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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
CEFUROXIME-AFT 250 mg contains Cefuroxime sodium equivalent to Cefuroxime 250 mg.
CEFUROXIME-AFT 750 mg contains Cefuroxime sodium equivalent to Cefuroxime 750 mg.
CEFUROXIME-AFT 1.5 g contains Cefuroxime sodium equivalent to Cefuroxime 1.5 g.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CEFUROXIME-AFT injection contains either, 250 mg 750 mg, or 1.5 g of cefuroxime. Each 750 mg vial contains 41 mg sodium.
For full list of excipients, see Section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
Powder for injection.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Cefuroxime is a bactericidal cephalosporin antibiotic which is resistant to most β-lactamases and is active against a wide range of Gram-positive and Gram-negative organisms.
It is indicated for the treatment of infections before the infecting organism has been identified or when caused by sensitive bacteria. Susceptibility to cefuroxime sodium will vary with geography and time and local susceptibility data should be consulted where available (see Section 5.1 Pharmacodynamic properties). Indications include:
- Respiratory tract infections for example, acute and chronic bronchitis, infected bronchiectasis, bacterial pneumonia, lung abscess and post-operative 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 and wound infections.
- Bone and joint infections for example, osteomyelitis and septic arthritis.
- Obstetric and gynaecological infections, pelvic inflammatory diseases.
- Gonorrhoea particularly when penicillin is unsuitable.
- Other infections including septicaemia, meningitis and peritonitis.
- Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal and vascular surgery where there is increased risk from infection.
Usually CEFUROXIME-AFT will be effective alone, but when appropriate it may be used in
combination with an aminoglycoside antibiotic, or in conjunction with metronidazole (orally or by suppository or injection), especially for prophylaxis in colonic or gynaecological surgery (see Section 4.4 Special warnings and precautions for use).
Where appropriate CEFUROXIME-AFT is effective when used prior to oral therapy with cefuroxime axetil in the treatment of pneumonia and acute exacerbations of chronic bronchitis.
4.2 Dose and method of administration
Dose
CEFUROXIME-AFT Injection for intravenous (IV) and/or intramuscular (IM) administration only.
No more than 750 mg should be injected at one intramuscular site.
General Recommendations
Adults
Many infections respond to 750 mg three times daily by intramuscular or intravenous injection. For more severe infections the dose should be increased to 1.5 g three times daily given intravenously. The frequency of administration may be increased to 6-hourly if necessary, giving total daily doses of 3 to 6 g. Where clinically indicated, some infections respond to 750 mg or 1.5 g twice daily (intravenously or intramuscularly) followed by oral therapy with cefuroxime axetil.
Infants and Children
30 to 100 mg/kg/day given as 3 or 4 divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
Neonates
30 to 100 mg/kg/day given as 2 or 3 divided doses (see Section 5.2 Pharmacokinetic properties).
Gonorrhoea
Adults
1.5 g as a single dose (as 2 x 750 mg injections given intramuscularly with different sites, e.g. each buttock).
Meningitis
CEFUROXIME-AFT is suitable for sole therapy of bacterial meningitis due to sensitive strains.
Adults
3 g given intravenously every eight hours.
Infants and Children
For 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 can be incorporated into the peritoneal dialysis fluid (usually 250 mg for every 2 liters of dialysis fluid).
For patients in renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration in intensive therapy units a suitable dosage is 750 mg twice daily. For low-flux haemofiltration follow the dosage recommended under impaired renal function.
Cefuroxime is also available as the axetil ester for oral administration (ZINNAT). This permits parenteral therapy with cefuroxime to be followed by oral therapy in situations where a change from parenteral to oral is clinically indicated.
Method of administration
For instructions on reconstitution of the medicine before administration, see Section 6.6 Special precautions for disposal and other handling.
4.3 Contraindications
Hypersensitivity to cephalosporin antibiotics.
4.4 Special warnings and precautions for use
Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.
Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with potent diuretics such as furosemide or aminoglycosides, as renal impairment has been reported with these combinations. Renal function should be monitored in these patients, the elderly, and those with pre-existing renal impairment (see Section 4.2 Dose and method of administration).
