Description
Crofelemer is used to relieve symptoms of non-infectious diarrhea in patients with human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Delayed Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of crofelemer in the pediatric population. Safety and efficacy have not been established.
Geriatric
Although appropriate studies on the relationship of age to the effects of crofelemer have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Infectious diarrhea—Use is not indicated in patients with this condition.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
You may take this medicine with or without food.
Swallow the delayed-release tablet whole. Do not crush, break, or chew it.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (delayed-release tablets):
- For treatment of non-infectious diarrhea in patients with HIV/AIDS:
- Adults—125 milligrams (mg) two times a day.
- Children—Use and dose must be determined by your doctor.
- For treatment of non-infectious diarrhea in patients with HIV/AIDS:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
If your symptoms do not improve or if they get worse, call your doctor.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Abdominal or stomach pain
- bleeding after defecation
- full or bloated feeling
- pressure in the stomach
- swelling of the abdominal or stomach area
- uncomfortable swelling around the anus
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Body aches or pain
- chills
- cough
- difficulty with breathing
- ear congestion
- fever
- headache
- loss of voice
- nasal congestion
- runny nose
- sneezing
- sore throat
- unusual tiredness or weakness
Less common
- Acid or sour stomach
- back pain
- belching
- bladder pain
- blemishes on the skin
- blistering, crusting, irritation, itching, or reddening of the skin
- bloody or cloudy urine
- cough producing mucus
- cracked, dry, scaly skin
- difficult, burning, or painful urination
- difficulty having a bowel movement (stool)
- difficulty with moving
- discouragement
- dizziness
- dry mouth
- excess air or gas in the stomach or intestines
- fear or nervousness
- feeling sad or empty
- frequent urge to urinate
- heartburn
- indigestion
- irritability
- loss of appetite
- loss of interest or pleasure
- lower back or side pain
- muscle aches
- muscle or bone pain
- muscle stiffness
- nausea and vomiting
- pain in the arms or legs
- pain in the groin or genitals
- pain in the joints
- pain or tenderness around the eyes and cheekbones
- painful blisters on the trunk of the body
- passing gas
- pimples
- sharp back pain just below the ribs
- stomach discomfort or upset
- tightness in the chest
- tiredness
- trouble concentrating
- trouble sleeping
- weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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