【中文名称】头孢地尼颗粒
【产品英文名称】Cefdinir Granules
【生产企业】Astellas Toyama Co.， Ltd. Takaoka Plant
【功效主治】对头孢地尼敏感的葡萄球菌属肺炎球菌伯雷汉氏菌大肠杆菌克雷白菌奇异变形杆菌流感杆菌等株所引起的下列感染：毛囊炎疖疖肿痛传染性脓痂疹丹毒蜂窝组织炎淋巴管炎淋巴管炎炭疽化脓性甲沟炎皮下脓肿汗腺炎粉瘤感染慢性脓皮症咽喉头炎急性支气管炎扁桃腺炎肺炎肾盂肾炎膀胱炎猩红热中耳炎副鼻窦炎
【化学成分】主要成份头孢地尼化学名称：（-）（6R7R）-7-[（Z）-2-（2-氨基噻唑-4-基）-2-羟亚氨基乙羟氨基乙酰氨基]-8-氧代3-乙烯基硫杂氮杂双环[420]辛-2-烯-2-羧酸
【药理作用】抗菌作用：对革兰氏性阳性菌和革兰阴性菌有广围的抗菌谱特别是对革兰氏阳性菌中的葡萄球菌属链球菌属等比过去的口服头孢菌素有更强的抗菌活性。其作用方式是杀菌性的对各种细菌产生的β-内酰胺酶稳定对β-内酰胺酶的产生菌也具有优异的抗菌活性作用机制，作用机制为阻止细胞壁的合成其作用点因菌种而异对青霉素结合蛋白（PBP）的1（1a,1bs）23位亲和性强
【药物相互作用】与铁剂合用可降吸收有减效的可能
【不良反应】休克：偶有休克发生要严密观察当有不适感口内异常感喘鸣眩晕便意耳鸣出汗等等症状时应停药过敏症：当有皮疹荨麻疹红斑瘙痒发烧等过敏症状出现时应停药并进行适当处理血液：偶有粒细胞减少嗜酸性白细胞增多当发现有上述异常时应停药此外有报告其它的头孢类抗生素曾有溶血性贫血的发生肝脏：偶有s—GPTS—GOT,ALP升高肾脏：偶有BUN升高此外有报告其它的头孢类抗生素偶可引起急性肾衰等重症肾功能障碍当发现异常时应停药进行适当处理消化道：其它的头孢类抗生素引起伴有血便的伪膜性大肠炎等重症大肠炎的报告此外偶有发生恶心腹泻腹痛胃部不适烧灼感食欲不振便秘等呼吸道：其它头孢类抗菌素有伴发烧咳嗽呼吸困难胸部X射线异常嗜酸性异常嗜酸性白细胞多等的间质性肺炎PIE症候群等当发现有上述异常时应停药进行适当处理如给予肾上腺皮激皮质激素等菌群失调 偶有口内炎念珠菌症维生素缺乏症偶有维生素K缺乏症（低凝血酶原血症出血倾向等）和B族维生素缺乏症（舌炎口内炎食欲不振神经炎等）其它：偶有头痛眩晕胸部压迫感
【禁忌症】对本品有休克史者禁用
【用法用量】成人服用的常规剂量为100mg一日3次，儿童服用的常规剂量为每日9~18mg，分3次口服。
【贮藏方法】密封保存
【注意事项】因有出现休克等过敏反应的可能，要进行详细问诊。下列患者应慎重使用对青肺素有过敏史者本人或亲属中有易发生支气管哮喘，皮疹，荨麻疹等过敏症状体质者。严重的肾功能障碍者不能很好进食或非经口报取营养，恶液质等患者（因可出现维生素K缺乏，要进行严密临床观察）对临床检验值的影响除尿糖试验纸法之处，在用Benedict试剂、Fehling试剂和Clinitest试验法进行尿糖检查时，可出现假阳性。

【原产地英文商品名】:Cefzon Granule 200g/bottle
【原产地英文药品名】:Cefdinir
【中文参考商品译名】:全泽复颗粒剂 200克/瓶
【中文参考药品译名】:头孢地尼
【生产厂家中文参考译名】:安斯泰来
【生产厂家英文名】:Astellas

Cefzon - General Information:
Cefzon (marketed by Abbott Laboratories under the brand name Omnicef) is a semi-synthetic, broad-spectrum antibiotic in the third generation of the cephalosporin class, proven effective for common bacterial infections of the ear, sinus, throat, and skin. It was approved by the U.S. Food and Drug Administration (FDA) in December of 1997.

