Flucloxacillin
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Capsules containing 250mg flucloxacillin (as flucloxacillin sodium)
Capsules containing 500mg flucloxacillin (as flucloxacillin sodium)
Oral solution containing 125mg/5ml of flucloxacillin (as flucloxacillin sodium)
Oral solution containing 250mg/5ml of flucloxacillin (as flucloxacillin sodium)
Sugar free oral solution containing125mg/5ml of flucloxacillin (as flucloxacillin sodium)
Sugar free oral solution containing 250mg/5ml of flucloxacillin (as flucloxacillin sodium)
Drugs List
Therapeutic Indications
Uses
Treatment of infections caused by Gram-positive organisms, including infections caused by beta-lactamase producing staphylococci and streptococci.
Types of infections include:
Skin and soft tissue infections including boils, abscesses, carbuncles, furunculosis, cellulitis, infected skin conditions (such as ulcer, eczema, acne), infected wounds, infected burns, protection for skin grafts, impetigo.
Respiratory tract infections including pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, quinsy.
Other infections including otitis media, otitis externa, osteomyelitis, enteritis, endocarditis, urinary tract infections, meningitis, septicaemia.
Prophylaxis of infection during major surgical procedures (e.g. cardiothoracic and orthopaedic surgery).
Treatment of staphylococcal lung infection in cystic fibrosis.
Parenteral usage is indicated where oral dosage is inappropriate.
Unlicensed Uses
Prophylaxis of staphylococcal lung infection in cystic fibrosis: primary and secondary prevention.
Dosage
Dosage will depend on the severity and nature of infection, and the age, weight and renal function of the patient.
Consideration should be given to official local guidance on the appropriate use of antibacterial agents.
Adults
250mg to 500mg, depending on severity of infection, four times a day.
Treatment of osteomyelitis or endocarditis
Up to 8g a day given in divided doses every 6 to 8 hours.
Prophylaxis of infection during major surgical procedures
1g to 2g administered intravenously at induction of anaesthesia. Followed by 500mg orally or parenterally every 6 hours for up to 72 hours post-surgery. Some sources suggest 500mg may be administered for up to 4 more doses in high risk procedures.
Elderly
Use with caution in patients over 50 years. In these patients, hepatic adverse effects may be severe and have rarely led to death.
Children
Children aged 10 to 18 years
(See Dosage; Adult)
Children aged 2 to 10 years
125mg four times a day.
Children under 2 years
62.5mg four times a day.
The following dosing schedule may also be suitable:
Children aged 2 to 10 years
125mg to 250mg four times a day.
Children aged 1 month to 2 years
62.5mg to 125mg four times a day.
Treatment of staphylococcal lung infection in cystic fibrosis:
25mg/kg four times daily, up to a maximum of 1g per dose.
Alternatively, 100mg/kg a day, given in 3 divided doses, up to a total daily dose of 4g.
Primary prevention of Staphylococcus aureus lung infection in cystic fibrosis (unlicensed)
Children under 3 years
125mg twice a day.
Secondary prevention of Staphylococcus aureus lung infection in cystic fibrosis (unlicensed)
50mg/kg twice a day. Maximum of 1g per dose.
Neonates
Special caution is essential due to the risk of hyperbilirubinaemia.
Flucloxacillin has been shown to displace bilirubin from plasma protein binding sites following parenteral administration. This may lead to kernicterus in a jaundiced baby.
Special caution is also essential due to a reduced rate of renal excretion, which may lead to high serum levels of flucloxacillin.
Neonate 21 to 28 days
25mg/kg four times daily.
Neonate 7 to 21 days
25 mg/kg three times daily.
Neonate under 7 days
25 mg/kg twice a day.
Patients with Renal Impairment
Excretion occurs mainly through the kidneys.
Mild to moderate renal impairment
Dosage reduction is not usually required
Severe renal impairment (creatinine clearance less than 10ml/minute)
A reduction in dose or increased dosage interval should be considered because of the risk of neurotoxicity.
Neurological disorders, such as convulsions, may occur following intravenous administration of high doses to patients with renal failure.
The Renal Drug Handbook suggests the following for a glomerular filtration rate below 10ml/minute: Dose as in normal renal function up to a total daily dose of 4g.
Haemodialysis
No supplementary dosages need be administered during or at the end of the dialysis period as flucloxacillin is not significantly removed by dialysis.
Patients with Hepatic Impairment
Use with caution in patients with hepatic impairment as a small proportion of flucloxacillin is excreted in the bile.
Hepatitis and cholestatic jaundice have been reported in patients taking flucloxacillin but neither have been shown to be related to the dose or route of administration. The onset of effects may be delayed for up to two months after treatment. The course of reactions may be protracted, sometimes severe and occasionally fatal. Most reports of deaths have been in patients aged 50 and over and in those with serious underlying disease.
Administration
For oral administration, to be taken 30-60 minutes before meals.
Contraindications
Hypersensitivity to beta-lactam antibiotics.
History of flucloxacillin-associated jaundice.
History of flucloxacillin-associated hepatic impairment.
Precautions and Warnings
Before initiating therapy, careful enquiry should be made concerning any previous hypersensitivity reactions have occurred after administration of beta-lactam antibiotics.
