Cefuroxim Stada

Cefuroxim Stada





Full Prescribing Info
Cefuroxime axetil.
Each film coated caplet contains cefuroxime axetil equivalent to 250mg of cefuroxime.
Excipients/Inactive Ingredients: Microcrystalline cellulose, maize starch, crocarmellose sodium, magnesium stearate, talc, hypromellose, polyethylene glycol, titanium dioxide.
Pharmacology: Pharmacodynamics: The in vivo bactericidal activity of cefuroxime axetil is due to cefuroxime's binding to essential target proteins and the resultant inhibition of cell-wall synthesis.
Cefuroxime has bactericidal activity against a wide range of common pathogens, including many beta-lactamase-producing strains. Cefuroxime is stable to many bacterial beta-lactamases, especially plasmid-mediated enzymes that are commonly found in enterobacteriaceae.
Cefuroxime has been demonstrated to be active against most strains of the following microorganisms both in vitro and in clinical infections.
Aerobic Gram-Positive Microorganisms: Staphylococcus aureus (including beta-lactamase-producing strains), Streptococcus pneumonia, Streptococcus pyogenes.
Aerobic Gram-Negative Microorganisms: Escherichia coli, Haemophilus influenza (including beta-lactamase-producing strains), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including beta-lactamase-producing strains), Neisseria gonorrhoeae (including beta-lactamase-producing strains).
Spirochetes: Borrelia burgdorferi.
Pharmacokinetics: Absorption and Metabolism: After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to cefuroxime. Absorption of the tablet is greater when taken after food (absolute bioavailability of cefuroxime tablets increases from 37% to 52%). Cefuroxime is not metabolized.
Distribution: Cefuroxime is subsequently distributed throughout the extracellular fluids. The axetil moiety is metabolized to acetaldehyde and acetic acid. Approximately 50% of serum cefuroxime is bound to protein.
Renal Excretion: Cefuroxime is excreted unchanged in the urine; in adults, approximately 50% of the administered dose is recovered in the urine within 12 hours. Because cefuroxime is renally excreted, the serum half-life is prolonged in patients with reduced renal function. Despite the lower elimination of cefuroxime in geriatric patients, dosage adjustment based on age is not necessary.
Lower respiratory tract infections: pneumonia, acute bronchitis, and acute exacerbations of chronic bronchitis.
Upper respiratory tract infections: ear, nose and throat infections, such as otitis media, sinusitis, tonsillitis, pharyngitis.
Genito-urinary tract infections: pyelonephritis, cystitis and urethritis.
Skin and soft tissue infections: furunculosis, pyoderma, impetigo.
Gonorrhea, acute uncomplicated gonococcal urethritis, and cervicitis.
Dosage/Direction for Use
Cefuroxime STADA may be administered without regard to meals.
Adults: Pneumonia: 500 mg bd.
Bronchitis: 250 mg bd.
Upper resp tract, GUT, skin and soft tissue infection, pyelonephritis: 250 mg bd.
UTI: 125mg bd. Uncomplicated gonorrhea: 1,000 mg as single dose.
Children: Most infections: 125 mg bd.
Otitis media and more severe infections: 250 mg bd.
Children under 5 years: oral suspension advised.
There is no experience in children under 3 months of age.
Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.
Cefuroxime are contraindicated in patients with known allergy to the cephalosporin group of antibiotics or to any of the excipients.
Special Precautions
Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients receiving therapy with beta-lactams. Before initiating therapy with Cefuroxim STADA, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, carbapenems or other beta-lactam agents. If an allergic reaction occurs, Cefuroxim STADA must be discontinued immediately and appropriate alternative therapy instituted.
If after administration of cefuroxime axetil sensitivity reactions occur, the use should be discontinued immediately and an appropriate treatment should be established.
As with other broad spectrum antibiotics, prolonged use of cefuroxime axetil may result in the overgrowth of non-susceptible organisms (e.g. candida, clostridium difficile, enterococci) which may require interruption of treatment.
Cefuroxime should be used with caution in the patients with impaired renal function.
In patients who develop severe diarrhea during or after use of cefuroxime axetil, the risk of life threatening pseudomembranous colitis should be taken into account and the use of cefuroxime axetil should be discontinued.
The use of cefuroxime axetil is not recommended in patients with severe gastrointestinal disease, since in these situations a sufficient absorption can not be guaranteed. Administration of a parenteral formulation of cefuroxime should be considered.
Use In Pregnancy & Lactation
Pregnancy: This drug should be used during pregnancy only if clearly needed.
Nursing mothers: Because cefuroxime is excreted in human milk, consideration should be given to discontinuing nursing temporarily during treatment with cefuroxime axetil.
Side Effects
The following events have been identified in patients treated with cefuroxime tablets and were reported spontaneously.
General: The following hypersensitivity reactions have been reported: anaphylaxis, angioedema, pruritus, rash, serum sickness-like reaction, uticaria.
Gastrointestinal: Pseudomembranous colitis.
Hematalogic: Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, and increased prothrombin time.
Hepatic: Hepatic impairment including hepatitis and cholestasis, jaundice.
Neurologic: Seizure.
Skin: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Urologic: Renal dysfunction.
In addition to the adverse reactions listed above that have been observed in patients treated with cefuroxime axetil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: toxic nephropathy, aplastic anemia, hemorrhafe, increased BUN, increased creatinine, false-positive test for urinary glucose, increased alkaline phosphatase, neutropenia, elevated bilirubin, and agranulocytosis.
Drug Interactions
Simultaneous use of medicines enhancing the pH of the stomach decreases the bioavailability of cefuroxime axetil. It is recommended to avoid this combination.
Since bacteriostatic drug may interfere with the bactericidal action of cephalosporins, it is advisable to avoid giving tetracyclines, macrolides, or chloramphenicol in conjunction with cefuroxime axetil.
Probenecid competes with cefuroxime for renal tubular secretion resulting in higher and more prolonged plasma concentrations of cefuroxime.
The use of cefuroxime axetil may be accompanied by a false positive Coombs test. This may interfere with the performance of cross matching tests with blood. Cefuroxime may interfere with the determination of glucose in urine with copper containing reagentia (Benedict- or Fehling-solution, Clinitest). For the determination of blood-and plasma sugar levels in patients receiving cefuroxime axetil, the glucose-oxidase- or hexokinase method is recommended.
In common with other antibiotics, cefuroxime axetil may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Cephalosporin antibiotics at high dosage should be given with caution to patients receiving potent diuretics, aminoglycosides, or amphotericin as these combination increase the risk of nephrotoxicity.
Store below 30°C. Do not use this medicinal product after the expiry date. Protect from light.
MIMS Class
ATC Classification
J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
FC caplet (white to off-white film coated caplet scored on one side and engraved "250" on the other side) 250 mg x 10's.
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