Indications

Ampicillin capsules are indicated for the oral therapy of bacterial infections caused by ampicillin-sensitive organisms. Such indications include infections of the upper and lower respiratory tract, genito-urinary tract and the gastro-intestinal tract. Specific indications include ear and soft tissue infections and gonorrhoea.

Dosage and Administration

Usage: Oral

Usual Adult/Elderly Dosage : the usual dosage is 250mg every 6 hours.

Usual children’s dosage: (Under 10 years) Half of the adult dosage

Renal Impairment: In severe renal impairment (ie, creatinine clearance)

Precautions & Warning:

1.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 betalactam antibiotics.

2.Prolonged use of an anti-infective may occasionally result in the development of super-infection due to organisms resistant to that anti-infective e.g. Candida or Pseudomonas.

3.Care should be taken with patients with renal impairment and dose adjustment may be required. Care should be taken when high doses are given; renal and haematological status should be monitored during high-dose and prolonged therapy. 4.Ampicillin should be avoided in glandular fever, cytomegalovirus (CMV), and/or acute and chronic lymphatic leukaemia and possibly HIV as erythematous rashes are more common.

5.Care is necessary when treating spirochaete infections particularly Syphilis.

Contraindications:

Use in patients with hypersensitivity to penicillins, ampicillin, cephalosporins or any of the excipients.

Adverse Reactions:

1.Side effects as with other penicillins are rare and usually of a mild or transitory nature. Occasionally, gastro-intestinal disturbances, nausea, vomiting and diarrhoea or haemorrhagic colitis or pseudomembranous colitis may occur.

2.Erythematous maculo-papular rashes, sore mouth and sore, black, hairy tongue have occurred. Two types of rashes have been observed: an urticarial rash which is usually indicative of true penicillin hypersensitivity and an erythematous rash which is generally specific to ampicillin. The latter is particularly seen in patients with infectious mononucleosis, cytomegalovirus, acute and chronic lymphatic leukaemia and possibly HIV. Erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis has been reported. If a rash occurs, treatment should be discontinued.

3.Angioedema and anaphylaxis have occasionally occurred.

4.Fever, joint pains, serum sickness-like symptoms have been reported.

5.There have been reports of haemolytic anaemia, thrombocytopenia, leucopenia, neutropenia and coagulation disorders.

6.Prolongation of bleeding time and prothrombin time have also been reported rarely. Particularly with high doses or in renal impairment, CNS toxicity including convulsions have occurred; with prolonged use paraesthesia.

7.Nephropathy and interstitial nephritis has been reported.

Drug interactions:

1.Ampicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.

2.Uricosurics: excretion of penicillin is decreased, giving an increased risk of toxicity e.g. Probenecid and sulfinpyrazone.

3.Allopurinol increases Ampicillin induced skin reactions.

4.Anti-coagulants: INR can be altered by the administration of Ampicillin while on Warfarin and Phenindione.

5.Vaccines: The efficacy of Oral Typhoid Vaccine may be reduced when ampicillin is coadministered

6.Cytotoxics: the excretion of methotrexate is reduced.

7.Chloroquine: absorption of ampicillin is reduced when taken concomitantly with chloroquine.

Storage instructions:

Store below 25°C. Keep the container tightly closed in order to protect from moisture.