英文药名：Cefdinir Fine Gr. 10% for Pediatric（Cefdinir）

中文药名：头孢地尼少儿用颗粒

生产厂家：武田制药

セフジニル細粒10％小児用「TYK」

治疗类别名称
口服头孢菌素制剂
批准上市日期：2009年5月
商標名
Cefdinir Fine Gr. 10% for Pediatric「TYK」
一般名
セフジニル、Cefdinir(JAN)
略号
CFDN
化学名
(6R,7R )-7-[(Z )-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetylamino]-8-oxo-3-vinyl-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid
分子式
C14H13N5O5S2
分子量
395.41
構造式

性状
白色至浅黄色的结晶粉末。
水，乙醇（95）或在乙醚中几乎不溶。
可溶于pH值7.0的0.1mol/L的磷酸盐缓冲液。
操作注意事项
1.避光，保存以避免湿气（凝固担心有由于衰落和水分由于光）
2.稳定性测试
使用最终的包装产品的加速试验（40℃，75％，6个月的相对湿度）的结果，这种药物据推测在市场流通的正常过程中稳定的三岁以下。
药效药理
头孢地尼的施加点的变化取决于物种，但1青霉素结合蛋白（PBP）（1α，1BS），亲和2和3是高，通过抑制细菌细胞壁的合成显示出抗菌活性。
有革兰氏阳性菌和阴性菌，尤其是革兰氏阳性菌的金黄色葡萄球菌，比常规的口服头孢烯剂如链球菌属的更强的广泛的抗菌谱，徒杀菌。
稳定到β-内酰胺酶，显示了抗菌活性，优于β-内酰胺酶生产菌。
适应病症
金黄色葡萄球菌的代理感性，链球菌属，肺炎链球菌，莫拉（布兰汉）卡他莫拉菌，大肠杆菌，克雷伯氏菌，变形杆菌，流感嗜血杆菌
浅表皮肤感染，深层皮肤感染，淋巴管，淋巴结炎，慢性脓皮病，咽炎，喉炎，扁桃体炎，急性支气管炎，肺炎，膀胱炎，肾盂肾炎，中耳炎，鼻窦火焰，猩红热。
用法与用量
正常，口服分为每天服用9〜18毫克（效价）/ kg的三倍，对儿童的头孢地尼。
用量应适当地根据年龄和状况进行调整。
包装规格
瓶装：100g
制造厂商
武田薬品工業株式会社

原研药品资料附件：http://www.info.pmda.go.jp/go/pack/6132013C1112_1_07/
Cefdinir Fine Gr. 10% for Pediatric（Cefdinir）
Cefzon - General Information:
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.