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FLOXAPEN VIALS FOR INJECTION 500MG

Active substance(s): FLUCLOXACILLIN SODIUM / FLUCLOXACILLIN SODIUM / FLUCLOXACILLIN SODIUM

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Patient leaflet: Information for the user
Floxapen 250mg, 500mg and 1g Vials for Injection
flucloxacillin

Read all of this leaflet carefully before you start taking this medicine, because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
- The full name of this product is Floxapen® 250mg, 500mg and 1g Vials for Injection, But
within the leaflet it will be referred to as Floxapen Vials.
What is in this leaflet:
1. What Floxapen Vials is and what it is used for
2. What you need to know before you take Floxapen Vials
3. How to take Floxapen Vials
4. Possible side effects
5. How to store Floxapen Vials
6. Contents of the pack and other information
1. What Floxapen Vials is and what it is used for
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.
Floxapen is used to treat a wide range of infections caused by bacteria which may include:
• those affecting the chest (pneumonia, emphysema and lung abscess)
• tonsils (tonsillitis, quinsy)
• pharynx (pharyngitis)
• sinuses (sinusitis)
• ears (otitis media and otitis external)
• skin and soft tissue (boils, abscesses, carbuncles, impetigo, cellulitis, furunculosis, ulcers,
eczema and acne)
• wounds, burns, 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
2. What you need to know before you take Floxapen Vials
Do not take this medicine if you:
• are allergic to flucloxacillin or any other penicillin antibiotics (see symptoms section 4).
• have had liver problems after taking this medicine (flucloxacillin)
• have ever had an allergic reaction to any of the other ingredients of this medicine – see
list of ingredients in section 6.
Warnings and precautions
• Talk to your doctor or pharmacist before taking this medicine if you:suffer from kidney
problems, as you may require a lower dose than normal
• suffer from liver problems
• are 50 years of age or older
• have other serious illnesses (apart from the infection this medicine is treating)
• have human immunodeficiency virus (HIV)
Other medicines and Floxapen Vials
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Especially:
• Probenecid (used to treat gout).
• The contraceptive pill as antibiotics can make these less effective (you will need to use
extra precautions such as condoms while taking flucloxacillin and for a full 7 days after
you finish taking it).
• Other antibiotics (used to treat infections)
Some medicines may affect the way others work. Always tell your doctor about all the
medicines you are taking. This means medicines you have bought yourself as well as
medicines on prescription from a doctor.
Pregnancy and breastfeeding
If you are pregnant, planning to become pregnant or are breast feeding ask your doctor or
pharmacist for advice before taking this medicine.
Tests
Regular monitoring of liver and kidney function should be performed whilst taking
flucloxacillin for a long period of time. Tell your doctor that you are taking Flucloxacillin if
you are having urine tests or blood tests because it may affect the results.
3. How to take Floxapen Vials
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 (intraarticular) 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 12 years:
The recommended total daily dosage of 1 g – 6 g administered in 3-6 divided doses, by i.v. or
i.m. injection.

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No intramuscular single bolus injection should exceed 2 g.
The maximum dose of 12 g per day should not be exceeded.
In cases of severe infections: Up to 8 g per day administered in three to four infusions (over
20 to 30 min).
Premature infants, neonates, sucklings and infants
Other pharmaceutical forms/strengths may be more appropriate for administration to this
population.
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
intra-articular – 250 mg to 500 mg once daily
Use in Children and adolescents - under 12 years of age
The recommended dose is 25 to 50 mg/kg/24 hours administered in three to four equally
divided doses by i.m. or i.v. injection.
In cases of severe infections: Up to 100 mg/kg/24 hours in three to four divided doses.
No single bolus injection or infusion should exceed 33 mg/kg.
Children and adolescents - aged 10 to 14 years the recommended dose is a daily dose of 1.5 g
to 2 g and children aged 6 to 10 years 0.75 g to 1.5 g, divided into three to four equal doses.
Severe kidney disease - your doctor may reduce your dose, maximum dose in adults is 1g
every 8 to 12 hours.
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.

4. Possible side effects
I
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Floxapen Vials and contact your doctor straight away if you experience
any of the following side effects:
• severe diarrhoea with bleeding
• notice your urine becoming darker or your faeces (otherwise known as poo) becoming
paler

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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).

Common side effects: may affect up to 1 in 10 people
• minor gastrointestinal disturbances e.g. stomach upset or diarrhoea.
Uncommon side effects – may affect up to 1 in 100 people
• 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.

Very rare side effects – may affect up to 1 in 10,000 people
• 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).
• 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.
• burning sensation at the site of injection
Not known: frequency cannot be estimated from the available data:
• a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis).
Contact a doctor immediately if you get any of these symptoms.

Some of these reactions can be delayed for several weeks after finishing treatment.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Floxapen Vials
Keep this medicine out of the sight and reach of children
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
Do not use this medicine after the expiry date which is stated on the carton/label after EXP.
The expiry date refers to the last day of the month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

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6. Contents of the pack and other information
What Floxapen Vials contains
Floxapen Injection contains the penicillin called flucloxacillin. Floxapen Injection is available
in three strengths. Each vial contains either 250mg, 500mg or 1g of flucloxacillin. Powder for
reconstitution for injection.
The vials for injection contain no other ingredients.
What Floxapen Vials look like and contents of the pack
The 250 mg, 500 mg and 1 g vials are supplied to your doctor in packs of 10.
Marketing authorisation holder:
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Manufacturer:
Beecham Pharmaceuticals
Worthing
West Sussex
BN14 8QH

This leaflet was last revised April 2017
Floxapen is a registered trademark of Accord Healthcare Limited

Accord Logo
For the Healthcare Professional
Floxapen 250mg, 500mg and 1g Vials for Injection
flucloxacillin
Dosage and Administration Information Only
Please refer to the Summary of Product Characteristics for further information
Preparation and administration
Routes of administration: intramuscular, intravenous, intrapleural, intra-articular 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.

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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.
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.

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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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