ZINNAT Tablet

Patients with known hypersensitivity to cephalosporin antibiotics.

Infections and infestations

Common: Overgrowth of Candida

Blood and lymphatic system disorders

Common: Eosinophilia

Uncommon: Positive Coombs’ test, thrombocytopenia, leukopenia (sometimes profound)

Very rare: Haemolytic anaemia

Cephalosporins as a class tend to be absorbed onto the surface of red cells membranes and react with antibodies directed against the drug to produce a positive Coombs’ test (which can interfere with cross-matching of blood) and very rarely haemolytic anaemia.

Immune system disorders

Hypersensitivity reactions including

Common: Skin rashes

Rare: Urticaria, pruritus

Very rare: Drug fever, serum sickness, anaphylaxis

Nervous system disorders

Common: Headache, dizziness

Gastrointestinal disorders

Common: Gastrointestinal disturbances including diarrhoea, nausea, abdominal pain

Uncommon: Vomiting

Rare: Pseudomembranous colitis.

Hepatobiliary disorders

Common: Transient increases of hepatic enzyme levels, [ALT(SGPT), AST(SGOT), LDH]

Very rare: Jaundice (predominantly cholestatic), hepatitis

Skin and subcutaneous tissue disorders

Very rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis)

See also Immune system disorders.

Drugs which reduce gastric acidity may result in a lower bioavailability of ZINNAT compared with that of the fasting state and tend to cancel the effect of enhanced post-prandial absorption.

In common with other antibiotics, ZINNAT may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

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 ZINNAT. This antibiotic does not interfere in the alkaline picrate assay for creatinine.

There is no experimental evidence of embryopathic or teratogenic effects attributable to ZINNAT but, as with all drugs, it should be administered with caution during the early months of pregnancy. Cefuroxime is excreted in human milk, and consequently caution should be exercised when ZINNAT is administered to a nursing mother.

Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.

As with other antibiotics, use of ZINNAT may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible organisms (e.g. enterococci and Clostridium difficile), which may require interruption of treatment.

Pseudomembranous colitis has been reported with the use of antibiotics, and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.

The Jarisch-Herxheimer reaction has been seen following ZINNATT treatment of Lyme disease, It results directly from the bactericidal activity of ZINNAT on the causative organism of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease.

With a sequential therapy regime the timing of change to oral therapy is determined by severity of the infection, clinical status of the patient and susceptibility of the pathogens involved. If there is no clinical improvement within 72 hours, then the parenteral course of treatment must be continued.

Please refer to the relevant prescribing information for cefuroxime sodium before initiating sequential therapy.

The prevalence of acquired resistance is geographically and time dependent and for select species may be very high. Local information on resistance is desirable, particularly when treating severe infections.

In vitro susceptibility of micro-organisms to Cefuroxime

Where clinical efficacy of cefuroxime axetil has been demonstrated in clinical trials this is indicated with an asterisk*

Commonly Susceptible Species

Gram-Positive Aerobes

Staphylococcus aureus (methicillin susceptible)*

Coagulase negative staphylococcus (methicillin susceptible)

Streptococcus pyogenes*

Beta-hemolytic streptococci

Gram-Negative Aerobes

Haemophilus influenzae* including ampicillin resistant strains

Haemophilus parainfluenzae*

Moraxella catarrhalis*

Neisseria gonorrhoea* including penicillinase and non-penicillinase producing strains

Gram-Positive Anaerobes

Peptostreptococcus spp.

Propionibacterium spp.

Spirochetes

Borrelia burgdorferi*

Organisms for which acquired resistance may be a problem

Gram-Positive Anaerobes

Streptococcus pneumoniae*

Gram-Negative Aerobes

Citrobacter spp. not including C.freundii

Enterobacter spp. not including E.aerogenes and E.cloacae

Escherichia coli*

Klebsiella spp. including Klebsiella pneumoniae*

Proteus mirabilis

Proteus spp. not including P.penneri and P.vulgaris

Providencia spp.

Gram-Positive Anaerobes:

Clostridium spp. not including C.difficile

Gram-Negative Anaerobes:

Bacteriodes spp. not including B.fragilis

Fusobacterium spp.

Inherently resistant organisms

Gram-Positive Aerobes:

Enterococcus spp. including E.faecalis and E.faecium

Listeria monocytogenes

Gram-Negative Aerobes

Acinetobacter spp.

Burkholderia cepacia

Campylobacter spp.

Citrobacter freundii

Enterobacter aerogenes

Enterobacter cloacae

Morganella morganii

Proteus penneri

Proteus vulgaris

Pseudomonas spp. including Pseudomonas aeruginosa

Serratia spp.

Stenotrophomonas maltophilia

Gram-Positive Anaerobes:

Clostridium difficile

Gram-Negative Anaerobes:

Bacteriodes fragilis

Others:

Chlamydia species

Mycoplasma species

Legionella species