部份中文氟氯西林处方资料（仅供参考）
药品英文名
Flucloxacillin
药品别名
氟氯苯甲异恶唑青霉素、氟氯苯唑青霉素、氟氯青霉素钠、氟沙星、Flucloxacillinum、Flucloxin
药理作用
本品为耐酸、耐酶的半合成青霉素。其抗菌作用及抗菌谱与苯唑西林相似，对金黄色葡萄球菌的抗菌作用较后者弱。对产β-内酰胺酶的革兰阳性细菌感染，与氨苄西林联合应用能保护后者不被β-内酰胺酶破坏。本药对产青霉素酶的金黄色葡萄球菌、表皮葡萄球菌、化脓性链球菌、肺炎链球菌、淋球菌、脑膜炎双球菌有较好抗菌活性。粪肠球菌、耐甲氧西林金黄色葡萄球菌、肠道阴性杆菌、铜绿假单胞菌、厌氧脆弱拟杆菌对本药耐药。
药动学
氟氯西林的口服生物利用率为30%～50%。口服250mg，1h后达血药浓度峰值，为6～20μg/ml。药物吸收后在体内分布良好。本药蛋白结合率高，为92%～94%，消除半衰期0.75～1.5h。仅部分药物在肝脏内进行代谢，大部分(50%～65%)药物以原形形式经肾随尿液排泄。血液透析不能有效清除药物。
适应证
用于由耐药金黄色葡萄球菌所致的各种严重感染，如心内膜炎、败血症(菌血症)、骨髓炎、脑膜炎、化脓性关节炎、肠道感染、烧伤创面感染、尿道感染、胆道感染、皮肤与软组织感染等。
禁忌证
对本药或其他青霉素类药过敏者。
注意事项
1.交叉过敏：对一种青霉素类药过敏者可能对其他青霉素类药过敏，也可能对青霉胺或头孢菌素类过敏。
2.慎用：
(1)孕妇及哺乳期妇女；
(2)新生儿；
(3)有哮喘、湿疹、枯草热、荨麻疹等过敏性疾病史者；
(4)肝、肾功能严重损害者。
3.治疗期间或治疗后出现发热、皮疹、皮肤瘙痒的患者，应监测肝脏功能。
不良反应
1.过敏反应：用药后可发生青霉素引起的各种过敏反应，较常见。
2.神经毒性：大剂量静脉注射可引起头痛、抽搐、惊厥等神经毒性反应，此反应尤易见于肾功能减退患者。
3.肝毒性：少数患者用药后可出现氨基转移酶暂时性升高，也有致急性肝脏胆汁淤积的报道。
4.肾毒性：偶有致急性间质性肾炎的报道。
5.血液系统：静脉给药后偶可出现中性粒细胞减少症或粒细胞缺乏症。也偶有致溶血性贫血的报道。
6.胃肠反应：口服给药后可出现恶心、呕吐、腹胀、腹泻、食欲减退等胃肠道症状，偶见假膜性结肠炎。
用法用量
1.口服给药：成人每次250～500mg，儿童每次100～125mg，每天3次，餐前1h服用。
2.肌内注药：每次250～500mg，儿童每天30～50mg/kg，分3～4次给予，溶于0.5%利多卡因注射剂中。
3.静脉注射：成人每次500mg，每天4次，儿童每天25～50mg/kg，分3次给予，溶于注射用水或葡萄糖注射剂10～20ml中静注。
药物相应作用
1.本药与阿莫西林合用可产生协同作用，现已有氟氯西林和阿莫西林等比例组成的复方制剂新灭菌。
2.本药与阿米卡星联用可增强对金黄色葡萄球菌的抗菌作用。
3.丙磺舒可阻滞本药排泄，升高血药浓度。
4.本药与伤寒活疫苗同用可降低伤寒活疫苗的免疫效应，其可能的机制是本药对伤寒沙门菌具有抗菌活性。
5.本药与甲氨蝶呤同用可使甲氨蝶呤的血浆浓度-时间曲线下面积(AUC)下降，但这种结果只有统计学上的显著性差异，而无临床意义。
专家点评
氟氯西林为耐金黄色葡萄球菌酶的半合成青霉素，临床上主要用于治疗产酶的金黄色葡萄球菌引起的各种严重感染，也用于手术后预防葡萄球菌感染，临床不用于耐甲氧西林葡萄球菌的感染。以本品治疗化脓性链球菌所致的呼吸系统感染，治愈率高达90%。另也适用于耐药金黄色葡萄球菌导致的尿道感染。
Flucloxacillin 125mg/5ml and 250mg/5ml Sugar-Free Powder for Oral Solution
Package leaflet: Information for the patient
Flucloxacillin 125mg/5ml Sugar Free Powder for Oral Solution
1 What your medicine is and what it is used for
Flucloxacillin is an antibiotic used to treat infections by killing the bacteria that can cause them. It belongs to a group of antibiotics called “penicillins”.
