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Active substance: FLUCLOXACILLIN

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Flucloxacillin 250mg, 500mg and 1g Powder for
Solution for
Injection or Infusion


Read all of this leaflet carefully before you start using this
-  eep this leaflet. You may need to read
it again.
- f you have further questions, please ask your doctor or nurse.
-  his medicine has been prescribed for you personally and you
should not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- f any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or nurse.
The name of your medicine is Flucloxacillin 250mg, 500mg and 1g
Powder for Solution for Injection or Infusion. In the rest of this leaflet
it is called Flucloxacillin Injection.
In this leaflet:
1.  hat Flucloxacillin Injection is and what it is used for
2. Before you are given Flucloxacillin Injection
3. How Flucloxacillin Injection should be given
4. Possible side effects
5. How to store Flucloxacillin Injection
6. Further information

Flucloxacillin belongs to a group of medicines called penicillins,
which are antibiotics. These medicines work by killing bacteria that
cause infections.
Flucloxacillin Injection is used for the treatment of a range of
bacterial infections including bone infections (osteomyelitis) and
infections within the lining of the heart (endocarditis). It is also used
to prevent infections that can occur during major surgical operations such as heart and lung operations (cardiothoracic surgery)
and bone, joint and muscle operations (orthopaedic surgery).

You should not be given Flucloxacillin Injection if you:
•  re allergic to flucloxacillin, cephalosporins, penicillin, or any other
ß-lactam antibiotic.
•  ave had jaundice (yellow skin and whites of eyes) or other liver

Flucloxacillin 250mg Powder for Solution for Injection or Infusion
Flucloxacillin 500mg Powder for Solution for Injection or Infusion
Flucloxacillin 1g Powder for Solution for Injection or Infusion
Sodium flucloxacillin monohydrate equivalent to flucloxacillin 250mg
Sodium flucloxacillin monohydrate equivalent to flucloxacillin 500mg
Sodium flucloxacillin monohydrate equivalent to flucloxacillin 1g
For full list of excipients, see section 6.1
Powder for solution for injection or infusion (Powder for injection or infusion)
Flucloxacillin sodium is supplied as a white or almost white
crystalline powder
4.1 Therapeutic indications
Flucloxacillin is indicated for the treatment of infections due to pencillinase producing staphylococci and
other gram positive organisms susceptible to this anti-infective (see Section 5.1).
Indications include osteomyelitis and endocarditis. Flucloxacillin is also indicated for use as a prophylactic
agent during major surgical procedures, when appropriate; for example cardiothoracic and orthopaedic
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 Posology and method for administration
The dosage depends on the severity and nature of the infection.
‘The usual routes of administration for Flucloxacillin 250mg, 500mg and 1g Powder for Solution for
Injection or Infusion are by slow intravenous injection and intravenous infusion.
Flucloxacillin 250mg and 500mg Powder for Solution for Injection or Infusion may also be administered
by intramuscular, intra-articular or intrapleural injection. Flucloxacillin 250mg may also be inhaled by
nebuliser.’ The solutions must be prepared as follows:
Intramuscular: Add 1.5ml of water for injections to 250mg vial contents or 2ml of water for injections
to 500mg vial contents.
Intravenous: Dissolve 250 to 500mg in 5 to 10ml of water for injections or 1g in 15 to 20ml of water
for injections. Administer by slow intravenous injection (over three to four minutes). Flucloxacillin may
also be added to infusion fluids or injected (suitably diluted) into the drip tube over three to four minutes.
Flucloxacillin may be added to most intravenous fluids (eg water for injections, sodium chloride 0.9%,
glucose 5%, sodium chloride 0.18% with glucose 4%).

problems when you have been given flucloxacillin previously
Speak to your doctor before being given Flucloxacillin Injection if you:
•  ave had any allergies especially to any other drugs (particularly
•  suffering from liver or kidney problems
• have heart failure
• have syphilis (a sexually transmitted disease)
•  uffer from porphyria (an inherited blood disorder)
Special care should be taken in newborn babies to avoid
overdose or high levels of a chemical in the blood which can
lead to brain damage.
If any of the above statements apply to you, speak to your doctor or
nurse before you are given Flucloxacillin Injection.
Taking other medicines
Taking another medicine while you are being given Flucloxacillin
Injection can affect how it or the other medicine works. Please
inform your doctor or nurse if you are taking or have recently taken
any other medicines, even those you may have bought yourself
without a prescription.
Please particularly check with your doctor if you are taking or need
to take any of the following:
•  ral contraceptives that contain oestrogen e.g. the combined pill.
If you are using this type of medicine you should take additional
precautions to prevent pregnancy while you are receiving Flucloxacillin Injection and for at least seven days afterwards. If these
seven days run beyond the end of a packet of contraceptive pills
you should start the next packet immediately without a break.
•  robenecid, a drug used for the treatment of gout.
•  ethotrexate, a drug used in the treatment of cancer.
•  ertain other “bacteriostatic” antibiotics (antibiotics that stop
bacteria growing but do not kill them), such as chloramphenicol
and tetracycline

