Description
Eluxadoline is used to treat adults with irritable bowel syndrome with diarrhea (IBS-D).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
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 eluxadoline in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of eluxadoline in the elderly. However, elderly patients are more likely to have unwanted side effects and stomach problems, which may require caution in patients receiving eluxadoline.
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Atazanavir
- Ceftobiprole Medocaril
- Cyclosporine
- Darolutamide
- Elexacaftor
- Eltrombopag
- Enasidenib
- Fostemsavir
- Gemfibrozil
- Grazoprevir
- Lopinavir
- Paritaprevir
- Rifampin
- Ritonavir
- Rosuvastatin
- Saquinavir
- Tipranavir
- Velpatasvir
- Voclosporin
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
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:
- Alcohol abuse or addiction or
- Bowel or stomach blockage, known or suspected or
- Constipation (severe), history of or
- Gallbladder blockage, known or suspected or
- Liver disease, severe or
- Pancreas problems (eg, blockage in the pancreas) or
- Pancreatitis (inflammation of the pancreas), history of or
- Patients who drink more than 3 alcoholic beverages a day or
- Patients without a gallbladder or
- Sphincter of Oddi disease, known or suspected—Should not be used in patients with these conditions.
- Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
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. To do so may increase the chance of side effects.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine with food.
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 (tablets):
- For irritable bowel syndrome with diarrhea:
- Adults—100 milligrams (mg) 2 times a day. Some patients may need 75 mg 2 times a day.
- Children—Use and dose must be determined by your doctor.
- For irritable bowel syndrome with diarrhea:
Missed Dose
If you miss a dose of this medicine, 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 to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
If your symptoms and condition do not improve within a few days, or if they become worse, check with your doctor.
This medicine may increase your risk for sphincter of Oddi spasm. This is more likely to occur if you do not have a gallbladder. Call your doctor right away if you have new or worsening stomach pain or pain in the upper right abdominal or stomach that may move to your back or shoulders, with or without nausea or vomiting.
This medicine may increase your risk for pancreatitis (swelling of the pancreas). Check with your doctor right away if you have the following symptoms: bloating, chills, darkened urine, sudden and severe stomach pain, nausea, vomiting, fever, lightheadedness, or yellow eyes or skin.
This medicine may cause severe constipation, which may require hospitalization. Check with your doctor right away if you have difficulty having a bowel movement.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
If you have liver problems, do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Avoid drinking excessive alcohol while using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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:
Rare
- Bloating
- chills
- constipation
- darkened urine
- fast heartbeat
- fever
- indigestion
- loss of appetite
- nausea
- pains in the stomach, side, or abdomen, possibly radiating to the back
- vomiting
- yellow eyes or skin
Incidence not known
- