FLUCLOXACILLIN 1000 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION - patient leaflet, side effects, dosage

Patient leaflet - FLUCLOXACILLIN 1000 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

Flucloxacillin sodium

Read all of this leaflet carefully before you start using this medicine because itcontains important information for you.

– Keep this leaflet. You may need to read it again.
– Ifyou have any furtherquestions, askyourdoctororpharmacist.
– 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 Flucloxacillin 500 mg or 1000 mg, powder for solution for injection or infusion, but within the leaflet it will be referred to as Flucloxacillin.

What is in this leaflet

1. What Flucloxacillin is and what it is used for
2. What you need to know before you use Flucloxacillin
3. Howto use Flucloxacillin
4. Possible side effects
5. How to store Flucloxacillin
6. Contents of the pack and otherinformation

1. what flucloxacillin is and what it is used for

Flucloxacillin is an antibiotic used to treat infections by killing the bacteria that cause them. It belongs to a group of antibiotics called “penicillins”.

Flucloxacillin is available in two strengths. Each vial contains 500 mg or 1000 mg flucloxacillin powderfor reconstitution for injection.

Flucloxacillin is used for the treatment of a range of bacterial infections including bone infections (osteomyelitis) and infections within the lining of the heart (endocarditis). Flucloxacillin can also be used to prevent infections that can occur during major surgical operations, such as heart (cardiothoracic surgery) or bone, joint and muscle operations (orthopaedic surgery).

2. what you need to know before you use flucloxacillinyou should not be given flucloxacillin:- ifyou are allergic to flucloxacillin

Flucloxacillin sodium

The following information is intended for medical or healthcare professionals only:

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned below.
Flucloxacillin should not be mixed with blood products or other proteinaceous fluids (e.g. protein hydrolysates) or with intravenous lipid emulsions.
If flucloxacillin is prescribed concurrently with an aminoglycoside, the two antibiotics should not be mixed in the syringe, intravenous fluid containerorgiving set; precipitation may occur.

Preparation and administration of Flucloxacillin reconstituted solutions

Routes of administration: intramuscular, intravenous, intrapleural, intra-articularand inhalation.

Flucloxacillin may be added to most intravenous fluids (e.g. Water for Injections, sodium chloride 0.9%, glucose 5%, sodium chloride 0.18% with glucose 4%, Hartmann's solution, Dextran 40 (10%) Intravenous Infusion in NaCI (0.9%) intravenous infusion, Dextran 40 (10%) Intravenous Infusion in glucose (5%) intravenous infusion).

Intramuscular. Add 2 ml Waterfor Injections to 500 mg vial contents. Add 3.0 ml Waterfor Injections to 1 g vial contents.

Intravenous: Dissolve 250–500 mg in 5–10 ml Water for Injections. Dissolve 1g in 20 ml Waterforlnjections. Administerby 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.

Intrapleural: Dissolve 250 mg in 5–10 ml Waterfor Injections.

Intra-articular: Dissolve 250–500 mg in up to 5 ml Waterfor Injections or 1.0% lidocaine hydrochloride solution.

Nebuliser solution: Dissolve 125–250 mg of the vial contents in 3 ml sterile water.

Any unused product or waste should be disposed of in accordance with local requirements.

How to store

Reconstituted solutions for IM or direct IV injection should normally be administered within 30 minutes of preparation.

Posology and method of administration

The usual adult dosage (including the elderly) is as follows:

By slow intravenous injection or by infusion: 250 mg to 1 g every six hours. These doses may be doubled in severe infections.

Osteomyelitis: Up to 8 g daily divided in 3 to 4 divided doses Endocarditis: 8 g daily in four divided doses in patients weighing up to 85 kg, and 12 g daily in 6 divided doses may be used in those weighing more.

During surgical prophylaxis, 1 to 2 g intravenously at induction of anaesthesia followed by 500 mg six hourly intravenously or

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 fourtimes a day for up to three days afteryour operation.

Children under 14years:

25–50 mg per kg body weight in 24 hours. This will be given in three or fourdivided doses.

Children aged 10–14 years usually receive a daily dose of 1.5 g – 2 g in three to fourdivided doses. Children aged 6–10 years usually receive a daily dose of 0.75 g – 1.5 g in three to four divided doses. For severe infections: Up to 100 mg per kg body weight in 24 hours. This will be given in three orfour divided doses each day.