As with other therapeutic regimens used in the treatment of meningitis, mild-to-moderate hearing loss has been reported in a few paediatric patients treated with cefuroxime sodium. Persistence of positive cerebral spinal fluid (CSF) cultures of Haemophilus influenzae at 18 to 36 hours has also been noted with cefuroxime sodium injection, as well as with other antibiotic therapies; however, the clinical relevance of this is unknown.
As with other antibiotics, use of cefuroxime may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible organisms (e.g. enterococci and Clostridium difficile), which may require interruption of treatment. Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
Intracameral use and ocular toxicity
Serious ocular toxicity, including corneal opacity, retinal toxicity and visual impairment has been reported following off-label intracameral use of CEFUROXIME-AFT. CEFUROXIME-AFT should not be administered intracamerally.
With a sequential therapy regime the timing of change to oral therapy is determined by severity of the infection, clinical status of the patient and susceptibility of the pathogens involved. If there is no clinical improvement within 72 hours, then the parenteral course of treatment must be continued.
Refer to the relevant prescribing information for cefuroxime axetil before initiating sequential therapy
4.5 Interaction with other medicines and other forms of interaction
In common with other antibiotics CEFUROXIME-AFT may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
CEFUROXIME-AFT does not interfere in enzyme-based tests for glycosuria.
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.
It is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving Cefuroxime.
Cefuroxime does not interfere in the alkaline picrate assay for creatinine.
4.6 Fertility, pregnancy and lactation
Pregnancy
There is no experimental evidence of embryopathic or teratogenic effects attributable to cefuroxime, but, as with all medicines, it should be administered with caution during the early months of pregnancy.
Breast-feeding
Cefuroxime is excreted in human milk, and consequently caution should be exercised when CEFUROXIME-AFT is administered to a nursing mother.
Fertility
There are no data on the effects of cefuroxime sodium on fertility in humans.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, based on known adverse reactions, cefuroxime is unlikely to have an effect on the
Vascular disorders Common Thrombophlebitis may follow intravenous injection.
Gastrointestinal disorders Uncommon Gastrointestinal disturbance. Very rare Pseudomembranous colitis (see Section 4.4 Special warnings and precautions for use).
Hepatobiliary disorders Common Transient rise in liver enzymes. Uncommon Transient rise in bilirubin.
Transient rises in serum liver enzymes or bilirubin occur, particularly in patients with pre-existing liver disease, but there is no evidence of harm to the liver.
Skin and subcutaneous tissue disorders Very rare Erythema multiforme, toxic epidermal necrolysis and Stevens Johnson Syndrome.
See also Immune system disorders.
Renal and urinary disorders Very rare Elevations in serum creatinine, elevations in blood urea nitrogen and decreased creatinine clearance (see Section 4.4 Special warnings and precautions for use).
See also Immune system disorders.
General disorders and administration site conditions Common Injection site reactions which may include pain and thrombophlebitis
Pain at the intramuscular injection site is more likely at higher doses. However it is unlikely to be a cause for discontinuation of treatment.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via: https://nzphvc.otago.ac.nz/reporting/
4.9 Overdose
Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.
For advice on the management of overdose please contact the National Poisons Centre on 0800
POISON (0800 764766).
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: antibacterial for systemic use, second- generation cephalosporins, ATC code: J01DC
Mechanism of Action
Cefuroxime is a well characterised and effective antibacterial agent which has bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains.
Cefuroxime has good stability to bacterial β-lactamase, and consequently is active against many ampicillin-resistant or amoxycillin-resistant strains.
The bactericidal action of cefuroxime results from inhibition of cell wall synthesis by binding to essential target proteins.
Pharmacodynamic Effects
The prevalence of acquired resistance is geographically and time dependent and for select species may be very high. Local information on resistance is desirable, particularly when treating severe infections.
In vitro susceptibility of micro-organisms to Cefuroxime
Where clinical efficacy of cefuroxime has been demonstrated in clinical trials this is indicated with an asterisk (*).
