部份中文头孢噻肟钠处方资料（仅供参考）
头孢噻肟钠（Cefotaxime Sodium）
开发单位：Hoechst (德国) 和Roussel (法国)
首次上市：1980年，德国
适应症
适用于敏感细菌所致的肺炎及其他下呼吸道感染、尿路感染、脑膜炎、败血症、腹腔感染、盆腔感染、皮肤软组织感染、生殖道感染、骨和关节感染等。头孢噻肟可以作为小儿脑膜炎的选用药物。
用法用量
成人一日2～6g，分2～3次静脉注射或静脉滴注；严重感染者每6～8小时2～3g，一日最高剂量不超过12g。治疗无并发症的肺炎链球菌肺炎或急性尿路感染，每12小时1g。
新生儿日龄小于等于7日者每12小时50mg/kg，出生大于7日者，每8小时50mg/kg。治疗脑膜炎患者剂量可增至每6小时75mg/kg，均以静脉给药。
严重肾功能减退病人应用本品时须适当减量。血清肌酐值超过424μmol/L(4.8mg)或肌酐清除率低于20ml/分时，本品的维持量应减半；血清肌酐超过751μmol/L(8.5mg)时，维持量为正常量的1/4。需血液透析者一日0.5～2g。但在透析后应加用1次剂量。
不良反应
不良反应发生率低，约3%～5%。
1．有皮疹和药物热、静脉炎、腹泻、恶心、呕吐、食欲不振等。
2．碱性磷酸酶或血清氨基转移酶轻度升高、暂时性血尿素氮和肌酐升高等。
3．白细胞减少、酸性粒细胞增多或血小板减少少见。
4．偶见头痛、麻木、呼吸困难和面部潮红。
5．极少数病人可发生粘膜念珠菌病。
禁忌
对头孢菌素过敏者及有青霉素过敏性休克或即刻反应史者禁用本品。
注意事项
1．交叉过敏反应：对一种头孢菌素或头霉素过敏者对其他头孢菌素类或头霉素也可能过敏。对青霉素或青霉胺过敏者也可能对本品过敏。
2．对诊断的干扰：应用本品的病人抗球蛋白(Coombs)试验可出现阳性；孕妇产前应用本品，此反应可出现于新生儿。用硫酸铜法测定尿糖可呈假阳性。血清碱性磷酸酶、血尿素氮、丙氨酸氨基转移酶、门冬氨酸氨基转移酶或血清乳酸脱氢酶值可增高。
3．头孢噻肟钠1.05g约相当于1g头孢噻肟，每1g头孢噻肟钠含钠量约为2.2mmol(51mg)。1g头孢噻肟溶于14ml灭菌注射用水形成等渗溶液。
4．配制肌内注射液时，0.5g、1.0g或2.0g的头孢噻肟分别加入2ml、3ml或5ml灭菌注射用水。供静脉注射的溶液，加至少10～20ml灭菌注射用水于上述不同量的头孢噻肟内，于5～10分钟内徐缓注入。静脉滴注时，将静脉注射液再用适当溶剂稀释至100～500ml。肌内注射剂量超过2g时，应分不同部位注射。
5．肾功能减退者应在减少剂量情况下慎用；有胃肠道疾病或肾功能减退者慎用。
6．本品与氨基糖苷类不可同瓶滴注。
孕妇及哺乳期妇女用药
本品可经乳汁排出，哺乳期妇女应用本品时虽无发生问题的报告，但应用本品时宜暂停哺乳。本品可透过血胎盘屏障进入胎儿血循环，孕妇应限用于有确切适应症的患者。
儿童用药
婴幼儿不宜作肌内注射。
老年用药
老年患者用药根据肾功能适当减量。
药物相互作用
1．与庆大霉素或妥布霉素合用对铜绿假单胞菌均有协同作用；与阿米卡星合用对大肠杆菌、肺炎克雷伯菌和铜绿假单胞菌有协同作用。
2．与氨基糖苷类抗生素联合应用时，用药期间应随访肾功能。
3．大剂量头孢噻肟与强利尿药联合应用时，应注意肾功能变化。
4．头孢噻肟可用氯化钠注射液或葡萄糖液稀释，但不能与碳酸氢钠液混合。
5．与阿洛西林或美洛西林等合用，可使本品的总清除率降低，如两者合用需适当减低剂量。
药物过量
本品无特效拮抗药，药物过量时主要给予对症治疗和大量饮水及补液等。
药理毒理
头孢噻肟为第三代头孢菌素，抗菌谱广，对大肠埃希菌、奇异变形杆菌、克雷伯菌属和沙门菌属等肠杆菌科细菌等革兰阴性菌有强大活性。对普通变形杆菌和枸橼酸杆菌属亦有良好作用。阴沟肠杆菌、产气肠杆菌对本品比较耐药。本品对铜绿假单胞菌和产碱杆菌无抗菌活性。头孢噻肟对流感杆菌、淋病奈瑟菌（包括产β内酰胺酶株）、脑膜炎奈瑟菌和卡他莫拉菌等均有强大作用。本品对金黄色葡萄球菌的抗菌活性较差，对溶血性链球菌、肺炎链球菌等革兰阳性球菌的活性强，肠球菌属对本品耐药。
药代动力学
肌内注射本品0.5g或1.0g后，0.5小时达血药峰浓度(Cmax)，分别为12mg/L和25mg/L，8小时后血中仍可测出有效浓度。于5分钟内静脉注射本品1g或2g，即刻血药峰浓度分别为102mg/L和215mg/L，4小时后2g组尚可测得3.3mg/L。30分钟内静脉滴注1g后的即刻血药浓度为41mg/L，4小时的血药浓度为1.5mg/L。头孢噻肟广泛分布于全身各种组织和体液中。正常脑脊液中的药物浓度很低；脑膜炎患者应用本品后，脑脊液中可达有效浓度。支气管分泌物、中耳溢液、胸腔积液、脓胸脓液、腹水、胆囊壁、胆汁、骨组织中亦均可达有效浓度。本品可透过血-胎盘屏障进入胎儿血循环，少量亦可进入乳汁。白内障病人静脉注射2g后，前房液中药物浓度为0.3～2.3mg/L。蛋白结合率30%～50%。1/3～1/2的药物在体内代谢成为去乙酰头孢噻肟（抗菌活 性为头孢噻肟的1/10）和其他无活性的代谢物。本品血消除半衰期(t1/2β)为1.5小时，老年人的t1/2β（2～2.5小时）较年轻人为长，肾功能不全者t1/2β可延长为14.6小时。约80%（74%～88%）的给药量经肾排泄，其中约50%～60%为原形药，10%～20%为去乙酰头孢噻肟，头孢噻肟经胆汁排泄的量甚少，约为给药量的0.01%～0.1%。丙磺舒可使头孢噻肟的肾清除减少5%，t1/2β延长45%。血液透析能将62.3%的药物自体内清除。腹膜透析对药物的清除量很少。
贮藏
密闭，在凉暗(避光并不超过20℃)干燥处保存。
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注：以下产品美国上市包装，不同规格和不同价格，采购以咨询为准
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CLAFORAN 1GM VIAFLEX+ DS 24  CEFOTAXIME SODIUM/DEXTROSE ISO     00039-0037-05
CLAFORAN 2GM VIAFLEX+ DS 24  CEFOTAXIME SODIUM/DEXTROSE ISO     00039-0038-05
CLAFORAN ADV 1GM 25  CEFOTAXIME SODIUM     00039-0023-25
CLAFORAN ADV 2GM 25  CEFOTAXIME SODIUM     00039-0024-25
CLAFORAN BOTTLE 10GM 100ML  CEFOTAXIME SODIUM     00039-0020-01
CLAFORAN VIAL 1GM 10  CEFOTAXIME SODIUM     00039-0018-10
CLAFORAN VIAL 2GM 10  CEFOTAXIME SODIUM     00039-0019-10
CLAFORAN VIAL 500MG 10  CEFOTAXIME SODIUM     00039-0017-10

