部份中文头孢地尼处方资料（仅供参考）
通用名称：头孢地尼
英文名称：Cefdinir
适应症
本品适用于治疗由敏感菌引起的轻度至中度感染。详见包装内部说明书。
用法用量
口服，通常成人每日3次，每次100mg(1粒)。一天最大用药量是600mg(6粒)。(详见说明书)
不良反应
美国3275例患者口服本品600mg/日，其不良反应情况如下。大部分副作用温和且具有自身限制性。无死亡或劳动力永久丧失病例。125例病人由于腹泻或恶心停止用药，17例病人由于出诊停止用药。这些不良反应可能与服用多重剂量头孢地尼有关。(详见说明书)
禁 忌
对头孢菌素药物过敏者禁用。
注意事项
1.一般情况：和其它光谱抗生素一样，长期使用可能会发生意外和耐药菌的增加，必须随时注意观察，治疗期间如果感染加重，需改变治疗方法。和其它广谱抗生素一样，对有结肠炎病史的患者需慎重用药。暂时的或持续的肾功能障碍患者(Clcr﹤30毫升/分)由于服用头孢地尼后血药浓度高且持续时间长，需减少每天的用药量。
2.患者须知：含镁或铝的抗酸药物影响头孢地尼的吸收。如果在服用头孢地尼期间必须服用上述抗酸药物，需间隔2小时以上。铁剂包括含铁的复合维生素影响头孢地尼的吸收。如果在服用头孢地尼期间必须服用上述铁剂药物，需间隔2小时以上。婴儿增铁配方对头孢地尼的吸收没有明显的影响，因此可以与悬浮液同时服用。
儿童用药
童用药参见头孢地尼颗粒说明书。
老年患者用药
根据对患者的临床观察调整剂量和给药间隔：
1.由于身体机能下降，老年患者可能容易出现不良反应。
2.由于维生素K缺乏，老年患者可能会有出血倾向。
孕妇及哺乳期妇女用药
有关妊娠期的用药，其安全性尚未确立。对孕妇或怀疑有妊娠的妇女，用药要权衡利弊，只有在利大于弊的情况下，才能使用。哺乳期妇女用药应权衡利弊，只有在利大于弊的情况下，才能使用。
药物相互作用
本品与下列药物合用时需慎重。铁制剂的体征、症状及治疗为由于可能导致头孢地尼的吸收降低约10%，因此建议避免与此类药物合用。如果合用不能避免，二者的给药间隔应大于3小时；机制及风险因素：本品可与铁离子在肠道中结合，形成一种难以吸收的复合物。华法林钾的体征、症状及治疗为华法林钾的作用可能加强，但尚无二者相互作用的报告；机制及风险因素：本品可能抑制肠道细菌产生维生素K。抗酸药（含铝或镁）的体征、症状及治疗为由于可导致头孢地尼的吸收降低而使其作用减弱，因此应在服用本品2个小时以后方可使用抗酸药物，机制及风险因素机制尚不明确。
药物过量
尚不明确。
药理毒理
头孢地尼为半合成的、广谱的口服第三代头孢菌素，其通过抑制细菌细胞壁的合成产生抗菌作用。本品对革兰氏阳性菌和阴性菌均有抗菌活性，并对大部分β－内酰胺酶稳定，所以许多耐青霉素和头孢菌素的微生物对本品敏感。体外和临床研究表明，本品对以下细菌敏感：革兰氏阳性需氧菌：金黄色葡萄球菌(含产β－内酰胺酶菌) 注意：本品对耐甲氧西林的葡萄球菌属无效。肺炎链球菌(仅对青霉素敏感的菌) 化脓链球菌革兰氏阴性需氧菌：流感嗜血菌(含产β－内酰胺酶菌) 副流感嗜血菌(含产β－内酰胺酶菌) 卡他莫拉菌属(含产β－内酰胺酶菌) 体外试验还表明，革兰氏阳性需氧菌的表皮葡萄球菌(仅对耐甲氧西林的菌)、无乳链球菌和革兰氏阴性需氧菌的异型枸橼酸杆菌、大肠杆菌、鼻硬结克雷伯杆菌、奇异变形杆菌对本品敏感。
药代动力学
血药浓度：–6名健康成人一次空腹口服50、100、200mg（效价）头孢地尼时，约经4小时后可达到血药峰浓度，分别为0.64、1.11和1.74µg/ml，其血浆半衰期为1.6~1.8小时。反分药子 6名健康成人一次空腹和进食后口服100mg（效价）头孢地尼，约经4小时后，可达到血药峰浓度，分别为1.25、0.79µg/ml。进食后给药，其吸收稍有降低。肾功能受损患者一次口服100mg（效价）头孢地尼，血浆半衰期延长与肾受损程度成正比。
贮 藏
避光、密封。
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.