FLUCLOXACILLIN SODIUM FOR INJECTION 500MG

Active substance: FLUCLOXACILLIN SODIUM

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SUMMARY OF PRODUCT CHARACTERISTICS

(creatinine clearance <10 ml/min) a reduction in dose or an extension of dose interval
should be considered. Flucloxacillin is not significantly removed by dialysis and hence no
supplementary dosages need to be administered either during, or at the end of the dialysis
period.

Flucloxacillin Sodium for Injection 250 mg, 500 mg, 1 g.
1.

Name of Medicinal Product
Flucloxacillin Sodium for Injection 250 mg
Flucloxacillin Sodium for Injection 500 mg
Flucloxacillin Sodium for Injection 1 g

2.

Qualitative and Quantitative Composition
Flucloxacillin sodium 250 mg per vial
Flucloxacillin sodium 500 mg per vial
Flucloxacillin sodium 1 g per vial

Intravenous Administration:
Dissolve 250-500 mg in 5-10 ml Water for Injections or 1-2g in 15-20 ml Water for Injections.
Administer by slow intravenous injection (three to four minutes). Flucloxacillin may also be
added to infusion fluids or injected, suitably diluted, into the drip tube over a period of three
to four minutes.

3.

Pharmaceutical Form
Powder for solution for injection

Intrapleural Administration:
Dissolve 250 mg in 5-10 ml Water for Injections.

4.

Clinical Particulars

Intraarticular Administration:
Dissolve 250-500 mg in up to 5ml Water for Injections or 0.5% lignocaine hydrochloride
solution.

Intramuscular Administration:
Add 1.5 ml Water for Injections to 250 mg vial contents or 2 ml Water for Injections to 500
mg vial contents.

4.1 Therapeutic Indications
Flucloxacillin is indicated for the treatment of infections due to Gram-positive organisms,
including infections caused by ß-lactamase-producing staphylococci and streptococci.
Typical indications include:
Skin and soft tissue infections: boils, abscesses, carbuncles, furunculosis, cellulitis; infected
skin conditions, e.g. ulcer, eczema and acne; infected wounds, infected burns, protection for
skin grafts and impetigo.
Respiratory tract infections: pneumonia, lung abscess, empyema, sinusitis, pharyngitis,
tonsillitis, quinsy, otitis media and externa.
Other infections caused by flucloxacillin-sensitive organisms: osteomyelitis, enteritis,
endocarditis, urinary tract infection, meningitis, septicaemia.
Flucloxacillin is also indicated for use as a prophylactic agent during major surgical procedures
where appropriate: for example, cardiothoracic and orthopaedic surgery.
Parental usage is indicated where oral dosage is inappropriate.

Nebuliser Solution Administration:
Dissolve 125-250 mg of the vial contents in 3 ml sterile water.
4.3 Contraindications
Flucloxacillin Sodium for Injection is contraindicated in patients with a penicillin or ß-lactam
(e.g. cephalosporins) hypersensitivity. It is also contraindicated in patients with a previous
history of flucloxacillin-associated jaundice/hepatic dysfunction. It is also contraindicated for
ocular administration.
4.4 Special Warnings and Precautions for Use
Before initiating therapy with flucloxacillin, careful enquiry should be made concerning previous
hypersensitivity reactions to ß-lactams. Serious and occasionally fatal hypersensitivity
reactions (anaphylaxis) have been reported in patients receiving ß-lactam antibiotics.
Although anaphylaxis is more frequent following parenteral therapy, it has occurred in
patients on oral therapy. These reactions are more likely to occur in people with a history of
ß-lactam hypersensitivity.
Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction,
patients ≥ 50 years of age and those with serious underlying disease. In these patients,
hepatic events may be severe, and in very rare circumstances, deaths have been reported
(see section 4.8).

4.2 Posology and Method of Administration
Adults:
Usual adult dosage (including elderly patients)
Intramuscular – 250 mg four times a day.
Intravenous – 250 mg to 1g four times a day
The above systemic dosages may be doubled where necessary;
Treatment of osteomyelitis, endocarditis – Up to 8g daily in divided doses six to eight hourly.
Surgical prophylaxis – 1 to 2g IV at induction of anaesthesia followed by 500mg six hourly
IV, or IM for up to 72 hours.
Flucloxacillin may be administered by other routes in conjunction with systemic therapy.
Intrapleural – 250 mg once daily
By nebuliser – 125 to 250 mg four times a day.
Intra-articular – 250 to 500 mg once daily.
Children:
Proportionately lower doses should be given in children.
Usual children’s dosage
2-10 years: half adult dose
Under 2 years: quarter adult dose.