CEFOTAXIME (CLAFORAN ®)
The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.    PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. 
Usual Diluents
D5W, NS 
Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate]
[0 to 2 grams] [50 ml] [30 min]
Stability / Miscellaneous
Label: Refrigerate.

Stability data:
Drug	Stability Refrigerated	Stability Room Temp.	Reconstituted Vial/Powder	Notes	P-Insert Updated
Cefotaxime Powder		Cefotaxime for Injection, USP in the dry state should be stored at 20º to 25ºC (68º to 77ºF). Solutions of Cefotaxime for Injection reconstituted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection in the ADD-Vantage flexible containers maintain satisfactory potency for 24 hours at or below 22°C. DO NOT FREEZE.	Powder	Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The dry material as well as solutions tend to darken depending on storage conditions and should be protected from elevated temperatures and excessive light.	01 21 16
Cefotaxime Solution	Store in a freezer capable of maintaining a temperature of -20°C/-4°F. The thawed solution is stable for 10 days under refrigeration (at or below 5°C). Do not refreeze thawed antibiotics.	Thaw frozen container at room temperature or under refrigeration (at or below 5°C). [DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.] The thawed solution is stable for 24 hours at or below 22°C. Do not refreeze thawed antibiotics.	Solution	Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.	04 30 15

DOSAGE AND ADMINISTRATION
Adults: Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). CLAFORAN may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.
Renal dosing:
>50/ Usual dose
10-50/ q8-12h
<10/ q24h
HD: 0.5 to 2g ivpb q24h AD.
PD: 1g ivpb q24h.
GUIDELINES FOR DOSAGE OF CLAFORAN