Driving and using machines
Flucloxacillin Injection is not known to affect your ability to drive or
use machines.
Important information about the sodium content of Flucloxacillin Injection 250mg
Flucloxacillin Injection 250mg contains less than 1mmol sodium
per vial i.e. essentially sodium free.
Important information about the sodium content of Flucloxacillin Injection 500mg and 1g
Flucloxacillin Injection 500mg and 1g contain 1.13mmol and
2.26mmol of sodium per vial respectively, which is to be taken into 
consideration by patients on a controlled sodium diet.

Your doctor or nurse will prepare your injection by mixing the
Flucloxacillin Injection powder with a liquid such as water for
injections, either in the vial or in another container. The mixture is
usually injected into a muscle, or into a vein when it will be given
slowly over three to four minutes using a syringe or drip (infusion).
In certain circumstances Flucloxacillin Injection can be injected
directly into an infected joint or the chest wall, or breathed in as a
Flucloxacillin should not be given into the eye or the spine.
The usual adult dose by intramuscular injection or infusion is
250mg every six hours. The usual adult dose by intravenous injection is 250mg to 1g every six hours. These doses may be doubled
in severe infections. Doses of up to 8g a day may be required for
osteomyelitis or endocarditis. To prevent surgical infections you will
be given 1 to 2g with your anaesthetic followed by 500mg every
six hours.

Flucloxacillin Injection may interfere with various laboratory tests.
If you have any doubts about whether you should be given this
medicine then talk to your doctor.
Pregnancy and breast-feeding
You should let your doctor know immediately if you are pregnant or
trying for a baby before this medicine is administered.
You should not breast-feed whilst being given Flucloxacillin Injection. You should let your doctor know if you are breast-feeding or
want to start breast-feeding while you are having treatment with
Flucloxacillin Injection.

Intrapleural: Dissolve 250mg in 5 to 10ml of water for injections.
Intra-articular: Dissolve 250 to 500mg in up to 5ml of water for injections or 0.5% lignocaine hydrochloride solution for injection.
Nebuliser Solution: Dissolve 125mg to 250mg of the vial contents in 3ml of water for injections.
The usual adult dosage (including the elderly) is as follows:
By intramuscular injection

250mg every six hours

The usual dose for children aged two to ten years is half the adult
dose. The usual dose for children under two years old is a quarter
of the adult dose.
Special care should be taken in newborn babies to prevent
the risk of overdosing.
Injections into joints or the chest, or
inhalation of Flucloxacillin Injection
The usual doses are:
• into infected joint - 250 to 500 mg once a day

reactions to ß-lactams. Cross sensitivity between penicillins and cephalosporins is well documented. Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving
ß-lactam antibiotics. These reactions are more likely to occur in individuals with a history of ß-lactam
hypersensitivity. Desensitisation may be necessary if treatment is essential.
Care is necessary if very high doses of flucloxacillin are given, especially if renal function is poor, because
of the risk of nephrotoxicity. The intrathecal route should be avoided. Care is also necessary if large doses
of sodium salts are given to patients with impaired renal function or heart failure. Flucloxacillin should be
used with caution in patients with evidence of hepatic dysfunction (see section 4.8). Renal, hepatic and
haematological status should be monitored during prolonged and high-dose therapy (e.g. osteomyelitis,
endocarditis). Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

By slow intravenous injection or by infusion
250mg to 1g every six hours

These doses may be doubled in severe infections. Doses of up to 8g daily have been suggested for
endocarditis or osteomyelitis.

Care is required when treating some patients with syphilis because of the Jarisch- Herxheimer reaction.

During surgical prophylaxis, doses of 1 to 2g should be given intravenously at induction of anaesthesia
followed by 500mg six hourly intravenously or intramuscularly.

