SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL    PRODUCT

Flucloxacillin Elixir BP 125mg/5ml

2.    Qualitative and Quantitative    Composition

Flucloxacillin sodium equivalent to Flucloxacillin 125mg

3.    Pharmaceutical Form

Powder for reconstitution.

Free flowing powder in 2 layers, the top layer being white, the bottom layer being pinkish.

Clinical Particulars

4.1    Therapeutic Indications

Treatment of infections due to penicillinase-producing staphylococci: as in skin and soft tissue infections, respiratory tract infections and other generalised infections.

4.2    Posology and Method of Administration

Route of administration Oral

Adults (including the elderly):

Oral - 250mg four times daily, to be administered 'A - 1 hour before meals. In serious infections, the dosages may be doubled.

Children: 2 -10 years: 125mg four times daily. Under 2 years: 62.5mg four times daily.

4.3 Contra-indications

Penicillin hypersensitivity.

4.4 Special Warnings and Precautions for Use

Abnormal renal function: 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.

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. 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. In very rare cases, a fatal outcome has been reported.

4.5    Interaction with other Medicaments and other forms of Interaction

Probenecid slows down the excretion of flucloxacillin.

4.6    Pregnancy and Lactation

Use in pregnancy is not contraindicated. Flucloxacillin is secreted into mother’s milk and may occasionally cause sensitisation of the infant.

4.7    Effects on Ability to Drive and Use Machines

None.

4.8    Undesirable Effects

Typical allergic reactions have been observed such as urticarial and erythematous rashes. Anaphylaxis has occasionally resulted from the oral use of penicillin compounds. Gastrointestinal symptoms may occur.

4.9    Overdose

With high doses (mainly parenteral), neurotoxicity may develop.

Pharmacological Properties

5.1    Pharmacodynamic Properties

Flucloxacillin is an isoxazolyl penicillin which is a potent inhibitor of the growth of most penicillinase-producing staphylococci. The drug is stable in an acidic medium. Flucloxacillin is markedly resistant to cleavage by penicillinase. It is less effective than benzylpenicillin or phenoxymethylpenicillin against non-penicillinase-producing staphylococci or other gram positive cocci.

5.2    Pharmacokinetic Properties

Flucloxacillin provides good absorption after oral administration (30 - 80% absorbed from GI tract). Absorption of the drug is more efficient when taken on an empty stomach. Peak plasma levels are attained at 1 hour after administration and ig dose provides peak plasma level of l5mcg/ml. The drug is rapidly excreted by the kidney, about 50% within 6 hours of administration. T ^ = 30 - 60 mins. About 95% of flucloxacillin in circulation is bound to plasma proteins.

5.3    Preclinical Safety Data

None.

Pharmaceutical Particulars

6.1    List of Excipients

Sodium benzoate, disodium edetate, saccharin sodium, mono-ammomum-glycyrrhiziante, sodium citrate (dried), flavour pineapple, flavour menthol, red F D & C no. 3 (E127) and sucrose (caster).

6.2    Incompatibilities

As for penicillins. Incompatible with colistin polymyxin B sulphate. Loss of potency after mixing with streptomycin has also been reported.

6.3    Shelf-life

36 months unopened; 7 days after reconstitution.

6.4    Special Precautions for Storage

Store in a cool, dry place at a temperature not exceeding +25°C.

6.5    Nature and Contents of Container

Pack size: 100ml, contained in either

150ml amber glass Beatson Clark container with polypropylene screw cap, or, 150ml high density polyethylene bottle with tamper evident cap.

6.6    Instruction for Use/Handling None.

7.    Marketing Authorisation Holder

Waymade PLC

Trading as Sovereign Medical

Sovereign House

Miles Gray Road

Basildon

Essex S14 3FR

United Kingdom

8.    Marketing Authorisation Number

PL 06464/1428

9.    Date of first authorisation/Renewal of Authorisation

31 January 2002

10    DATE OF REVISION OF THE TEXT

31/01/2002