部份中文头孢克洛处方资料（仅供参考）
英文名：Cefaclor for Oral Suspension
商品名：CEFACLOR
中文名：头孢克洛口服混悬剂
生产商：ZYLERA PHARMACEUTICALS
药品简介
持证商：ZYLERA PHARMACEUTICALS LLC
上市国：USA
临床药理学
口服禁食对象后，头孢克洛吸收良好。无论药物与食物一起服用还是不与食物一起服用，总吸收都是相同的。但是，当与食物一起服用时，所达到的峰值浓度是对禁食对象给药时所观察到的峰值浓度的50％至75％，通常在四分之三至一小时后出现。给空腹受试者服用250 mg，500mg和1g剂量后，在30至60分钟内分别获得大约7、13和23 mcg/mL的平均峰值血清水平。大约60％至85％的药物会在8小时内不经尿液排泄，大部分则在头2小时内排泄。在这8小时内，250mg，500 mg和1g剂量后的峰值尿液浓度分别约为600、900和1,900 mcg/mL。正常受试者的血清半衰期为0.6至0.9小时。在肾功能降低的患者中，头孢克洛的血清半衰期略有延长。在完全没有肾功能的患者中，完整分子的血浆半衰期为2.3至2.8小时。肾功能明显受损的患者的排泄途径尚未确定。血液透析使半衰期缩短了25％至30％。
适应症
当由指定微生物的易感菌株引起的头孢克洛可用于以下感染的治疗：
由肺炎链球菌，流感嗜血杆菌，葡萄球菌和化脓性链球菌引起的中耳炎
剂量和给药
头孢克洛口服。
大人
成人通常的剂量是每8小时250毫克。 对于更严重的感染（如肺炎）或由较不易感染的生物引起的感染，剂量可加倍。
小儿患者
小儿患者通常的建议每日剂量为每8小时20毫克/千克/天。 对于更严重的感染，中耳炎和由不易感染的生物引起的感染，建议每天40 mg / kg，最大剂量为1 g / day。
禁忌症
头孢克洛是对头孢菌素类抗生素过敏的患者禁用的药物。
包装供应方式
USP的Cefaclor口服混悬剂以带有防儿童进入瓶盖的瓶子形式提供，例如：
125毫克/5毫升草莓味：NDC 13551-125-01（150毫升规格）
250毫克/5毫升草莓味NDC 13551-250-01（150毫升规格）
375mg/5 mL草莓味NDC 13551-375-01（100 mL大小）
混合后，存放在冰箱中。 使用前请摇匀。保持密闭。该混合物可以保持14天而没有明显的效力损失。14天后丢弃未使用的部分。
将干粉存放在20°至25°C（68°至77°F）的温度下。[请参见USP控制的室温]。
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CEFACLOR 125MG/5ML ORAL SUS 150 ML  CEFACLOR  ZYLERA PHARMACEUTICALS LLC  NDC:23594012501
CEFACLOR 250MG/5ML ORAL SUS 150 ML  CEFACLOR  ZYLERA PHARMACEUTICALS LLC  NDC:23594025001
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: Cefaclor for Oral Suspension is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
WARNINGS AND PRECAUTIONS:
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactam antibiotics such as cefaclor. If an allergic reaction occurs, discontinue use of Cefaclor for Oral Suspension. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures as clinically indicated.
Exercise caution in penicillin-sensitive patients as cross-hypersensitivity with beta-lactam antibiotics has been observed in up to 10% of patients with penicillin allergy.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibiotics, including Cefaclor for Oral Suspension, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients presenting with diarrhea after taking antibiotics, and can occur over 2 months after administration of antibiotics. Ongoing antibiotic use not directed against C. difficile may need to be discontinued.
Use cautiously in patients who have demonstrated some form of allergy, particularly to drugs.
Use only in proven or strongly suspected bacterial infections of susceptible organisms. Do not use for prophylactic use.
Prolonged use may result in overgrowth of nonsusceptible organisms. If superinfection occurs appropriate measures should be taken.
Positive direct Coombs tests have been reported during treatment with cephalosporin antibiotics.
Use with caution in patients with impaired renal function. Careful clinical and laboratory observation are warranted.
As with other beta-lactam antibiotics, renal excretion of Cefaclor is inhibited by probenecid.
Exercise caution in patients with history of gastrointestinal disease, particularly colitis.
ADVERSE REACTIONS:
The most frequently occurring adverse reactions related to cefaclor therapy include: gastrointestinal symptoms, including diarrhea (2.5%); hypersensitivity reactions including morbilliform eruptions (1.5%); and serum-sickness-like reactions (≤0.5%).
DRUG INTERACTIONS:
Increase in anticoagulant effect may occur when cefaclor is used concomitantly with oral anticoagulants.
USE IN PEDIATRIC PATIENTS:
Safety and effectiveness of cefaclor has not been established in pediatric patients less than 1 month of age.
INDICATIONS FOR USE: Cefaclor for Oral Suspension is indicated for the treatment of otitis media, lower respiratory tract infections, pharyngitis and tonsillitis, urinary tract infections, and skin and skin structure infections caused by susceptible strains of the designated microorganisms:
Otitis Media due to Streptococcus pneumoniae, Haemophilus influenzae*, staphylococci, and Streptococcus pyogenes
Lower respiratory tract infections, including pneumonia, due to Streptococcus pneumoniae, Haemophilus influenzae*, and Streptococcus pyogenes
Pharyngitis and Tonsillitis due to Streptococcus pyogenes
Urinary tract infections, including pyelonephritis and cystitis, due to Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci
Skin and skin structure infections due to Staphylococcus aureus and Streptococcus pyogenes
*Note: β-lactamase-negative, ampicillin-resistant strains (BLNAR) of Haemophilus influenzae should be considered resistant to Cefaclor.