Special caution is essential in the newborn because of the risk of hyperbilirubinemia. Studies have shown
that, at high dose following parenteral administration, flucloxacillin can displace bilirubin from plasma
protein binding sites, and may therefore predispose to kernicterus in a jaundiced baby. In addition, special
caution is essential in the newborn because of the potential for high serum levels of flucloxacillin due to a
reduced rate of renal excretion. Sodium content: Flucloxacillin for Injection 250mg, 500mg and 1g contains
approximately 0.57mmol, 1.13mmol and 2.26mmol of sodium respectively per vial. This should be
included in the daily allowance of patients on sodium restricted diets.

By intrapleural injection
By intra-articular injection
By nebuliser

250mg once daily
250mg to 500mg once daily
125mg to 250mg every six hours

Any route of administration may be used. For children under two years old, a quarter of the adult dose
should be administered. For children two to ten years old, half of the adult dose should be administered.
Impaired renal function:
Dosage reduction is not usually required. In severe renal failure, however, (creatinine clearance less than
10ml/min) a reduction in dose or extension of dose interval should be considered.
No supplementary dosages need be administered during or at the end of the dialysis period, as flucloxacillin is not significantly removed by dialysis.
4.3 Contraindications
Flucloxacillin should not be given to patients with a history of hypersensitivity to ß-lactam antibiotics (e.g.
penicillins, cephalosporins).
Flucloxacillin is contraindicated in patients with a previous history of flucloxacillin-associated jaundice/
hepatic dysfunction.
Ocular or subconjunctival administration is contraindicated.
4.4 Special warning and precautions for use
Flucloxacillin should be given with caution to patients with a history of allergy, especially to drugs. Before
initiating therapy with flucloxacillin, careful enquiry should be made concerning previous hypersensitivity

Contact with flucloxacillin should be avoided since skin sensitisation may occur.
Caution is advised in patients with porphyria.

4.5 Interaction with other medicinal products and other forms of interaction
Other antibacterials: Since bacteriostatic drugs such as chloramphenicol and tetracycline may interfere
with the bactericidal effect of penicillins in the treatment of meningitis or in other situations in which a rapid
bactericidal effect is necessary, it is best to avoid concurrent therapy.
Immunosuppressants: There is reduced excretion of methotrexate (increased risk of toxicity).
Oral contraceptives: Flucloxacillin may decrease the efficacy of oestrogen-containing oral contraceptives.
Uricosuric agents: Plasma concentrations of flucloxacillin are enhanced if probenecid is given
Interference with diagnostic tests: Penicillins may produce false-positive results with the direct
antiglobulin (Coombs’) test, falsely high urinary glucose results with the copper sulphate test and falsely
high urinary protein results, but glucose enzymatic tests (e.g. Clinistix) and bromophenol blue tests (e.g.
Multistix or Albustix) are not affected.
4.6 Pregnancy and lactation
There has been no evidence of a teratogenic effect in animals or untoward effect in humans. However,
use in pregnancy should be reserved for essential cases.



• into chest - 250 mg once daily
• by inhaler - 125 to 250mg every six hours.
Severe kidney disease
If you have severe kidney failure you may be given a lower dose or
you may receive your doses less frequently.
Your doctor will decide the dose that is best for you. If you do not
understand, or are in any doubt, ask your doctor or nurse.
If you are given more Flucloxacillin Injection than you should
A doctor or a nurse will give you this medicine. If you think you may
have received too much Flucloxacillin Injection, please tell your
doctor or nurse immediately.
If you think you have missed a dose of Flucloxacillin Injection
A doctor or a nurse will give you this medicine. If you think you
have missed a dose, please tell your doctor or nurse.

Like many medicines, Flucloxacillin Injection may cause side effects
in some patients, although not everybody gets them.
Tell you doctor immediately if you notice any of the following
side effects as they may be a sign of an allergic or sensitivity
• rash
• itching
• redness and blistering of the skin
• fever
• aching joints
• swelling of the face, throat or hands
• difficulty breathing
• anaemia
• kidney problems.
Also tell your doctor immediately if you develop any of the
• enderness of the upper abdomen which may indicate inflamat
tion of the liver or jaundice (yellow skin and whites of eyes)
•  evere diarrhoea.Treatment with Flucloxacillin can affect the normal
bacteria in the gut, causing a new infection (pseudomembranous
Hepatitis (inflammation of the liver) and jaundice may be long lasting. They are more likely in the elderly or patients who have been
given flucloxacillin for more than two weeks.
You should tell your doctor if you develop any of the symptoms above, even if they occur some weeks after you have
stopped having the injections.

