Flucloxacillin Capsules Bp 250mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucloxacillin Capsules BP 250mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Flucloxacillin Sodium equivalent to 250mg Flucloxacillin.
Excipient(s) with known effect:
Each capsule contains approximately 13 mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Grey and brown, size 2, hard gelatin capsules marked with a ‘G’ and ‘FN 250’ in black, containing a white to off-white powder.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Flucloxacillin is indicated for the treatment of infections due to gram-positive organisms including those caused by B-Lactamase - producing staphylococci associated, for example, with:-
Skin and soft tissue: Boils, abscesses, carbuncles, infected skin conditions (acne, ulcer, eczema), infected wounds and burns, cellulitis, furunculosis, otitis media and external impetigo and protection for skin grafts.
Respiratory Tract: Pneumonia, lung abscess, sinusitis, pharyngitis, tonsillitis, empyema and quinsy.
Other: Prophylaxis during major surgical procedures where appropriate (cardiothoracic and orthopaedic surgery), osteomyelitis, enteritis, urinary tract infection, endocarditis, meningitis, septicaemia.
Flucloxacillin should be reserved for those infections caused by penicillinase-producing staphylococci shown to be sensitive.
Consideration should be given to official local guidance (eg. 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
Posology
Adults and the Elderly:
250mg every 6 hours. For more severe infections this dosage may be doubled.
Osteomyelitis and Endocarditis: Up to 8g daily, in divided doses six to eight hourly.
Surgical Prophylaxis: 1 to 2g intravenous at induction of anaesthesia followed by 500mg every six hours orally or by intravenous, intramuscular injection for up to 72 hours.
Patients with renal impairment
In common with other penicillins, Flucloxacillin usage in patients with renal impairment does not usually require dosage reduction. However, in the presence of severe renal failure (creatinine clearance < 10 ml/minute) a reduction in dose or an extension of dose interval should be considered.
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.
Paediatric Population
Children over ten years: As for adults.
Childen aged two to ten years: Half of the adult dose.
Children under two years: Quarter of the adult dose.
Method of administration For oral administration only.
Doses should be administered half to one hour before meals.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Flucloxacillin is contraindicated in patients with P-lactam antibiotics (e.g. penicillin, cephalosporin) hypersensitivity; ocular administration.
Flucloxacillin is contraindicated in patients with a previous history of flucloxacillin-associated jaundice/hepatic dysfunction.
4.4 Special warnings and precautions for use
Careful enquiry should be made concerning previous hypersensitivity reactions to P-lactam antibiotics before initiating therapy with flucloxacillin.Discontinue treatment if rash appears and change to an alternative non-penicillin antibiotic. Cross-sensitivity with other p-lactam antibiotics has been reported.
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving P-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 P-lactam hypersensitivity.
Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction (see section 4.8).Care should be exercised in patients with a history of allergy or with impaired renal function.
Special caution is essential in the new-born because of the risk of hyperbilirubinaemia. Studies with parenteral administration of high doses have shown that, 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 new-born because of the potential for high serum levels of Flucloxacillin due to a reduced rate of renal excretion.
During prolonged use (e.g. in osteomyelitis, endocarditis), monitoring of hepatic and renal functions regularly is recommended.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
This medicinal product contains approximately 13 mg sodium per capsule. To be taken into consideration by patients on a controlled sodium diet.
4.5 Interaction with other medicinal products and other forms of interaction
Oral courses of broad spectrum anti-bacterials affect the hypoprothrombinaemic response to oral anticoagulants. Pseudomembranous colitis has been reported rarely and has usually been associated with use of Flucloxacillin in combination with other antibiotics.
Methotrexate excretion is reduced by Penicillins. Patients should be monitored carefully for signs of methotrexate toxicity.
Probenecid decreases the renal excretion of penicillins. Plasma concentrations are enhanced if probenecid is given concomitantly.
4.6 Fertility, pregnancy and lactation
Pregnancy
Animal studies with Flucloxacillin have shown no teratogenic effects. The product has been in clinical use since 1970 and the limited number of reported cases of use in human pregnancy have shown no evidence of untoward effect. The use of Flucloxacillin in pregnancy should be reserved for cases considered essential by the physician.
