DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Zinacef (Cefuroxime Sodium) - Summary



(cefuroxime for injection)

(cefuroxime injection)

Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl)acetamido]ceph-3-em-4-carboxylate.

ZINACEF is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:

  1. 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.
  2. Urinary Tract Infections caused by Escherichia coli and Klebsiella spp.
  3. Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp.
  4. Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp.
  5. Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  6. Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females.
  7. Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).

Clinical microbiological studies in skin and skin-structure infections frequently reveal the growth of susceptible strains of both aerobic and anaerobic organisms. ZINACEF 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, ZINACEF may be used concomitantly with an aminoglycoside (see PRECAUTIONS). The recommended doses of both antibiotics may be given depending on the severity of the infection and the patient's condition.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZINACEF and other antibacterial drugs. ZINACEF should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Prevention: The preoperative prophylactic administration of ZINACEF may prevent the growth of susceptible disease-causing bacteria and thereby may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures (e.g., 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. ZINACEF should usually be given one-half to 1 hour before the operation to allow sufficient time to achieve effective antibiotic concentrations in the wound tissues during the procedure. The dose should be repeated intraoperatively if the surgical procedure is lengthy.

Prophylactic administration is usually not required after the surgical procedure ends and should be stopped within 24 hours. 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 perioperative use of ZINACEF 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 therapy with ZINACEF be continued for at least 48 hours 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.

See all Zinacef indications & dosage >>


Published Studies Related to Zinacef (Cefuroxime)

Neither moxifloxacin nor cefuroxime produces significant attenuation of inflammatory mediator release in patients exposed to cardiopulmonary bypass: a randomized controlled trial. [2011.10.03]
OBJECTIVES: (i) the inflammatory response to CPB may be different from that of infectious disease states that were used to establish the immunomodulatory effects of moxifloxacin; and (ii) a single intravenous dose, which was used in this investigation, may not lead to high enough plasma and intracellular concentrations..

Comparative bioavailability study of cefuroxime axetil (equivalent to 500 mg cefuroxime/tablet) tablets (Zednad(R) versus Zinnat(R)) in healthy male volunteers. [2011.09]
This study was performed to investigate the bioequivalence of cefuroxime axetil tablets between a generic test product (A) Zednad(R) Tablet (500 mg cefuroxime/ tablet, Diamond Pharma, Syria), and the Reference Product (B) Zinnat(R) Tablet (500 mg cefuroxime/tablet, GlaxoSmithKline, Saudi Arabia).Therefore, the two formulations were considered to be bioequivalent.

Cefuroxime as a prophylactic preoperative antibiotic in septoplasty. A double blind randomized placebo controlled study. [2011.03]
BACKGROUND: Prophylactic antibiotics are often used in septoplasty. However, the number of controlled studies, especially randomized double blind placebo controlled studies on the effect of antibiotics in septum surgery, is very low. The PURPOSE OF THE PRESENT STUDY was to investigate if intravenous cefuroxime given as preoperative antimicrobial prophylaxis 30 minutes prior to surgery diminishes the risk of infection after septoplasty during the first postoperative month among patients with normal immune function... CONCLUSIONS: We recommend the use of one dose of 1500 mg intravenous cefuroxime prior to septoplasty in patients having crusts or purulent secretion in the nasal cavities or if the operation is expected to be prolonged.

Ampicillin/sulbactam versus cefuroxime as antimicrobial prophylaxis for cesarean delivery: a randomized study. [2010.11.30]
BACKGROUND: The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of post-cesarean infectious morbidity has not been assessed... CONCLUSIONS: Ampicillin/sulbactam was as safe and effective as cefuroxime when administered for the prevention of infections following cesarean delivery. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01138852.