Flucloxacillin is used to treat:
•chest infections
•ear infections
•heart infections
•meningitis
•blood infections
•kidney, bladder or urethra (the tube which carries urine from the bladder) infections.
•throat or nose infections
•skin and soft tissue infections
•bone and joint infections
•digestive system infections
Flucloxacillin can also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery.
2 What you need to know before you take your medicine
Do not take this medicine if you:
•Are allergic to flucloxacillin or any other penicillin antibiotics (see symptoms in section 4),
•Are allergic to any of the other ingredients of this medicine (listed in section 6),
•Have had liver problems after taking this medicine (flucloxacillin).
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
•Suffer from kidney problems, as you may require a lower dose than normal,
•Suffer from liver problems,
•Are 50 years of age or older,
•Have other serious illnesses (apart from the infection this medicine is treating).
Other medicines and Flucloxacillin Sugar Free Powder for Oral Solution
Check with your doctor or pharmacist before taking this medicine if you are taking any other medicines, especially:
•Probenecid or sulfinpyrazone (used to treat gout),
•Methotrexate (a chemotherapy drug),
•Oral typhoid vaccine (antibiotics can make this less effective),
•Sugammadex (used with general anaesthetics),
•Piperacillin (an antibiotic taken by injection),
•Other antibiotics (used to treat infections),
•Warfarin (medicine to prevent blood clotting).
Some medicines may affect the way others work. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This means medicines you have bought yourself as well as medicines on prescription from a doctor.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Tests
Regular monitoring of liver and kidney function should be performed whilst taking flucloxacillin for a long period of time. Tell your doctor that you are taking flucloxacillin if you are having urine tests or blood tests because it may affect the results.
Your medicine contains sorbitol and sodium.
This medicinal product contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
The 125mg/5ml solution contains 17.08mg sodium per 5ml dose, and the 250mg/5ml solution contains 49.41mg sodium per 5ml dose. To be taken into consideration by patients on a controlled sodium diet.
3 How to take your medicine
Always take this medicine exactly as your doctor or pharmacist has told you. Their directions may differ from the information contained in this leaflet. The pharmacist’s label should tell you how much to take and how often. Check with your doctor or pharmacist if you are not sure.
How much of your medicine to take and when to take it
The dose will depend on the patient and will be decided by your doctor. However, the usual doses for each age group are –
Adults (including the elderly): 250mg four times a day
Children (2-10 years of age): 125mg four times a day
Children under 2 years of age: 62.5mg four times a day
Flucloxacillin Sugar Free Oral Solution is not recommended for premature or babies less than 4 weeks old.
Severe kidney disease - your doctor may reduce your dose, the maximum dose in adults is 1g every 8 to 12 hours.
