Crofelemer is an antidiarrheal indicated for symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. It is available as tablets for oral use. MedsAcross supplies Crofelemer for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
MYTESI is indicated for symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. MYTESI is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy.
Source: US FDA prescribing information
Crofelemer is an inhibitor of both the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (Cl¯) channel, and the calcium-activated Cl¯ channels (CaCC) at the luminal membrane of enterocytes. The CFTR Cl¯ channel and CaCC regulate Cl¯ and fluid secretion by intestinal epithelial cells. Crofelemer acts by blocking Cl¯ secretion and accompanying high volume water loss in diarrhea, normalizing the flow of Cl¯ and water in the gastrointestinal tract.
Source: US FDA prescribing information
Before starting MYTESI, rule out infectious etiologies of diarrhea. The recommended adult dosage of MYTESI is 125 mg taken orally two times a day, with or without food. Do not crush or chew MYTESI tablets. Swallow whole. The recommended adult dosage is 125 mg taken orally twice a day, with or without food. Do not crush or chew the tablets. Swallow whole.
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
Risks of Treatment in Patients with Infectious Diarrhea: Consider infectious etiologies of diarrhea before starting treatment to reduce the risk of inappropriate therapy and worsening disease. 5. 1 Risks of Treatment in Patients with Infectious Diarrhea Before starting MYTESI, rule out infectious etiologies of diarrhea. If infectious etiologies are not considered, and MYTESI is initiated based on a presumptive diagnosis of non-infectious diarrhea, then there is a risk that patients with infectious etiologies will not receive the appropriate treatments, and their disease may worsen. MYTESI is not indicated for the treatment of infectious diarrhea.
Source: US FDA prescribing information
Most common adverse reactions (≥ 3%) are upper respiratory tract infection, bronchitis, cough, flatulence and increased bilirubin.
Source: US FDA prescribing information
Nelfinavir, Zidovudine, and Lamivudine MYTESI administration did not have a clinically relevant interaction with nelfinavir, zidovudine, or lamivudine in a drug-drug interaction trial.
Source: US FDA prescribing information
Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C-30°C (59°F-86°F). See USP Controlled Room Temperature.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Crofelemer, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Mytesi 125 mg tabletOral | Napo Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 31 December 2012 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Crofelemer and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Crofelemer, including Mytesi.
Yes. The US FDA first approved Crofelemer on 31 December 2012, according to Drugs@FDA.
No listed presentation of Crofelemer is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Crofelemer is classified under ATC code A07XA06 (Crofelemer).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.