Each film-coated tablet contains: Cefuroxime Axetil USP.
Equivalent to Cefuroxime: 205 mg.
Structure Name: (RS)-1-hydroxyethyl (6R, 7R)-7-[2-(2-furyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate.
CHEMICAL NAME: C20H22N4O10S.
Pharmacotherapeutic Group: Semisynthetic, broad-spectrum second generation cephalosporin antibiotic.
Pharmacology: 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 wide range of common pathogens, including many betalactamase-producing strains. Cefuroxime is stable to many bacterial beta-lactamases, espeially plasmid-mediated enzymes that are commonly found in enterobacteriaceae.
Cefuroxime is 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 pneumoniae; Streptococcus pyogenes; Streptococcus epidermidis; Staphylococcus saprophyticus; Streptococcus agalactiae.
Aerobic Gram-negative Microorganisms: Escherichia coli; Haemophilus influenzae (including beta-lactamase-producing strains); Haemophilus parainfluenzae; Klebsiella pneumoniae, Moraxella catarrhalis (including beta-lactamase-producing strains); Neisseria gonorrhoeae (including beta-lactamase-producing strains); Morganella morganii; Proteus inconstans; Proteus mirabilis; Providencia rettgeri.
Spirochetes: Borrelia burgdorferi.
Anaerobic Microorganisms: Peptococcus niger.
Pharmacokinetics: 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.
Cefuroxime is subsequentlt distributed throughout the extracellular fluids. The axetil moiety is metabolized to acetaldehyde and acetic acid. Approximately 33-50% of serum cefuroxime is bound to protein. Absorption of the tablet is greater when taken after food (absolute bioavailability of cefuroxime axetil tablets increases from 37% when given on empty stomach to 52%). Cefuroxime is excreted unchanged in urine; by glomerular filtration and excreted by kidney. In adults, approximately 50% of the administered dose is recovered in the urine within 12 hours with half-life of 1.2-1.6 hours. Because cefuroxime is renally excreted, the serum half-life is prolonged in patients with reduced renal function and in neonates. Despite the lower elimination of cefuroxime in geriatric patients, dosage adjustment based on age is not necessary.
For the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed as follows: Pharyngitis/Tonsilitis: Caused by Streptococcus pyogenes, (group A β-hemolytic Streptococci).
Acute Bacterial Otitis Media: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase producing strains), or Streptococcus pyogenes.
Acute Bacterial Maxillary Sinusitis: Caused by Streptococcus pneumoniae or Haemophilus influenzae (non-betalactamase producing strains only).
Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infection of Acute Bronchitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (beta lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains).
Uncomplicated Skin and Skin-Structure Infections: Caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
Uncomplicated Urinary Tract Infection: Caused by Escherichia coli or Klebsiella penumoniae.
Uncomplicated Gonorrhea, Urethral and Endocervical: Caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae and uncomplicated rectal gonorrhea in females, caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae.
Early Lyme Disease (erythema migrans): Caused by Borrelia burgdoferi.
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Dosage in Renal Impairment:
Modification of usual dosage of cefuroxime is unnecessary in patients with creatinine clearances greater than 20 ml/minute. However, in patients with creatinine clearances of 20 ml/minute or less, doses and/or frequency of administration of this drug must be modified in response to the degree of renal impairment.
Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneaal dialysis.
Cefuroxime axetil is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Do not use in hypersensitive patients.
This drug may cause allergic reaction and may be fetal.
If rashes, irritation or edema is observed, stop taking drug and consult physician.
Before the therapy with cefuroxime axetil products is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefuroxime axetil products, other cephalosporins, penicillins, or other drugs.
If this product is to be given to penicillin-sensitive patients, caution should be exercised because cross hypersensitivity among beta-lactam has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy.
As with other broad-spectrum antibiotics, prolonged administration of cefuroxime axetil may result in overgrowth of non susceptible microorganisms. If superinfection occurs during therapy, appropriate measures should be taken.
Cephalosporins, including cefuroxime axetil, should be given with caution to patients receiving concurrent treatment with potent diuretics because there diuretics are suspected of adversely affecting renal function.
Cefuroxime axetil, as with other broad-spectrum antibiotics, should be prescribed with caution in individuals with a history of colitis. The safety and effectiveness of cefuroxime axetil have not been established in patients with gastrointestinal malabsorption. Patients with gastrointestinal malabsorption were excluded from participating in clinical trials of cefuroxime axetil.
Cephalosporins may be associated with fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy.
Cefuroxime can cross placenta and although no harms were detected in animal studies but animal reproduction studies are not always predictive of human response; this drug should be used during pregnancy only if clearly needed.
Because cefuroxime is excreted in human milk; consideration should be given to discontinuing nursing temporarily during treatment with cefuroxime axetil.
Cefuroxime is generally well tolerated. The most common observed adverse effects are gastrointestinal disturbances, including diarrhea, nausea, vomiting and abdominal pain.
Other less commonly observed adverse effects are transient elevation in AST, transient elevation in ALT, Alkaline phosphatase and LDH. Whereas Hemoglobin and Hematocrit decrease. Elevation of eosinophilia, abdominal cramps, flatulence, indigestion, headache, vaginitis; vulvar itch, rash, hives, itch, dysuria, chills, chest pain, pain, shortness of breath, mouth ulcers, swollen tongue, sleepiness, thirst, and anorexia.
Concomitant administration of probenecid with cefuroxime axetil tablets increases the serum concentration.
Drugs that reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil.
Concurrent use of cefuroxime axetil and aminoglycosides may increase the risk of nephrotoxicity during therapy.
Concurrent use of this drug with diuretics may increases risk of adverse renal effects.
Plasma concentrations of cefuroxime may be reduced by coadministration of H2-antagonists, decreasing antibiotic effect.
24 months from the date of manufacturing.
Store in a dry place below 25°C. Protect from direct sunlight.
J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
FC tab 250 mg x 1 x 10's.