Skip to Content

FLUCLOXACILLIN 250MG/5ML ORAL SOLUTION BP

Active substance(s): FLUCLOXACILLIN SODIUM POWDER

View full screen / Print PDF » Download PDF ⇩
Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 250mg/5ml Oral Solution BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted each 5ml contains 250mg flucloxacillin as flucloxacillin
sodium.
Excipients with known effect:
Each 5ml dose contains 2.96g sucrose.
Each 5ml dose contains 24.09mg sodium.
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Powder for Oral Solution. Free flowing pink coloured powder.

4.1

Therapeutic indications
Treatment of infections due to sensitive Gram-positive organisms, including
infections caused by β-lactamase-producing Staphylococci and Streptococci.
Typical indications include:
Skin and soft tissue infections:
Boils
Infected burns
Impetigo
Furunculosis
Abscesses
Protection for skin grafts
Infected wounds
Cellulitis
Carbuncles
Infected skin conditions e.g. Ulcers, eczema and acne
Respiratory tract infections:
Pneumonia
Lung abscess
Empyema
Sinusitis
Otitis media and externa

Pharyngitis
Tonsillitis
Quinsy

Other infections caused by flucloxacillin-sensitive organisms:

Osteomyelitis
Enteritis
Endocarditis

Septicaemia
Meningitis
Urinary-tract infection

Flucloxacillin is also indicated for use as a prophylactic during major surgical
procedures such as cardiothoracic and orthopaedic surgery. Parenteral usage is
indicated where oral dosage is inappropriate.
Consideration should be given to official local guidance (e.g. national
recommendations) on the appropriate use of antibacterial agents.
Susceptibility of the causative organism to the treatment should be tested (if
possible), although therapy may be initiated before the results are available.
4.2

Posology and method of administration
The dosage depends on the age, weight and renal function of the patient, as
well as the severity of the infection.
Route of administration
Oral: To be administered ½ - 1 hour before meals.
Adults (including the elderly)
Oral: 250mg four times daily.
In serious infections, the dosage may be doubled.
Children’s dose:

Less than 2 years: 62.5 mg four times daily

2-10 years:
125mg four times daily

10-18 years:
250mg four times daily
In cases of severe renal impairment (creatinine clearance < 10ml/min) a
reduction in dosage may be necessary. Flucloxacillin 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.
Endocarditis or osteomyelitis
Up to 8g daily in divided doses six to eight hourly

4.3

Surgical prophylaxis
1 to 2g IV at induction of anaesthesia followed by 500mg six hourly IV, IM or
orally for up to 72 hours.
Contraindications
Flucloxacillin should not be given to patients with a history of hypersensitivity to
beta- lactam antibiotics (e.g. penicillins, cephalosporins) or excipients.

Flucloxacillin is contraindicated in patients with a previous history of flucloxacillinassociated jaundice/hepatic dysfunction.

4.4

Special warnings and precautions for use
The use of flucloxacillin (like other penicillins) in patients with renal
impairment does not usually require dosage reduction. In the presence of
severe renal failure (creatinine clearance less than 10ml/min), however, a
reduction in dose or an extension of dose interval should be considered
because of the risk of neurotoxicity.
Flucloxacillin is not significantly removed by dialysis and so no
supplementary dosages need to be administered either during or at the end of
the dialysis period.
Hepatitis and cholestatic jaundice have been reported. These reactions are
related neither to the dose nor to the route of administration. Flucloxacillin
should be used with caution in patients with evidence of hepatic dysfunction,
patients >50 years or patients with underlying disease. In these patients,
hepatic events may be severe and in extremely rare circumstances, deaths have
been reported (see section 4.8).
As for other penicillins contact with the skin should be avoided as sensitisation
may occur.
Patients with a known history of allergy are more likely to develop a
hypersensitivity reaction.
Prolonged use of an anti-infective agent may occasionally result in overgrowth
of non-susceptible organisms.
Before initiating therapy with flucloxacillin, careful enquiry should be made
concerning previous hypersensitivity reactions to beta-lactams. Serious and
occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported
in patients receiving β-lactam antibiotics. Although anaphylaxis is more
frequent following parenteral therapy, it has occurred in patients on oral
therapy. These reactions are more likely to occur in individuals with a history
of beta-lactam hypersensitivity.
If anaphylaxis occurs flucloxacillin should be discontinued and the appropriate
therapy instituted. Serious anaphylactic reactions may require immediate
emergency treatment with adrenaline (epinephrine). Ensure adequate airway
and ventilation and give 100% oxygen. IV crystalloids, hydrocortisone,
antihistamine and nebulised bronchodilators may also be required.
Special caution is essential in the newborn because of the risk of
hyperbilirubinaemia. Studies have shown that, at high dose following
parenteral administration, flucloxacillin can displace bilirubin from plasma
protein binding sites, and may therefore predispose to kernicterus in a
jaundiced baby. In addition, special caution is essential in the newborn because
of the potential for high serum levels of flucloxacillin due to a reduced rate of
renal excretion. During prolonged treatments (e.g. osteomyelitis, endocarditis),
regular monitoring of hepatic and renal functions is recommended.