Liquid chromatography/electrospray tandem mass spectrometry method for the determination of cefuroxime in human plasma: application to a pharmacokinetic study. [2010.02.01]
A rapid, selective and sensitive high performance liquid chromatography-tandem mass spectrometry method (LC-MS/MS) was developed and validated for the determination and pharmacokinetic investigation of cefuroxime in human plasma. Cefuroxime and the internal standard (IS), cefoxitin, were extracted from plasma samples using solid phase extraction with Oasis HLB cartridges...

more studies >>

Clinical Trials Related to Zinacef (Cefuroxime)

Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section [Completed]
The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed. Women scheduled for cesarean delivery were randomized to receive a single dose of either 3g of ampicillin-sulbactam or 1. 5g of cefuroxime intravenously, after umbilical cord clamping. An evaluation for development of postoperative infections and risk factor analysis was performed.

Pharmacokinetics of Small Spectrum Beta-lactam Antibiotics (Amoxicillin/Clavulanic Acid and Cefuroxime) in Patients on Intensive Care Units [Recruiting]
Adequate antibiotic therapy is very important in the treatment of infections. Spectrum and dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic can't be changed, but the dosing scheme can be optimized. Recent studies proved that an optimized dosing scheme can improve the efficacy of the treatment. Broad-spectrum antibiotics have unpredictable pharmacokinetics in patients on intensive care units. This is due to the pathophysiologic processes in the patients on intensive care units: increased distribution volume, hypoproteinemia, organ failureā€¦ The investigators guess that similar processes influence the pharmacokinetics of small spectrum antibiotics (like amoxicillin and cefuroxime), but data lacks. Because the pharmacokinetics of broad spectrum antibiotics in seriously ill patients are better known, physicians are more confident prescribing these drugs. Studying the pharmacokinetic interactions of small spectrum antibiotics in seriously ill patients, can help to give the physician the confidence to prescribe these small-spectrum antibiotics. In this study, the investigators will study the pharmacokinetics of amoxicillin/clavulanic acid and cefuroxime, in 60 patients on intensive care. 8 blood samples will be drawn via a central catheter on different moments after one administration of the antibiotic in the steady state phase. All the patients are prescribed the antibiotics for the treatment of their infections: they get the antibiotic therapy anyway. By measuring the concentrations on different moments after one administration, the investigators can reconstruct the pharmacokinetic function.

Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome [Completed]

- While doxycycline is a standard antibiotic for treatment of erythema migrans in Europe

as well as in the USA, the effectiveness of cefuroxime axetil in the treatment of adult patients with erythema migrans has been assessed only in the USA where the causative agent of Lyme disease is Borrelia burgdorferi, but not in Europe where the main etiologic agents are B. afzelii and B. garinii.

- Controversy exists over the significance and even the existence of post-Lyme disease

symptoms because of the high rate of similar background symptoms in the general population. Purpose: The two main purposes of this European, prospective clinical trial in which doxycycline and cefuroxime axetil are compared in the treatment of adult patients with erythema migrans and which included a control group to address the significance of post-Lyme disease symptoms are:

- To assess and compare the effectiveness of doxycycline and cefuroxime axetil in the

treatment of erythema migrans using clinical and bacteriological criteria (noninferiority testing approach), and

- to compare the frequency of post-Lyme disease symptoms in adult patients treated for EM

with antibiotics and the frequency of similar symptoms in control subjects without Lyme disease.

The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery [Completed]
The study investigates whether placing an antibiotic inside the eye at the end of cataract surgery in children will reduce the amount of fibrin formation (fibrin formation can block the pupil and reduce vision). We hypothesize that the fibrin is caused by a low-level infection and could be prevented by the antibiotic.

Study of the Efficacy of Preoperative Cefuroxime Prophylaxis to Prevent Surgical Site Infection in Herniated Disk Surgery [Completed]
The purpose of the study is to determine whether a single, pre-operative dose of cefuroxime is effective in preventing surgical site infection in patients undergoing surgery for herniated disk

more trials >>

Reports of Suspected Zinacef (Cefuroxime) Side Effects

Cholestatic Liver Injury (6)Condition Aggravated (6)Pyrexia (5)Leukocytoclastic Vasculitis (4)Renal Failure Acute (3)Anaphylactic Shock (2)Skin Discolouration (2)Diarrhoea Haemorrhagic (2)Endocarditis (2)Blood Creatinine Increased (2)more >>

Page last updated: 2011-12-09

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017