英文药名: Ceclor (Cefaclor Capsules)

中文药名: 头孢克洛胶囊

药品名称

【分类】抗生素/β-内酰胺类/头孢菌素类
【别名】头孢氯氨苄、新达罗；欣可诺；喜福来-光华；可福乐；头孢克罗、希刻劳、单水头孢氯氨苄
【外文名】Cefaclor，Alfatil，Ceclor，Distaclor，Ketlor，Panacef，Panoral
适应症

本品为半合成的第二代头孢菌素，抗菌谱及抗菌活性与头孢唑啉相似。对肺炎球菌、化脓性链球菌、葡萄球菌、奇异变形杆菌、大肠杆菌和肺炎杆菌、流感嗜血杆菌、淋病双球菌及厌氧菌等有良好抗菌活性。对产酶金葡菌、A型溶血性链球菌、草绿色链球菌和表皮葡萄球菌的活性与头孢羟氨苄相似。对奇异变形杆菌的活性也较强。临床主要用于呼吸道感染、如气管炎、肺炎、咽炎、扁桃体炎；尿路感染，如肾盂肾炎、膀胱炎、淋球菌性尿道炎；皮肤软组织感染。T1/2=0.6-0.9h。
用法用量

空腹口服：
成人：一次250mg，每日3次，较重感染可加倍。
儿童：每日20mg/kg(体重)分3次服用。
任何疑问，请遵医嘱！
不良反应

①胃肠道反应：胃部不适感、食欲不振、软便、腹泻等。
②过敏反应：皮疹、皮痒。
③过性SGPT升高及可逆性间质性肾炎。
④Coomb's试验可为阳性。
注意事项

①对头孢菌素过敏者禁用，青毒素过敏者慎用。
②严重肾功能损害者慎用。
③有结肠炎者慎用。
规格

胶囊剂：250mg;  500mg
干糖浆：5ml：125mg，5m1：250mg

【原产地英文商品名】Cefaclor 500mg/capsule 100capsules/box
【原产地英文药品名】Cefaclor
【中文参考商品译名】
注：以下产品不同的规格和不同的价格，购买时请咨询为准
·头孢克洛 500毫克/胶囊 100胶囊/盒
·头孢克洛 250毫克/胶囊 100胶囊/盒
【中文参考药品译名】头孢克洛
【生产厂家中文参考译名】Novopharm
【生产厂家英文名】Novopharm

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.