Beta-lactam antibiotics have been reported to cause serious and occasionally fatal hypersensitivity reactions (anaphylaxis). These reactions are more common following parenteral therapy, although they have occurred in patients on oral therapy. Hypersensitivity reactions are more likely to occur in patients with a history of hypersensitivity to beta-lactams.
Treatment should be discontinued if drug related rash or other hypersensitivity reactions occur.
Treatment should be discontinued and appropriate therapy initiated if pseudomembranous colitis occurs.
Severe renal impairment - see Dosage section; 'Renal Impairment'.
Hepatic impairment - see Dosage section; 'Hepatic impairment'.
Hepatic, renal and haematological function should be monitored during prolonged or high-dose therapy (e.g. when treating osteomyelitis or endocarditis).
Patients over 50 years - see Dosage section; 'Elderly'.
Neonates - see Dosage section; 'Neonate'.
Some formulations contain sodium. This should be taken into account when treating patients on restricted sodium diets.
Presentations with sorbitol are unsuitable for use in patients with hereditary fructose intolerance.
Some formulations contain sucrose and should not be used in patients with hereditary fructose intolerance and glucose - galactose malabsorption syndrome.
Prolonged use may result in overgrowth of non-susceptible organisms.
Avoid contact with the skin as sensitisation may occur.
Pregnancy - see 'Pregnancy' section.
Breastfeeding - see 'Lactation' section.
CSM Warnings
CSM has advised that very rarely cholestatic jaundice and hepatitis may occur up to several weeks after treatment with flucloxacillin has been stopped. Administration for more than 2 weeks and increasing age are risk factors.
CSM has reminded that:
- flucloxacillin should not be used in patients with a history of hepatic dysfunction associated with flucloxacillin;
- flucloxacillin should be used with caution in patients with hepatic impairment;
- careful enquiry should be made about hypersensitivity reactions to beta-lactam antibacterials.
Use in Porphyria
Flucloxacillin has been associated with acute attacks of porphyria and is considered possibly porphyrogenic.
Pregnancy and Lactation
Pregnancy
Flucloxacillin has been in clinical use since 1970 and in the limited number of reported cases of use in human pregnancy, there has been no evidence of untoward effects. Animal studies have shown no teratogenic effects. Schaefer concludes that penicillins, including flucloxacillin can be safely used during pregnancy and are the antibiotic of choice (Schaefer 2007).
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 14-17 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 ).
Licensed in pregnancy? - Yes.
Animal data - Studies have shown no teratogenic effects.
Other information - Flucloxacillin has been in clinical use since 1970 with no evidence of untoward effects.
Lactation
Flucloxacillin is excreted in trace amounts into breast milk, and is not known to be harmful, but be alert for hypersensitivity reactions in the breast-fed infant.
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
Drug excreted in breast milk? - Yes, in trace amounts
Drug substance licensed in infants? - Yes.
Effects on Ability to Drive and Operate Machinery
None known
Counselling
For oral administration, to be taken 30-60 minutes before meals.
Side Effects
Gastro-intestinal disturbances
Nausea
Diarrhoea
Pseudomembranous colitis
Antibiotic-associated colitis
Altered liver function tests
Hepatitis
Cholestatic jaundice
Rash
Angioedema
Anaphylaxis
Fever
Arthralgia
Myalgia
Interstitial nephritis
Hypersensitivity reactions
Urticaria
Purpura
Erythema multiforme
Stevens-Johnson syndrome
Toxic epidermal necrolysis
CNS toxicity
Convulsions
Neutropenia
Agranulocytosis
Thrombocytopenia
Serum sickness-like reactions
Haemolytic anaemia
Prolonged bleeding
Impaired platelet function
Joint pain
Paraesthesia
Sore mouth
Black tongue
Erythematous rash
Vomiting
Coagulation disorders
Effects on Laboratory Tests
Flucloxacillin may produce false-positive results with the Coombs' test, falsely high urinary glucose results with the copper sulfate test and falsely high urinary protein results.
Overdosage
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 ).
Shelf Life and Storage
Capsules
Do not store above 25 degrees C
Store in a cool dry place
Protect from light
Store in original container
Oral solution/Sugar-free oral solution
Store powder in a cool dry place below 25 degrees C
Store reconstituted solution in a refrigerator at 2 to 8 degrees C for 7 days.
Further Information
Last Full Review Date: July 2011
Reference Sources
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, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Summary of Product Characteristics: Floxapen Capsules 250mg. Actavis UK. Revised May 2010.
Summary of Product Characteristics: Floxapen Capsules 500mg. Actavis UK. Revised May 2010.
Summary of Product Characteristics: Flucloxacillin 250mg Capsules. Aurobindo Pharma Ltd. Revised April 2011.
Summary of Product Characteristics: Flucloxacillin 500mg Capsules. Aurobindo Pharma Ltd. Revised April 2011.
Summary of Product Characteristics: Flucloxacillin 125mg/5ml Oral Solution. Aurobindo Pharma Ltd. Revised April 2011.
Summary of Product Characteristics: Flucloxacillin 250mg/5ml Sugar-Free Powder for Oral Solution. Actavis UK. Revised June 2011.
The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.
The Norwegian Porphyria Centre (NAPOS) Drug Database for Acute Porphyria at https://www.drugs-porphyria.org/languages/UnitedKingdom/index.php?l=gbr Accessed July 18th, 2011
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 September 2017
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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