部分中文氟氯西林处方资料（仅供参考）
【别名】
氟氯苯甲异恶唑青霉素钠;氟氯青;氟氯青霉素钠;氟氯西林;氟沙星 ,奥佛林 ,氟氯苯唑青霉素钠
【外文名】
Flucloxacillin Na,FLUCLOXACILLIN
【成分】
氟氯西林钠
【性状】
为白色或类白色结晶性粉末，易溶于水（１：１），溶于乙醇（１：１２），或丙酮（１：１２）。
【药理作用】
本品有抗耐葡萄球菌所产生的β－内酰胺酶能力。肌注同量的本品与氯唑西林，本品的血药浓度明显较高，血中有效浓度维持时间较长。
【适应症】
主要用于治疗耐青霉素金黄色葡萄球菌的严重感染，以及呼吸道感染（如急性咽炎、化脓性扁桃体炎）、治疗感冒继发细菌感染、急慢性气管炎、支气管炎、肺炎、肺脓肿、脓胸、骨髓炎、化脓性关节炎、急慢性中耳炎、鼻副窦炎、牙周炎、疖、痈、丹毒、蜂窝组织炎、破伤风、甲沟炎、创面及伤口感染、烧伤感染、导尿后引起的尿道炎、前列腺炎、淋病、心内膜炎、革兰阳性菌尤是金黄色葡萄球菌引起的败血症。
【用量用法】
静滴、静注：２～４ｇ／日，分２～４次注射。溶于２０ｍｌ注射用水中，在３～４分钟内缓注或加入输液中静滴。胸腔内注射：２５０ｍｇ／日，溶于５～１０ｍｌ注射用水中。关节腔注射：２５０～５００ｍｇ／日，溶于５ｍｌ注射用水中。口服：０．２５～０．５ｇ／次，４～６次／日，饭前２小时服。儿童：２～１０岁为成人剂量的一半，＜２岁为成人剂量的１／４。
【注意事项】
偶有过敏反应（如皮疹）、恶心、呕吐、上腹不适、结肠炎等。长期应用应检查肝功能。在怀疑复合感染时，可合用阿莫西林、氨芐西林、头孢三嗪、头孢他啶等治疗。用前需做皮试。
【类别】
抗生素
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产地国家: 英国
原产地英文商品名:
Flucloxacillin Solution 125mg/5ml 100ml
原产地英文药品名:
FLUCLOXACILLIN
中文参考商品译名:
Flucloxacillin口服溶液 125毫克/5毫升 100毫升
中文参考药品译名:
氟氯西林
生产厂家英文名:
Teva

-------------------------------------------------         
产地国家: 英国
原产地英文商品名:
Flucloxacillin Solution 250mg/5ml 100ml
原产地英文药品名:
FLUCLOXACILLIN
中文参考商品译名:
Flucloxacillin口服溶液 250毫克/5毫升 100毫升
中文参考药品译名:
氟氯西林
生产厂家英文名:
Teva

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Flucloxacillin 125mg/5ml Oral solution
1. Name of the medicinal product
Flucloxacillin 125mg/5ml Oral solution BP
2. Qualitative and quantitative composition
Each 5ml dose contains Flucloxacillin Sodium equivalent to Flucloxacillin 125mg.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Powder for oral solution.
Pinkish colour free flowing granular powder with characteristic odour, which on reconstitution becomes clear red colour solution.
4. Clinical particulars
4.1 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:
Skin and soft tissue infections:
Boils, Cellulitis, Infected burns, Abscesses, Infected skin conditions, e.g. ulcer, eczema, and acne, Protection for skin grafts, Carbuncles, Furunculosis, Infected wounds and Impetigo
Respiratory tract infections:
Pneumonia, Lung abscess, Empyema, Sinusitis, Pharyngitis, Otitis media and externa, Tonsillitis and Quinsy
Other infections caused by Flucloxacillin-sensitive organisms:
Osteomyelitis, Urinary tract infection, Enteritis, Meningitis, Endocarditis and Septicaemia
Flucloxacillin Sodium is also indicated for use as a prophylactic agent during major surgical procedures when appropriate; for example cardiothoracic and orthopaedic surgery.
Parenteral usage is indicated where oral dosage is inappropriate.
4.2 Posology and method of administration
Depends on the age, weight and renal function of the patient, as well as the severity of the infection.
Usual adult dosage (including elderly patients)
Oral- 10ml four times daily
Usual children's dosage
2-10 years: 5ml four times daily
Under 2 years: 2.5ml four times daily
Abnormal renal function:
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/min) 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
Administration
Oral: Oral doses should be administered half to one hour before meals
4.3 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 with a previous history of flucloxacillin-associated jaundice/hepatic dysfunction.
