FLUCLOXACILLIN Capsule (2021)
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Περιεχόμενα
Name of the medicinal product
Flucloxacillin 250mg Capsules BP.
Qualitative and quantitative composition
Flucloxacillin Sodium equivalent to 250mg Flucloxacillin per Capsule. For a full list of excipients, see section 6.1.
Pharmaceutical form
Capsules. Hard gelatin size 2 capsules with Caramel body and Black cap printed with FLU250 MIL and filled with white to almost white granular powder.
Therapeutic indications
Flucloxacillin Sodium is indicated for the treatment of infections due to sensitive Gram-positive organisms, including β-lactamase producing staphylococci and streptococci. Typical indications include: ...
Posology and method of administration
Posology The dosage depends on the age, weight and renal function of the patient, as well as on the severity of the infection. Usual adult dosage (Including elderly patients) Oral – 250mg four times a ...
Contraindications
Flucloxacillin should not be given to patients with a history of hypersensitivity to β-lactam antibiotics (e.g. penicillins, cephalosporins) or excipients. Flucloxacillin is contra-indicated in patients ...
Special warnings and precautions for use
The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthematous pustulosis (AGEP) (see section 4.8). In case of ...
Interaction with other medicinal products and other forms of interaction
Probenecid and sulfinpyrazone slow down the excretion of flucloxacillin by decreasing tubular secretion. Other drugs, such as piperacillin, which are excreted via renal tubular secretion, may interfere ...
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 ...
Effects on ability to drive and use machines
Adverse effects on the ability to drive or operate machinery have not been observed.
Undesirable effects
The following convention has been utilised for the classification of undesirable effects: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1,000), very rare ...
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Beta-Lactamase Resistant Penicillins ATC code: J01CF05 Properties Flucloxacillin is a narrow-spectrum antibiotic of the group of isoxazolyl penicillins; it is not inactivated ...
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. ...
Preclinical safety data
No further information of relevance to add.
List of excipients
Magnesium stearate (E572) Colloidal anhydrous Silica <u>Capsule Shell Components:</u> <em>Body:</em> Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin <em>Cap:</em> Black iron ...
Incompatibilities
None stated.
Shelf life
<u>3 years:</u> polypropylene containers. <u>2 years:</u> blister strips.
Special precautions for storage
<u>Container:</u> Do not store above 25°C. Store in the original container. Keep tightly closed. <u>Blister:</u> Do not store above 25°C. Store in the original pack.
Nature and contents of container
<u>White polypropylene container with polyethylene lid:</u> 14, 28, 100, 250, 500 and 1000 capsules. <u>Blister Strips:</u> 14, 28 and 100 capsules. The blister strips are packed in the carton along with ...
Special precautions for disposal and other handling
Nothing stated.
Marketing authorization holder
Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip, HA4 6QD, United Kingdom
Marketing authorization number(s)
PL 16363/0041
Date of first authorization / renewal of the authorization
14/05/2002
Date of revision of the text
18/01/2021
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