CO-FLUAMPICIL

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.

Blood and lymphatic system disorders:

As with other b-lactam antibiotics haematological effects including reversible leucopenia, reversible thrombocytopenia and haemolytic anaemia have been reported rarely. 4-warnings) has been reported rarely. If any hypersensitivity reaction occurs, the treatment should be discontinued.

Late sensitivity reactions may include serum sickness-like reactions (featuring symptoms such as arthralgia, rash, urticaria, fever, angioedema, lymphadenopathy), haemolytic anaemia and acute interstitial nephritis. ) Psychiatric disorders: There is a potential for hallucinations to occur rarely with flucloxacillin.

Nervous System Disorders Coma may develop with high doses of Flucloxacillin.

Respiratory, thoracic and mediastinal disorders:

Bronchospasm may occur as a result of penicillin allergy. There is a potential for acute, severe dyspnoea to occur with flucloxacillin.

Gastrointestinal disorders:

Minor gastrointestinal disturbances, including occasionally nausea, vomiting and diarrhoea may occur during treatment. Pseudomembranous colitis has been reported rarely.

Hepatobiliary disorders:

Hepatitis and cholestatic jaundice have been reported rarely. These may be delayed for up to two months after withdrawal of treatment. In some cases the course of these conditions has been protracted and lasted for several months. Very rarely deaths have been reported from hepatic effects but are mostly limited to patients with serious underlying disease.

As with most other antibiotics, a moderate transient increase in transaminases has been reported.

Before initiating therapy with co-fluampicil careful enquiries should be made concerning previous hypersensitivity reactions to -lactam antibiotics. Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving -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 -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.

Care is required when treating some patients with spirochaete infections such as syphilis or leptospirosis because the Jarisch-Herxheimer reaction may occur shortly after treatment with a penicillin is started. Caution is advised when flucloxacillin is administered concomitantly with paracetamol due to the increased risk of high anion gap metabolic acidosis (HAGMA).

Patients at high risk for HAGMA are in particular those with severe renal impairment, sepsis or malnutrition especially if the maximum daily doses of paracetamol are used. After co-administration of flucloxacillin and paracetamol, a close monitoring is recommended in order to detect the appearance of acid–base disorders, namely HAGMA, including the search of urinary 5-oxoproline.

5). 8). Care is necessary if very high doses of flucloxacillin are given, especially if renal function is poor, because of the risk of nephrotoxicity and/or neurotoxicity. Care is also necessary if large doses of sodium (salts) are given to patients with impaired renal function or heart failure.

g. penicillins, cephalosporins) or excipients. Co-fluampicil is contraindicated in patients with a history of flucloxacillin- associated jaundice/hepatic dysfunction.