ZOLTAX Cefuroxime 500mg Film-Coated Tablet 1's
RXDRUG-DR-XY37463-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Treatment of susceptible infections which include bone and joint infections, bronchitis (and other lower respiratory tract infections), gonorrhea, meningitis (although treatment failures have been reported in Haemophilus influenzae meningitis), otitis media, peritonitis, pharyngitis, sinusitis, skin infections (including soft tissue infection) and UTI.
Cefuroxime is also used for surgical prophylaxis.
Cefuroxime is also used for surgical prophylaxis.
Dosage/Direction for Use
Zoltax: Adults: Usual Oral Dose: Uncomplicated Urinary Tract Infections: 125 mg twice daily.
Respiratory Tract Infections: 250-500 mg twice daily.
Pneumonia or Acute Exacerbations of Chronic Bronchitis: Adults: May respond to sequential therapy with parental cefuroxime 1.5 g twice daily or 750 mg twice daily, respectively, followed by oral cefuroxime 500 mg twice daily in each case.
Lyme Disease: 500 mg oral dose twice daily for 20 days.
Uncomplicated Gonorrhea: 1 g single oral dose and probenecid 1 g may be given.
Renal Impairment: Doses may need to be reduced in patients with renal impairment.
Zoltax Injection: Adults: Usual Dose: 750 mg to 1.5 g every 8 hrs, usually for 5-10 days.
Uncomplicated Urinary Tract Infections, Skin and Skin Structure Infections, Disseminated Gonococcal Infections and Uncomplicated Pneumonia: 750 mg every 8 hrs is recommended.
Severe or Complicated Infections: 1.5 g dose every 8 hrs.
Bone and Joint Infections: 1.5 g dose every 8 hrs. In clinical trials, surgical intervention was performed when indicated as an adjunct to cefuroxime therapy. A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of cefuroxime.
Life-Threatening Infections or Infections Due to Less Susceptible Organisms: 1.5 g every 6 hrs may be required.
Bacterial Meningitis: The dosage should not exceed 3 g every 8 hrs.
Preventive Use for Clean, Contaminated or Potentially Contaminated Surgical Procedure: 1.5-g dose administered IV just before surgery (approximately ½-1 hr before the initial incision) is recommended. Thereafter, give 750 mg IV every 8 hrs when the procedure is prolonged.
Preventive Use During Open Heart Surgery: 1.5-g dose administered IV at the induction of anesthesia and every 12 hrs thereafter for a total of 6 g is recommended.
Renal Impairment: A reduced dosage must be employed when renal function is impaired. Dosage should be determined by the degree of renal impairment and the susceptibility of the causative organism.
Since cefuroxime is dialyzable, patients on hemodialysis should be given a further dose at the end of the dialysis.
Note: As with antibiotic therapy in general, administration of cefuroxime for injection should be continued for a minimum of 48-72 hrs after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyogenes in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic UTI and may be required for several months after therapy has been completed. Persistent infections may require treatment for several weeks and doses smaller than those indicated previously should not be used. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.
Children >3 Months: 50-100 mg/kg/day in equally divided doses every 6-8 hrs has been successful for most infections susceptible to cefuroxime. Severe Serious Infections: Higher dosage of 100 mg/kg/day (not to exceed maximum adult dose).
Bone and Joint Infections: 150 mg/kg/day (not to exceed the maximum adult dosage) is recommended in equally divided doses every 8 hrs. In clinical trials, course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration of cefuroxime.
Bacterial Meningitis: A larger dosage of cefuroxime is recommended 200-240 mg/kg/day IV in divided doses every 6-8 hrs.
Children with Renal Impairment: The frequency of dosing should be modified consistent with the recommendation for adults.
Administration: The reconstituted injection is given by deep IM injection into a large muscle mass (eg, the gluteus or lateral part of the thigh). Before injecting IM, aspiration is necessary to avoid inadvertent injection in a blood vessel.
For direct intermittent IV administration, slowly inject over a period of 3-5 min or give it through the tubing system by which the patient is also receiving other IV solutions.
For intermittent IV infusion with a V-type administration set, dosing can be accomplished through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing cefuroxime, it is advisable to temporarily discontinue administration of any other solutions at the same site.
Respiratory Tract Infections: 250-500 mg twice daily.