Trace quantities of penicillin can be detected in breast milk with the
potential for hypersensitivity reactions (e.g. drug rashes) in the breast-fed neonate or acute alterations in
the neonatal bowel flora with resultant diarrhoea.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
The most common adverse effects are sensitivity reactions including urticaria, maculo-papular rashes,
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), pruritus,
fever, joint pains and angioedema. Anaphylaxis occasionally occurs and has sometimes been fatal. Late
sensitivity reactions may include serum sickness-like reactions, haemolytic anaemia, nephropathy and
acute interstitial nephritis, which is reversible when treatment is discontinued.
Other adverse effects are generally associated with large intravenous doses of flucloxacillin or impaired
renal function. These include transient leucopenia and thrombocytopenia, haemolytic anaemia, agranulocytosis and neutropenia (which might have some immunological basis); prolongation of bleeding time and
defective platelet function; convulsions and other signs of central nervous system toxicity (encephalopathy
has been reported following intrathecal administration and can be fatal); electrolyte disturbances due to
administration of large amounts of sodium (see Section 4.4).
Hepatic effects: Changes in liver function test results may occur, but are reversible when treatment is
discontinued. Hepatitis and cholestatic jaundice have been reported. These reactions are related neither
to the dose nor to the route of administration; administration for more than two weeks and increasing age
are risk factors. The onset of these effects may be delayed for up to two months post-treatment; in several
cases the course of the reactions has been protracted and lasted for some months. In very rare cases, a
fatal outcome has been reported, almost always in patients with serious underlying disease.

Other side effects include:
• feeling sick
• being sick
• thrush in the mouth
•  lood problems (causing a sore throat, mouth ulcers, repeated
infections or a tendency to bleed easily)
•  ts (convulsions) and other problems affecting the nervous
• high salt levels in the blood.
• redness and pain around the area of infusion

What Flucloxacillin Injection looks like and contents of the
Flucloxacillin Injection is a white or almost white powder for solution
for injection/infusion.

If you have syphilis
Patients who have syphilis have occasionally suffered from a type
of reaction (Jarisch-Herxheimer reaction) shortly after their injection,
with fever, chills, headache and sometimes heart or eye problems.

Please be ready to give the following information:

If you receive high doses or a long course of treatment
Your doctor may take blood tests during your treatment to check
your liver, kidneys and blood, particularly if you receive high doses
or a long course of treatment.
If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or nurse immediately.

Flucloxacillin Injection must be kept out of the reach and sight
of children.
•  lucloxacillin Injection should not be used after the expiry date
given on the vial. The expiry date refers to the last day of that
•  our doctor, nurse or pharmacist will be responsible for storing
and preparing Flucloxacillin Injection before use and for checking
that the vials have not passed their expiry date.
•  he medicine should not be used if it shows any signs of deterioration such as going cloudy.
•  o not store above 25°C.
•  nce the solution has been diluted the product should be used
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

Product Name
Flucloxacillin 250mg
Powder for Solution for
Injection or Infusion

Reference Number

Flucloxacillin 500mg
Powder for Solution for
Injection or Infusion


Flucloxacillin 1g Powder
for Solution for Injection or


This is a service provided by the Royal National Institute of Blind
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham,
LL13 9UF, UK.
This leaflet was revised in July 2012.

What Flucloxacillin Injection contains
Each vial contains 250mg, 500mg or 1g of the active ingredient
flucloxacillin sodium monohydrate. There are no other ingredients.

but sufficient to be useful when these organisms are present with penicillin-resistant staphylococci. It is
virtually ineffective against Enterococcus faecalis.
5.2 Pharmacokinetic properties
After the intramuscular administration of a single 250 or 500mg dose of flucloxacillin to volunteers, mean
peak concentrations of the drug in serum were approximately 10.5 and 16mg.l-1 respectively. Mean
urinary excretion of flucloxacillin following its intramuscular use is 61% of the administered dose.

Flucloxacillin may also be administered by intravenous bolus injection or by slow intravenous infusion.
High serum levels of the drug are achieved by these modes of administration: 30 minutes and 2 hours
after a single 500mg intravenous bolus injection of flucloxacillin the mean serum concentration of the drug
was 38 and 7.5mg.l-1, respectively; 30 minutes and 3 hours after a single 1g intravenous bolus injection
of flucloxacillin, the mean serum concentrations were 60 and 4mg.l-1 respectively. The administration of
2g flucloxacillin by intravenous infusion over 20 minutes resulted in mean serum concentrations of 244
and 27.7mg.l-1 15 minutes and 120 minutes respectively after the end of the infusion.

