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 详细处方信息以本药内容附件PDF文件（201881422144016.pdf）的“原文Priscribing Information”为准
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部分中文CEFACLOR处方资料（仅供参考）

不同适应症和各年龄组别患者的用法用量 
口服给药
适用于尿道感染, 上下呼吸道感染, 皮肤感染, 中耳炎
成人: 头孢克洛一水化物：250-500 mg,每8小时一次。最大剂量：4 g/天。
儿童: >1个月：20 mg/kg/天，分3次服用，必要时增加至40 mg/kg/天。<1岁：62.5 mg，每天3次；1-5岁：125 mg，每天3次；>5岁：250 mg，每天3次。

服药与进食 
服药不受进食影响
 
禁忌 
已知对头孢菌素类过敏者禁用。

注意事项 
 慎用于严重肾脏损伤者，有青霉素过敏史者，孕妇和哺乳期妇女。

不良反应 
 过敏反应，腹泻，恶心，呕吐，念珠菌病，嗜酸粒细胞增多，血转氨酶升高。严重不良反应: 过敏性反应，伪膜性结肠炎。

药物相互作用 
 丙磺舒会降低本药的肾小管分泌。严重药物相互作用: 会增加氨基糖甙类和呋赛米的肾毒性。与抗凝剂同用可能引起出血。
 
对实验室检查结果的影响 
导致直接血清抗人球蛋白试验和尿糖测试（Benedict，Fehling或非酶检测方法）结果假阳性。干扰Jaffe法血清肌酐测定结果。

与食物的相互作用 
食物会引起本药血浆浓度轻微降低。  
 
贮藏/有效期
口服给药: 存于15-30°C。

药理作用 
头孢克洛与一个或多个青霉素结合蛋白结合，抑制细菌细胞壁内肽聚糖合成过程中的转肽作用，干扰肽聚糖的生物合成，使细胞壁的组装停止，导致细菌死亡。对革兰阴性菌，如致病大肠杆菌、肺炎链球菌、淋病奈瑟菌、奇异变形杆菌和流感嗜血杆菌有抗菌活性。
吸收: 口服胃肠道吸收良好；吸收率因进食而改变，但吸收程度不受影响。
分布: 在体内广泛分布；可穿过胎盘和进入乳汁（低浓度）。蛋白结合率：25%。
排泄: 在8小时内通过肾脏经尿液排泄（85%为原形药）；绝大部分在2小时以内排出。消除半衰期：0.5-1小时，会因肾功能损伤而略微延长。血液透析可清除。

BACTICLOR
Cefaclor(Capsules, Tablets and Oral Suspension) 

DESCRIPTION
Bacticlor capsules contain cefaclor USP equivalent to 250 mg or 500 mg of anhydrous cefaclor.

Bacticlor for oral suspension contains cefaclor USP equivalent to 125 mg or 250 mg of anhydrous cefaclor per 5mL constituted suspension.

Bacticlor MR 375mg film-coated tablets contain cefaclor USP equivalent to 375 mg anhydrous cefaclor.

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INDICATIONS
Bacticlor is indicated for the treatment of the following infections when caused by susceptible strains of the designated organisms in the following conditions:

Respiratory tract infections
Upper respiratory tract infections including otitis media, pharyngitis, tonsillitis and sinusitis due to Streptococcus pyogenes (group A ß-haemolytic streptococci), Haemophilus influenzae, or Streptococcus pneumoniae.

Lower respiratory tract infections:
Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) due to Haemophilus influenzae (non-ß-lactamase-producing strains only), Moraxella catarrhalis (including ß-lactamase-producing strains) or Streptococcus pneumoniae.

Secondary Bacterial Infection of Acute Bronchitis (SBIAB) due to Haemophilus influenzae (non-ß-lactamase-producing strains only), Moraxella catarrhalis (including ß-lactamase-producing strains) or Streptococcus pneumoniae.

Pneumonia due to Streptococcus pneumoniae, Haemophilus influenzae (non-ß-lactamase-producing strains only), or Moraxella catarrhalis (including ß-lactamase-producing strains).

Urinary tract infections including cystitis, pyelonephritis and asymptomatic bacteriuria due to E. coli, Proteus mirabilis, Klebsiella pneumoniae, or Staphylococcus saprophyticus.

Skin and skin structure infections due to Staphylococcus aureus (methicillin-susceptible strains), Streptococcus pyogenes, or Staphylococcus epidermidis (including ß-lactamase-producing strains).

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DOSAGE AND ADMINISTRATION
Dosage in the different Bacticlor forms/strengths:

Bacticlor capsules (250 mg and 500 mg), children over 12 years and adults:
The usual recommended dosage is 250 mg every 8 hours, doubled for severe infections; maximum 4 g daily.

