药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(20212421341236.pdf,20212421335820.pdf)的原文为准 ---------------------------------------------------------------
DIFICID是一种大环内酯类抗菌药物,适用于治疗艰难梭菌相关性腹泻的成人(≥18岁)。为了减少耐药细菌的发展并保持DIFICID和其他抗菌药物的有效性,DIFICID应仅用于治疗已证实或强烈怀疑由艰难梭菌引起的感染。
【剂量和给药】
每天两次口服200mg片剂,连续10天
【剂量形式和强度】
薄膜包衣片剂:200毫克
【禁忌症】
对于已知过敏性tofidaxomicin或DIFICID中任何其他成分的患者,禁用DIFICID。
【警告和注意事项】
DIFICID仅应用于治疗艰难梭菌相关性腹泻。由于非达霉素的全身吸收最小,DIFICID对治疗其他类型的感染无效。
已报道急性过敏反应(血管性水肿,呼吸困难,瘙痒和痉挛)。如果发生严重反应,请停止使用DIFICID。
【不良反应】
最常见的不良反应(发生率≥2%)是恶心,呕吐,腹痛,胃肠道出血,贫血和中性粒细胞减少。
What is DIFICID?
DIFICID is an antibiotic medicine used to treat an infection called Clostridioides difficile-associated
diarrhea (CDAD) in adults and children 6 months of age and older. Clostridioides difficile (C-diff) is a
bacterium that can cause an infection that can damage your colon and cause stomach pain and severe
diarrhea.
DIFICID is not to be used to treat other types of infections in the body.
Sometimes infections are caused by viruses rather than bacteria. Antibiotic medicines, including
DIFICID, do not kill viruses.
It is not known if DIFICID is safe and effective in children under 6 months old.
Who should not take DIFICID?
Do not take DIFICID if you are allergic to fidaxomicin, or any other ingredient in DIFICID. See the end of
this Patient Information for a complete list of ingredients in DIFICID.
What should I tell my doctor before taking DIFICID?
Pregnancy
If you are pregnant or plan to become pregnant, tell your doctor before you take DIFICID.
It is not known if DIFICID will harm your baby while you are pregnant.
If you are pregnant, you and your doctor should decide together if you will take DIFICID.
Breastfeeding
If you are breastfeeding or plan to breastfeed, tell your doctor before you take DIFICID.
It is not known if DIFICID passes into breast milk.
If you are breastfeeding, you and your doctor should decide together if you will take DIFICID.
Other Medicines
Tell your doctor about all of the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal and dietary supplements.
Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist
when you get a new medicine.
Allergic Reactions
If you are allergic to other kinds of antibiotics called macrolides (for example: azithromycin
(Zithromax) or clarithromycin (Biaxin)) or any other ingredient in DIFICID, tell your doctor.
See the end of this Patient Information for a complete list of ingredients in DIFICID.
How do I take DIFICID?
Take DIFICID tablets or oral suspension exactly as prescribed by your doctor.
Take DIFICID twice a day (approximately every 12 hours). For example, if you take your first dose at
8:00 a.m. you should take your second dose at 8:00 p.m.
You can take DIFICID with or without food.
Do not skip any doses or stop taking DIFICID until you finish your prescribed treatment, even if you
begin to feel better, unless you have a serious allergic reaction (see “What are the possible side
effects of DIFICID?”).
This will lower the chance that the bacteria will become resistant to DIFICID. If this happens, DIFICID
and other antibiotic medicines may not work in the future.
What are the possible side effects of DIFICID?
DIFICID can cause serious side effects, including:
Allergic reaction. If you get a severe allergic reaction while taking DIFICID, including problems
breathing or shortness of breath, rash, itching or hives, or swelling of the mouth, throat, or face, stop
taking DIFICID and get emergency medical help right away.
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