Pneumonia or Acute Exacerbations of Chronic Bronchitis: Adults: May respond to sequential therapy with parental cefuroxime 1.5 g twice daily or 750 mg twice daily, respectively, followed by oral cefuroxime 500 mg twice daily in each case.
Lyme Disease: 500 mg oral dose twice daily for 20 days.
Uncomplicated Gonorrhea: 1 g single oral dose and probenecid 1 g may be given.
Renal Impairment: Doses may need to be reduced in patients with renal impairment.
Zoltax Injection: Adults: Usual Dose: 750 mg to 1.5 g every 8 hrs, usually for 5-10 days.
Uncomplicated Urinary Tract Infections, Skin and Skin Structure Infections, Disseminated Gonococcal Infections and Uncomplicated Pneumonia: 750 mg every 8 hrs is recommended.
Severe or Complicated Infections: 1.5 g dose every 8 hrs.
Bone and Joint Infections: 1.5 g dose every 8 hrs. In clinical trials, surgical intervention was performed when indicated as an adjunct to cefuroxime therapy. A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of cefuroxime.
Life-Threatening Infections or Infections Due to Less Susceptible Organisms: 1.5 g every 6 hrs may be required.
Bacterial Meningitis: The dosage should not exceed 3 g every 8 hrs.
Preventive Use for Clean, Contaminated or Potentially Contaminated Surgical Procedure: 1.5-g dose administered IV just before surgery (approximately ½-1 hr before the initial incision) is recommended. Thereafter, give 750 mg IV every 8 hrs when the procedure is prolonged.
Preventive Use During Open Heart Surgery: 1.5-g dose administered IV at the induction of anesthesia and every 12 hrs thereafter for a total of 6 g is recommended.
Renal Impairment: A reduced dosage must be employed when renal function is impaired. Dosage should be determined by the degree of renal impairment and the susceptibility of the causative organism.
Since cefuroxime is dialyzable, patients on hemodialysis should be given a further dose at the end of the dialysis.
Note: As with antibiotic therapy in general, administration of cefuroxime for injection should be continued for a minimum of 48-72 hrs after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyogenes in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic UTI and may be required for several months after therapy has been completed. Persistent infections may require treatment for several weeks and doses smaller than those indicated previously should not be used. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.
Children >3 Months: 50-100 mg/kg/day in equally divided doses every 6-8 hrs has been successful for most infections susceptible to cefuroxime. Severe Serious Infections: Higher dosage of 100 mg/kg/day (not to exceed maximum adult dose).
Bone and Joint Infections: 150 mg/kg/day (not to exceed the maximum adult dosage) is recommended in equally divided doses every 8 hrs. In clinical trials, course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration of cefuroxime.
Bacterial Meningitis: A larger dosage of cefuroxime is recommended 200-240 mg/kg/day IV in divided doses every 6-8 hrs.
Children with Renal Impairment: The frequency of dosing should be modified consistent with the recommendation for adults.
Administration: The reconstituted injection is given by deep IM injection into a large muscle mass (eg, the gluteus or lateral part of the thigh). Before injecting IM, aspiration is necessary to avoid inadvertent injection in a blood vessel.
For direct intermittent IV administration, slowly inject over a period of 3-5 min or give it through the tubing system by which the patient is also receiving other IV solutions.
For intermittent IV infusion with a V-type administration set, dosing can be accomplished through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing cefuroxime, it is advisable to temporarily discontinue administration of any other solutions at the same site.
Overdosage
Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.
Administration
Should be taken with food.
Contraindications
Patients with known allergy to the cephalosporin group of antibiotics.
Special Precautions
Cefuroxime is considered to be unsafe in patients with porphyria although there is conflicting experimental evidence of porphyrinogenicity.
Adverse Reactions
Zoltax: Gastrointestinal disturbances including drug diarrhea, nausea and vomiting have occurred in some patients receiving cefuroxime axetil. There have been reports of erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis. Mild to moderate hearing loss has been reported in some children receiving cefuroxime for the treatment of meningitis.
In clinical trials of cefuroxime axetil, diarrhea and pseudomembranous colitis appeared to be dose-related and therefore, it is recommended that higher doses should be reserved for severe infections.
In clinical trials of cefuroxime axetil, diarrhea and pseudomembranous colitis appeared to be dose-related and therefore, it is recommended that higher doses should be reserved for severe infections.
