MAGNAPEN

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

Intramuscular/Intravenous: 500mg four times a day.

Usual children’s dosage:

Intramuscular/intravenous: Under 2 years: quarter adult dose, four times a day. 2-10 years: half adult dose, four times a day. The above dosages for adults and children may be doubled where necessary. Therapy may be continued for as long as it is indicated by the nature of infection.

5m1 Water for Injections BP to vial contents.

Intravenous:

Dissolve 500mg in l0ml Water for Injections BP. Administer by slow intravenous injection. Co-fluampicil Injection may be added to infusion fluids or injected, suitably diluted into the drip tube over a period of 3 - 4 minutes.

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 Convulsions may be associated with IV administration of high doses to patients with underlying renal failure. 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.

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 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. 8). 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) Special caution is essential in the newborn because of the risk of hyperbilirubinemia. Studies have shown that, at high dose following parenteral administration, flucloxacillin can displace bilirubin from plasma protein binding sites, and may therefore predispose to kernicterus in a jaundiced baby.

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