4.4 Special warnings and precautions for use
Before initiating therapy with flucloxacillin, careful enquiry should be made concerning previous hypersensitivity reactions to β-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 β-lactam hypersensitivity.
Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction, (patients ≥50 years and those with serious underlying disease. In these patients, hepatic events may be severe, and in very rare circumstances, deaths have been reported (see section 4.8).
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.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
Flucloxacillin oral solution contains approximately 10.72mg of sodium per 5ml.
4.5 Interaction with other medicinal products and other forms of interaction
Probenecid decreases the renal tubular secretion of flucloxacillin. Concurrent administration of probenecid delays the renal excretion of flucloxacillin.
In common with other antibiotics, flucloxacillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
4.6 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 effects. The decision to administer any drug during pregnancy should be taken with the utmost care. Therefore flucloxacillin should only be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.
Lactation: Trace quantities of flucloxacillin can be detected in breast milk. The possibility of hypersensitivity reactions must be considered in breast-feeding infants. 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
Adverse effects on the ability to drive or operate machinery have not been observed.
4.8 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, <1/1000), very rare (<1/10,000).
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. These are reversible when treatment is discontinued. Haemolytic anaemia.
Immune system disorders
Very rare: Anaphylactic shock (exceptional with oral administration) (see Item 4.4 Warnings), angioneurotic oedema.
If any hypersensitivity reaction occurs, the treatment should be discontinued. (See also Skin and subcutaneous tissue disorders).
Gastrointestinal disorders
*Common: Minor gastrointestinal disturbances.
Very rare: Pseudomembranous colitis.
If pseudomembranous colitis develops, flucloxacillin treatment should be discontinued and appropriate therapy, e.g. oral vancomycin should be initiated.
Hepato-biliary disorders
Very rare: Hepatitis and cholestatic jaundice. (See Section 4.4 Special Warnings and Special Precautions for Use). Changes in liver function laboratory test results (reversible when treatment is discontinued).
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 and toxic epidermal necrolysis.
(See also Immune system disorders).
Musculoskeletal and connective tissue disorders
Very rare: Arthralgia and myalgia sometimes develop more than 48 hours after the start of the treatment.
Renal and urinary disorders
Very rare: Interstitial nephritis.
This is reversible when treatment is discontinued.
General disorders and administration site conditions
Very rare: Fever sometimes develops more than 48 hours after the start of the treatment.
*The incidence of these AEs was derived from clinical studies involving a total of approximately 929 adult and paediatric patients taking flucloxacillin.
4.9 Overdose
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
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 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) staphylococci. It is not active against methicillin-resistant 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 into the cerebrospinal fluid of subjects whose meninges are not inflamed.
Crossing into mothers' milk: Flucloxacillin is excreted in small quantities in mothers' 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
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical particulars
6.1 List of excipients
Sodium Benzoate (E211)
Disodium Edetate
Saccharin Sodium
Mono-Ammonium-Glycyrrhizinate
Sodium Citrate Anhydrous (E331)
Flavour Pineapple
Flavour Menthol
Erythrosine (E127)
Sucrose
6.2 Incompatibilities
As for Penicillin. Incompatible with Colistin Polymixin B Sulphate. Loss of potency after mixing with Streptomycin has also been reported.
6.3 Shelf life
Unopened: 3 years
After reconstitution or when the container is opened for the first time: 7 days
6.4 Special precautions for storage
Unopened bottle: Do not store above 25ºC. Store in the original container. Keep the container tightly closed.
Reconstituted solution: Store at 2-8ºC.
6.5 Nature and contents of container
Nature: 150ml amber glass Beatson Clark container with polypropylene screw cap or 150ml high density polyethylene bottle with tamper evident cap: 100ml
6.6 Special precautions for disposal and other handling
To reconstitute, add 58ml of water, replace the lid and shake the bottle well.
7. Marketing authorisation holder
Milpharm Limited
Ares
Odyssey Business Park
West End Road
South Ruislip
HA4 6QD
United Kingdom
8. Marketing authorisation number(s)
PL 16363/0043
9. Date of first authorisation/renewal of the authorisation
06/11/2001
10. Date of revision of the text
16/08/2011
This medicine is also available as[注：以下产品不同规格和不同价格，购买以咨询为准]
•Flucloxacillin 250mg capsules
•Flucloxacillin 500mg capsules
•Flucloxacillin 1g powder for solution for injection vials
•Flucloxacillin 250mg powder for solution for injection vials
•Flucloxacillin 500mg powder for solution for injection vials
•Flucloxacillin 125mg/5ml oral solution sugar free
•Flucloxacillin 250mg/5ml oral solution sugar free