Flucloxacillin 500mg Powder for Solution for Injection or Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Flucloxacillin sodium monohydrate

Available from:

Pinewood Laboratories Ltd

ATC code:

J01CF; J01CF05

INN (International Name):

Flucloxacillin sodium monohydrate

Dosage:

500 milligram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

Beta-lactamase resistant penicillins; flucloxacillin

Authorization status:

Marketed

Authorization date:

2003-09-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCLOXACILLIN 250 MG, 500 MG AND 1 G POWDER FOR SOLUTION FOR
INJECTION OR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have further questions, please ask your doctor or nurse.
−
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in
this leaflet. See section 4.
The name of your medicine is Flucloxacillin 250 mg, 500 mg and 1 g
Powder for Solution for Injection or Infusion.
In the rest of this leaflet it is called Flucloxacillin Injection.
WHAT IS IN_ _THIS LEAFLET:
1. What Flucloxacillin Injection is and what it is used for
2. What you need to know before you use Flucloxacillin Injection
3. How to use Flucloxacillin Injection
4. Possible side effects
5. How to store Flucloxacillin Injection
6. Contents of the pack and other information
1. WHAT FLUCLOXACILLIN INJECTION IS AND WHAT IT IS USED FOR
Flucloxacillin belongs to a group of medicines called penicillins,
which are antibiotics. These medicines work
by killing bacteria that cause infections.
Flucloxacillin Injection is used for the treatment of a range of
bacterial infections including bone infections
(osteomyelitis) and infections within the lining of the heart
(endocarditis). It is also used to prevent infections
that can occur during major surgical operations such as heart and lung
operations (cardiothoracic surgery)
and bone, joint and muscle operations (orthopaedic surgery).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLUCLOXACILLIN INJECTION_ _
DO NOT USE FLUCLOXACILLIN INJECTION:
•
If you are allergic to flucloxacillin or any of the other ingredients
of this medicine (listed in section 6)
•
If you_ _are allergic to cephalosporins, penicillin, or any other
β-lactam antibiotic
•
If you_ _have had jaundice (yellow skin and whites of eyes) or other
liver problems when you have been
given flucloxacillin

Summary of Product characteristics

Health Products Regulatory Authority
13 June 2023
CRN00DL7G
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 500mg Powder for Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium flucloxacillin monohydrate equivalent to flucloxacillin 500mg
For the full list of excipients, see section6.1
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion (Powder for injection or
infusion)
Flucloxacillin sodium is supplied as a white or almost white
crystalline powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flucloxacillin is indicated for the treatment of infections due to
penicillinase producing staphylococci and other gram positive
organisms susceptible to this anti-infective (see Section 5.1).
Indications include: osteomyelitis and endocarditis.
Flucloxacillin is also indicated for use as a prophylactic agent
during major surgical procedures when appropriate; for example
cardiothoracic and orthopaedic surgery.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage depends on the severity and nature of the infection.
Method of administration
The usual routes of administration are by intramuscular injection,
slow intravenous injection and intravenous infusion.
Flucloxacillin may also be administered by intra-articular or
intrapleural injection or inhaled by nebuliser. The solutions must
be prepared as follows:
_ADULTS AND THE ELDERLY_
INTRAMUSCULAR: Add 1.5ml of water for injections to 250mg vial
contents or 2ml of water for injections to 500mg vial contents.
INTRAVENOUS: Dissolve 250 to 500mg in 5 to 10ml of water for
injections or 1g in 15 to 20ml of water for injections. Administer
by slow intravenous injection (over three to four minutes).
Flucloxacillin may also be added to infusion fluids or injected
(suitably diluted) into the drip tube over three to four minutes.
Flucloxacillin may be added to most intravenous fluids (eg
wa