Mytesi（crofelemer）缓释片是唯一的抗艾滋病腹泻药物，经FDA批准用于缓解艾滋病毒阳性患者的腹泻。以前商品名以Fulyzaq上市。
Mytesi（crofelemer）缓释片作为艾滋病病毒+患者免受非感染性腹泻的唯一FDA批准的治疗方案
Mytesi（crofelemer）从Croton lechleri树的乳胶中提取。 通过囊性纤维化跨膜电导调节（CFTR）通道减少过量的氯离子分泌。 氯化物通道CFTR通过控制氯离子分泌和钠吸收来调节肠中的水分平衡。
Mytesi特别指出，在抗逆转录病毒治疗中，艾滋病毒/艾滋病患者的非感染性腹泻症状缓解。
Mytesi作为口服给药的缓释片剂提供。 推荐剂量是每天口服两次，每次一次125mg缓释片剂，有或没有食物。 片剂不应该被粉碎或咀嚼。 片剂应全部吞咽。
作用机制
Mytesi（crofelemer）从Croton lechleri树的乳胶中提取。它是环腺苷酸（cAMP）刺激的囊性纤维化跨膜电导调节剂（CFTR）氯离子（Cl-）通道和肠细胞腔膜上的钙激活的Clc通道（CaCC）的抑制剂。 CFTR Cl通道和CaCC调节肠上皮细胞的Cl-和液体分泌。 Crofelemer通过阻止Cl分泌和伴随腹泻的大量水分流失，使GI和GI的流量正常化。

MYTESI DR 125 MG DR 60
MYTESI Rx Generic Name and Formulations:
Crofelemer 125mg; delayed-release tablets; enteric-coated.
Company:
Napo Pharmaceuticals, Inc.
Indications for MYTESI:
Symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.
Adult:
Swallow whole. One tab twice daily.
Children:
<18yrs: not established.
Warnings/Precautions:
Rule out infectious etiologies of diarrhea before starting. Pregnancy (Cat. C). Nursing mothers: not recommended.
Pharmacological Class:
Antidiarrheal.
Adverse Reactions:
Upper respiratory tract infection, bronchitis, cough, flatulence, increased bilirubin.
Note:
Formerly known under the brand name Fulyzaq.
Generic Availability:
NO
How Supplied:
Tabs—60
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45584fba-8081-4cd1-a21e-3ea8237f62ff
Napo Pharmaceuticals Launches Mytesi (crofelemer) as the Only FDA-Approved Treatment for Relief of Noninfectious Diarrhea in HIV+ Patients
Launch Includes Copay Savings and Patient Assistance Programs to Ensure  Mytesi™, Formerly Marketed as Fulyzaq®
NEW YORK, Oct. 13, 2016 /PRNewswire/ -- Napo Pharmaceuticals, Inc., announced today the launch and general availability of Mytesi (crofelemer), the only antidiarrheal studied in and FDA-approved for the relief of diarrhea in HIV+ patients.1 Previously marketed as Fulyzaq, the product launch under the Mytesi brand importantly includes the unveiling of the Mytesi Copay Savings Program and NapoCares™ Patient Assistance Program to provide people living with HIV/AIDS with broad, affordable access to the drug.
Chronic, symptomatic diarrhea remains a significant, underreported consequence of HIV, whether due to the side effects of antiretroviral therapy (ART) or the direct effect of HIV on the gastrointestinal (GI) tract. This problem is only going to increase as the HIV+ population gets older; more than 40 percent of people currently living with HIV/AIDS in the United States are over the age of 50," commented Lisa Conte, CEO and founder of Napo. "By launching Mytesi, not only are we making this important drug widely available, we are including two important patient assistance programs to ensure that patients can gain access to our drug, regardless of insurance or economic status. The launch of Mytesi also highlights Napo's dedication to both superior patient care and corporate responsibility."
"One of the major reasons diarrhea among HIV+ patients remains underrecognized is due to a disconnect between physicians and their patients: patients often do not report the true extent of their diarrhea, and physicians are not always fully aware of the negative impact of diarrhea on their patients' lifestyles. In addition, both groups may not be aware that a specific treatment is available," added Rodger D. MacArthur, MD, Professor of Medicine, Division of Infectious Diseases at the Medical College of Georgia, an HIV specialist who was an investigator in and is the author of the ADVENT Trial, the pivotal study that led to regulatory approval of crofelemer. "Some healthcare providers believe that diarrhea is only associated with ART and that newer antiretroviral medications cause less diarrhea.  However, HIV enteropathy, which is chronic diarrhea due to the direct or indirect effects of HIV on the GI tract, is a problem for many HIV+ patients, independent of their ART regimen."
Many patients who are HIV+ are only aware of Imodium®2 and Lomotil®3 as treatments for diarrhea, but these agents have not been studied in patients who are HIV+, and the effect of these drugs on antiretroviral medications is not known. Also, Lomotil and Imodium are opioids that work by slowing movement through the GI tract, which can cause constipation. Mytesi is a prescription treatment for diarrhea that works to normalize the flow of water in the GI tract, and subgroup analyses in the pivotal clinical trial showed a more pronounced effect in HIV+ patients who had longstanding infection (≥12 years) or who tried other antidiarrheal medications.
About Mytesi™
Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest.  Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
More information and complete Prescribing Information are available at Mytesi.com.
About Napo Pharmaceuticals, Inc.

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产地国家：美国
原产地英文商品名:
Mytesi 125mg/tablet 60tablet/Bottle
原产地英文药品名:
crofelemer delayed-release 
中文参考商品译名:
Mytesi缓释片 125毫克/片 60片/瓶
中文参考药品译名:
crofelemer 
生产厂家英文名:
Napo Pharmaceuticals