Drug Interactions
Zoltax: Concomitant administration of probenecid with cefuroxime axetil tablet increases the area under the serum concentration versus time curve by 50%. The peak serum cefuroxime concentration after a 1.5-g single dose is greater when taken with 1 g of probenecid (mean=14.8 mcg/mL) than without probenecid (mean=12.2 mcg/mL). Drugs that reduce gastric acidity may result in a lower bioavailability of cefuroxime, compared with that of fasting state and tend to cancel the effect of postprandial absorption.
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 contraceptive.
Zoltax Injection: A false-positive reaction for glucose in the urine may occur with copper reduction test (Benedict's or Fehling's solution or with Clinitest 5f tablets) but not with enzyme-based test for glycosuria. As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine plasma glucose levels in patients receiving cefuroxime.
Cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.
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 contraceptive.
Zoltax Injection: A false-positive reaction for glucose in the urine may occur with copper reduction test (Benedict's or Fehling's solution or with Clinitest 5f tablets) but not with enzyme-based test for glycosuria. As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine plasma glucose levels in patients receiving cefuroxime.
Cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.
Caution For Usage
Zoltax Injection: Directions for Reconstitution: In a 750-mg vial, add 3 mL sterile water for injection.
For IV: Add 6 mL sterile water. Shake gently the vial.
Each 750-mg vial may be reconstituted with 100 mL sterile water for injection or with other commonly used infusion fluids.
For IV: Add 6 mL sterile water. Shake gently the vial.
Each 750-mg vial may be reconstituted with 100 mL sterile water for injection or with other commonly used infusion fluids.
Storage
Store at temperatures not exceeding 30°C.
Zoltax: Keep in a cool dry place.
Zoltax: Keep in a cool dry place.
Action
Pharmacology: Pharmacokinetics: Zoltax: Cefuroxime axetil is absorbed from the GIT and is rapidly hydrolyzed in the intestinal mucosa and blood to cefuroxime; absorption is enhanced in the presence of food. Peak plasma concentrations are reported to about 2-3 hrs after an oral dose.
Up to 50% of cefuroxime in the circulation is bound to plasma proteins. The plasma t½ is about 70 min and is prolonged in patients with renal impairment and in neonates.
Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid and adequate humor, but only achieves therapeutic concentrations in the cerebrospinal fluid (CSF) when the meninges are inflamed. It crosses the placenta and has been detected in breast milk.
Cefuroxime is excreted unchanged by glomerular filtration and renal tubular secretion and high concentrations are achieved in the urine.
Probenecid competes for renal tubular secretion with cefuroxime resulting in higher and more prolonged plasma concentrations of cefuroxime. Small amounts of cefuroxime are excreted in bile.
Plasma concentration are reduced by dialysis.
Food Effect on Pharmacokinetics: Absorption of the tablet is greater when taken after food (absolute bioavailability of cefuroxime axetil tablet increases from 37-52%). Despite this difference in absorption, the clinical and bacteriologic responses of patients were independent of food intake at the time of tablet administration in 2 studies where this was assessed.
Renal Excretion: Cefuroxime is excreted unchanged in the urine. In adults, approximately 50% of the administered dose is recovered in the urine within 12 hrs. The pharmacokinetics of cefuroxime in the urine of pediatric patients have not been studied at this time. Until further data are available, the renal pharmacokinetic properties of cefuroxime axetil established in adults should not be extrapolated to pediatric patients.
Zoltax Injection: Cefuroxime sodium is given by IM or IV injection. Peak plasma concentrations of about 27 mcg/mL have been achieved 45 min after an IM dose of 750 mg with measurable amounts present 8 hrs after a dose.
Up to 50% of cefuroxime in the circulation is bound to plasma proteins. The plasma half-life (t½) is about 70 min and is prolonged in patients with renal impairment and in neonates.
Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid and adequate humor, but only achieves therapeutic concentrations in the cerebrospinal fluid when the meninges are inflamed. It crosses the placenta and has been detected in breast milk.
Cefuroxime is excreted unchanged by glomerular filtration and renal tubular secretion and high concentrations are achieved in the urine.
Following injection, most of the dose of cefuroxime is excreted within 24 hrs, the majority within 6 hrs.
Probenecid competes for renal tubular secretion with cefuroxime resulting in higher and more prolonged plasma concentrations of cefuroxime. Small amounts of cefuroxime are excreted in bile.
