Product Details

Product Information of Ampiclox 500mg Capsules

Contraindications
– AMPICLOXshould not be given to patients with a history of hypersensitivity to
beta-lactam antibiotics (e.g., penicillins, cephalosporins) or excipients (See List of
Excipients).
– AMPICLOXis contraindicated for ocular administration.

Warnings and Precautions

Caution should be observed when administering AMPICLOXneonatal oral drops to babies whose mothers are hypersensitive to penicillin. Before initiating therapy with AMPICLOX, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactams. Cross-sensitivity between penicillins and cephalosporins is well documented. 4 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. If an allergic reaction occurs, AMPICLOXshould be discontinued and the appropriate alternative therapy instituted. All adverse reactions should be treated symptomatically. AMPLICLOX 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. Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further. Dosage should be adjusted in patients with renal impairment (See Dosage and Administration, Renal impairment). Cloxacillin can displace bilirubin from protein-binding sites. Normal caution should therefore be exercised in the treatment of jaundiced neonates. AMPLICLOX neonatal oral suspension and suspension contain sodium benzoate which is a mild irritant to the skin, eyes, and mucous membrane. It may increase the risk of jaundice in newborn babies. The sodium content of the formulation must be included in the daily allowance of patients on sodium restricted diets. Each AMPICLOX 500mg vial contains 29.63mg of sodium. Each AMPICLOX 500mg capsule contains 13.17mg of sodium. AMPICLOX suspension 250mg contains 12.14mg sodium per 5 mL dose. AMPICLOX Neonatal oral drops contains 2.46 mg sodium per 0.6mL dose. Interactions Probenecid decreases the renal tubular excretion of AMPICLOX. Concurrent use with AMPICLOX may result in increased and prolonged blood levels of AMPICLOX. 5 In common with other antibiotics, AMPICLOX may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives. Sulphonamides and acetylsalicylic acid inhibit serum protein binding of cloxacillin in vitro. This may result in increased levels of free cloxacillin in serum in vivo. Bacteriostatic drugs may interfere with the bactericidal action of AMPICLOX. Concurrent administration of allopurinol during treatment with AMPICLOX can increase the likelihood of allergic skin reactions. Pregnancy and Lactation Adequate human data on use during pregnancy are not available. However, animal studies have not identified any risk to pregnancy or embryo-foetal development. Adequate human and animal data on use during lactation are not available. Ability to perform tasks that require judgment, motor or cognitive skills No adverse effects on the ability to drive or operate machinery have been observed