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【药品名称】

  通用名称：头孢特仑新戊酯片

  商品名称：头孢特仑新戊酯片

  英文名称：Cefteram Pivoxil Tablets

 

【主要成份】 盐酸头孢他美酯 。

【性 状】 本品为浅橙色薄膜包衣片，除去包衣后显白色至类白色。

【适应症/功能主治】 用于链球菌属(肠球菌除外)、肺炎球菌、化脓性链球菌属、淋球菌、大肠杆菌、柠檬酸菌属、克雷伯氏菌属、肠杆菌属、沙雷氏菌属、变形杆菌属、流感嗜血杆菌等敏感细菌引起的感染性疾病。

【规格型号】 50mg*6s

【用法用量】 咽喉炎（咽炎、喉炎）、扁桃体炎（扁桃体周围炎、扁桃体周围脓肿）、急性支气管炎、肾孟肾炎、膀肤炎、子宫附件炎、子宫内膜炎、子宫内感染、巴氏腺炎、巴氏腺脓肿时：成人常规剂量为一日三次，一次50-1 OOmg，饭后口服慢性支气管炎、弥漫性细支气管炎、支气管扩张（感染时）、慢性呼吸系统疾病的重复感染、肺炎、中耳炎、副鼻窦炎、淋菌性尿道炎、牙周炎、冠周炎、上领炎时：成人常规剂量为一日三次，一次100-200mg，饭后口服。对干重度肾功能不全患者，应慎重服药，适当调整剂量和间隔。

【不良反应】 1.消化系统：常见腹泻、恶心、呕吐。偶有伪膜性肠炎、腹胀、胃灼热、腹部不适、血中胆红素升高、氨基转移酶一过性升高等。 2.皮肤：偶有出现瘙痒、局部浮肿、紫癜、皮疹等。 3.中枢神经系统：偶有出现头痛、眩晕、衰弱、疲劳感等。 4.血液系统：偶有白细胞减少、嗜酸性粒细胞增多、血小板增多等，均为一过性反应。 5.其它罕见的反应有：齿龈炎、直肠炎、结膜炎、药物热等。

【禁 忌】 对头孢特仑或本剂成分过敏的患者。

【注意事项】 1.对青霉素类药物过敏者慎用。 2.若发生严重过敏反应，应立即停药，并紧急治疗。 3.在使用本品期间，由于肠道微生物的改变，可能导致伪膜性肠炎。若发生假膜性肠炎，应积极治疗(推荐使用万古霉素)。 4.本品应放到儿童触及不到的地方。
请仔细阅读说明书并遵医嘱使用。

【儿童用药】 尚不明确。

【老年患者用药】 尚不明确。

【孕妇及哺乳期妇女用药】 1.由于缺乏有关人类胎儿的临床数据，妇女妊娠期间，不推荐使用本品。若有对该药敏感的微生物严重感染时，必须充分权衡利弊。 2.在乳汁中尚未发现本品的代谢物。

【药物相互作用】 抗酸剂，H2受体拮抗剂对本品的药代动力学无影响。目前尚未见到本品对实验室检测值和/或方法有影响的报道，也未观察到伴随利尿药治疗的患者在使用本品时对肾功能的损伤。

【药物过量】 尚不明确。

【药理毒理】 本品的作用机制是阻断细菌细胞壁的合成。头孢特仑与青霉素结合蛋白(PBP)中的3、1A、1Bs具有很强的结合性，从而发挥杀菌作用。头孢特仑对革兰阳性菌、阴性菌均有抗菌作用。尤其对革兰阳性菌中的链球菌属、肺炎球菌，革兰阴性菌中的大肠杆菌、克雷伯氏菌属，淋球菌、流感嗜血杆菌及厌氧的消化链球菌属等更显示很强的抗菌作用。对以往口服头孢制剂(先锋IV号、头孢克洛等)不敏感的沙雷氏菌属、吲哚阳性变形杆菌、肠杆菌属、柠檬酸菌属等显示良好的抗菌作用。头孢特仑对各种细菌产生的β-内酰胺酶稳定，故对产β-内酰胺酶的菌株有效。 未见头孢特仑致癌和致畸的文献报道。