Plasma concentration are reduced by dialysis.
Microbiology: Cefuroxime is a 2nd-generation cephalosporin antibiotic used in the treatment of susceptible infections. It is bactericidal and has a similar spectrum of antimicrobial action and pattern of resistance to those of cefamandole. Cefuroxime is more resistant to hydrolysis by β-lactamases than cefamandole and therefore, may be more active against β-lactamase-producing strains eg, Haemophilus influenzae and Neisseria gonorrhoeae. However, treatment failures have occurred in patients with H. influenzae meningitis given cefuroxime and might be associated with a relatively high minimum bacterial concentration when compared with minimum inhibitory concentration or with a significant inoculum effect. Reduced affinity of penicillin-binding proteins for cefuroxime has also been reported to be responsible in a β-lactamase-negative strain of H. influenzae.
Zoltax: Cefuroxime has been demonstrated to be active against most strains of the following organisms: Aerobic Gram-Positive Microorganisms: Staphylococcus aureus (including β-lactamase-producing strains), Streptococcus pneumoniae, Streptococcus pyogenes.
Aerobic Gram-Negative Microorganisms: Escherichia coli, H. influenzae (including β-lactamase-producing strains), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis and N. gonorrhoeae (including β-lactamase-producing strains).
Spirochetes: Borrelia burgdorferi.
Cefuroxime has been shown to be active in vitro against most strains of the following microorganisms; however, the clinical significance of these findings is unknown.
Cefuroxime exhibits in vitro minimum inhibitory concentrations (MICs) of ≤4 mcg/mL (systemic susceptible breakpoint) against most (≥90%) strains of the following microorganisms; however, the safety and effectiveness of cefuroxime in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled trials.
Aerobic Gram-Positive Microorganisms: Staphylococcus epidermidis, Staphylococcus saprophyticus, Streptococcus agalactiae.
Note: Listeria monocytogenes and certain strains of enterococci eg, Enterococcus faecalis (formerly Streptococcus faecalis), are resistant to cefuroxime. Methicillin-resistant staphylococcus are resistant to cefuroxime.
Aerobic Gram-Negative Microorganisms: Morganella morganii, Proteus inconstans, Proteus mirabilis, Providencia retigen.
Note: Pseudomonas spp, Campylobacter spp, Acinetobacter calcoaceticus, Legionella spp and most strains of Serratia spp and Proteus vulgaris are resistant to most 1st- and 2nd-generation cephalosporins. Some strains of Morganella morganii, Enterobacter cloacae and Citrobacter spp have been shown by in vitro test to be resistant to cefuroxime and other cephalosporins.
Anaerobic Microorganism: Peptococcus niger.
Note: Most strains of Clostridium difficile and Bacteroides fragilis are resistant to cefuroxime.
Zoltax Injection: Cefuroxime for injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organism in the following diseases: Lower respiratory tract infections including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp, Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes and Escherichia coli.
Urinary tract infections caused by Escherichia coli and Klebsiella spp.
Skin and skin structure infections caused by S. aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli, Klebsiella and Enterobacter spp.
Septicemia caused by S. aureus (penicillinase- and non-penicillinase-producing strains), S. pneumoniae, E. coli, H. influenzae (including ampicillin-resistant strains) and Klebsiella spp.
Meningitis caused by S. pneumoniae, H. influenzae (including ampicillin-resistant strains), Neisseria meningitidis and S. aureus (penicillinase- and non-penicillinase-producing strains).
Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females.
Bone and joint infections caused by S. aureus (penicillinase- and non-penicillinase-producing strains).
Clinical microbiological studies in skin and skin structure infection frequently reveal the growth of susceptible strains of both aerobic and anaerobic organisms. Cefuroxime has been used successfully in these mixed infections in which several organisms have been isolated.
In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefuroxime may be used concomitantly with an aminoglycoside. The recommended doses of both antibiotics may be given depending on the severity of the infection and the patient's condition.
Prevention: Cefuroxime is also used for surgical infection prophylaxis. The preoperative prophylactic administration of cefuroxime may prevent the growth of susceptible disease-causing bacteria and thereby reduce the incidence of certain postoperative infections in patients undergoing surgical procedures (eg, vaginal hysterectomy) that are classified as clean-contaminated or potentially contaminated procedures. Effective prophylactic use of antibiotics in surgery depends on the time of administration. Cefuroxime should usually be given ½-1 hr before the operation to allow sufficient time to achieve effective antibiotic concentrations in the wound tissue during procedure. The dose should be repeated intraoperatively if the procedure is lengthy.
