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  • Zinacef 750 mg
    / GSK


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    5 X 750 mg

    partial basket chart 9575 26012

    Dosage

    Adults and children >40 kg
    Community acquired pneumonia and acute exacerbations of chronic bronchitis, Soft-tissue infections: cellulitis, erysipelas and wound infections, Intra-abdominal infections: 750 mg every 8 hours (intravenously or intramuscularly).
    Sinusitis, septic arthritis: 750 mg every 8 hours (intravenously or intramuscularly). For more severe infections, this dose should be increased to 1.5g every 8 hours i.v. The frequency of i.m. or i.v. injections can be increased to six-hourly if necessary, giving total doses of 3g to 6g daily. Where clinically indicated, some infections respond to 750 mg or 1.5 g twice daily (i.v. or i.m.).
    Complicated urinary tract infections, including pyelonephritis: 1.5 g every 8 hours (intravenously or intramuscularly).
    Severe infections: 750 mg every 6 hours (intravenously). 1.5 g every 8 hours (intravenously)
    Surgical prophylaxis for gastrointestinal, gynaecological surgery (including caesarean section) and orthopaedic operations: 1.5 g with the induction of anaesthesia. This may be supplemented with two 750 mg doses (intramuscularly) after 8 hours and 16 hours.
    Surgical prophylaxis for cardiovascular and oesophageal operations: 1.5 g with induction of anaesthesia followed by 750 mg (intramuscularly) every 8 hours for a further 24 hours.
    Children < 40 kg
    Community acquired pneumonia,  Complicated urinary tract infections, including pyelonephritis,Soft-tissue infections: cellulitis, erysipelas and wound infections, Intra-abdominal infections: Infants and toddlers > 3 weeks and children < 40 kg : 30 to 100 mg/kg/day (intravenously) given as 3 or 4 divided doses; a dose of 60 mg/kg/day is appropriate for most infections. Infants (birth to 3 weeks): 30 to 100 mg/kg/day (intravenously) given as 2 or 3 divided doses.
    Sinusitis, septic arthritis: Infants and toddlers > 3 weeks and children < 40 kg: Doses of 30 to 100 mg/kg/day given as three or four divided doses. A dose of 60mg/kg/day is appropriate for most Infections. Infants (birth to 3 weeks): Doses of 30 to 100 mg/kg/day given as two or three divided doses.
    Renal impairment: Cefuroxime is primarily excreted by the kidneys. Therefore, as with all such antibiotics, in patients with markedly impaired renal function it is recommended that the dosage of Cefuroxime should be reduced to compensate for its slower excretion.
    Recommended doses for Cefuroxime in renal impairment: Creatinine clearance > 20 mL/min/1.73 m²:It is not necessary to reduce the standard dose (750 mg to 1.5 g three times daily). Creatinine clearance 10-20 mL/min/1.73 m²: 750 mg twice daily. Creatinine clearance < 10 mL/min/1.73 m²: 750 mg once daily. Patients on haemodialysis: A further 750 mg dose should be given intravenously or intramuscularly at the end of each dialysis; in addition to parenteral use, cefuroxime sodium can be incorporated into the peritoneal dialysis fluid (usually 250 mg for every 2 litres of dialysis fluid). Patients in renal failure on continuous arteriovenous haemodialysis (CAVH) or high-flux haemofiltration (HF) in intensive therapy units:  750 mg twice daily; for low-flux haemofiltration follow the dosage recommended under impaired renal function.
    Hepatic impairment: Cefuroxime is primarily eliminated by the kidney. In patients with hepatic dysfunction this is not expected to affect the pharmacokinetics of cefuroxime.
    Method of administration: Cefuroxime should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or via a drip tube or infusion over 30 to 60 minutes, or by deep intramuscular injection. Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 750 mg should be injected at one site. For doses greater than 1.5 g intravenous administration should be used. For instructions on reconstitution of the medicinal product before administration, see prescribing information.
    See prescribing information for full details.


    Indications

    Zinacef is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth).
    • Community acquired pneumonia
    • Acute exacerbations of chronic bronchitis
    • Complicated urinary tract infections, including pyelonephritis
    • Soft-tissue infections: cellulitis, erysipelas and wound infections
    • Intra-abdominal infections
    • Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including caesarean section)
    • Nose infections for example, sinusitis
    • Septic arthritis
    In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents.
    Consideration should be given to official guidance on the appropriate use of antibacterial agents.