Special caution is essential in the newborn because of the risk of hyperbilirubinaemia. 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. Also, special caution is essential in the newborn because of the potential risk
for high serum levels of flucloxacillin due to a reduced rate of renal excretion.
During prolonged treatments (eg osteomyelitis, endocarditis), regular monitoring of hepatic
and renal function is recommended.
Flucloxacillin injection contains approximately 51 mg sodium per g. This should be included
in the daily allowance of patients on sodium restricted diets.
Prolonged use of an anti-infective may occasionally result in overgrowth of non-susceptible
organisms.

Abnormal renal function:
In common with other penicillins, Flucloxacillin usage in patients with renal impairment does
not usually require dosage reduction. However, in the presence of severe renal failure

4.5 Interactions with other medicinal products and other forms of Interaction
Flucloxacillin may decrease the efficacy of oestrogen containing contraceptives. The
plasma concentration is enhanced if probenesid is given concurrently. There is decreased
excretion of methotrexate (increased risk of toxicity).

Please see section 6.2.
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Flucloxacillin Sodium for Injection 250 mg, 500 mg, 1 g.

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Flucloxacillin may also be used to prevent infections during major operations such as heart and
lung operations or bone and muscle operations.

The name of your medicine is Flucloxacillin Sodium for Injection 250 mg, 500 mg, 1 g, which will
be referred to as Flucloxacillin throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or nurse.

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In this leaflet:
1. What Flucloxacillin is and what it is used for
2. Before you use Flucloxacillin
3. How you are given Flucloxacillin
4. Possible side effects
5. How to store Flucloxacillin
6. Further information

2. Before you use Flucloxacillin
Do not use Flucloxacillin:
- if you are allergic (hypersensitive) to flucloxacillin
- if you have ever had an allergic (hypersensitive) reaction to penicillin or any other similar
antibiotics (called “beta-lactams”)
- if you have a history of liver problems related to the use of flucloxacillin
Take special care with Flucloxacillin
Tell your doctor before you start using Flucloxacillin if:
- you have liver problems
- you are on a sodium restricted diet
- you are 50 years or over
- you have a serious illness, other than this infection
• You might need regular checks of your liver and kidneys if you take flucloxacillin for a long period
of time.
• If you take flucloxacillin for a long time, it may become less effective against some bacteria and
you may develop other infections (known as super-infections)
• Newborn babies receiving flucloxacillin may be at a greater risk of jaundice (yellowing of the skin
and whites of the eyes).

1. What Flucloxacillin is and what it is used for

Taking other medicines:
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines,
including medicines obtained without a prescription.

Flucloxacillin is an antibiotic belonging to the group known as penicillins. Antibiotics are used to
kill the bacteria or “germs” which cause infections. Flucloxacillin can be given as an injection or
breathed-in using a nebulizer (a device used to give a medicine as a liquid mist).

Flucloxacillin should not be given with:
- blood products such as plasma
- nutritional fluids which are given through a drip

Flucloxacillin is given to treat:
- skin and soft tissue infections, e.g. boils and abscesses
- infected wounds and burns
- protection for skin grafts
- infections of the inner and outer ear (Otitis media and externa)
- infected skin conditions, e.g. ulcers, eczema and acne and infection of the skin, usually affecting
the face and scalp (Impetigo)
- chest infections such as pneumonia and lung abscess
- infection of the sinuses (Sinusitis)
- infection of the pharynx, which is found at the back of the mouth (Pharyngitis)
- infection of the tonsils which are found at the back of the mouth (Tonsillitis)

It is especially important to tell your doctor if you are taking:
- probenecid, a drug used for the treatment of gout
- methotrexate, a drug used in the treatment of cancer
- oral contraceptives that contain oestrogen (e.g. the combined pill)
Flucloxacillin may reduce the effectiveness of oral contraceptives that contain oestrogen.

