Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Suprax 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 occuring 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. Suprax 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 meticillin- resistant strains) are resistant to Suprax. In addition, most strains of Pseudomonas, Bacteriodes fragalis, Listeria monocytogenes and Clostridia are resistant to Suprax.
The usual course of treatment is 7 days. This may be continued for up to 14 days if required.
The recommended adult dosage is 200-400 mg daily according to the severity of infection, given either as a single dose or in two divided doses.
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 (See “Dosage in Renal Impairment”).
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.
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.
For oral administration.
Absorption of Suprax is not significantly modified by the presence of food.
There is a risk of encephalopathy in cases of administration of beta-lactam antibiotics, including cefixime, particularly in case of overdose or renal impairment.
Adverse reactions seen at dose levels up to 2 g Suprax in normal subjects did not differ from the profile seen in patients treated at the recommended doses.
Cefixime is not removed from the circulation in significant quantities by dialysis.
No specific antidote exists. General supportive measures are recommended.
2 years.
Do not store above 25°C.
PVC/aluminium foil blister packs – pack sizes of 1, 2, 7 and 14.
Not all pack sizes may be marketed.
No special requirements for disposal.
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