Prophylactic administration is usually not required after the surgical procedure ends and should be stopped within 24 hrs. In the majority of surgical procedures, continuing prophylactic administration of any antibiotic does not reduce the incidence of subsequent infections but will increase the possibility of adverse reactions and the development of bacterial resistance.
The preoperative use of cefuroxime has also been effective during open heart surgery for surgical patients in whom infections at the operative site would present a serious risk. For these patients, it is recommended that cefuroxime therapy be continued for at least 48 hrs after the surgical procedure ends. If an infection is present, specimens for culture should be obtained for the identification of the causative organism and appropriate antimicrobial therapy should be instituted.
Up to 50% of cefuroxime in the circulation is bound to plasma proteins. The plasma t½ is about 70 min and is prolonged in patients with renal impairment and in neonates.
Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid and adequate humor, but only achieves therapeutic concentrations in the cerebrospinal fluid (CSF) when the meninges are inflamed. It crosses the placenta and has been detected in breast milk.
Cefuroxime is excreted unchanged by glomerular filtration and renal tubular secretion and high concentrations are achieved in the urine.
Probenecid competes for renal tubular secretion with cefuroxime resulting in higher and more prolonged plasma concentrations of cefuroxime. Small amounts of cefuroxime are excreted in bile.
Plasma concentration are reduced by dialysis.
Food Effect on Pharmacokinetics: Absorption of the tablet is greater when taken after food (absolute bioavailability of cefuroxime axetil tablet increases from 37-52%). Despite this difference in absorption, the clinical and bacteriologic responses of patients were independent of food intake at the time of tablet administration in 2 studies where this was assessed.
Renal Excretion: Cefuroxime is excreted unchanged in the urine. In adults, approximately 50% of the administered dose is recovered in the urine within 12 hrs. The pharmacokinetics of cefuroxime in the urine of pediatric patients have not been studied at this time. Until further data are available, the renal pharmacokinetic properties of cefuroxime axetil established in adults should not be extrapolated to pediatric patients.
Zoltax Injection: Cefuroxime sodium is given by IM or IV injection. Peak plasma concentrations of about 27 mcg/mL have been achieved 45 min after an IM dose of 750 mg with measurable amounts present 8 hrs after a dose.
Up to 50% of cefuroxime in the circulation is bound to plasma proteins. The plasma half-life (t½) is about 70 min and is prolonged in patients with renal impairment and in neonates.
Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid and adequate humor, but only achieves therapeutic concentrations in the cerebrospinal fluid when the meninges are inflamed. It crosses the placenta and has been detected in breast milk.
Cefuroxime is excreted unchanged by glomerular filtration and renal tubular secretion and high concentrations are achieved in the urine.
Following injection, most of the dose of cefuroxime is excreted within 24 hrs, the majority within 6 hrs.
Probenecid competes for renal tubular secretion with cefuroxime resulting in higher and more prolonged plasma concentrations of cefuroxime. Small amounts of cefuroxime are excreted in bile.
Plasma concentration are reduced by dialysis.
Microbiology: Cefuroxime is a 2nd-generation cephalosporin antibiotic used in the treatment of susceptible infections. It is bactericidal and has a similar spectrum of antimicrobial action and pattern of resistance to those of cefamandole. Cefuroxime is more resistant to hydrolysis by β-lactamases than cefamandole and therefore, may be more active against β-lactamase-producing strains eg, Haemophilus influenzae and Neisseria gonorrhoeae. However, treatment failures have occurred in patients with H. influenzae meningitis given cefuroxime and might be associated with a relatively high minimum bacterial concentration when compared with minimum inhibitory concentration or with a significant inoculum effect. Reduced affinity of penicillin-binding proteins for cefuroxime has also been reported to be responsible in a β-lactamase-negative strain of H. influenzae.
Zoltax: Cefuroxime has been demonstrated to be active against most strains of the following organisms: Aerobic Gram-Positive Microorganisms: Staphylococcus aureus (including β-lactamase-producing strains), Streptococcus pneumoniae, Streptococcus pyogenes.