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Pharmacology:
Cefzon is a third generation cephalosporin with a broad spectrum of activity against enteric gram-negative rods. Cefzon is stable in the presence of some, but not all, b-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins are susceptible to cefdinir. Cephalosporins work the same way as penicillins: they interfere with the peptidoglycan synthesis of the bacterial wall by inhibiting the final transpeptidation needed for the cross-links. This effect is bactericidal.

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Cefzon for patients
Patients should be counseled that antibacterial drugs including OMNICEF should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When OMNICEF is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by OMNICEF or other antibacterial drugs in the future.

Antacids containing magnesium or aluminum interfere with the absorption of cefdinir. If this type of antacid is required during OMNICEF therapy, OMNICEF should be taken at least 2 hours before or after the antacid.

Iron supplements, including multivitamins that contain iron, interfere with the absorption of cefdinir. If iron supplements are required during OMNICEF therapy, OMNICEF should be taken at least 2 hours before or after the supplement.

Iron-fortified infant formula does not significantly interfere with the absorption of cefdinir. Therefore, OMNICEF for Oral Suspension can be administered with iron-fortified infant formula.

Diabetic patients and caregivers should be aware that the oral suspension contains 2.86 g of sucrose per teaspoon.

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Cefzon Interactions
Antacids (aluminum- or magnesium-containing)
Concomitant administration of 300-mg cefdinir capsules with 30 mL Maalox® TC suspension reduces the rate (Cmax) and extent (AUC) of absorption by approximately 40%. Time to reach Cmax is also prolonged by 1 hour. There are no significant effects on cefdinir pharmacokinetics if the antacid is administered 2 hours before or 2 hours after cefdinir. If antacids are required during OMNICEF therapy, OMNICEF should be taken at least 2 hours before or after the antacid.

Probenecid
As with other b-lactam antibiotics, probenecid inhibits the renal excretion of cefdinir, resulting in an approximate doubling in A.C. a 54% increase in peak cefdinir plasma levels, and a 50% prolongation in the apparent elimination half-life.

Iron Supplements and Foods Fortified With Iron
Concomitant administration of cefdinir with a therapeutic iron supplement containing 60 mg of elemental iron (as FeSO4) or vitamins supplemented with 10 mg of elemental iron reduced extent of absorption by 80% and 31%, respectively. If iron supplements are required during OMNICEF therapy, OMNICEF should be taken at least 2 hours before or after the supplement.

The effect of foods highly fortified with elemental iron (primarily iron-fortified breakfast cereals) on cefdinir absorption has not been studied.

Concomitantly administered iron-fortified infant formula (2.2 mg elemental iron/6 oz) has no significant effect on cefdinir pharmacokinetics. Therefore, OMNICEF for Oral Suspension can be administered with iron-fortified infant formula.

There have been rare reports of reddish stools in patients who have received cefdinir in Japan. The reddish color is due to the formation of a nonabsorbable complex between cefdinir or its breakdown products and iron in the gastrointestinal tract.

Drug/Laboratory Test Interactions
A false-positive reaction for ketones in the urine may occur with tests using nitroprusside, but not with those using nitroferricyanide. The administration of cefdinir may result in a false-positive reaction for glucose in urine using Clinitest®, Benedictís solution, or Fehling's solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix® or Tes-Tape®) be used. Cephalosporins are known to occasionally induce a positive direct Coombsí test.

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Cefzon Contraindications
OMNICEF (cefdinir) is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

セフジニル小児用細粒10％「ＣＨ」

組成

性状

注册证号 H20110060
原注册证号 
产品名称（中文） 头孢地尼颗粒
产品名称（英文） Cefdinir Granules
商品名（中文） 全泽复
商品名（英文） Cefzon
剂型（中文） 颗粒剂
规格（中文） 50mg
注册证号备注 
包装规格（中文） 6袋、9袋/盒
生产厂商（中文） 
生产厂商（英文） Astellas Toyama Co., Ltd. Takaoka Plant
厂商地址（中文） 
厂商地址（英文） 30 Toidesakae-machi, Takaoka city, Toyama 939-1118，Japan
厂商国家（中文） 日本
厂商国家（英文） Japan
分包装批准文号 
发证日期 2011-02-01
有效期截止日 2016-01-31
分包装企业名称 
分包装企业地址 
分包装文号批准日期 
分包装文号有效期截止日 
产品类别 化学药品
药品本位码 86979363000364
药品本位码备注 
公司名称（中文） 
公司名称（英文） Astellas Pharma Inc.
地址（中文） 
地址（英文） 3-11, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo 103-8411，Japan
国家（中文） 日本
国家（英文） Japan