20 8RB

PL 17736/0070

25 February 2005

21^st March 2005

POM