Commonly Susceptible Species
Gram-Positive Aerobes:
Staphylococcus aureus (methicillin susceptible)* Coagulase negative staphylococcus (methicillin susceptible) Streptococcus pyogenes* Beta-hemolytic streptococci
Gram-Negative Aerobes:
Haemophilus influenzae including ampicillin resistant strains*
Haemophilus parainfluenzae* Moraxella catarrhalis* Neisseria gonorrhoea* including penicillinase and non-penicillinase producing strains Neisseria meningitidis Shigella spp.
Stenotrophomonas maltophilia
Gram-Positive Anaerobes: Clostridium difficile
Gram-Negative Anaerobes: Bacteroides fragilis
Others: Chlamydia species Mycoplasma species Legionella specie
5.2 Pharmacokinetic properties
Absorption
Peak levels of cefuroxime are achieved within 30 to 45 minutes after intramuscular administration.
Distribution
Protein binding has been variously stated as 33 to 50% depending on the methodology used.
Concentrations of cefuroxime in excess of the minimum inhibitory levels for common pathogens can be achieved in bone, synovial fluid and aqueous humour. Cefuroxime passes the blood-brain barrier when the meninges are inflamed.
Biotransformation
Cefuroxime is not metabolised and is excreted by glomerular filtration and tubular secretion.
Elimination
The serum half-life after either intramuscular or intravenous injection is approximately 70 minutes.
In the first weeks of life the serum half-life of cefuroxime can be 3 to 5 times that in the adult.
Concurrent administration of probenecid prolongs the excretion of the antibiotic and produces an elevated peak serum level. There is an almost complete recovery (85-90%) of unchanged cefuroxime in urine within 24 hours of administration. The major part is excreted in the first six hours. Serum l e v e l s of cefuroxime are reduced by dialysis.
5.3 Preclinical safety data
No additional data of relevance.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None.
6.2 Incompatibilities
CEFUROXIME-AFT should not be mixed in the syringe with aminoglycoside antibiotics.
The pH of 2.74% w/v sodium bicarbonate injection BP considerable affects the colour of the solution and therefore this solution is not recommended for the dilution of CEFUROXIME-AFT. However, if required, for patients receiving sodium bicarbonate injection by infusion the CEFUROXIME-AFT may be introduced into the tube of the giving set.
6.3 Shelf life
24 months from date of manufacture stored at or below 25°C protect from light.
Reconstituted solution can be stored for 24 hours at 2° to 8°C (Refrigerate, do not freeze).
6.4 Special precautions for storage
Store below 25 °C. Protect from light.
It is recommended that the reconstituted suspensions or solutions be used immediately after preparation but they are stable for up to 24 hours when stored in the refrigerator.
Some increase in the colour of prepared solutions and suspensions of CEFUROXIME-AFT may occur on storage.
6.5 Nature and contents of container
Cefuroxime-AFT 250 mg, 750 mg and 1.5 g are available in packs containing 1 and 10 vials.
6.6 Special precautions for disposal and other handling
Cefuroxime sodium is a white to off-white powder which when reconstituted with appropriate amounts of water provides either an off-white suspension for intramuscular (I.M) use or a yellow solution for intravenous (I.V.) use. Variations in colour intensity do not indicate any change in the product safety or efficacy.
Instructions for reconstitution
Intramuscular
CEFUROXIME-AFT 250 mg and 750 mg vials are intended for I.M. administration. Add into the vial, 1 mL of Water for Injections to the 250 mg strength or 3 mL of Water for Injections to the
in intravenous infusion with:
- Heparin (10 and 50 units/mL) in 0.9% Sodium Chloride Injection;
- Potassium Chloride (10 and 40mEqL) in 0.9% Sodium Chloride Injection.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
7. MEDICINE SCHEDULE
Prescription Medicine
8. SPONSOR
AFT Pharmaceuticals Ltd PO Box 33- Takapuna Auckland Email:customer.service@aftpharm.com
9. DATE OF FIRST APPROVAL
21 October 2010
10. DATE OF REVISION OF THE TEXT
9 January 2020
Summary table of changes:
Section changed Summary of new information All Reformatted