Instructions for reconstitution of the powder
1. Remove the cap and add the correct volume of potable water (87ml if you have been given the 125mg/5ml strength of product and 79ml if you have been given the 250mg/5ml strength of product)
2. Replace the cap and shake well.
3. Remove the cap once more and place the adaptor (Fig 1) into the bottle opening. The adaptor should not be removed at any stage.
4. Replace the cap, do not shake any further.
Instructions for use of the syringe
1. Remove the cap and if necessary push the adaptor into the neck of the bottle (Fig 1).
2. Push the plunger of the syringe to remove all the air.
3. Insert the syringe into the adaptor until it is firmly in place (Fig 2).
4. Whilst holding the bottle and syringe shake the contents well.
5. While holding the bottle, turn the entire assembly upside down.
6. Whilst supporting the syringe draw off the required amount of medicine into the syringe (Fig 3).
7. Turn the assembly back up the right way and remove the syringe from the bottle.
8. Replace the cap onto the bottle.
Administer the dose by introducing the tip of the syringe into the mouth of the infant/child, then apply a light pressure on the plunger to slowly release the solution. Keep it out of the reach of children.
Note: For subsequent dosage follow steps 3 and 4 above, before shaking in order to prevent leakage.
When to take your medicine
Take your medicine on an empty stomach, at least thirty minutes to one hour before meals/food. It is important that you take your medicine at the right times.
If you take more of your medicine than you should
If you (or somebody else) takes too much of your medicine, talk to your doctor or pharmacist immediately.
If you forget to take your medicine
If you forget to take a dose, take it as soon as you remember, then carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking your medicine
Keep taking your medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, your infection may return or get worse. If you are still unwell after taking all the medicine, go and see your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If they occur, they are likely to be temporary, and not serious. However, some may be serious and need medical attention.
STOP taking flucloxacillin and contact your doctor if you experience
•Allergy or hypersensitivity including itchy rash, itching, sore mouth or eyes, swelling of the face, lips, throat or tongue or breathing problems
•Severe, bloody diarrhoea
•Jaundice (yellow colour in the skin and whites of the eyes)
•Severe skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome) or a severe rash with reddening, peeling and swelling of the skin that looks like a burn (toxic epidermal necrolysis).
Tell your doctor if you notice any of the following effects
•Common (may affect up to 1 in 10 people):
Diarrhoea, stomach upset and feeling sick, this should be mild and wear off after a few days. If severe or lasting longer, tell your doctor.
•Very rare (may affect up to 1 in 10,000 people):
Inflammation of the kidney or liver, changes in the numbers of blood cells (might cause bleeding, easy bruising or skin discolouration), anaemia, skin rash with circular red patches (erythema multiforme). Joint or muscle pains or fever (may develop 2 days after starting treatment).
•Some of these reactions to flucloxacillin can be delayed for up to 2 months after finishing the treatment.
Check with your doctor if you have any problems while taking this medicine, even if you think the problems are not connected with the medicine, or are not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store your medicine
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Once reconstituted (mixed) by the pharmacist, store the solution at 2°C to 8°C in a refrigerator and use within 7 days.
Do not use this medicine after the expiry date which is stated on the label.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Flucloxacillin Sugar Free Oral Solution contains
The active substance is flucloxacillin as flucloxacillin sodium.
The other ingredients are sodium citrate anhydrous, disodium edetate, sodium benzoate, citric acid monohydrate, colloidal anhydrous silica, xanthan gum, saccharin sodium, menthol flavour, lemon flavour, strawberry flavour and sorbitol.
Please see further information on sorbitol and sodium in section 2.
What Flucloxacillin Sugar Free Oral Solution looks like and contents of the pack
Unconstituted powder: a free-flowing white granular powder with a slight lemon smell.
Reconstituted solution: an opaque off-white coloured solution with a lemon smell and flavour.
The solution may become more yellow as time progresses.
On reconstitution, each bottle contains 100ml of Flucloxacillin Sugar Free Oral Solution.