Bacticlor oral suspension (125 mg and 250 mg/5mL after constitution):
The usual recommended dosage is 20 mg/kg in divided doses every 8 hours, doses doubled for severe infections.
1 month-1 year: 62.5 mg
1-5 years: 125 mg
over 5 years: 250 mg

Bacticlor MR 375 mg tablets
The recommended dosage is one tablet twice daily, dosage doubled in severe infections.
Bacticlor MR may be given orally regardless to meals. However, absorption is enhanced when administered with food. The tablet should not be cut, crushed, or chewed.
Bacticlor should be administered for at least 10 days in the treatment of ß-haemolytic streptococcal infections.

Renal Impairment
Cefaclor should be administered cautiously in the presence of markedly impaired renal function. Dosage recommendations in such condition are:

Creatinine clearance         24 hour dose
(mL/min/1.73m2)
> 40                         No modification
40 to 10                     50 % of usual 24 hour dose 
< 10                         25 % of usual 24 hour dose 

Hepatic impairment
As cefaclor is not metabolised in the liver, no change in dosage is necessary in patients with hepatic impairment.

Method of preparation of oral suspension
Shake the bottle to loose the powder, add appropriate amount of water (40 mL) in two portions. Invert the bottle and shake it well after each addition. When constituted as specified, the forming suspension is red with a sweet taste and strawberry like flavour, the 5 mL of the resulting suspension contains 125 mg or 250 mg of cefaclor activity as the monohydrate. Shake well before using. Keep bottle tightly closed and after mixing store it in a refrigerator. The mixture may be kept for 14 days without significant loss of potency. Discard unused portion after 14 days.

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CONTRAINDICATIONS
Bacticlor (cefaclor) is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

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PRECAUTIONS
General
Prolonged use of cefaclor may result in the overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.
Bacticlor should be given cautiously to penicillin-sensitive patients. There is evidence of partial cross-allerginicity between cephalosporins and penicillins. If an allergic reaction occurs during therapy, the drug should be discontinued and the patient should be treated with appropriate medicine such as e.g. antihistamines, corticosteroids, and adrenaline. 

Usage in Pregnancy, Labor and Delivery: Reproduction studies using cefaclor have been performed in mice, rats at doses up to 3-5 times the maximum human dose (1500mg/day) based on mg/m2. These studies have revealed no harm to the fetus due to cefaclor. There are, however, no adequate and well-controlled studies in pregnant women. Cefaclor should be used during pregnancy only if clearly needed.
The drug has not been studied for use during labor and delivery. Treatment should be given only if clearly needed.

Nursing Mothers: Small amounts of cefaclor (

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential for cefaclor. Reproduction studies have revealed no evidence of impaired fertility.

Drug Interactions: The extent of absorption of Bacticlor is diminished when given within 1 hour with aluminium or magnesium hydroxide-containing antacids. H2 blockers do not alter either the rate or the extent of absorption of Bacticlor. The renal excretion of cefaclor is inhibited by probenicid.

Laboratory test interactions: Cephalosporin antibiotics may result in false-positive reaction for glucose in the urine when the test is performed using Benedict’s and Fehling’s solutions and also with Clinitest tablets but not with enzyme-based tests.

Pediatric and Geriatric use: Bacticlor suspension is not recommended for infants less than 1 month. No dosage adjustment is required for geriatric patients with normal renal functions.

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ADVERSE REACTIONS
The majority of adverse reactions observed in clinical trials of Bacticlor were mild and transient. The most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain, and hypersensitivity reactions such as rash and urticaria. Other reported adverse reactions were: slight elevations of SGOT, SGPT, serum creatinine, prolonged prothrombin time, genital pruritis and vaginal moniliasis. Dizziness, somnolence, insomnia have been reported rarely.
The following adverse reactions known to be associated with cephalosporin antibiotics were not observed in clinical trials but rare occurrences have been reported as serum-like sickness and pseudomembranous colitis.

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OVERDOSAGE
The treatment of overdosage includes: activated charcoal to decrease the absorption of the drug from the gastrointestinal tract, protection of patient’s airways, support ventilation and perfusion. Monitoring blood gases and serum electrolytes. Although cefaclor is considered dialysable, neither forced diuresis, peritoneal dialysis, hemodialysis, nor charcoal hemoperfusion have been demonstrated to be beneficial in an overdose of cefaclor.

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STORAGE
Store below 25 °C, protected from moisture.

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KEEP ALL MEDICINES OUT OF REACH OF CHILDREN PRESENTATION
Bacticlor capsules
Box containing 12 capsules of: 250 mg or 500 mg in two blister strips.

Bacticlor oral suspension
Bottle of 60 mL
125 mg/5mL after reconstitution
250 mg/5 mL after reconstitution

Bacticlor MR 375 mg film-coated tablets
Box containing 10 tablets in one strip.

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 详细处方信息以本药内容附件PDF文件（201881422144016.pdf）的“原文Priscribing Information”为准
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