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  药店国别: 美国药房
产地国家: 美国
所属类别: 皮肤科药物->治疗痤疮药物
处方药:处方药
包装规格: 30克/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
PharmaDerm
生产厂家英文名:
PharmaDerm
该药品相关信息网址1:
http://www.drugs.com/pro/clindamax-gel.html
该药品相关信息网址2:
http://wiki.medpedia.com/Clinical:Clindamax_(Clindamycin_Phosphate)
原产地英文商品名:
CLINDAMAX 1% GEL
原产地英文药品名:
CLINDAMYCIN PHOSPHATE
中文参考商品译名:
CLINDAMAX 1%凝胶 30克/瓶
中文参考药品译名:
氯林可霉素磷酸酯
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Acne vulgaris
临床试验期:
完成
中文适应病症参考翻译1:
寻常性痤疮
药品信息:

Information on CLINDAMAX

Indications and Usage
ClindaMax® (Clindamycin Phosphate Gel) is indicated in the treatment of acne vulgaris. In view of the
potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate.

CONTRAINDICATIONS
ClindaMax® (Clindamycin Phosphate Gel) is contraindicated in individuals with a history of
hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

WARNINGS
Orally and parenterally administered clindamycin has been associated with severe colitis which may
result in patient death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.
When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be
considered to establish a definitive diagnosis in cases of severe diarrhea.

Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile. The usual adult dosage is 500 mg to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days.Cholestyramine or colestipol resins bind vancomycin in vitro. If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug.Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

Adverse Reactions
Orally and parenterally administered clindamycin has been associated with severe colitis which may end
fatally.
Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported
as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin.
Abdominal pain and gastrointestinal disturbances as well as gram-negative folliculitis have also been
reported in association with the use of topical formulations of clindamycin.

OVERDOSAGE
Topically applied clindamycin topical solution can be absorbed in sufficient amounts to produce
systemic effects.

DOSAGE AND ADMINISTRATION
Apply a thin film of ClindaMax® (Clindamycin Phosphate Gel) twice daily to affected area.
Keep container tightly closed.

HOW SUPPLIED
ClindaMax® Gel (Clindamycin Phosphate Gel USP, 1%) containing clindamycin phosphate equivalent to 10 mg
clindamycin per gram is available in the following sizes:
30 gram tube NDC 0462 - 0390 - 30     60 gram tube NDC 0462-0390-60
Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

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部分中文 CLINDAMAX 处方信息(仅供参考)

【药物名称】氯林可霉素磷酸酯凝胶
【主要成分】本品主要成分是氯林可霉素磷酸酯。 
【药理作用】氯林可霉素是林可霉素的衍生物,为窄谱抗生素。对厌氧菌和革兰氏阳性菌具有较强的抗菌活性。体外
试验表明:本品具有抑制痤疮丙酸杆菌、颗粒丙酸杆菌、金黄色葡萄球菌、表皮葡萄球菌等菌的生长作用。
【适应症】寻常性痤疮。
【用法与用量】清洗并抹干患处,将本品适量涂于患处,每日一次,或遵医嘱。
【不良反应】常见不良反应有:局部皮肤干燥、接触性皮炎、皮肤刺激反应、过敏症状、腹痛、胃肠不适、眼睛刺痛
等;个别可能有腹泻、结肠炎包括伪膜性结肠炎等。
【注意事项】1. 本品禁用于对克林霉素或林可霉素有过敏史的患者。
 2.偶有氯林可霉素外用制剂引起伪膜性肠炎的报道,应警惕。
 3.哺乳期妇女若使用本品,应停止哺乳。
 4.孕妇应权衡利害关系后决定是否使用本品,一般不宜使用。
 5.本品应避免触及眼睛及口。若误进眼睛,应以清水彻底冲洗。 
【贮藏】密闭,在阴凉处保存。

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更新于2010年1月17日

更新日期: 2010-1-17
附件:






 
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