【药代动力学】 头孢特仑新戊酯在体内代谢成头孢特仑后，发挥抗菌活性。健康人饭后口服本品200mg时，抗菌活性成分头袍特仑在血液中达到很高的浓度，3小时达血药浓度峰值2.9μg/ml，半衰期为0.9小时。头袍特仑吸收后在痰液、中耳液、扁桃体、上领窦粘膜、奥息肉、筛窦粘膜、尿道分泌物、子宫中均达到较高的浓度。头抱特仑新戊醋吸收后，在肠壁被酯酶代谢成为有抗菌活性的头孢特仑和三甲基醋酸。三甲基醋酸和肉毒碱结合后，以三甲基肉毒碱形式从尿中排泄。部分头孢特仑以活性形式经胆汁排泄，大部分经尿排泄。几乎不从乳汁中分泌。健康人口服本品200mg时，服药后8小时尿中平均回收率为32.8%肾功能不全息者在饭后连续放用本品100mg时，如下表所示，随着肾功能下降，血液中药物的半衰期延长。

【贮 藏】 遮光，密封保存。

 

 

 

 

 

 

 

 

Description

This medicine kills bacteria. It is cephem antibiotics used to treat infections.
It is usually used in the treatment of wide-range infections such as respiratory infections, otological infections, urinary tract infections, etc.

Presentation

Feature

pale orange tablet (φ: 6.6 mm, thickness: 3.1 mm)

Active Ingredients

Cefteram pivoxil 50mg

Effect/Efficacy

This medicine kills bacteria. It is cephem antibiotics used to treat infections.
It is usually used in the treatment of wide-range infections such as respiratory infections, otological infections, urinary tract infections, etc.

Usage/Dosage

General dosage regimen:
For pharyngitis/laryngitis, tonsillitis (including peritonsillitis and peritonsillar abscess), acute bronchitis, cystitis, pyelonephritis, bartholinitis, intrauterine infection, uterine adnexitis, for adults, take 1-2 tablet(s) (50-100 mg of the active ingredient) at a time, 3 times a day, after meal. The dosage should be adjusted according to the disease, age or symptoms. Strictly follow the instructions of your doctor/pharmacist.
For pneumonia, secondary infection of chronic respiratory disease, urethritis, otitis media, sinusitis, periodontal inflammation, pericoronitis, jaw inflammation, for adults, take 2-4 tablets (100-200 mg of the active ingredient) at a time, 3 times a day, after meal. The dosage should be adjusted according to the disease, age or symptoms. Strictly follow the instructions of your doctor/pharmacist.

Take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose.

If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.

Do not stop taking the medicine without the instructions of your doctor.

Cautions

Before using this medicine, be sure to tell your doctor and pharmacist

If you ever experienced any allergic reaction (itch, rash, etc.) to any medicine.
If you or your family have allergic tendency (bronchial asthma, rash, urticaria, etc.).
If you are a patient with renal dysfunction, poor ingestion/parenteral nutrition, poor general status.

If you are pregnant or breastfeeding.

If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Keep out of the reach of children. Store away from direct sunlight, heat, moisture.
Store with care as it may be discolored by light over time.
Discard the remainder. Do not store them.

Contraindication

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: diarrhea, rash, loss of appetite, discomfort in stomach, etc.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.

breathing difficulty, swelling around eyes or lips, systemic redness accompanied by itching [shock, anaphylactoid symptoms]
redness in the skin, blister, bulbar conjunctival congestion [toxic epidermal necrosis, Stevens-Johnson syndrome]
edema, decreased urine output, loss of appetite [acute renal failure]
abdominal pain, diarrhea, melena [pseudomembranous colitis]
general malaise, loss of appetite, yellowing in the skin or conjunctiva [hepatic dysfunction, jaundice]

The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.