    Contra-Indications

    Hypersensitivity to cefuroxime or to any of the excipients. Patients with known hypersensitivity to cephalosporin antibiotics. History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).


    Special Precautions

    Hypersensitivity reactions: As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with cefuroxime must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to cefuroxime, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if cefuroxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.
    Concurrent treatment with potent diuretics or aminoglycosides:
    Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with potent diuretics such as furosemide or aminoglycosides. Renal impairment has been reported during use of these combinations. Renal function should be monitored in the elderly and those with known pre-existing renal impairment.
    Overgrowth of non-susceptible microorganisms: Use of cefuroxime may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible microorganisms (e.g. enterococci and Clostridium difficile), which may require interruption of treatment. Antibacterial agent–associated pseudomembranous colitis has been reported with use of cefuroxime and may range in severity from mild to life threatening. This diagnosis should be considered in patients with diarrhoea during or subsequent to the administration of cefuroxime. Discontinuation of therapy with cefuroxime and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
    Intracameral use and eye disorders: Zinacef is not formulated for intracameral use. Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intracameral use of cefuroxime sodium compounded from vials approved for intravenous/intramuscular administration. These reactions included macular oedema, retinal oedema, retinal detachment, retinal toxicity, visual impairment, visual acuity reduced, vision blurred, corneal opacity and corneal oedema.
    Intra-abdominal infections: Due to its spectrum of activity, cefuroxime is not suitable for the treatment of infections caused by Gram-negative non-fermenting bacteria or by Bacteroides fragilis.
    Interference with diagnostic tests: The development of a positive Coomb’s Test associated with the use of cefuroxime may interfere with cross matching of blood. Slight interference with copper reduction methods (Benedict’s, Fehling’s, Clinitest) may be observed. However, this should not lead to false-positive results, as may be experienced with some other cephalosporins. As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving cefuroxime sodium.
    Important information about excipients: This medicinal product contains 42 mg sodium per vial, equivalent to 2.1 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.


    Side Effects

    The most common adverse reactions are neutropenia, eosinophilia, transient rise in liver enzymes or bilirubin, particularly in patients with pre-existing liver disease, but there is no evidence of harm to the liver and injection site reactions.
    See prescribing information for full details.


    Drug interactions

    Cefuroxime may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
    Cefuroxime is excreted by glomerular filtration and tubular secretion. Concomitant use of probenicid is not recommended. Concurrent administration of probenecid prolongs the excretion of the antibiotic and produces an elevated peak serum level.
    Potential nephrotoxic drugs and loop diuretics: High-dosage treatments with cephalosporins should be carried out with caution on patients who are taking strong-acting diuretics (such as furosemide) or potential nephrotoxic preparations (such as aminoglycoside antibiotics), since impairment of renal function through such combinations cannot be ruled out.
    Other Interactions: Concomitant use with oral anticoagulants may give rise to increased international normalised ratio (INR).


    Pregnancy and Lactation

    Pregnancy: There are limited amounts of data from the use of cefuroxime in pregnant women. Cefuroxime should be prescribed to pregnant women only if the benefit outweighs the risk. Cefuroxime has been shown to cross the placenta and attain therapeutic levels in amniotic fluid and cord blood after intramuscular or intravenous dose to the mother.
    Lactation: Cefuroxime is excreted in human milk in small quantities. Adverse reactions at therapeutic doses are not expected, although a risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from cefuroxime therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
    See prescribing information for full details.


    Overdose

    Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment.
    Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.


    Important notes

    Compatibility: Cefuroxime is compatible with most commonly used intravenous fluids and electrolyte solutions. The pH of 2.74% w/v sodium bicarbonate injection BP considerably affects the colour of solutions and therefore this solution is not recommended for the dilution of Cefuroxime. However, if required, for patients receiving sodium bicarbonate injection by infusion the Cefuroxime may be introduced into the tube of the giving set. Cefuroxime should not be mixed in the syringe with aminoglycoside antibiotics.
    Special precautions for storage: Store below 25ºC and protect from light. After reconstitution, Cefuroxime should be stored at 2 – 8ºC for no longer than 24 hours. From a microbial point of view the product should be used immediately.


    Manufacturer
    GlaxoSmithKline Manufacturing S.p.A, Parma, Italy
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