CEFIXIME

1). Elderly patients Elderly patients may be given the same dose as recommended for adults. 4). Adolescents ≥ 12 years of age Adolescents ≥ 12 years of age may be given the same dose as recommended for adults. Children from 6 months to 11 years of age It is recommended that children from 6 months to 11 years of age be given cefixime as an oral suspension because 200 mg cannot be adequately dosed for this age group.

The recommended dosage for children in this age group is 8 mg / kg body weight / day administered as a single dose or in two divided doses. Children less than 6 months of age The safety and efficacy of cefixime has not been established in children less than 6 months of age.

Renal insufficiency Cefixime may be administered in the presence of impaired renal function in adult patients. Normal dose and schedule may be given in adult 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. There are insufficient data regarding use of cefixime in the pediatric and adolescent age group in the presence of renal insufficiency: the use of cefixime in these patient- groups is not recommended.

Method of administration Cefixime tablets are for oral administration only. Cefixime tablets should be taken with a sufficient amount of water. 2). Duration of treatment The usual course of treatment is 7 days. This may be continued for up to 14 days if required.

4) Eosinophilia RareBlood and lymphatic system disorders Leucopenia, agranulocytosis, pancytopenia, thrombocytopenia, haemolytic anaemia Very rare Hypersensitivity RareImmune system disorders Anaphylactic shock, serum sickness Very rare Metabolism and nutrition disorders Anorexia Rare Headache Uncommon Vertigo Rare Nervous system disorders Psychomotor hyperactivity Very rare Diarrhoea Common Abdominal pain, nausea, vomiting Uncommon Gastrointestinal disorders Flatulence Rare Hepatobiliary disorders Hepatitis, cholestatic jaundice Very rare Rash Uncommon Angioneurotic oedema, pruritus Rare Skin and subcutaneous tissue disorders Stevens-Johnson syndrome, toxic epidermal necrolysis Very rare Renal and urinary disorders Interstitial nephritis Very rare General disorders and administration site conditions Mucosal inflammation, pyrexia Rare Hepatic enzyme increased (transaminase, alkaline phosphatase) Uncommon Blood urea increased Rare Investigations Blood creatinine increased Very rare

Cefixime should be given with caution to patients who have shown hypersensitivity to other drugs. Cephalosporins should be given with caution to penicillin-sensitive patients, 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. 3). If severe hypersensitivity reactions or anaphylactic reactions occur after administration of cefixime, the use of cefixime should be discontinued immediately and appropriate emergency measures should be initiated.

2). There are insufficient data regarding use of cefixime in the pediatric and adolescent age group in the presence of renal insufficiency: the use of cefixime in these patient-groups is not recommended. Prolonged use of cefixime may result in the overgrowth of non-susceptible organisms.

Treatment with broad spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated diarrhoea.

Pseudomembranous colitis is associated with the use of broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins, lincosamides and cephalosporins including cefixime); it is therefore important to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics.

8). The use of cefixime should be discontinued and appropriate treatment measures should be established. Management of pseudomembranous colitis should include sigmoidoscopy, appropriate bacteriologic studies, fluids, electrolytes and protein supplementation.

If the colitis does not improve after the drug has been discontinued, or if the symptoms are severe, oral vancomycin is the drug of choice for antibiotic- associated pseudomembranous colitis produced by C. difficile. Other causes of colitis should be excluded.

Hypersensitivity to cefixime, other cephalosporin antibiotics or to any of the excipients. Previous, immediate and/or severe hypersensitivity reaction to penicillin or any beta- lactam antibiotic.