Cefuroxime axetil oral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulation containing cefuroxime as cefuroxime axetil
Antibiotic sensitive infections
Urinary tract infection
Indicated for the treatment of infections caused by sensitive bacteria including:
Lower respiratory tract infections - acute bronchitis, acute exacerbations of chronic bronchitis, pneumonia.
Upper respiratory tract infections - ear, nose and throat infections such as otitis media, sinusitis, tonsillitis, pharyngitis.
Genitourinary tract infection - pyelonephritis, cystitis, urethritis.
Skin and soft tissue infections - furunculosis, pyoderma, impetigo.
Gonorrhoea - acute uncomplicated gonococcal urethritis, cervicitis.
Treatment of early Lyme disease and subsequent prevention of late Lyme disease in adults and children over 12 years.
Cefuroxime is also available as the sodium salt for parenteral administration. When changes from parenteral to oral therapy are necessary, sequential therapy with the same antibiotic is possible. Where appropriate, oral cefuroxime axetil is effective when used following initial parenteral administration of cefuroxime sodium to treat pneumonia and acute exacerbations of chronic bronchitis.
Treatment of Lyme disease in children under 12 years
Duration of treatment is determined by the severity of the infection and the clinical status of the patient. The usual course of treatment is 7 days but may range from 5 to 10 days.
The manufacturer suggests the oral formulations of cefuroxime are not bioequivalent, however there are no suggested differences in dose.
Acute tonsillitis and pharyngitis, acute bacterial sinusitis: 250mg twice daily.
Acute otitis media: 500mg twice daily.
Acute exacerbations of chronic bronchitis: 500mg twice daily.
Cystitis: 250mg twice daily.
Pyelonephritis: 250mg twice daily.
Uncomplicated skin and soft tissue infections: 250mg twice daily. Lyme disease: 500mg twice daily for fourteen days (range of ten to twenty one days). An unlicensed duration of twenty eight days is recommended in Lyme arthritis.
Lower urinary tract infection: 125mg twice daily.
Children weighing 40kg or over
(See Dosage; Adult)
Children aged over 3 months and weighing under 40kg
Acute tonsillitis and pharyngitis, acute bacterial sinusitis: 10mg/kg twice daily to a maximum of 125mg twice daily. Otitis media or, where appropriate, with more severe infections (children over 2 years only): 15mg/kg twice daily to a maximum of 250mg twice daily.
Cystitis: 15mg/kg twice daily to a maximum of 250mg twice daily.
Pyelonephritis: 15mg/kg twice daily to a maximum of 250mg twice daily for ten to fourteen days.
Uncomplicated skin and soft tissue infections: 15mg/kg twice daily to a maximum of 250mg twice daily.
Lyme disease: 15mg/kg twice daily to a maximum of 250mg twice daily for ten to twenty one days.
The following alternative dosing schedules may be suitable:
Children aged 12 to 18 years
250mg twice a day. Double dose in severe infections or suspected pneumonia.
Children aged 2 to 12 years
15mg/kg twice daily to a maximum of 250mg per dose.
Children aged 3 months to 2 years
10mg/kg twice daily to a maximum of 125mg per dose.
Children aged 12 to 18 years
An unlicensed dose of 500mg twice a day for fourteen to twenty one days. An unlicensed duration of twenty eight days is recommended in Lyme arthritis.
Children aged 3 months to 12 years
15mg/kg twice a day (up to an unlicensed maximum of 500mg per dose) for fourteen to twenty one days. An unlicensed duration of twenty eight days is recommended in Lyme arthritis.
Lower urinary tract infections
125mg twice daily.
Patients with Renal Impairment
Cefuroxime is primary excreted by the kidneys. In patients with renal impairment the dose of cefuroxime should be reduced to compensate.
Cefuroxime is effectively removed by dialysis.
Creatinine clearance equal to or greater than 30ml/minute/1.73 square metre
No dose adjustment needed.
Creatinine clearance 10 to 29ml/minute/1.73 square metre
Standard individual dose given every 24 hours.
