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 详细处方信息以本药内容附件PDF文件（2019101414213723.pdf）的“原文Priscribing Information”为准
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 部分中文红霉素乙基琥珀酸酯片处方资料（仅供参考）

【英文名称】Erythromycin Ethylsuccinate Tablet

【适用证】

为减少耐药菌的产生并保持红霉素乙基琥珀酸酯片，USP和其他抗菌药物红霉素乙基琥珀酸酯片的使用，USP仅应用于治疗或预防已被证实或强烈怀疑引起感染的疾病通过易感细菌。当可获得培养物和药敏性信息时，在选择或修改抗菌疗法时应考虑它们。在缺乏此类数据的情况下，局部流行病学和易感性模式可能有助于经验性治疗的选择。

红霉素乙基琥珀酸酯片可用于治疗以下疾病中由指定生物体的易感菌株引起的感染：

由化脓性链球菌，肺炎链球菌或流感嗜血杆菌引起的轻度至中度上呼吸道感染（当与足够剂量的磺胺类药物同时使用时，由于许多流感嗜血杆菌菌株对通常达到的红霉素浓度不敏感（请参阅适当的磺酰胺标签以获取处方信息。）

由肺炎链球菌或化脓性链球菌引起的轻度至中度严重程度的下呼吸道感染。

李斯特菌引起的李斯特菌病。

百日咳博德特氏菌引起的百日咳。红霉素可以有效地从感染者的鼻咽中清除该生物体，使其无感染力。一些临床研究表明，红霉素可能有助于预防易感人群中的百日咳。

由于肺炎支原体引起的呼吸道感染。

由化脓性链球菌或金黄色葡萄球菌引起的轻度至中度的皮肤和皮肤结构感染（治疗期间可能出现耐药性葡萄球菌）。
 

【用法用量】 可以服用红霉素乙基琥珀酸酯片而不考虑进餐。为避免味道不佳，请勿咀嚼400毫克片剂。

儿童

感染的年龄，体重和严重程度是确定适当剂量的重要因素。在轻度至中度感染中，儿童红霉素乙基琥珀酸酯的常规剂量为每6小时30到50 mg / kg /天，均分。对于更严重的感染，该剂量可以加倍。如果需要每天两次，则每12小时可提供每日总剂量的一半。每天也可通过每8小时服用每日总剂量的三分之一来给予3次剂量。

对于轻度至中度感染，建议使用以下剂量表：

体重；总日剂量

10磅以下； 30至50mg / kg /天15至25 mg / lb /天

10至15磅； 200毫克

16至25磅； 400毫克

26至50磅； 800毫克

51至100磅； 1200毫克

超过100磅； 1600毫克

成人

通常每6小时服用400 mg的琥珀酸红霉素。根据感染的严重程度，每天可增加剂量至4g。如果需要每天两次，则每12小时可提供每日总剂量的一半。每天也可通过每8小时服用每日总剂量的三分之一来给予3次剂量。

对于成人剂量计算，使用400毫克红霉素活性作为琥珀酸乙酯与250毫克红霉素活性作为硬脂酸酯，碱或雌二醇的比例。

在治疗链球菌感染时，应给予治疗剂量的琥珀酸红霉素至少10天。在持续预防风湿性心脏病史的人中链球菌感染的复发中，通常的剂量是每天两次400 mg

用于治疗由于沙眼衣原体或解脲支原体引起的尿道炎 每天三次，每次800 mg，共7天。

用于治疗原发性梅毒

成人48至64 g，分10到15天服用。

用于肠道阿米巴病

成人每天四次服用400毫克，持续10至14天。

30至50 mg / kg /天的儿童分剂量服用10至14天
 

【禁忌】

对这种抗生素过敏的患者禁用红霉素。

服用特非那定，阿司咪唑，匹莫唑或西沙必利的患者禁忌使用红霉素（请参阅预防措施-药物相互作用）。

不要将红霉素与被CYP 3A4广泛代谢的HMG CoA还原酶抑制剂（他汀类药物）同时使用（洛伐他汀或辛伐他汀），因为这会增加肌病的风险，包括横纹肌溶解症。
 

【INDICATIONS AND USAGE】

To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets, USP and other antibacterial drugs, erythromycin ethylsuccinate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Erythromycin ethylsuccinate tablets, USP are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below:

Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved (See appropriate sulfonamide labeling for prescribing information.)

Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes.

Listeriosis caused by Listeria monocytogenes.

Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.

Respiratory tract infections due to Mycoplasma pneumoniae.

Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment).
 

【DOSAGE AND ADMINISTRATION】

Erythromycin ethylsuccinate tablets may be administered without regard to meals. To avoid unpleasant taste, the 400 mg tablets should not be chewed.

Children

Age, weight, and severity of the infection are important factors in determining the proper dosage. In mild to moderate infections, the usual dosage of erythromycin ethylsuccinate for children is 30 to 50 mg/kg/day in equally divided doses every 6 hours. For more severe infections this dosage may be doubled. If twice-a-day dosage is desired, one-half of the total daily dose may be given every 12 hours. Doses may also be given three times daily by administering one-third of the total daily dose every 8 hours.

The following dosage schedule is suggested for mild to moderate infections:

Body Weight；Total Daily Dose

Under 10 lbs；30 to 50mg/kg/day 15 to 25 mg/lb/day

10 to 15 lbs； 200 mg

16 to 25 lbs； 400 mg

26 to 50 lbs； 800 mg

51 to 100 lbs； 1200 mg

over 100 lbs； 1600 mg

Adults

400 mg erythromycin ethylsuccinate every 6 hours is the usual dose. Dosage may be increased up to 4g per day according to the severity of the infection. If twice-a-day dosage is desired, one-half of the total daily dose may be given every 12 hours. Doses may also be given three times daily by administering one-third of the total daily dose every 8 hours.

For adult dosage calculation, use a ratio of 400 mg of erythromycin activity as the ethylsuccinate to 250 mg of erythromycin activity as the stearate, base or estolate.

In the treatment of streptococcal infections, a therapeutic dosage of erythromycin ethylsuccinate should be administered for at least 10 days. In continuous prophylaxis against recurrences of streptococcal infections in persons with a history of rheumatic heart disease, the usual dosage is 400 mg twice a day

For Treatment of Urethritis Due to C. trachomatis or U. urealyticum

800 mg three times a day for 7 days.

For Treatment of Primary Syphilis

Adults 48 to 64 g given in divided doses over a period of 10 to 15 days.

For Intestinal Amebiasis

Adults 400 mg four times daily for 10 to 14 days.

Children 30 to 50 mg/kg/day in divided doses for 10 to 14 days
 

【CONTRAINDICATIONS】

Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic.

Erythromycin is contraindicated in patients taking terfenadine, astemizole, pimozide, or cisapride (see PRECAUTIONS - Drug Interactions).

Do not use erythromycin concomitantly with HMG CoA reductase inhibitors (statins) that are extensively metabolized by CYP 3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis.
 

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 详细处方信息以本药内容附件PDF文件（2019101414213723.pdf）的“原文Priscribing Information”为准
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