Zinnat Suspension

/ GSK

Adults and children ( ≥ 40 kg)
Acute tonsillitis and pharyngitis, acute bacterial sinusitis 250 mg twice daily.
Acute otitis media 500 mg twice daily.
Acute exacerbations of chronic bronchitis 500 mg twice daily.
Cystitis 250 mg twice daily.
Pyelonephritis 250 mg twice daily.
Uncomplicated skin and soft tissue infections 250 mg twice daily.
Lyme disease 500 mg twice daily for 14 days (range of 10 to 21 days).
Children (<40 kg)
Acute tonsillitis and pharyngitis, acute bacterial sinusitis 10 mg/kg twice daily to a maximum of 125 mg twice daily.
Children aged two years or older with otitis media or, where appropriate, with more severe infections 15 mg/kg twice daily to a maximum of 250 mg twice daily.
Cystitis 15 mg/kg twice daily to a maximum of 250 mg twice daily.
Pyelonephritis 15 mg/kg twice daily to a maximum of 250 mg twice daily for 10 to 14 days.
Uncomplicated skin and soft tissue infections 15 mg/kg twice daily to a maximum of 250 mg twice daily.
Lyme disease 15 mg/kg twice daily to a maximum of 250 mg twice daily for 14 days (10 to 21 days).
For full details see prescribing information.

Zinnat is indicated for the treatment of the infections listed below in adults and children from the age of 3 months.
– Acute streptococcal tonsillitis and pharyngitis.
– Acute bacterial sinusitis.
– Acute otitis media.
– Acute exacerbations of chronic bronchitis.
– Cystitis.
– Pyelonephritis.
– Uncomplicated skin and soft tissue infections.
– Treatment of early Lyme disease.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Hypersensitivity to cefuroxime or to any of the excipients listed. Patients with known hypersensitivity to cephalosporin antibiotics.
History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of betalactam antibacterial agent (penicillins, monobactams and carbapenems).

Hypersensitivity reactions: Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactam antibiotics because there is a risk of cross-sensitivity. As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with cefuroxime must be discontinued immediately and adequate emergency measures must be initiated.
Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to cefuroxime, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if cefuroxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.
Jarisch-Herxheimer reaction: The Jarisch-Herxheimer reaction has been seen following cefuroxime axetil treatment of Lyme disease. It results directly from the bactericidal activity of cefuroxime axetil on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be reassured that this is a common and usually selflimiting consequence of antibiotic treatment of Lyme disease.
Overgrowth of non-susceptible microorganisms: As with other antibiotics, use of cefuroxime axetil may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible microorganisms (e.g. enterococci and Clostridium difficile), which may require interruption of treatment.
Antibacterial agent–associated pseudomembranous colitis have been reported with nearly all antibacterial agents, including cefuroxime and may range in severity from mild to life threatening. This diagnosis should be considered in patients with diarrhoea during or subsequent to the administration of cefuroxime. Discontinuation of therapy with cefuroxime and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Interference with diagnostic tests: The development of a positive Coomb’s Test associated with the use of cefuroxime may interfere with cross matching of blood.
As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil.
Important information about excipients: The sucrose content of cefuroxime axetil suspension should be taken into account when treating diabetic patients and appropriate advice provided.
Zinnat Suspension 125 mg/5 ml Contains 3.062 g of sucrose per 5 mL dose
Zinnat Suspension 250 mg/5 ml Contains 2.289 g of sucrose per 5 mL dose
Cefuroxime axetil suspension contains aspartame, which is a source of phenylalanine and so should be used with caution in patients with phenylketonuria.
For full details see prescribing information.

The most common adverse reactions are Candida overgrowth, eosinophilia, headache, dizziness, gastrointestinal disturbances and transient rise in liver enzymes. The frequency categories assigned to the adverse reactions below are estimates, as for most reactions suitable data (for example from placebo-controlled studies) for calculating incidence were not available. In addition the incidence of adverse reactions associated with cefuroxime axetil may vary according to the indication. Data from large clinical studies were used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (i.e. those occurring at <1/10,000) were mainly determined using postmarketing data and refer to a reporting rate rather than true frequency. Placebocontrolled trial data were not available. Where incidences have been calculated from clinical trial data, these were based on drug-related (investigator assessed) data. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. For full details see prescribing information.

Drugs which reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with that of the fasting state and tend to cancel the effect of enhanced absorption after food. Cefuroxime axetil may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives. Cefuroxime is excreted by glomerular filtration and tubular secretion. Concomitant use of probenicid is not recommended. Concurrent administration of probenecid significantly increases the peak concentration, area under the serum concentration time curve and elimination half-life of cefuroxime. Concomitant use with oral anticoagulants may give rise to increased INR.

Pregnancy: There are limited data from the use of cefuroxime in pregnant women. Studies in animals have shown no harmful effects on pregnancy, embryonal or foetal development, parturition or postnatal development. Zinnat should be prescribed to pregnant women only if the benefit outweighs the risk.
Breastfeeding: Cefuroxime is excreted in human milk in small quantities. Adverse effects at therapeutic doses are not expected, although a risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded. Breastfeeding might have to be discontinued due to these effects. The possibility of sensitisation should be taken into account. Cefuroxime should only be used during breastfeeding after benefit/risk assessment by the physician in charge.
Fertility: There are no data on the effects of cefuroxime axetil on fertility in humans. Reproductive studies in animals have shown no effects on fertility.

Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment.
Serum levels of cefuroxime can be reduced by haemodialysis and peritoneal dialysis.