Indications:
Cefixime tablets is an orally active cephalosporin antibiotic which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms.
It is indicated for the treatment of the following acute infections when caused by susceptible micro-organisms:
Upper Respiratory Tract Infections (URTI): e.g. otitis media; and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk.
Lower Respiratory Tract Infection: e.g. bronchitis.
Urinary Tract Infections: e.g. cystitis, cystourethritis, uncomplicated pyelonephritis.
Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Kliebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobacter species. Cefixime tablets is highly stable in the presence of beta-lactamase enzymes.
Most strains of enterococci (Streptococcus faecalis, group D Streptococci) and Staphylococci (including coagulase positive and negative strains and methicillin-resistant strains) are resistant to Cefixime tablets. In addition, most strains of Pseudomonas, Bacteriodes fragalis, Listeria monocytogenes and Clostridia are resistant to Cefixime tablets.
Dosage and administration：
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:
Cefixime tablets 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:
Cefixime tablets 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 Cefixime tablets is not significantly modified by the presence of food.
Contraindications:
Hypersensitivity to cephalosporin antibiotics or to any of the excipients.
Precautions:
l Encephalopathy
l Severe cutaneous adverse reactions
l Hypersensitivity to penicillins
l Haemolytic anaemia
l Acute renal failure
l Renal impairment
l Paediatric use
l Antibiotic-associated colitis
Drug interactions:
Anticoagulants
In common with other cephalosporins, increases in prothrombin times have been noted in a few patients. Care should therefore be taken in patients receiving anticoagulation therapy.
Cefixime should be administered with caution to patients receiving coumarin-type anticoagulants, e.g. warfarin potassium. Since cefixime may enhance effects of the anticoagulants, prolonged prothrombin time with or without bleeding may occur.
Storage:
Do not store above 25°C.