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  药店国别: 土耳其药房
产地国家: 美国
所属类别: 皮肤科药物->皮肤感染
处方药:处方药
包装规格: 500毫克/瓶 1瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
Novartis
生产厂家英文名:
Novartis
该药品相关信息网址1:
http://www.cubicin.com/
该药品相关信息网址2:
http://www.drugs.com/cubicin.html
该药品相关信息网址3:
http://www.rxlist.com/cubicin-drug.htm
原产地英文商品名:
CUBICIN powder for infusion solution 500mg/vial 1vials (Minimum order qty: 3)
原产地英文药品名:
DAPTOMYCIN
中文参考商品译名:
CUBICIN粉剂输液 500毫克/瓶 1瓶 (最低订货量:3)
中文参考药品译名:
达托霉素
原产地国家批准上市年份:
2003/09/12
英文适应病症1:
Skin infection
英文适应病症2:
Skin structure infections
临床试验期:
完成
中文适应病症参考翻译1:
皮肤感染
中文适应病症参考翻译2:
皮肤结构感染
药品信息:

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 详细处方信息以本药内容附件PDF文件(2010102419042332.pdf)的“原文Priscribing Information”为准
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部分中文Cubicin处方资料(仅供参考)

    Chiron公司和Cubist药物公司于2004年12月2日宣布他们已向欧洲药物机构(EMEA)递交了批准注射用Cubicin(daptomycin)在欧盟销售的申请,用于治疗G+菌引起的皮肤和软组织感染。这项申请包括了2项Ⅲ期临床试验的安全性和有效性数据。该药目前在美国已被批准用于有下列革氏阳性菌引起的皮肤和皮肤结构感染的治疗:Staphylococcus  aureus  (包括抗methicillin株),Streptococcus  pyogenes,S.agalactiae,S.dysgalactiae subsp equisimilie和Enterococcus faecalis(对vancomycin敏感株)。该药不应用于肺炎的治疗。常见不良反应为轻微,或中等程度的便秘,恶心,注射部位反应和头痛。为了减少耐药菌的产生和保持该药的疗效,Cubicin最好只用于治疗或预防已被证明或高度怀疑由对该药敏感的细菌所引起的感染。
    Daptomycin是屬於cyclic lipopeptide的新一類抗生素,最近被美國食品藥物管理局核准,以靜脈注射劑型用於治療複雜性皮膚及其組織方面的感染。並可由每日單次給藥方式代替vancomycin來治療MRSA (methicillin-resistant Staphylococcus aureus)之感染。

複雜性皮膚及其組織方面的感染:
   複雜性皮膚及其組織方面的感染包括皮膚膿瘍(abscesses)、手術後傷口感染、潰瘍性傷口感染及皮膚組織之蜂窩組織炎(cellulites)等,通常是由金黃色葡萄球菌(Staphylococcus aureus)、Staphylococcus epidermidis或Streptococcus pyogenes所引起,甚少是因為多重細菌感染或由革蘭氏陰性菌所造成。在此類感染之經驗療法當中,首選抗生素是以抗葡萄球菌之盤尼西林(anti-staphylococcal penicillin) 如:oxacillin or nafcillin或第一代cephalosporin如:cefazolin較為合理的選擇,但由於近年來在臨床上MRSA之盛行率增加,造成對anti-staphylococcal penicillin及cephalosporin產生抗藥性,使得vancomycin的用量大為增加。至於針對少數vancomycin-resistant (VRSA)菌種或vancomycin-intermediate (VISA) 菌種可使用linezolid (Zyvox)或quinupristin/dalfopristin (Synercid)來治療,有時甚至再併用rifampin (Rifadin)或gentamicin (Garamycin)。

抗菌作用
    在體外,daptomycin相較於vancomycin、linezolid或quinupristin/dalfopristin更具快速殺菌的能力(MJ Rybak et al, Antimicrob Agents Chemother 2000;44:1062;PC Fuchs et al, Antimicrob Agents Chemother 2002;49:467),其作用機轉為daptomycin可與細菌之細胞膜結合,造成細胞膜去極化作用及釋放出細胞內之離子,終而使細胞衰竭死亡 (JA Silverman et al, Antimicrob Agents Chemother 2003;47:2538)。Daptomycin之抗菌範圍與vancomycin相近,包括MRSA、MRSE及penicillin-resistant Streptococcus pneumoniae,並如同linezolid,daptomycin可有效對抗VISA、VRSA及vancomycin-resistant Enterococcus faecium及Enterococcus faecalis (VRE);Quinupristin/dalfopristin亦可有效對抗上述的菌種,但除了Enterococcus faecalis之外。在體外,甚少菌種會對daptomycin產生抗藥性。

藥物動力學
    Daptomycin之分佈體積(volume of distribution)接近0.1 L/kg,在血清中與蛋白質之結合率為92% ( 87% - 96% ),大部份之藥物以原形自尿液中排出,daptomycin之半衰期平均為9 ( 7 – 11 )小時,可是對肌酸酐清除率(creatinine clearance)低於 30 mL/min之病患,其半衰期可延長為30小時,故必須要調整給藥之劑量。

