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For the Healthcare Professional Floxapen® Vials for Injection flucloxacillin

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:    Up to 8 g daily, in divided doses six to eight

hourly

Surgical prophylaxis:    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:    half adult dose

Under 2 years:    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.

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.

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

Availability	Strength	Packs	Product Licence
	250 mg	10	PL 30306/0019
	500 mg	10	PL 30306/0020
	1 g	10	PL 30306/0021

Legal category POM.

Product Licence Actavis Group PTC ehf Reykjvikurvegi 76 - 78 Holder    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.

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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 Reykjvikurvegi 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,

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.

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 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

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).

•    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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