Zocef

Zocef

cefuroxime

Manufacturer:

Alkem Lab

Distributor:

Getz Bros
Full Prescribing Info
Contents
Cefuroxime (tab/powd for oral susp: axetil; inj: sodium)
Description
Each film-coated tablet contains Cefuroxime Axetil EP equivalent to Cefuroxime 250 mg or 500 mg.
Each vial contains Cefuroxime (as Sodium salt) equivalent to Cefuroxime 750 mg or 1.5 g.
Action
Pharmacotherapeutic group Cephalosporins and Related Substances. ATC code J01DA06.
Pharmacology: Pharmacodynamics: Pharmacological effects/mode of action: Tablet: Cefuroxime, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefuroxime interferes with an autolysin inhibitor.
Cefuroxime axetil is an oral prodrug of the bactericidal cephalosporin antibiotic cefuroxime, which is resistant to most beta-lactamase and is active against a wide range of gram-positive and gram-negative organisms.
Injection: Cefuroxime is a cephalosporin antibiotic.
All cephalosporins (β-lactam antibiotics) inhibit cell wall production and are selective inhibitors of peptidoglycan synthesis. The initial step in drug action consists of binding of the drug to cell receptors, called penicillin-binding proteins. After a β-lactam antibiotic has bound to these receptors, the transpeptidation reaction is inhibited and peptidoglycan synthesis is blocked. Bacterial lysis is the end result.
Mechanisms of Resistance to Cefuroxime: Known mechanisms of resistance in targeted pathogens are the following: Production of β-lactamases which are able to hydrolyse Cefuroxime efficiently (eg, several of the extended-spectrum and chromosomally mediated β-lactamases); reduced affinity of penicillin-binding proteins for Cefuroxime (eg, penicillin-resistant Streptococcus pneumoniae); cell wall impermeability; efflux pumps.
Indications/Uses
Tablet: Cefuroxime Axetil Tablet are indicated 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/Tonsillitis caused by Streptococcus pyogenes.
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-beta-lactamase-producing strains only).
Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections 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 Infections caused by Escherichia coli or Klebsiella pneumoniae. Uncomplicated Gonorrhea, urethral and endocervical, caused by penicillinase-producing and non-penicillinase-producing strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase-producing strains of Neisseria gonorrhoeae.
Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Injection: Cefuroxime sodium for injection is indicated for the treatment of infections caused by susceptible strains of the designated micro-organisms, or before the infecting organism has been identified, in the diseases listed as follows:
Respiratory tract infections, for example, acute and chronic bronchitis, infected bronchiectasis, bacterial pneumonia, lung abscess and postoperative chest infections.
Ear, nose and throat infections, for example, sinusitis, tonsillitis, pharyngitis and otitis media.
Urinary tract infections, for example, acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria.
Soft tissue infections, for example, cellulitis, erysipelas, peritonitis and wound infections.
Bone and joint infections, for example, osteomyelitis and septic arthritis.
Obstetric and gynaecological infections, pelvic inflammatory disease.
Gonorrhoea, particularly if penicillin is unsuitable.
Other infections, including septicaemia and meningitis.
Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal and vascular surgery where there is increased risk from infection.
Post splenectomy sepsis of unclear etiology.
Dosage/Direction for Use
Tablet: Cefuroxime axetil tablets administered by oral route without regard to meal and the dosage and administration in Adults and Pediatric patients is given as follows: (see Table 1.)
Click on icon to see table/diagram/image

Injection: Usually cefuroxime is effective when administered alone. General Dosage: Adults: Many infections will respond to 750 mg three times daily by intramuscular or intravenous injection. For more severe infections this dose should be increased to 1.5 g three times daily intravenously. The frequency of dosage may be increased to six-hourly injections, intramuscular or intravenous, giving total daily doses of 3 g to 6 g.
Infants and children: Doses of 30 to 100 mg/kg/day given in three or four divided doses. A dose of 60 mg/kg/day will be appropriate for most infections.
Neonates: Doses of 30 to 100 mg/kg/day given in two or three divided doses. In the first weeks of life the serum half-life of cefuroxime can be three to five times that in adults.
Gonorrhea: 1.5 g should be given as a single dose or as two 750 mg injections into different sites, eg, each buttock.
Meningitis: Cefuroxime therapy is suitable for sole therapy of bacterial meningitis due to sensitive strains.
Infants and children: 200 to 240 mg/kg/day intravenously in three or four divided doses. This dosage may be reduced to 100 mg/kg/day after three days or when clinical improvement occurs.
Neonates: The initial dosage should be 100 mg/kg/day intravenously. This dosage may be reduced to 50 mg/kg/day after three days or when clinical improvement occurs.
Adults: 3 g intravenously every eight hours. No data is currently available to recommend a dose for intrathecal administration.
Prophylaxis: The usual dose is 1.5 g intravenously with induction of anaesthesia. For orthopaedic, pelvic and abdominal operations this may be followed with two 750 mg doses 8 and 16 hours later. For vascular, cardiac, oesophageal and pulmonary operations this may be supplemented with 750 mg intramuscularly three times a day for a further 24 to 48 hours.
Dosage in Impaired Renal Function: As Cefuroxime is excreted by the kidneys, the dosage should be reduced to allow for slower excretion in patients with impaired renal function, once creatinine clearance falls below 20 mL/min, as follows: (See Table 2.)