Breast-feeding
Breast-feeding is not contraindicated with Flucloxacillin. Trace quantities of Penicillins can be detected in breast milk. While adverse effects are apparently rare, three potential problems exist for the nursing infant:
- modification of bowel flora
- direct effects on the infant such as allergy/ sensitisation
- interference with interpretation of culture results when pyrexia of unknown origin occurs.
4.7 Effects on ability to drive and use machines
Adverse effects on the ability to drive or operate machinery have not been observed.
4.8 Undesirable effects
The side effects of Flucloxacillin are characteristic of penicillins. They are uncommon and mainly of a mild transitory nature
The most commonly reported adverse drug reactions are gastro-intestinal and skin reactions (>1 % but < 10 %).
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/l0), common (>1/100 and <1/10), uncommon (>1/1000 and <1/100), rare (> 1/10,000 and
<1/1000) and very rare (<1/10,000), not known (cannot be estimated from the available data).
Blood and lymphatic system disorders Uncommon: Eosinophilia
Rare: Agranulocytosis, Neutropenia, Leukopenia, Thrombocytopenia.
Immune system disorders Rare: Anaphylactic Reaction
Nervous system disorders Common: Headache
Gastrointestinal disorders Common: Diarrhoea and Nausea Rare: Pseudomembranous colitis
Hepatobiliary disorders
Rare: Hepatitis and cholestatic jaundice
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 Common: Exanthema Uncommon: Angiooedema, Urticaria
Very Rare: Stevens-Johnson syndrome and toxic epidermal necrolysis
Musculoskeletal and connective tissue disorders Uncommon: Myalgia, arthralgia
Renal and urinary disorders
Rare: Interstitial Nephritis, Nephropathy
General disorders and administration site disorders Uncommon: Fever
4.9 Overdose
Problems with overdosage with Flucloxacillin are unlikely to occur, but if encountered may be treated symptomatically. More specific measures may be necessary in patients with impaired renal function. Flucloxacillin is not significantly removed by dialysis.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Beta-lactamase resistant pencillins, ATC code: J01C F05
Flucloxacillin is a semi-synthetic penicillin of the isoxazolyl group which is bacterial and staphylococcal penicillinase resistant. It acts by inhibiting cell wall synthesis, probably by acylation of membrane - bound transpeptidase enzymes. This prevents cross linkage of peptidoglycan chains which is necessary for bacterial cell wall strength and rigidity. Also, cell division and growth are inhibited and lysis and elongation of susceptible bacteria frequently occur. Rapidly dividing bacteria are most susceptible to the action of penicillins.
5.2 Pharmacokinetic Properties
Flucloxacillin is rapidly but incompletely absorbed (30-80%) after oral administration and the presence of food impairs absorption.
Flucloxacillin in common with other penicillins, is widely distributed throughout the body. It is highly bound (90-95%) to plasma proteins. The half-life of Flucloxacillin is 30-60 minutes. It is rapidly excreted by the kidneys. Hepatic and biliary elimination also occur.
5.3 Preclinical Safety Data
There are no preclinical safety data of relevance to the prescriber which are additional to those already included in other sections of the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Magnesium stearate
Capsule shells containing-Gelatin
Titanium dioxide Black iron oxide Yellow iron oxide Red iron oxide
Printing ink containing-Shellac
Iron Oxide Black (E172)
N-Butyl Alcohol Propylene Glycol Isopropyl Alcohol Ammonium Hydroxide
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months.
6.4 Special Precautions for Storage
Store in a dry place below 25°C.
6.5 Nature and contents of container
Polypropylene container with polyethylene cap (with optional polyethylene ullage filler).
Glass container with a screw cap closure.
PVC/foil blister packs.
High density polyethylene containers (HDPE) with polyethylene snap closures.
Each pack type is available in pack sizes of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 250 and 500 capsules. Not all pack sizes may be marketed.
6.6 Special precautions for disposal No special requirements.
Any unused medicinal products or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Generics [UK] Limited t/a Mylan
Station Close
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 04569/0039
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Last renewal granted: 11 March 2009
10 DATE OF REVISION OF THE TEXT
25/05/2016
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