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Flucloxacillin 500mg Capsules

Document: spc-doc_PL 06464-1427 change

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Flucloxacillin 500mg capsules.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Flucloxacillin Sodium Monohydrate BP 544 mg (equivalent to Flucloxacillin 500 mg)

3. PHARMACEUTICAL FORM

Capsules

4    CLINICAL PARTICULARS

4.1 Therapeutic indications

Therapeutic Indications

Treatment of infections due to gram-positive organisms, including P-lactamase-producing staphylococci. Such indications include:

Respiratory tract infections such as pneumonia, pharyngitis, tonsillitis, lung abcess, emphysema, sinusitis, quinsy.

Skin and soft tissue infections such as boils, abcesses, carbuncles, skin ulcers, eczema and acne, furunculosis cellulitis, infected wounds and burns, skin-graft protection, impetigo, otitis media and externa.

Infections due to flucloxacillin-sensitive organisms such as enteritis, endocarditis, meningitis, osteomyelitis, septicaemia and urinary tract infections.

Prophylaxis during major surgery, where appropriate, for example, cardiothoracic and orthopaedic surgery.

4.2 Posology and Method of Administration Adults (including the elderly)

By oral route, 250mg four times daily, administered 0.5 to 1 hour before meals. In serious infections, these dosages may be doubled.

Children

This preparation (500mg capsule) is not suitable for children who should be given flucloxacillin elizir BP 125 mg/5ml, based on the following schedule:

Under 2 years of age: 62.5mg four times a day

2-10 years of age: 125mg four times a day or 50mg/kilo body weight per 24 hours, divided into four doses, half to one hour before food.

In serious infections the dosage may be doubled.

4.3 Contra-indications

Flucloxacillin is a penicillin and should not be given to penicillin-hypersensitive patients.

4.4 Special Warnings and Special 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 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 cause of the reactions has been protracted and lasted for some months. In very rare cases, a fatal outcome has been reported.

4.5 Interactions with other Medicaments and other forms of Interaction

As with other penicillins, flucloxacillin excretion is delayed when administered with probenecid.

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 stated.

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 side effects, such as nausea, vomiting and diarrhoea, have been reported.

4.9 Overdose

Problems of overdose with this capsule presentation are unlikely, but if encountered they may be treated symptomatically. With high doses, mainly after parenteral administration, neurotoxicity may develop.

5 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 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 1g dose provides peak plasma level of 15 mcg/ml. The drug is rapidly excreted by the kidney, about 50% within 6 hours of administration. T1/2 = 30-60 min. About 95% of flucloxacillin in the circulation is bound to plasma proteins.

5.3 Preclinical Safety Data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Magnesium stearate, blue/blue gelatin capsule (indigo carmine E132, titanium dioxide E171).

6.2    Incompatibilities

None stated.

6.3    Shelf-life

36 months.

6.4    Special Precautions for Storage

Store below 25°C in a dry place.

6.5    Nature and Contents of Container

Containers with grey body and white lid: 100, 250, 500 and 1000 pack sizes

PVC/PVdC Aluminium blister pack (250microns PVC coated externally with 40GSM PVdC, 20microns hard tempered aluminium): 4 and 28 pack sizes

For bulk supply only, packs of 5,000 and 10,000 capsules will be available in polybags, free from additives, inside a cardboard outer carton.

6.6 Instruction for Use/Handling

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Waymade PLC

Trading as Sovereign Medical

Sovereign House

Miles Gray Road

Basildon

Essex SS14 3FR

United Kingdom

8. Marketing Authorisation Number

PL 06464/1427

9. Date of first authorisation/Renewal of Authorisation

31 January 2002

10. Date of (Partial) Revision of the Text

March 2005