Aerobic Gram-Negative Microorganisms: Escherichia coli, H. influenzae (including β-lactamase-producing strains), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis and N. gonorrhoeae (including β-lactamase-producing strains).
Spirochetes: Borrelia burgdorferi.
Cefuroxime has been shown to be active in vitro against most strains of the following microorganisms; however, the clinical significance of these findings is unknown.
Cefuroxime exhibits in vitro minimum inhibitory concentrations (MICs) of ≤4 mcg/mL (systemic susceptible breakpoint) against most (≥90%) strains of the following microorganisms; however, the safety and effectiveness of cefuroxime in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled trials.
Aerobic Gram-Positive Microorganisms: Staphylococcus epidermidis, Staphylococcus saprophyticus, Streptococcus agalactiae.
Note: Listeria monocytogenes and certain strains of enterococci eg, Enterococcus faecalis (formerly Streptococcus faecalis), are resistant to cefuroxime. Methicillin-resistant staphylococcus are resistant to cefuroxime.
Aerobic Gram-Negative Microorganisms: Morganella morganii, Proteus inconstans, Proteus mirabilis, Providencia retigen.
Note: Pseudomonas spp, Campylobacter spp, Acinetobacter calcoaceticus, Legionella spp and most strains of Serratia spp and Proteus vulgaris are resistant to most 1st- and 2nd-generation cephalosporins. Some strains of Morganella morganii, Enterobacter cloacae and Citrobacter spp have been shown by in vitro test to be resistant to cefuroxime and other cephalosporins.
Anaerobic Microorganism: Peptococcus niger.
Note: Most strains of Clostridium difficile and Bacteroides fragilis are resistant to cefuroxime.
Zoltax Injection: Cefuroxime for injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organism in the following diseases: Lower respiratory tract infections including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp, Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes and Escherichia coli.
Urinary tract infections caused by Escherichia coli and Klebsiella spp.
Skin and skin structure infections caused by S. aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli, Klebsiella and Enterobacter spp.
Septicemia caused by S. aureus (penicillinase- and non-penicillinase-producing strains), S. pneumoniae, E. coli, H. influenzae (including ampicillin-resistant strains) and Klebsiella spp.
Meningitis caused by S. pneumoniae, H. influenzae (including ampicillin-resistant strains), Neisseria meningitidis and S. aureus (penicillinase- and non-penicillinase-producing strains).
Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females.
Bone and joint infections caused by S. aureus (penicillinase- and non-penicillinase-producing strains).
Clinical microbiological studies in skin and skin structure infection frequently reveal the growth of susceptible strains of both aerobic and anaerobic organisms. Cefuroxime has been used successfully in these mixed infections in which several organisms have been isolated.
In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefuroxime may be used concomitantly with an aminoglycoside. The recommended doses of both antibiotics may be given depending on the severity of the infection and the patient's condition.
Prevention: Cefuroxime is also used for surgical infection prophylaxis. The preoperative prophylactic administration of cefuroxime may prevent the growth of susceptible disease-causing bacteria and thereby reduce the incidence of certain postoperative infections in patients undergoing surgical procedures (eg, vaginal hysterectomy) that are classified as clean-contaminated or potentially contaminated procedures. Effective prophylactic use of antibiotics in surgery depends on the time of administration. Cefuroxime should usually be given ½-1 hr before the operation to allow sufficient time to achieve effective antibiotic concentrations in the wound tissue during procedure. The dose should be repeated intraoperatively if the procedure is lengthy.
Prophylactic administration is usually not required after the surgical procedure ends and should be stopped within 24 hrs. In the majority of surgical procedures, continuing prophylactic administration of any antibiotic does not reduce the incidence of subsequent infections but will increase the possibility of adverse reactions and the development of bacterial resistance.
The preoperative use of cefuroxime has also been effective during open heart surgery for surgical patients in whom infections at the operative site would present a serious risk. For these patients, it is recommended that cefuroxime therapy be continued for at least 48 hrs after the surgical procedure ends. If an infection is present, specimens for culture should be obtained for the identification of the causative organism and appropriate antimicrobial therapy should be instituted.
MedsGo Class
Cephalosporins
Features
Brand
Zoltax
Full Details
Dosage Strength
500mg
Drug Ingredients
- Cefuroxime
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Cefuroxime
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY37463
Drug Classification
Prescription Drug (RX)
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