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FLOXAPEN VIAL FOR INJECTION 250MG

Active substance(s): FLUCLOXACILLIN SODIUM

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For the Healthcare Professional

Floxapen Vials for Injection
flucloxacillin

Dosage and Administration Information Only
Please refer to the Summary of Product Characteristics for further information

Presentation
Floxapen Injection is available in vials containing the equivalent of 250 mg,
500 mg or 1 g of flucloxacillin presented as flucloxacillin sodium as a powder
for reconstitution.
Dosage
Floxapen dosage depends upon the age, weight and renal function of a
patient, as well as the severity of the infection.
Usual adult dosage (including elderly patients):
Intramuscular:
250 mg four times a day.
Intravenous:
250 mg-1 g four times a day
The above systemic dosages may be doubled where necessary.
Osteomyelitis, Endocarditis:
Surgical prophylaxis:

Up to 8 g daily, in divided doses six to eight
hourly
1 to 2 g IV at induction of anaesthesia
followed by 500 mg six hourly IV, IM or
orally for up to 72 hours

Floxapen may be administered by other routes in conjunction with systemic
therapy. (Proportionately lower doses should be given in children.)
Intrapleural:
250 mg once daily
By nebuliser:
125-250 mg four times a day
Intra-articular:
250 mg-500 mg once daily
Usual children's dosage:
Two to 10 years:
Under 2 years:

half adult dose
quarter adult dose

Abnormal renal function
In common with other penicillins, Floxapen usage in patients with renal
impairment does not usually require dosage reduction. However, in the
presence of severe renal failure (creatinine clearance <10 ml/min) a reduction
in dose or an extension of dose interval should be considered.

Floxapen 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.
Parenteral usage is indicated where oral dosage is inappropriate.

Preparation and administration
Routes of administration: intramuscular, intravenous, intrapleural, intraarticular and inhalation.
Intramuscular:

Add 1.5 ml Water for Injections BP to 250 mg vial
contents or 2 ml Water for Injections BP to 500 mg
vial contents.

Intravenous:

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

Intrapleural:

Dissolve 250 mg in 5-10 ml Water for Injections
BP.

Intra-articular:

Dissolve 250-500 mg in up to 5 ml Water for
Injections BP or 0.5% lidocaine hydrochloride
solution.

Nebuliser solution:

Dissolve 125-250 mg in 3 ml sterile water.

Displacement volumes:

250 mg - 0.2 ml
500 mg - 0.4 ml
1 g - 0.7 ml

Stability and compatibility
Reconstituted solutions for IM and direct IV injection should normally be
administered within 30 minutes of preparation. However, aqueous solutions of
Floxapen Injection retain their activity for up to 24 hours when stored in a
refrigerator (2-8°C).
Reconstitution of the injection and preparation of infusion solutions must be
carried out under appropriate aseptic conditions if these extended storage
periods are required. Refrigerated solutions should be restored to ambient
temperature before use.
N.B. Floxapen Vials are not suitable for multidose use.

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Any residual Floxapen solution should be discarded.
Stability in intravenous infusions
Floxapen when reconstituted in the following infusion fluids has satisfactory
stability for up to 24 hours when stored in a refrigerator (2-8°C).
Intravenous infusion
Water for Injections BP
Sodium Chloride Intravenous Infusion BP (0.9% w/v)
Glucose Intravenous Infusion BP (5% w/v)
Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion BP
Dextran 40 Intravenous Infusion (10%) in Sodium Chloride Intravenous
Infusion (0.9%)
Dextran 40 Intravenous Infusion (10%) in Glucose Intravenous Infusion (5%)
Sodium Lactate Intravenous Infusion BP (one-sixth molar)
Compound Sodium Lactate Intravenous Infusion BP
(Ringer-Lactate Solution; Hartmann’s Solution)
Floxapen should not be mixed with blood products or other proteinaceous
fluids (e.g. protein hydrolysates) or with intravenous lipid emulsions.
If Floxapen 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.
Storage

Floxapen vials should be stored in a cool, dry place.

Availability

Strength

Packs

Product Licence

250 mg
500 mg
1g

10
10
10

PL 30306/0019
PL 30306/0020
PL 30306/0021

Legal category

POM.

Product Licence
Holder

Actavis Group PTC ehf Reykjvìkurvegi 76 – 78
220 Hafnarfjordur Iceland

Further information

Our Customer Contact Centre is available for
further information. Telephone: 0800 221 441.

Leaflet Date: May 2007
Floxapen is a registered trademark of the Actavis Group PTC ehf of
Companies
© 2007 Actavis Group PTC of Companies.
Actavis Logo

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Actavis Logo
Patient Information Leaflet

Floxapen Vials for Injection
flucloxacillin
This leaflet tells you about Floxapen Injection. Please read it carefully. If there
is anything you do not understand, or if you want to know more about your
treatment, ask your doctor, nurse or pharmacist.
Please keep this leaflet. You may want to read it again.
What is Floxapen Injection?
Powder for reconstitution for injection.
Floxapen Injection contains the penicillin called flucloxacillin.
Floxapen Injection is available in three strengths. Each vial contains either
250 mg, 500 mg or 1 g of flucloxacillin. Powder for reconstitution for injection.
Your doctor will decide which strength you need.
The vials for injection contain no other ingredients.
The 250 mg, 500 mg and 1 g vials are supplied to your doctor in packs of 10.
Who makes Floxapen Injection?
Product Licence holder: Actavis Group PTC ehf Reykjvìkurvegi 76 – 78 220
Hafnarfjordur Iceland.
Manufacturer: Beecham Pharmaceuticals, Worthing, West Sussex BN14 8QH
What is Floxapen?
Floxapen is an antibiotic for treating infections. It belongs to a group of
antibiotics called “penicillins”. Floxapen works by killing the bacteria that
cause infection.
Why is your doctor giving you Floxapen?
Floxapen is used to treat a wide range of infections caused by bacteria which
may include those affecting the chest (pneumonia, empyema and lung
abscess), tonsils (tonsillitis, quinsy), pharynx (pharyngitis), sinuses (sinusitis),
ears (otitis media and otitis externa), skin and soft tissue (boils, abscesses,
carbuncles, impetigo, cellulitis, furunculosis, ulcers and acne), wounds, burns,