Click on icon to see table/diagram/image
Overdosage
Overdosage of cephalosporins can lead to cerebral irritation and seizures. With seizures the drug should be discontinued and appropriate anticonvulsive and supportive therapy administered. Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.
Contraindications
Cefuroxime is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Special Precautions
Tablet: Before therapy with cefuroxime axetil is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefuroxime axetil, 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 antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If a clinically significant allergic reaction to cefuroxime axetil occurs, discontinue the drug and institute appropriate therapy. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated. Cephalosporins, including Cefuroxime Axetil, should be given with caution to patients receiving concurrent treatment with potent diuretics because these 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. Cephalosporins may be associated with a 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. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.
Injection: Cephalosporin antibiotics may, in general, be given safely to patients who are hypersensitive to penicillins, although cross-reactions have been reported. Special care is indicated in patients who have experienced an anaphylactic reaction to penicillin.
Cephalosporin antibiotics at high dosage should be given with caution to patients receiving potent diuretics or aminoglycosides, as these combinations are suspected of adversely affecting renal function. Clinical experience has shown that this is not likely to be a problem at the recommended dose levels.
Use In Pregnancy & Lactation
Studies in animals revealed no evidence of embryopathic or teratogenic effects due to cefuroxime, but, as with all drugs, it should be used with caution during pregnancy.
Since cefuroxime is excreted in human milk, caution should be exercised when administering cefuroxime to a nursing mother.
Adverse Reactions
Tablet: The following hypersensitivity reactions have been reported: anaphylaxis, angioedema, pruritus, rash, serum sickness-like reaction, urticaria.
Gastrointestinal: Pseudomembranous colitis.
Hematologic: 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.
The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to Cefuroxime Axetil tablets in multiple-dose clinical trials: Diarrhea/loose stools, nausea/vomiting, transient elevation in AST, transient elevation in ALT, eosinophilia, transient elevation in LDH, abdominal pain, abdominal cramps, flatulence, indigestion, headache, vaginitis, vulvar itch, chills, rash, hives, itch, dysuria, chest pain.
Injection: Hypersensitivity reactions: Including skin rashes (maculopapular and urticarial), interstitial nephritis, drug fever and, very rarely, anaphylaxis. As with any antibiotic, prolonged use may lead to overgrowth of non-susceptible organisms, eg, Candida.
As with other cephalosporins, there have been rare reports of erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Gastro-intestinal disturbance: Including, very rarely, pseudomembranous colitis, nausea, vomiting, diarrhoea & cramps, which has been reported with most broad spectrum antibiotics.
Haematological: A decrease in haemoglobin concentration, eosinophilia, leucopenia and neutropenia have been observed. Positive Coombs' tests have been reported. As with other cephalosporins, thrombocytopenia has been reported rarely.
Hepatic: Transient rises in liver enzymes or serum bilirubin have been observed, particularly in patients with pre-existing liver disease, but there is no evidence of hepatic involvement.
Renal: There may be some variation in the results of biochemical tests of renal function, but these results do not appear to be of clinical significance.
Other: Transient pain may be experienced at the site of intramuscular injection. Occasionally thrombophlebitis may occur at the site of intravenous injection. A burning sensation may be observed after intravenous injection. Mild to moderate hearing loss has been reported in some children treated for meningitis. Dizziness and headache has been reported in patients receiving cefuroxime.
Drug Interactions
Tablet: In common with other antibiotics, Cefuroxime axetil may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
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 axetil. This antibiotic does not interfere in the alkaline picrate assay for creatinine.
Concurrent administration of probenecid increases the area under the mean serum concentration time curve by 50%. Serum levels of cefuroxime are reduced by dialysis. A positive Coomb's test has been reported during treatment with cephalosporins. This phenomenon can interfere with cross matching of blood.
Injection: Concurrent administration of probenecid prolongs the excretion of cefuroxime and produces an elevated peak serum level.
Concurrent administration of potent diuretics, aminoglycosides may adversely affect renal function.
Storage
Store at temperatures not exceeding 30°C. Store in a dry place and protect from light.
In keeping with good pharmaceutical practice, freshly constituted suspensions or solutions should be used immediately. If this is not practicable then solution may be stored at 2°C-8°C (in a refrigerator) for up to 24 hours.
MIMS Class
ATC Classification
J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 250 mg x 10's, 50's. 500 mg x 10's, 50's. Powd for oral susp 125 mg/5 mL x 30 mL x 1's. Powd for inj (vial) 750 mg x 1's.
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