INDICATIONS AND USAGE

CLEOCIN T Gel is indicated for topical application 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. 

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 culture 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.
Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeksfollowing 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.

OVERDOSE

Topically applied CLEOCIN T Gel may be absorbed in sufficient amounts to produce systemic effects.

DOSAGE AND ADMINISTRATION

Apply a thin film of CLEOCIN T Gel once daily to the skin where acne lesions appear. Use enough to cover the entire affected area lightly. Keep container tightly closed.

部分中文 CLEOCIN T Gel 处方信息（仅供参考）

【药物名称】氯林可霉素磷酸酯凝胶CLINDAGEL1%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。