Eroxmit 500

Each film-coated tablet contains Cefuroxime (as axetil), USP 500 mg.

Microbiology: Cefuroxime (as axetil) owes its in vivo bactericidal activity to the parent compound, cefuroxime. It is a well-characterized and effective antibacterial agent which has bactericidal activity against a wide range of common pathogens, including β-lactamase-producing strains.
Cefuroxime has good stability to bacterial β-lactamase and consequently is active against many ampicillin-resistant or amoxicillin-resistant strains.
The bactericidal action of cefuroxime results from inhibition of cell-wall synthesis by binding to essential target proteins.
Gram-Negative Aerobes: Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae (including penicillinase- and non-penicillinase-producing strains), Escherichia coli, Klebsiella spp, Proteus mirabilis, Providencia spp, Proteus rettgeri.
Gram-Positive Aerobes: Staphylococcus aureus and Staphylococcus epidermidis (including penicillinase-producing strains but excluding methicillin-resistant strains), Streptococcus pyogenes (and other β-hemolytic streptococci), Streptococcus pneumoniae, Streptococcus group B (Streptococcus agalactiae).
Anaerobes: Gram-positive and gram-negative cocci (including Peptococcus and Peptostreptococcus spp), gram-positive bacilli (including Clostridium species) and gram-negative bacilli (including Bacteroides and Fusobacterium spp), Propionibacterium spp.
Other Organisms: Borrelia burgdorferi.
The following organisms are not susceptible to cefuroxime: Clostridium difficile, Pseudomonas spp, Campylobacter spp, Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus and Staphylococcus epidermidis and Legionella spp.
Some strains of the following genera are not susceptible to cefuroxime: Enterococcus (Streptococcus) faecalis, Morganella morganii, Proteus vulgaris; Enterobacter spp., Citrobacter spp. and Serratia spp., Bacteroides fragilis.

Cefuroxime (as axetil) is an oral prodrug of the bactericidal cephalosporin antibiotic cefuroxime, which is resistant to most β-lactamases and is active against a wide range of Gram-positive and Gram-negative organisms.
It is indicated for the treatment of infections caused by sensitive bacteria.
Upper respiratory tract infections for example, ear, nose and throat infections such as otitis media, sinusitis, tonsillitis and pharyngitis.
Lower respiratory tract infections for example, pneumonia, acute bronchitis and acute exacerbations of chronic bronchitis. Genito-urinary tract infections for example, pyelonephritis, cystitis and urethritis.
Skin and soft tissue infections for example, furunculosis, pyoderma and impetigo.
Gonorrhoea, acute uncomplicated gonococcal urethritis and cervicitis.
Treatment of early Lyme disease and subsequent prevention of late Lyme disease in adults and children over 12 years.
Cefuroxime is also available as the sodium salt for parenteral administration. This permits the use of sequential therapy with the same antibiotic, when a change from parenteral to oral therapy is clinically indicated.
Where appropriate Cefuroxime (as axetil) is effective when using following initial parenteral bronchitis.

The usual course of therapy is seven days (range 5 to 10 days).
Cefuroxime (as axetil) should be taken after food for optimum absorption.
Adults: Most infections: 250 mg twice daily.
Urinary tract infections: 125 mg twice daily.
Mild to moderate lower respiratory tract infection e.g. bronchitis: 250 mg twice daily.
More severe lower respiratory tract infections, or if pneumonia is suspected: 500 mg twice daily.
Pyelonephritis: 250 mg twice daily.
Uncomplicated gonorrhoea: single dose 1 g.
Lyme disease in adults and children over the age of 12 years: 500 mg twice daily for 20 days.
Children: Most infections: 125 mg (1 x 125 mg tablet) twice daily, to a maximum of 250 mg daily.
Children aged two years or older with otitis media or, where appropriate, with more severe infections: 250 mg (1 x 250 mg tablet or 2 x 125 mg tablets) twice daily, to a maximum of 500 mg daily.

Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.

Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.
As with other antibiotics, prolonged use of Cefuroxime (as axetil) may result in the overgrowth of other nonsusceptible organisms (eg, Candida, Enterococci, Clostridium difficile), which may require interruption of treatment.
Pseudomembranous colitis has been reported with the use of broad-spectrum antibiotics, therefore, it is important to consider its diagnosis in patients who develop serious diarrhea during or after antibiotic use.
The Jarisch-Herxheimer reaction has been seen following Cefuroxime (as axetil) treatment of Lyme disease. It results directly from the bactericidal activity of Cefuroxime (as axetil) 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 regimen 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 hrs, then the parenteral course of treatment must be continued.
Effects on the Ability to Drive or Operate Machinery: As medicine may cause dizziness, patients should be warned to be cautious when driving or operating machinery.

There is no experimental evidence of embryopathic or teratogenic effects attributable to Cefuroxime (as axetil) 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 Cefuroxime (as axetil) is administered to a nursing mother.

Adverse drug reactions to Cefuroxime (as axetil) are generally mild and transient in nature. The frequency categories assigned to the adverse reactions 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 (as 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 (ie, those occurring at <1/10,000) were mainly determined using post-marketing data and refer to a reporting rate rather than true frequency. Placebo-controlled trial data were not available. Where incidences have been calculated from clinical trial data, these were based on drug-related (investigator assessed) data.
The following convention has been used for the classification of frequency: Very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10,000 and <1/1000) and very rare (<1/10,000).
Common: Overgrowth of Candida from prolonged use.
Blood and Lymphatic System Disorders: Common: Eosinophilia.
Uncommon: Positive Coombs' test, thrombocytopenia, leukopenia (sometimes profound).
Very Rare: Hemolytic anemia.
Cephalosporins as a class tend to be absorbed onto the surface of red-cell 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, hemolytic anemia.
Immune System Disorders: Hypersensitivity reactions including: Uncommon: Skin rashes.
Rare: Urticaria, pruritus.
Very Rare: Drug fever, serum sickness, anaphylaxis.
Nervous System Disorders: Common: Headache, dizziness.
Gastrointestinal Disorders: Common: Gastrointestinal disturbances including diarrhea, 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: Common: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis).

Drugs which reduce gastric acidity may result in a lower bioavailability of Cefuroxime (as axetil) compared with that of the fasting state and tend to cancel the effect of enhanced post-prandial absorption.
In common with other antibiotics, Cefuroxime (as axetil) may affect the gut flora, leading to lower estrogen 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 a blood/plasma glucose levels in patients receiving Cefuroxime (as axetil).
This antibiotic does not interfere in the alkaline picrate assay for creatinine.

Store at temperatures not exceeding 30°C.

Cephalosporins

J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.

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