2011年5月27日，美国食品药品监督管理局(FDA)批准Dificid（fidaxomicin）用于治疗艰难梭菌相关性腹泻(CDAD)。

艰难梭菌为引起痢疾的细菌，并可引发结肠炎、其他严重的肠道疾病，甚至死亡。艰难梭菌会出现在感染者的粪便中，他人接触到沾染细菌或菌孢的物品后接触口部的也会引起感染。

通过对564名成年患者、两项临床试验对Dificid的安全性及有效性进行评估，艰难梭菌感染者分别使用Dificid或普通CDAD抗菌药万古霉素。使用选择的两组样本临床反应类似，并有CDAD复发患者。在治疗结束3周后Dificid组较万古霉素组有明显的持续治愈效果

FDA药品评价及研究中心，抗菌药办公室负责人Edward Cox博士表示：近年来，艰难梭菌感染的流行度有所升高，Dificid能有效治疗并为艰难梭菌相关性腹泻患者提供了新的选择。

Dificid为大环内酯抗菌药，每日两次，用药10天，佐餐使用或空腹均可。其常见不良反应有：恶心、呕吐、头疼、胃痛及痢疾等。易感染该病菌的人群有老年人、住院患者、疗养群居人员及服用抗生素治疗其他感染的患者等，预防CDAD的有效方法是用肥皂及热水洗手。

Dificid由位于圣地亚哥的Optimer制药有限公司开发。

Dificid (fidaxomicin) has been approved by the U.S. Food and Drug Administration to treat diarrhea associated with Clostridium difficile infection.

(HealthDay News) — Dificid was evaluated in clinical studies involving 564 people with C. diff-associated diarrhea. More people who took Dificid were still symptom-free three weeks after stopping treatment than those who took vancomycin, the FDA said.

Recommended dosage with Dificid is twice daily for 10 days. The most common side effects reported included nausea, vomiting, headache, abdominal pain, and diarrhea.

DIFICID

Generic Name for DIFICID
Fidaxomicin 200mg; tabs.

Legal Classification:
Rx

Pharmacological Class for DIFICID
Macrolide antibiotic.

Manufacturer of DIFICID
Optimer Pharmaceuticals, Inc.
Indications for DIFICID
For the treatment of Clostridium difficile-associated diarrhea.

Adult dose for DIFICID
≥18yrs: 200mg twice daily for 10 days.

Children's dosing for DIFICID
<18yrs: not recommended.

Warnings/Precautions for DIFICID
Not for treating systemic infections (minimal systemic absorption). Pregnancy (Cat. B). Nursing mothers.

Adverse Reactions for DIFICID
Nausea, vomiting, abdominal pain, GI hemorrhage, anemia, neutropenia.

How is DIFICID supplied?
Tabs—20, 60, 100 (10x10 blister cards)

Related Disease:
Diarrhea