Co-fluampicil 250mg/250mg Hard Capsules

1. Name of the medicinal product

Magnapen® Hard Capsules or Co-fluampicil 250mg/250mg Hard Capsules

2. Qualitative and quantitative composition

Co-fluampicil Capsules contain 250mg ampicillin as ampicillin trihydrate with 250mg flucloxacillin as flucloxacillin sodium (co-fluampicil 250/250).

3. Pharmaceutical form

Capsules

Black and turquoise capsules overprinted Magnapen/Magnapen or CF500/CP

4. Clinical particulars

4.1 Therapeutic indications

Co-fluampicil is indicated for the treatment of severe infections where the causative organism is unknown, and for mixed infections involving β-lactamase-producing staphylococci. Typical indications include:

In general practice: Chest infections, ENT infections, skin and soft tissue infections, and infections in patients whose underlying pathology places them at special risk.

In hospital (prior to laboratory results being available): severe respiratory tract infections, post-operative chest and wound infections, septic abortion, puerperal fever; septicaemia, prophylaxis in major surgery, infections in patients receiving immuno-suppressive therapy.

The spectrum of activity of co-fluampicil also makes it suitable for the treatment of many mixed infections, particularly those where β-lactamase-producing staphylococci are suspected or confirmed.

Parenteral usage is indicated where oral dosage is inappropriate.

4.2 Posology and method of administration

Usual adult dosage (including elderly patients and children over 10 years): 

Oral: 1 capsule four times a day.

Usual children's dosage:

Oral: Under 10 years: half adult dose, using Co-fluampicil Syrup.

The above dosages for adults and children may be doubled where necessary.

Oral doses should be administered half to one hour before meals.

4.3 Contraindications

Co-fluampicil contains ampicillin and flucloxacillin which are penicillins, and should not be given to patients with a history of hypersensitivity to β-lactam antibiotics (e.g. penicillins, cephalosporins) or excipients.

Co-fluampicil is contraindicated in patients with a history of flucloxacillin-associated jaundice/hepatic dysfunction.

4.4 Special warnings and precautions for use

Before initiating therapy with co-fluampicil careful enquiries should be made concerning previous hypersensitivity reactions to β-lactam antibiotics.

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

Co-fluampicil contains ampicillin and 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.

In case of severe and persistent diarrhoea, the possibility of pseudomembranous colitis should be considered; flucloxacillin therapy should be discontinued.