Flucloxacillin may also be used to treat other infections:
- inside bones (Osteomyelitis)
- within the bowels (Enteritis)
- within the lining of the heart (Endocarditis)
- that cause pain when passing water (Urinary tract infections)
- within the lining of the brain (Meningitis)
- within the blood (Septicaemia)

Pregnancy and Breast-feeding:
Inform your doctor if you are pregnant, planning to become pregnant or if you are breast-feeding.
Your doctor will decide if you may be given Flucloxacillin.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
There should be no effect on the ability to drive and operate machinery.
Important information about some of the ingredients of Flucloxacillin:
Flucloxacillin contains sodium (51 mg per gram). This should be taken into consideration if you
are on a low sodium diet.
3. How to use Flucloxacillin.
Flucloxacillin is usually given in a hospital by a doctor or nurse as an injection. Your doctor will
decide how you are given Flucloxacillin and your dose. The dose you will receive depends upon
how you are given flucloxacillin and the condition being treated. Flucloxacillin should not be

4.6 Pregnancy and lactation
Pregnancy: Animal studies with flucloxacillin have shown no teratogenic effects. The product
has been in clinical use since 1970 and the limited number of reported cases of use in human
pregnancy have shown no evidence of untoward effect. The use of flucloxacillin in pregnancy
should be reserved for cases considered essential by the clinician.
Lactation: During lactation, trace quantities of penicillins can be detected in breast milk.
Consequently, the possibility of hypersensitivity reactions must be considered in breast-feeding
infants. Therefore, flucloxacillin should only be administered to a breast-feeding mother when
the potential benefits outweigh the potential risks associated with the treatment.
4.7 Effects on Ability to Drive and Use Machines
None
4.8 Undesirable Effects
Side-effects, as with other penicillins, are uncommon and mainly of a mild and transitory
nature.
Gastrointestinal:
Gastrointestinal upsets (eg nausea, diarrhoea) may occur. Pseudomembranous colitis
has been reported rarely and has usually been associated with the use of flucloxacillin in
combination with other antibiotics.
Hepatic:
Very rare: Hepatitis and cholestatic jaundice (see section 4.4 Special warnings and
precautions for use). Changes in liver function laboratory test results (reversible when
treatment is discontinued).
These reactions are related neither to the dose nor to the route of administration. 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. Hepatic events may
be severe and in very rare circumstances a fatal outcome has been reported. Most reports of
deaths have been in patients ≥ 50 years and in patients with serious underlying disease.
Hypersensitivity reactions:
Rashes have been reported. In common with other ß-lactam antibiotics angioedema and
anaphylaxis have been reported. Delayed onset reactions (e.g. fever, arthralgia, myalgia)
may sometimes occur, developing more than 48 hours after the start of treatment. Interstitial
nephritis has been reported rarely. If any hypersensitivity reaction occurs, the treatment
should be discontinued.
CNS
Neurological disorders, e.g. convulsions, may be associated with IV administration of high
doses to patients with underlying renal failure.
Haematological effects:
Neutropenia and thrombocytopenia may occur but are reversible when treatment is
discontinued.
4.9 Overdose
Problems of overdosage with flucloxacillin are unlikely to occur; nausea, vomiting and
diarrhoea may be seen; if encountered they may be treated symptomatically. Flucloxacillin is
not removed from the circulation by haemodialysis.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinaseproducing staphylococci. Flucloxacillin is a semisynthetic member of the penicillin family. The
penicillin nucleus consists of a thiazolidine ring fused with a β-lactam ring to which is attached
a side chain. The side chain determines most of the antibacterial properties of the penicillin in
question. Flucloxacillin kills bacteria by interfering in the synthesis of the bacterial cell wall.

Flucloxacillin is active against Gram-positive organisms with the exception of Streptococcus
faecalis. In general, it is not active against Gram-negative bacilli or anerobes. It is also
regarded as not being effective against methicillin resistant staphylococcus aureus.
5.2 Pharmacokinetic Properties
Flucloxacillin has been reported to have a plasma half-life of approximately 1 hour. The
half-life is prolonged in neonates. About 95% of flucloxacillin in the circulation is bound to
plasma proteins.
Flucloxacillin is metabolised to a limited extent and the unchanged drug and metabolites are
excreted in the urine by glomerular filtration and the renal tubular secretion. About 50% of a
dose by mouth and up to 90% of an intramuscular dose is excreted in the urine within 6 hours.
Only small amounts are excreted in the bile. Flucloxacillin is not removed by haemodialysis.
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to that
already included in other sections of the SPC.
6.

