FLOXAPEN VIAL FOR INJECTION 250 MG - patient leaflet, side effects, dosage

Patient leaflet: Information for the user

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.

2. what you need to know before you take floxapen vials 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)
• are taking or will be taking paracetamol.

There is a risk of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, particularly in certain groups of patients at risk, e.g. patients with severe renal impairment, sepsis or malnutrition, especially if the maximum daily doses of paracetamol are used. High anion gap metabolic acidosis is a serious disease that must have urgent treatment.

The use of flucloxacillin, especially in high doses, may reduce the potassium levels in the blood (hypokalaemia). Your doctor may measure your potassium levels regularly during the therapy with higher doses of flucloxacillin.

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.

This medicine contains 48.8 mg sodium (main component of cooking/table salt) per 1g of injection. This is equivalent to 2.4% of the recommended maximum daily dietary intake of sodium for an adult.

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.

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
• 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
• Very rare cases of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, generally in the presence of risk factors (see section 2).

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.
• 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. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

6. contents of the pack and other informationfloxapen 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 February 2021

Floxapen is a registered trademark of Accord Healthcare Limited

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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.

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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