英文药名: Spectracef(Cefditoren Tablets)

中文药名: 头孢妥仑匹酯片

药品说明

【中文品名】头孢托仑匹酯 　　
【药效类别】抗生素>头孢菌素类 　　
【通用药名】头孢妥仑匹酯,头孢妥仑匹酯片,Meiact,Spectracef,美爱克,头孢托仑酯,Cefditoren Pivoxil Tablets,再乐 　　
【别　名】Spectracef 　　
【化学名称】 5-Thia-1-azabicyclo[4,2,0]oct-2-ene-2-carboxylic acid, 7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[(1Z)-2-(4-methyl-5-thiazolyl)ethenyl]-8-oxo-, (2,2-dimethyl-1-oxopropoxy)methyl ester, (6R,7R)- 　　
化学名为：（-）-（6R，7R）-2，2-二甲基丙酰氧甲基7-[（Z）-2-（2-氨基-4-噻唑基）-2-甲氧基亚氨乙酰氨基]-3-[（Z）-2-（4-甲基-5-噻唑基）乙烯基]-8-氧代-5-硫杂-1-氮杂二环[4，2，0]辛-2-烯-2-羧酸酯. 　　
【分 子 式】C25H28N6O7S3 　　
【分 子 量】：620.73 　　

适应症
头孢妥仑匹酯是有日本明治制果株式会社研发的，于1994年4月1日首次在日本上市。本品在日本的批准适应症为：治疗各种感染症如呼吸道、皮肤感染、尿路感染等。上市后的临床评价皮肤科领域的有效率为93.1%，外科领域的有效率为100%，呼吸科领域为97.9%，尿路感染为94.6%，猩红热为100%，百日咳为100%，耳鼻喉科维100%。

用法用量
成人
·常规剂量
·口服给药一次200mg，一日2次。
[国外用法用量参考]
成人
·常规剂量
·口服给药
1.慢性支气管炎：一次400mg，一日2次，连续10日。
2.社区获得性肺炎：一次400mg，一日2次，连续14日。
3.咽炎和扁桃体炎：一次200mg，一日2次，连续10日。
4.皮肤及皮肤附件感染：一次200mg，一日2次，连续10日。
5.泌尿道感染：有报道，一次100-200mg，一日3次，对泌尿道感染有效。
·肾功能不全时剂量
肾功能不全者应根据肌酐清除率调整用药剂量：
(1)肌酐清除率小于30ml/min者，用药剂量不应超过一次200mg，一日1次。
(2)肌酐清除率为30-49ml/min者，用药剂量不应超过一次200mg，一日2次。
(3)肌酐清除率为50-80ml/min者，无需调整剂量。
儿童
·常规剂量
·口服给药12岁以上儿童，用法与用量同成人。12岁以下儿童的用药安全性和有效性尚未确立，但在儿童临床用药研究中，也有使用一次3-6mg/kg，一日3次，连续用药2周的方法。

给药说明
1.本药宜餐时或餐后服用，以利吸收。
2.本药不宜与抗酸药或任何会降低胃酸的药物同服，以免影响吸收。
3.本药不宜长期使用，以免血清肉毒碱浓度降低。

不良反应
1.过敏反应皮疹、瘙痒、荨麻疹和发热等较多见。
2.胃肠道恶心、呕吐、腹泻、腹痛、消化不良等症状较多见；罕见假膜性肠炎。
3.血液可出现嗜酸粒细胞增多症、白细胞减少等；大剂量用药可出现低凝血因子Ⅱ血症。
4.肾脏偶见尿素氮及血清肌酸酐值升高。
5.肝脏偶见碱性磷酸酶、血清丙氨酸氨基转移酶、血清天门冬氨酸氨基转移酶暂时性升高。
6.其它有报道，长期用药可降低血清中肉毒碱浓度。
[国外不良反应参考]
除以上不良反应外，国外尚有用药后偶致血小板增多、头痛、阴道念珠菌病的报道。

