Crofelemer
Diarrhea
.svg)
Drug Status
Government Approvals
US(FDA)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
Antidiarrheal
Controlled Drug Substance
No
Crofelemer
Summary
Crofelemer is used to provide symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS who are on antiretroviral therapy. It is not used for the treatment of infectious diarrhea.
Crofelemer works by inhibiting chloride ion channels in the intestines. This reduces fluid secretion and normalizes water flow in the gastrointestinal tract, which helps to control diarrhea.
The typical adult dose for Crofelemer is 125 mg taken orally twice a day, with or without food. The tablets should be swallowed whole, not crushed or chewed.
Common side effects of Crofelemer include upper respiratory tract infection, bronchitis, cough, flatulence, increased bilirubin, nausea, back pain, arthralgia, urinary tract infection, nasopharyngitis, musculoskeletal pain, hemorrhoids, giardiasis, anxiety, increased alanine aminotransferase, and abdominal distension.
Before starting Crofelemer, it's important to rule out infectious causes of diarrhea as the medication is not indicated for infectious diarrhea. Patients should inform their healthcare provider of any allergies or other medications they are taking. Pregnant women should consult their healthcare provider before using Crofelemer.
Indications and Purpose
How does Crofelemer work?
Crofelemer works by inhibiting the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion channel and calcium-activated chloride channels in the intestines. This reduces chloride and fluid secretion, helping to control diarrhea.
Is Crofelemer effective?
Crofelemer's effectiveness was evaluated in a randomized, double-blind, placebo-controlled study involving HIV-positive patients with non-infectious diarrhea. The study showed that a significantly larger proportion of patients taking Crofelemer experienced clinical response compared to those taking a placebo, indicating its effectiveness in managing diarrhea in this population.
What is Crofelemer?
Crofelemer is used to control non-infectious diarrhea in HIV-positive patients on anti-retroviral therapy. It works by inhibiting chloride channels in the intestines, reducing fluid secretion and normalizing water flow in the gastrointestinal tract. This helps alleviate diarrhea symptoms.
Directions for Use
For how long do I take Crofelemer?
Crofelemer is typically used for as long as the symptoms of non-infectious diarrhea persist in patients with HIV/AIDS on anti-retroviral therapy. The duration of use should be determined by a healthcare provider based on individual patient needs.
How do I take Crofelemer?
Crofelemer should be taken orally, 125 mg twice a day, with or without food. There are no specific food restrictions while taking this medication. It is important to take it at the same times every day and swallow the tablets whole without crushing or chewing.
How should I store Crofelemer?
Store Crofelemer in its original container, tightly closed, at room temperature away from excess heat and moisture. Keep it out of reach of children. Do not store it in the bathroom. Dispose of unneeded medication through a take-back program, not by flushing it down the toilet.
What is the usual dose of Crofelemer?
The usual adult dose for Crofelemer is 125 mg taken orally twice a day, with or without food. The safety and effectiveness of Crofelemer have not been established in pediatric patients, so there is no recommended dose for children.
Warnings and Precautions
Can Crofelemer be taken safely while breastfeeding?
There are no data on the presence of Crofelemer in human milk or its effects on breastfed infants. Due to the potential for HIV transmission and adverse effects, mothers taking Crofelemer are advised not to breastfeed.
Can Crofelemer be taken safely while pregnant?
Crofelemer is minimally absorbed and is not expected to result in fetal exposure. Animal studies showed no adverse fetal effects in rats, but some effects in rabbits at high doses. Pregnant women should consult their doctor before use, as the background risk of birth defects is unknown.
Can I take Crofelemer with other prescription drugs?
Crofelemer does not have clinically relevant interactions with nelfinavir, zidovudine, or lamivudine. However, it has the potential to inhibit certain transporters in the gut. Patients should inform their doctor of all medications they are taking to avoid potential interactions.
Is Crofelemer safe for the elderly?
Clinical studies with Crofelemer did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. Therefore, elderly patients should use Crofelemer with caution and under the guidance of a healthcare provider.
Who should avoid taking Crofelemer?
Before starting Crofelemer, it is important to rule out infectious causes of diarrhea, as it is not indicated for infectious diarrhea. Patients should also inform their doctor of any allergies to Crofelemer or its ingredients. Pregnant or breastfeeding women should consult their doctor before use.