This product contains 2.96g sucrose per 5ml dose. Patients with hereditary
problems of fructose intolerance, glucose-galactose malabsorption, or sucraseisomaltase insufficiency should not take this medicine.
This medicinal product contains 24.09mg sodium per 5ml dose. This should
be taken into consideration by patients on a controlled sodium diet.
4.5

Interaction with other medicinal products and other forms of interaction

Probenecid and sulfinpyrazone slow down the excretion of flucloxacillin.
Other drugs, such as piperacillin, which are excreted via renal tubular secretion, may
interfere with flucloxacillin elimination.

Oral typhoid vaccine may be inactivated by flucloxacillin.
Flucloxacillin reduces the excretion of methotrexate which can cause methotrexate
toxicity.
Flucloxacillin may reduce the response to sugammadex.
There are rare cases of altered international normalised ratio (INR) in patients taking
warfarin and prescribed a course of flucloxacillin. If co-administration is necessary,
the prothrombin time or international normalised ratio should be carefully monitored
during addition or withdrawal of flucloxacillin.
4.6

Fertility, pregnancy and lactation
Animal studies with Flucloxacillin have shown no teratogenic effects. Flucloxacillin
preparations have been in use since 1970 and the limited numbers of reported cases of
use in human pregnancy have shown no evidence of untoward effect. Flucloxacillin
should only be used in pregnancy when the potential benefits outweigh the risks
associated with treatment.
Flucloxacillin is secreted into mother's milk and may occasionally cause sensitisation
of the infant. Therefore flucloxacillin should only be administered to a breast-feeding
mother when the potential benefits outweigh the potential risks associated with the
treatment.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
The following convention has been utilised for the classification of undesirable
effects: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to
<1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be
estimated from the available data).

The most common adverse effects of flucloxacillin are hypersensitivity reactions
especially skin rashes.
Unless otherwise stated, the frequency of the adverse events has been derived from
more than 30 years of post-marketing reports.

Blood and lymphatic system disorders
Very rare: Neutropenia (including agranulocytosis) and thrombocytopenia.
Haemolytic anaemia. Coagulation disorders.

Immune system disorders
Very rare: Anaphylactic shock (see section 4.4), angioneurotic oedema.
If any hypersensitivity reaction occurs, the treatment should be discontinued. (See
also Skin and subcutaneous tissue disorders).

Nervous system disorders
Very rare: Convulsions

Gastrointestinal disorders
Common: Diarrhoea, nausea
Uncommon: Sore mouth or tongue, black hairy tongue
Very rare: Pseudomembranous colitis.

Hepatobiliary disorders
Very rare: Hepatitis and cholestatic jaundice. (See section 4.4). Changes in liver
function laboratory test results.
These reactions are related neither to the dose nor to the route of administration. The
onset of these effects may be delayed for up to two months post-treatment; in several
cases the course of the reactions has been protracted and lasted for some months.
Hepatic events may be severe and in very rare circumstances a fatal outcome has been
reported. Most reports of deaths have been in patients ≥50 years and in patients with
serious underlying disease.

Skin and subcutaneous tissue disorders
Uncommon: Rash, urticaria and purpura.
Very rare: Erythema multiforme, Stevens-Johnson syndrome, serum sickness-like
reaction and toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders
Very rare: Arthralgia and myalgia

Renal and urinary disorders
Very rare: Interstitial nephritis.