注意事项
1.交叉过敏对一种头孢菌素类药过敏者对其它头孢菌素类药也可能过敏；对青霉素类、青霉素衍生物或青霉胺过敏者也可能对头孢菌素类药过敏。
2.禁忌症
(1)对本药或其它头孢菌素类药过敏者。
(2)先天性肉毒碱缺陷患者或存在可能导致肉毒碱缺陷的代谢障碍者(国外资料)。
(3)对酪蛋白过敏者(国外资料)。
3.慎用
(1)对青霉素类药有过敏史者。
(2)高度过敏性体质者(国外资料)。
(3)严重肾功能不全者(国外资料)。
(4)有慢性胃肠道疾病病史者，特别是溃疡性结肠炎、克罗恩病或假膜性肠炎者。
4.药物对儿童的影响小于12岁儿童的用药安全性尚未确定。
5.药物对妊娠的影响妊娠期用药的安全性尚未确定，孕妇或可能妊娠的妇女，应权衡利弊后用药。美国药品和食品管理局(FDA)对本药的妊娠安全性分级为B级。
6.药物对哺乳的影响大鼠试验中本药可排泄至乳汁中。药物是否能经人乳汁分泌尚不清楚，哺乳妇女应慎用。
7.药物对检验值或诊断的影响
(1)本尼迪克特尿糖试验、费林尿糖试验或用Clintesttabets试纸检查尿糖时可呈假阳性。
(2)直接抗球蛋白试验(Coombs)可呈阳性反应。
8.用药前后及用药时应当检查或监测
(1)长期用药应检测肉毒碱浓度。
(2)应定期监测凝血酶原时间，尤其是肝肾功能不全者和营养不良者。
(3)应定期监测肝、肾功能。
规格：200mg  *60 片

Brand name:
Spectracef
Generic name: Cefditoren

Why is Spectracef prescribed?
Spectracef cures mild-to-moderate bacterial infections of the skin, throat, and respiratory tract. Among these infections are pneumonia, strep throat, and tonsillitis. Spectracef is also prescribed for acute flare-ups of chronic bronchitis. Spectracef is a cephalosporin antibiotic.

Most important fact about Spectracef
If you are allergic to either penicillin or cephalosporin antibiotics (such as cefuroxime and cefdinir), consult your doctor before taking Spectracef. An allergy to either type of medication may indicate a possible allergy to Spectracef, and if a reaction does occur, it could be extremely severe. Seek medical attention immediately if you develop any signs of an allergic reaction, including rash, hives, breathing problems, or swelling of the face or throat.

How should you take Spectracef?
Spectracef should be taken with meals to enhance absorption. Do not take it with antacids or other medications that reduce stomach acid.

To make certain your infection is completely cleared up, take all of the medication exactly as your doctor prescribes, even if you begin to feel better after the first few days.

Certain antibiotics are known to interfere with oral contraceptives; however, it's okay to take Spectracef if you're using birth control pills.

If you miss a dose...
Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take two doses at once.
Storage instructions...
Store at room temperature; protect from light and moisture.
What side effects may occur?
Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe to continue using Spectracef.

Side effects may include:
Diarrhea, headache, nausea, vaginal infection
Special warnings about Spectracef
Notify your doctor if you have had allergic reactions to penicillins or cephalosporin antibiotics.

If you have a history of gastrointestinal disease, particularly colitis, take Spectracef with caution. If you develop diarrhea while taking Spectracef, check with your doctor. The problem could be a sign of a serious condition.

Be sure to tell your doctor if you have kidney problems. Your dosage may have to be lowered.

Spectracef should be used only for short-term treatment. Taking this medication for too long could lead to a deficiency of the amino acid carnitine. Certain people, especially those with kidney problems or decreased muscle mass, are more likely to develop a carnitine deficiency.

Cephalosporin antibiotics such as Spectracef could interfere with blood clotting. Especially at risk are people who have kidney or liver problems, are undernourished, or have been taking blood thinners or long-term antibiotic treatment.

Repeated use of Spectracef may result in an overgrowth of bacteria that do not respond to the medication and can cause a secondary infection. Therefore, do not save this medication for use at another time. Take this medication only when directed to do so by your doctor.

Possible food and drug interactions when taking Spectracef
If Spectracef is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Spectracef with the following:

Antacids

Blood thinners such as warfarin

Probenecid

Ulcer drugs known as H2 blockers such as famotidine。

Special information if you are pregnant or breastfeeding

The effects of Spectracef during pregnancy or labor and delivery have not been adequately studied. If you are pregnant or plan to become pregnant, tell your doctor immediately.

Animal studies show that Spectracef can appear in breast milk. If this medication is essential to your health, your doctor may advise you to stop breastfeeding until your treatment is finished.

Recommended dosage for Spectracef
ADULTS AND CHILDREN 12 YEARS AND OLDER

For Acute Flare-ups of Chronic Bronchitis

The usual dose is 400 milligrams twice a day for 10 days.

For Pharyngitis, Tonsillitis, and Skin Infections

The usual dose is 200 milligrams twice a day for 10 days.

For Community-Acquired Pneumonia

The usual dose is 400 milligrams twice a day for 14 days.

If you have kidney disease, the dose may be lower.

CHILDREN LESS THAN 12 YEARS OLD

Spectracef has not been studied in children less than 12 years old and should not be used in this age group.

Overdosage
Although no specific information is available, an overdose of cephalosporin antibiotics has been known to cause nausea, vomiting, stomach problems, and convulsions. Any medication taken in excess can have serious consequences. If you suspect an overdose of Spectracef, seek medical attention immediately.