Flucloxacillin may be administered by other routes, together with systemic therapy:

– by injection into the lining of the lung (intrapleural): 250 mg once daily, – by injection into a joint (intra-articular): up to 250 – 500 mg once daily, – inhalation by nebulizer: 125 mg – 250 mg fourtimes a day.

Ifyou are given more Flucloxacillin than you should

As this medicine will normally be given to you by a nurse or a doctor, it is unlikely you will be given too much, but ifyou think you have been given too much flucloxacillin tell your doctor or nurse immediately. Signs may be nausea, vomiting and diarrhoea.

Ifyou thinkyou have missed a dose of Flucloxacillin

As this medicine will normally be given to you by a nurse or a doctor, it is unlikely you will miss a dose, but if you have any concerns discuss this with yourdoctorornurse.

If you have any further questions on the use of this medicine, ask your doctor or healthcare professional.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Prolonged treatment with flucloxacillin may result in increased growth of resistant organisms.

If you notice any of the following side effects soon after receiving this medicine, tell your doctor or nurse immediately. Ifyou get them you may have had a serious allergic reaction or other type of reaction to this medicine. You may need urgent medical attention, if you have:

Stomach pain ordiarrhoea (possibly with bleeding)
Your skin or the white of your eyes turn yellow
Your urine becomes darker or yourfaeces become paler
Any unexplained bleeding, bruising or skin discolouration
Skin rash and itching
Blistering of the skin, mouth, eyes and genitals
Any sudden wheeziness, difficulty in breathing or dizziness
Any swelling of the face, neck, or tongue
Serious skin reactions
A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis)
Severe bloody diarrhoea (pseudomembranous colitis)

Some of these reactions can be delayed for several weeks after finishing treatment.

Common side effects (may affect up to 1 in 10 people):

stomach upset or diarrhoea
Reduction in blood cell counts which makes infections more likely
Inflammation of the kidney which can cause swollen ankles or high blood pressure
Joint pain, muscle pain orfever. This may develop after 2 days or more from the start of treatment.
Convulsions (“fits”) in patients taking high doses.
High anion gap metabolic acidosis in patients taking flucloxacillin togetherwith paracetamol (see section 2).
Low potassium levels in the blood (hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythm.

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.

UK patients can report side effects directly to MHRAvia the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

Irish patients can report side effects directly to HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: ; E-mail:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store flucloxacillin

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the vial and outer carton after the abbreviation EXP. The expiry date refers to the last day of that month.

Reconstituted solutions for IM or direct IV injection should normally be administered within 30 minutes of preparation.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measureswill help protect the environment.

6. contents of the pack and other informationwhat flucloxacillin contains- the active substance is flucloxacillin. each vial contains either 500 mg or 1000 mg flucloxacillin as flucloxacillin sodium.

– There are no otheringredients.

What Flucloxacillin looks like and contents of the pack

Flucloxacillin 500 mg and 1000 mg powder for solution for injection or infusion is a fine white powder. Flucloxacillin is supplied in packs of 10 vials in a carton with a package leaflet.

Marketing Authorisation Holder for U K:

Intrapharm Laboratories Ltd

The Courtyard Barns

Choke Lane

Maidenhead

Berkshire SL66PT

Marketing Authorisation Holderfor Ireland:

RIEMSER Pharma GmbH

AnderWiek7

17493Greifswald-1nsel Riems

Germany

Manufacturer:

Antibiotice SA

1 Valea Lupului Street 707410 Iasi, Romania

This leaflet was last revised in February 2021.

P353PIE1/01A

intramuscularly for up to 48 hours.

By intramuscular injection: 250 mg fourtimes daily.

By intrapleural injection: 250 mg once daily.

By nebuliser: 125 to 250 mg fourtimes daily.

By intra-articularinjection: 250 to 500 mg once daily.

No single bolus injection or infusion should exceed 2 g.

The maximum dose of 12 g per day should not be exceeded.

Paediatric population:

Children under 14 years of age

25 to 50 mg/kg/24 hours administered in three to four equally divided doses by IM or IV injection.

Children aged 10 to 14 years usually receive 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.

In cases of severe infections: Up to 100 mg/kg/24 hours in three to four divided doses.

No single bolus injection orinfusion should exceed 33 mg/kg.

Renal impairment

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 (creatinine clearance <10 ml/min) a reduction in dose or an extension of dose interval should be considered. The maximum recommended dose is 1 g every 8 to 12 hours. Flucloxacillin is not significantly removed by dialysis and hence no supplementary dosages need be administered either during, or at the end of the dialysis period.

Hepatic impairment

Dose reduction in patients with reduced hepatic function is not necessary.