Type of Infection	Daily Dose (grams)	Frequency and Route
Gonococcal urethritis/   cervicitis in males and females	0.5	0.5 gram IM (single dose)
Rectal gonorrhea in females	0.5	0.5 gram IM (single dose)
Rectal gonorrhea in males	1	1 gram IM (single dose)
Uncomplicated infections	2	1 gram every 12 hours IM or IV
Moderate to severe infections	3–6	1–2 grams every 8 hours IM or IV
Infections commonly needing   antibiotics in higher dosage (e.g., septicemia)	6–8	2 grams every 6–8 hours IV
Life-threatening infections	up to 12	2 grams every 4 hours IV

If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefotaxime sodium has no activity against this organism.
To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery.
Cesarean Section Patients: The first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose.
Neonates, Infants, and Children: The following dosage schedule is recommended:
Neonates (birth to 1 month):
0–1 week of age 50 mg/kg per dose every 12 hours IV
1–4 weeks of age 50 mg/kg per dose every 8 hours IV
It is not necessary to differentiate between premature and normal-gestational age infants.
Infants and Children (1 month to 12 years):
For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams.
Preparation of CLAFORAN Sterile
CLAFORAN for IM or IV administration should be reconstituted as follows:

Diluent (mL)	Withdrawable Volume (mL)	Approximate Concentration (mg/mL)
1g vial (IM)	3	3.4	300
2g vial (IM)	5	6.0	330
1g vial (IV)	10	10.4	95
2g vial (IV)	10	11.0	180

Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of CLAFORAN range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.
For intramuscular use
Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic Water for Injection as described above.
For intravenous use
Reconstitute VIALS with at least 10 mL of Sterile Water for Injection. For other diluents, see COMPATIBILITY AND STABILITY section.
NOTE: Solutions of CLAFORAN must not be admixed with aminoglycoside solutions. If CLAFORAN and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.
A SOLUTION OF 1 G CLAFORAN IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.
IM Administration
As with all IM preparations, CLAFORAN should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.
IV Administration
The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.
For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Cefotaxime should not be administered over a period of less than three minutes. With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing CLAFORAN, it is advisable to discontinue temporarily the administration of other solutions at the same site.
For the administration of higher doses by continuous IV infusion, a solution of CLAFORAN may be added to IV bottles containing the solutions discussed below.
Preparation of CLAFORAN Sterile in ADD-Vantage System
CLAFORAN Sterile 1 g or 2 g may be reconstituted in 50 mL or 100 mL of 5% Dextrose or 0.9% Sodium Chloride in the ADD-Vantage diluent container. Refer to enclosed, separate INSTRUCTIONS FOR ADD VANTAGE SYSTEM.
Compatibility and Stability
Solutions of CLAFORAN Sterile reconstituted as described above ( Preparation of CLAFORAN Sterile) remain chemically stable (potency remains above 90%) as follows when stored in original containers and disposable plastic syringes:

Strength	Reconstituted Concentration mg/mL	Stability at or below 22°C	Stability under Refrigeration (at or below 5°C)
			Original Containers	Plastic Syringes
1g vial IM	300	12 hours	7 days	5 days
2g vial IM	330	12 hours	7 days	5 days
1g vial IV	95	24 hours	7 days	5 days
2g vial IV	180	12 hours	7 days	5 days

Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.
Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22°C, and at least 5 days under refrigeration (at or below 5°C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; Lactated Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL® (Amino Acid) Injection without Electrolytes.
Solutions of CLAFORAN Sterile reconstituted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection in Viaflex® plastic containers maintain satisfactory potency for 24 hours at or below 22°C, 5 days under refrigeration (at or below 5°C) and 13 weeks frozen. Solutions of CLAFORAN Sterile reconstituted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection in the ADD-Vantage flexible containers maintain satisfactory potency for 24 hours at or below 22°C. DO NOT FREEZE.
NOTE: CLAFORAN solutions exhibit maximum stability in the pH 5–7 range. Solutions of CLAFORAN should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
HOW SPPLIED
Sterile CLAFORAN is a dry off-white to pale yellow crystalline powder supplied in vials containing cefotaxime sodium as follows:
1 g cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 0039-0018-49).
2 g cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 0039-0019-49).
1 g cefotaxime (free acid equivalent) in ADD-Vantage System vials in packages of 25 (NDC 0039-0023-49).
2 g cefotaxime (free acid equivalent) in ADD-Vantage System vials in packages of 25 (NDC 0039-0024-49).
ADD-Vantage System diluents (5% Dextrose or 0.9% Sodium Chloride) are available from Abbott Laboratories.
Also available:
Pharmacy Bulk Package:
10g cefotaxime (free acid equivalent) in bottles (NDC 0039-0020-49)
NOTE: CLAFORAN in the dry state should be stored below 30°C. The dry material as well as solutions tend to darken depending on storage conditions and should be protected from elevated temperatures and excessive light
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06DE783B-0762-4031-991E-2E726DA33E16