Creatinine clearance less than 10ml/minute/1.73 square metre
Standard individual dose given every 48 hours.
An additional standard individual dose should be given at the end of each dialysis.
Children under 3 months
Acute renal failure
Precautions and Warnings
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Renal impairment - creatinine clearance below 30 ml/minute
Reduce dose in patients with creatinine clearance below 30ml/min
Some formulations contain aspartame - caution in phenylketonuria
Advise patient dizziness may affect ability to drive or operate machinery
Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Some formulations contain sucrose
Advise patient to take with or after food
Consider pseudomembranous colitis if patient presents with diarrhoea
Jarisch-Herxheimer reaction possible in treatment of Lyme disease
Prolonged use may result in superinfection with non-susceptible organisms
May affect results of some laboratory tests
Discontinue if drug-related rash or other hypersensitivity reactions occur
Not licensed for all indications in all age groups
The Jarisch-Herxheimer reaction is possible when cefuroxime axetil is used for the treatment of Lyme disease. This is due to the bactericidal activity of cefuroxime axetil on the causative organism of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be advised that this reaction often occurs and is a self-limited consequence of antibiotic treatment of Lyme disease.
Some brands contain aspartame. This is a source of phenylalanine and consequently should be used with caution in patients with phenylketonuria.
The oral suspension contains sucrose. This should be taken into account when treating patients with diabetes.
Pregnancy and Lactation
Use cefuroxime with caution in pregnancy.
Schaefer suggests cephalosporins can be used safely during pregnancy if required. Older cephalosporins are prefered. Briggs suggests use of cefuroxime during pregnancy is compatible. No teratogenic risks were found in a large human study in 2001. The manufacturer suggests cefuroxime should only be used during pregnancy if the benefit outweighs the risk.
At the time of writing, there are limited data from the use of cefuroxime during pregnancy. No harmful effects on pregnancy, embryonal or foetal development, parturition or postnatal development have been shown in animal studies.
Cefuroxime readily crosses the placenta in late pregnancy and labour, achieving therapeutic concentrations in foetal serum and amniotic fluid.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Use cefuroxime with caution in breastfeeding.
Schaefer suggests that second generation cephalosporins such as cefuroxime are the antibiotics of choice during breastfeeding. Occasionally, disruption of the infant's gastrointestinal flora, causing diarrhoea or thrush have been reported with cephalosporins, though these effects have not been adequately evaluated. The manufacturer suggests cefuroxime should only be used in breastfeeding after an assessment of the benefit to risk. Adverse effects are not expected but cannot be ruled out. Diarrhoea and fungus infection of mucous membranes cannot be excluded and breastfeeding may have to be discontinued because of the effects. The possibility of sensitisation should be taken into account.
Cefuroxime is excreted in human milk in small quantities. Even though the quantities are small, potential problems may include, direct effects on the infant, modification to bowel flora and interference with the interpretation of culture results if a fever work-up is required.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Advise patients that are being treated for Lyme disease that the reaction known as Jarisch-Herxheimer is a self limited consequence of the antibiotic treatment of the condition.
Advise patients cefuroxime may cause dizziness and therefore may affect ability to drive or operating machinery.
Increase in hepatic enzymes (transient)
Possible alteration of laboratory tests
Serum sickness-like reactions
Toxic epidermal necrolysis
Effects on Laboratory Tests
Cefuroxime may produce a false negative result in the ferricyanide test. To determine blood/plasma glucose levels, either the glucose oxidase or hexokinase methods should be used.
A false positive Coombs' test has been reported during treatment with cephalosporins and this can interfere with cross-matching of blood.
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: November 2015
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Cefuroxime 250 mg tablets. Sandoz Ltd. Revised March 2013.
Summary of Product Characteristics: Zinnat suspension. GlaxoSmithKline UK. Revised February 2015.
Summary of Product Characteristics: Zinnat tablets 125mg. GlaxoSmithKline UK. Revised February 2015.
Summary of Product Characteristics: Zinnat tablets 250mg. GlaxoSmithKline UK. Revised February 2015.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 September 2017
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