Pharmaceutical Particulars

6.1 List of Excipients
None
6.2 Incompatibilities
Flucloxacillin should not be mixed with blood products or other proteinaceous fluids (eg
protein hydrolysates) or with intravenous lipid emulsions.
It is advisable not to combine flucloxacillin with other drugs in solution for parenteral
administration.
If flucloxacillin is prescribed concurrently with an aminoglycoside, the two antibiotics should
not be mixed in the syringe, intravenous fluid container or giving set as precipitation may
occur.
6.3 Shelf Life
36 months
6.4 Special Precautions for Storage
Do not store above 25°C. Keep container in outer carton.
From a microbiological point of view, 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 re-constitution / dilution has
taken place in controlled and validated aseptic conditions.
6.5 Nature and Contents of Container
Type III uncoloured glass vials with rubber stoppers.
Packs of 5, 10, 50, 100
6.6 Special precautions for disposal
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%).
Reconstitution of flucloxacillin injections and preparation of flucloxacillin infusion solutions
must be carried out under appropriate aseptic conditions if the extended storage periods are
required.
Flucloxacillin vials are not suitable for multidose use. Any residual flucloxacillin should be
discarded.

Flucloxacillin resists the action of bacterial penicillinase probably because of the steric
hindrance induced by the acyl side chain which prevents the opening of the β-lactam ring.

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- joint pain
combined with other drugs in the same syringe.
It is important to tell the doctor about any of your medical conditions, so that your doctor can - aching muscles, muscle tenderness or weakness, not caused by exercise
- convulsions
ensure that the injection is administered properly.
- problems with your blood, which may cause you to bruise or bleed easily
- severe diarrhoea, which may also be bloody
The usual dose is:
Adults and elderly
Injections into the muscle (Intramuscular)
- 250 mg of Flucloxacillin four times a day

The following side effects have also been reported:
- nausea
- diarrhoea

Injections into a vein (Intravenous)
- 250 mg to 1g of Flucloxacillin four times a day

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

The dose may be doubled for certain serious infections, when necessary.

5. How to store Flucloxacillin
Your doctor or pharmacist will know how to store Flucloxacillin.

For treatment of infections inside the bones (osteomyelitis) or infections inside the heart
(endocarditis) the amount of flucloxacillin may be increased up to 8 g each day, and given in equal
doses every six to eight hours.
Prevention of infection during operations
- between 1 g to 2 g, given into a vein, just as you receive your anaesthetic. A further dose of 500
mg every six hours will be given for up to 72 hours.

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Flucloxacillin may be given in other ways when you are receiving other treatments at the same
time. These are:
- into the lining of the lung (intrapleural injections) – 250 mg once daily.
- breathing the drug in through a mask (by nebuliser) – 125 to 250 mg four times a day.
- into an artery (intra-articular injections) – 250 to 500 mg once daily.
Flucloxacillin should not be given into the eye
Children aged 2-10 years
- half the adult dose
Children under 2 years
- one quarter of the adult dose
If you use more Flucloxacillin than you should
Your doctor or nurse will know how much to give you. If you think you have been given too much
Flucloxacillin you should talk to your nurse or doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Flucloxacillin can cause side effects, although not everybody gets them.
If the following happen tell your doctor or nurse immediately:
- an allergic reaction e.g. if you have difficulty in breathing, swelling of the eyelids, face or lips, rash
or itching especially affecting your whole body (angioedema and anaphylaxis)
- yellowing of the skin or whites of the eyes (jaundice or hepatitis)
These are very serious side effects and may occur up to 48 hours after treatment. Treatment
should be stopped and you may need urgent medical attention.
Tell your doctor if you experience any of the following as treatment may be discontinued:
- fever

Flucloxacillin must be stored below 25°C and kept in the original carton.
Keep out of the reach and sight of children.
Do not use Flucloxacillin after the expiry date, which is stated on the label. The expiry date refers
to the last day of that month.
6. Further information
What Flucloxacillin contains:
The active substance is Flucloxacillin Sodium.
What Flucloxacillin Injection looks like and contents of the pack
- Flucloxacillin Injection comes in Type III uncoloured glass vials with rubber stoppers.
- It is available in pack sizes of 5, 10, 50 and 100 vials.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Villerton Invest S.A.
40, Avenue Monterey
L-2163 Luxembourg
Manufacturer:
Mitim S.r.l
and IBI Istituto Biochimico Italiano G.
Via Cacciamali 34-36-38
Lorenzini S.p.A.,
25125 Brescia
Via di Fossignano, 2
Italy
04011 Aprilia (LT) – Italy
and
BIOPHARMA S.r.l.
Via delle Gerbere 22/30
00134 Santa Palomba (Roma)
Distributor in the UK:
Flynn Pharma Ltd
Alton House
4 Herbert Street
Dublin 2
Ireland
This leaflet was last updated in October 2011
PL 24780/0013-0015

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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.

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