SUPRAX

The usual course of treatment is 7 days. This may be continued for up to 14 days if required.

Posology Adults and Children over 10 years or weighing more than 50 kg:

The recommended dose is 200 – 400 mg daily according to the severity of infection, given either as a single dose or in two divided doses.

Children under 10 years:

Suprax Tablets 200 mg are not recommended for use in children under 10 years old. The safety and efficacy of cefixime has not been established in children less than 6 months.

Elderly:

Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed, and dosage should be adjusted in severe renal impairment.

Renal impairment:

Suprax may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearances of 20 ml/min or greater. In patients whose creatinine clearance is less than 20 ml/min, it is recommended that a dose of 200 mg once daily should not be exceeded.

The dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or haemodialysis should follow the same recommendation as that for patients with creatinine clearances of less than 20 ml/min. Method for administration For oral administration.

Absorption of Suprax is not significantly modified by the presence of food.

Suprax is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature. The following adverse reaction (Preferred term# or equivalent) will be considered listed: Blood and lymphatic system disorders: Eosinophilia Hypereosinophilia Agranulocytosis Leucopenia Neutropenia Granulocytopenia Haemolytic anaemia Thrombocytopenia Thrombocytosis Gastrointestinal disorders: Abdominal pain Diarrhoea* Dyspepsia Nausea Vomiting Flatulence Hepatobiliary disorders: Jaundice Infections and infestations: Pseudomembranous colitis Vaginitis Investigations: Aspartate aminotransferase increased Alanine aminotransferase increased Blood bilirubin increased Blood urea increased Blood creatinine increased Nervous system disorders: Dizziness Headache Cases of convulsions have been reported with cephalosporins including cefixime (frequency not known) ** Beta-lactams, including cefixime, have been associated with encephalopathy risk (which may include convulsions, confusion, decreased consciousness, movement disorders), particularly in elderly patients, in patients with severe renal impairment or central nervous system disorders and in case of overdose.

4). 4) General disorders and administrative site conditions: Drug Fever Arthralgia Pyrexia Face oedema Genital pruritus The above mentioned listed adverse reactions have been observed during clinical studies and/or during marketed use.

0) *Diarrhoea has been more commonly associated with higher doses. Some cases of moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of therapy. Suprax should be discontinued if marked diarrhoea occurs.

**Cannot be estimated from available data Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Encephalopathy Beta-lactams, including cefixime, have been associated with encephalopathy risk (which may include convulsions, confusion, decreased consciousness, movement disorders), particularly in elderly patients, in patients with severe renal impairment or central nervous system disorders and in case of overdose.

If cefixime-associated encephalopathy is suspected discontinuation should be considered. 9) Severe cutaneous adverse reactions Severe cutaneous adverse reactions (SCARS) including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS) drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in association with cefixime.

Patients should be informed about the signs and symptoms of serious skin manifestations and monitored closely. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of skin hypersensitivity.

Suprax should be given with caution to patients who have shown hypersensitivity to other drugs. Hypersensitivity to penicillins As with other cephalosporins, cefixime should be given with caution to patients with a history of hypersensitivity to penicillin, as there is some evidence of partial cross- allergenicity between the penicillins and cephalosporins.

Patients have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Suprax, the drug should be discontinued and the patient treated with appropriate agents if necessary. Haemolytic anaemia Drug-induced haemolytic anaemia, including severe cases with a fatal outcome, has been described for cephalosporins (as a class).

The recurrence of haemolytic anaemia after re-administration of cephalosporins in a patient with a history of cephalosporin (including cefixime) –associated haemolytic anaemia has also been reported. Acute renal failure As with other cephalosporins, cefixime may cause acute renal failure including tubulointerstitial nephritis as an underlying pathological condition.

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