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heart (endocarditis), bones and joints (osteomyelitis), membranes of the brain
(meningitis), gut (enteritis), blood (septicaemia) and the kidney, bladder or the
urethra (the tube which carries urine from the bladder).
Floxapen Injection can also be used to prevent infections following skin grafts
or during major surgical procedures, particularly in heart or orthopaedic
surgery.
Be this medicine
Before having this medicine
Let your doctor know if any of the following apply to you:









you have ever had a skin rash or swelling of the face or neck when taking
an antibiotic
you know that you are allergic to penicillin or any other antibiotic
you have ever had a serious complaint – when taking an antibiotic
you are pregnant, think you might be pregnant, or are breast-feeding
you are being treated for kidney problems or gout
you are being treated for liver problems
you are on a low sodium diet
you are 50 years old or over

If any of the above apply to you, your doctor may decide that you need
another medicine instead of Floxapen or a different dose of Floxapen.
Having this medicine
Your medicine will usually be given to you by injection into the muscle
(intramuscular) or injection into a vein (intravenous). It can also be given to
you by injection into a joint (intra-articular) or injection into the lining of the
lung (intrapleural), or by breathing in the medicine from a mask (nebuliser).
Floxapen should not be administered into the eye.
Your doctor will decide how much you need each day and how often the
injections should be given.
The usual dose for treating infection is:
Adults and children over 10 years: intramuscular – 250 mg four times a day
intravenous – 250 mg to 1 g four times a
day
For infections of the bones and joints (osteomyelitis), or the heart
(endocarditis) – up to 8 g daily can be given, in divided doses six to eight
hourly.
Floxapen may be administered by other routes, together with systemic
therapy (proportionally lower doses should be given in children)
intrapleural – 250 mg once daily
by nebuliser – 125 mg to 250 mg four times a day
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intra-articular – 250 mg to 500 mg once daily
Children two to 10 years receive half the adult dose
Children under two years receive a quarter of the adult dose
These doses can be increased in more serious infections.
To prevent infections after an operation the usual dose is 1 to 2 g before the
operation when you are given your anaesthetic. This is then followed by 500
mg four times a day for up to three days after your operation.
If you think you have missed an injection, or had too many injections, speak to
your doctor or nurse.
Information on possible side effects
I
As with all medicines, some people may experience side effects with
Floxapen.
The more common side effects of Floxapen that could happen to more than 1
in 100 people taking it include:
 minor gastrointestinal disturbances e.g. stomach upset or diarrhoea.
Uncommon side effects that could happen to between 1 in 100 and 1 in
1,000 people taking Floxapen include:
 allergic skin reactions e.g. ‘hives’ or ‘nettle’ rash. If you start to itch or get
a rash tell your doctor or nurse at once, and treatment should be
discontinued.
Rare side effects could happen to between 1 in 1,000 and 1 in 10,000 people.
There are no rare side effects documented for Floxapen.
Very rare side effects that could happen to less than 1 in 10,000 people
taking Floxapen include:
 hypersensitivity or severe allergic reaction including swollen face or
breathing problems. An unexpected skin reaction, e.g. a rash and/or a sore
mouth or eyes. Tell your doctor or nurse straight away if you notice any of
these symptoms and STOP taking Floxapen
 reduction (reversible) in blood cell counts
 inflammation of the kidney, bowel and/or liver. Liver problems may be
severe and very rarely deaths have been reported (mainly in people with
pre-existing liver problems or over 50’s).

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 joint or muscle pain. This may develop after 2 days or more from the start
of treatment with Floxapen
 fever. This may develop after 2 days or more from the start of treatment
with Floxapen.
See your doctor straight away if you experience any of the following very rare
side effects:
 severe diarrhoea with bleeding
 notice your urine becoming darker or your faeces (otherwise known as
poo) becoming paler
 notice your skin or the white of your eyes turning yellow
 notice any unexplained bleeding, bruising or skin discolouration
 convulsions (at high dosage)
 tiredness, breathlessness, light-headedness, a rapid weak pulse,
palpitations or headaches, these may be signs of the destruction of red
blood cells (causing anaemia).
Some of these reactions can be delayed for several weeks after finishing
treatment.
If you get any unwanted effects while taking Floxapen tell your doctor or
nurse.
Storing Floxapen


Floxapen Vials for Injection should be stored in a cool, dry place



Once reconstituted Floxapen solutions should be stored in a refrigerator
(2-8°C) and used within 24 hours



There is an expiry date on the label, the doctor or nurse will check that this
date has not passed.

Leaflet date: February 2016
Floxapen is a registered trademark of the Actavis Group PTC ehf of
Companies
© 2007 Actavis Group PTC of Companies
Actavis Logo

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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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