The percentage of a dose of intravenous flucloxacillin recovered in urine in an 8 hour collection period
varies from 60 to 76%.
About 95% of flucloxacillin in the circulation is bound to plasma proteins. Flucloxacillin has been reported
to have a plasma half-life of approximately one hour. The half-life is prolonged in neonates.
The serum half-life of flucloxacillin in patients with severe kidney disease has been reported as 135 to
173 minutes. No significant difference in the half-life was found between patients on or off haemodialysis.
Flucloxacillin is not removed by haemodialysis.

Some patients with syphilis may experience a Jarisch-Herxheimer reaction shortly after treatment is
started. Symptoms include fever, chills, headache and reaction at the site of lesions. The reaction can
be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such
as with optic atrophy.
Gastrointestinal effects (diarrhoea, nausea and vomiting) reported with flucloxacillin commonly occur after
oral or parenteral administration. Pseudomembranous colitis has been reported with most antibiotics.
Prolonged use of penicillins may lead to the development of oral candidiasis.

5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to those included in
other sections.

Phlebitis has followed intravenous infusion.

6.1 List of excipients

5.1 Pharmacodynamic properties
Flucloxacillin is bactericidal with a similar mode of action to benzylpenicillin. It is resistant to staphylococcal
penicillinase and therefore active against penicillinase-producing and non-penicillinase-producing staphylococci. It has minimum inhibitory concentrations in the range of 0.25 to 0.5µg per ml. Its activity against
streptococci such as Streptococcus pneumoniae and Str. pyogenes is less than that of benzylpenicillin

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Flucloxacillin is metabolised to a limited extent and the unchanged drug and metabolites are excreted
in the urine by glomerular filtration and renal tubular secretion. Up to 90% of an intramuscular dose is
excreted in the urine within six hours. Only small amounts are excreted in the bile.

Flucloxacillin is unlikely to be excreted in breast milk to any significant extent. Similarly, placental transfer
is unlikely to occur to any appreciable extent.

4.9 Overdose
Problems with overdosage are unlikely to occur. If they do occur, treatment is symptomatic.

Flucloxacillin Injection is available in packs of 10 vials.

6.2 Incompatibilities
Flucloxacillin may be administered in combination with other antibiotics including ampicillin to produce a
wider spectrum of antibacterial activity. If used concurrently with an aminoglycoside the two antibiotics
should not be mixed in the syringe, container or giving set as precipitation may occur.
Flucloxacillin should not be mixed with blood products or other proteinaceous fluids (e.g. protein hydrolysates) or with intravenous lipid emulsions.

The following drugs are incompatible with flucloxacillin: amiodarone, atropine sulphate, buprenorphine,
calcium gluconate, chlorpromazine hydrochloride, ciprofloxacin, diazepam, dobutamine, hydrochloride,
erythromycin lactobionate, gentamicin sulphate, metoclopramide hydrochloride, morphine sulphate,
netilmicin sulphate, ofloxacin, papaveretum, pethidine hydrochloride, prochlorperazine edisylate,
promethazine hydrochloride, tobramycin and verapamil hydrochloride.
6.3 Shelf life
3 years
The unreconstituted dry powder is stable for 3 years. For the reconstituted solution, chemical and physical
in-use stability has been demonstrated for 24 hours at 2-8°C. From a microbiological point of view, once
opened, the product should be used immediately. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at
2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
Flucloxacillin for Injection is supplied in Type II clear glass vials containing 250mg, 500mg or 1g of flucloxacillin equivalent. The vials are closed with a Type I chlorobutyl rubber stopper, sealed with an aluminium
ring. The vials are packed in cartons of 10 vials.
6.6 Special precautions for disposal. None.
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Flucloxacillin for Injection 250mg
- PL 29831/0091 and PA 1339/8/1
Flucloxacillin for Injection 500mg
- PL 29831/0092 and PA 1339/8/2
Flucloxacillin for Injection 1g
- PL 29831/0093 and PA 1339/8/3

Date of first authorisation: 3 March 2008 (UK)

13 June 2008 (Ireland)
July 2012


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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.