General disorders and administration site conditions
Very rare: Fever

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the national reporting system:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

4.9

Overdose
With high doses (mainly parenteral) neurotoxicity may develop.
Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident
and should be treated symptomatically.
Flucloxacillin is not removed from the circulation by haemodialysis.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

ATC Code: J01CF05
Group – Beta-lactamase resistant penicillins
Properties: Flucloxacillin is a narrow-spectrum antibiotic of the group of
isoxazolyl penicillins; it is not inactivated by staphylococcal β-lactamases.
Activity: Flucloxacillin, by its action on the synthesis of the bacterial wall,
exerts a bactericidal effect on streptococci, except those of group D
(Enterococcus faecalis), and staphylococci. It is not active against methicillinresistant staphylococci.
5.2

Pharmacokinetic properties
Absorption: Flucloxacillin is stable in acid media and can therefore be
administered either by the oral or parenteral route. The peak serum levels of
flucloxacillin reached after one hour are as follows.
-

After 250mg by the oral route (in fasting subjects): Approximately
8.8mg/l.
After 500mg by the oral route (in fasting subjects): Approximately
14.5mg/l.
After 500mg by the IM route: Approximately 16.5mg/l.

The total quantity absorbed by the oral route represents approximately 79% of
the quantity administered.
Distribution: Flucloxacillin diffuses well into most tissue. Specifically, active
concentrations of flucloxacillin have been recovered in bones: 11.6mg/l
(compact bone) and 15.6mg/l (spongy bone), with a mean serum level of
8.9mg/l.
Crossing the meningeal barrier: Flucloxacillin diffuses in only small
proportion in to the cerebrospinal fluid of subjects whose meninges are not
inflamed.
Crossing into mother’s milk: Flucloxacillin is excreted in small quantities in
mother’s milk.
Metabolism: In normal subjects approximately 10% of the flucloxacillin
administered is metabolised to penicilloic acid. The elimination half-life of
flucloxacillin is in the order of 53 minutes.
Excretion: Excretion occurs mainly through the kidney. Between 65,5% (oral
route) and 76.1% (parenteral route) of the dose administered is recovered in
unaltered active form in the urine within 8 hours. A small portion of the dose
administered is excreted in the bile. The excretion of flucloxacillin is slowed
in cases of renal failure.
Protein binding: The serum protein-binding rate is 95%.
5.3

Preclinical safety data

No relevant information additional to that already contained elsewhere in the
SPC.
6.1

List of Excipients
Sodium Benzoate
Disodium edetate
Saccharin Sodium
Ammonium glycyrrhizinate
Sodium citrate
Flavour pineapple
Flavour menthol
Erythrosine (E127)
Sucrose

6.2

Incompatibilities
As for penicillins, incompatibilities with Colistin Polymyxin B sulphate. Loss
of potency after mixing with streptomycin has also been reported.

6.3

Shelf life
Dry powder Bottle not placed in Aluminium pouch – 9 months
Bottle in Aluminium pouch – 24 months
Once removed from the pouch, reconstitute immediately.
Once reconstituted the mixture may be stored for a maximum of 7 days when stored
in the original container at 2 ºC-8 ºC in a refrigerator.

6.4

Special precautions for storage
Dry powder: Do not store above 25oC.
Store in the original container in order to protect from light and moisture.
For storage conditions of the reconstituted medicinal product, see section 6.3.

6.5

Nature and contents of container
150ml natural high density polyethylene (HDPE) bottle with tamper evident cap.
or
150ml natural high density polyethylene (HDPE) bottle with tamper evident/child
resistant (CRC) cap.
Contents of the bottle after reconstitution: 100ml
Optional – Bottle placed in Aluminium pouch.
Hugo Meding – polypropylene spoon - Article number – 7229

5ml MediSpoon

6.6

Special precautions for disposal and other handling

To the pharmacist:
100ml: Add 58ml of potable water and shake until all contents are dissolved
To the patient:
Keep cap tightly closed.
preparation

7

Shake well before use.

Use within 7 days

MARKETING AUTHORISATION HOLDER
ATHLONE PHARMACEUTICALS LIMITED
BALLYMURRAY
ROSCOMMON
COUNTY ROSCOMMON
IRELAND

8

MARKETING AUTHORISATION NUMBER(S)
PL 30464/0002

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/03/2009

10

DATE OF REVISION OF THE TEXT
05/04/2016

Expand view ⇕

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.

Hide