臨床試驗
    有兩項以daptomycin為主,並由FDA認證,但尚未發表過之隨機試驗中,總病患數約1000人之皮膚及其組織方面的感染,針對由Staphylococcus aureus (包括MRSA)、Streptococcus pyogenes及對vancomycin具敏感性(vancomycin-susceptible)之 Enterococcus faecalis等菌種,使用daptomycin的臨床治癒率約為70 – 90%,這與使用半合成之penicillin (包括nafcillin、oxacillin、cloxacillin或flucloxacillin)或vancomycin治療相近;可是針對Staphylococcus epidermidis、Enterococcus faecium及對vancomycin產生抗藥性之Enterococcus faecalis等菌種,因試驗數量太少而對於抗菌效果則尚無法做出有效的結論。
    至目前為止還沒有一項試驗來比較daptomycin與linezolid或quinupristin/dalfopristin之間的有效性,但有一項尚未發表的大型臨床試驗,並根據FDA所做的報告指出,對於社區性感染之肺炎治療效果比較,ceftriaxone ( Rocephin ) 優於daptomycin,特別是在較為嚴重的感染更為明顯。據藥廠所提供之資料顯示,在動物試驗中發現,daptomycin能穿透肺泡的力量較弱。

藥物副作用
    臨床試驗中發現有胃腸道不適、注射部位反應、發燒、頭痛、失眠、暈眩及皮膚紅疹等之副作用。在臨床試驗中通常會使用較高劑量與頻次,以致於使肌酸磷酸肌酉每(creatine phosphokinase;CPK) 增加而導致有肌肉不適及無力等現象產生,但此為可逆性反應,一旦停藥後即可恢復正常(BH Dvorchik et al, Antimicrob Agents Chemother 2003;47:1318)。在一般建議劑量下則很少會發生無症狀性之CPK上升,因此藥品製造商建議在使用daptomycin期間,應避免與statin類藥物合併使用,以免造成橫紋肌溶解症( rhabdomyolysis )。

劑型與劑量
    Daptomycin之一般建議劑量為每日一次靜脈注射4mg/kg,注射時間需大於30分鐘,對於creatinine clearance低於 30 mL/min之病患(包括洗腎患者在內),daptomycin的劑量需調整為每隔48小時靜脈注射4mg/kg一次,daptomycin的劑型為每vial含500mg,當稀釋後之daptomycin可置於冰箱內冷藏保存48小時。

結論
    有少數尚未發表之臨床報告顯示,daptomycin對於治療複雜性皮膚及其組織方面的感染,其效果與vancomycin相近,至於使用此兩種抗生素來比較治療關於菌血症或感染性心內膜炎,則尚未有報告。使用daptomycin治療肺炎則無臨床療效。

Cubicin
Generic Name: daptomycin (DAP to my sin)
Brand Names: Cubicin

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What is Cubicin?
Cubicin is an antibiotic that fights bacteria in the body.

Cubicin is used to treat bacterial infections of the skin and underlying tissues.

Cubicin may also be used for other purposes not listed in this medication guide.

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What is the most important information I should know about Cubicin?
Before using Cubicin, tell your doctor if you are taking a blood thinner or a cholesterol-lowering medication.

Cubicin is given as an injection into a vein. You may be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

Use Cubicin for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cubicin will not treat a viral infection such as the common cold or flu. Call your doctor at once if you have any numbness or tingling, or any unusual muscle pain, tenderness, or weakness.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

To be sure Cubicin is helping your condition, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any scheduled appointments.

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What should I discuss with my healthcare provider before using Cubicin?
Do not use Cubicin if you are allergic to daptomycin.
Before using Cubicin, tell your doctor if you are allergic to any drugs, or if you have:
kidney disease; or
a nerve or muscle disorder.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use Cubicin.

FDA pregnancy category B. Cubicin is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Cubicin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. This medicine should not be used in a child younger than 18 years old.

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How should I use Cubicin?
Cubicin is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. The medicine must be given slowly through an IV infusion, and can take up to 30 minutes to complete.

Cubicin is usually given every 24 hours for 1 to 2 weeks. Follow your doctor's instructions.

You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Use Cubicin for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cubicin will not treat a viral infection such as the common cold or flu.

To be sure Cubicin is helping your condition, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any scheduled visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using Cubicin.

Cubicin must be stored in a refrigerator and kept from freezing. Each vial (bottle) of this medicine is for one use only.

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What happens if I miss a dose?
Call your doctor if you miss a dose of this medicine.

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What happens if I overdose?
Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of a Cubicin overdose are not known.

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What should I avoid while using Cubicin?
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

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Cubicin side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
unusual muscle pain, tenderness, or weakness;
numbness or tingling;
pain or burning when you urinate;
diarrhea that is watery or bloody;
pale skin, weakness, easy bruising or bleeding;
swelling; or
chest pain.

Less serious side effects may include:
constipation, nausea, diarrhea, vomiting;
redness, discomfort, or irritation where the injection was given;
headache;
cough, sore throat;
back pain;
loss of appetite;
headache;
anxiety, confusion, sleep problems (insomnia); or
mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect Cubicin?
Before taking Cubicin, talk to your doctor if you are taking any of the following medicines:
a blood thinner such as warfarin (Coumadin);
tobramycin (Nebcin); or
cholesterol-lowering medicines such as lovastatin (Mevacor), simvastatin (Zocor), pravastatin (Pravachol), fluvastatin (Lescol), atorvastatin (Lipitor), or cerivastatin (Baycol).

This list is not complete and there may be other drugs that can interact with Cubicin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Where can I get more information?
Your pharmacist can provide more information about Cubicin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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 详细处方信息以本药内容附件PDF文件(2010102419042332.pdf)的“原文Priscribing Information”为准
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更新日期: 2014-11-06
附件:






2010102419042332.pdf    

 
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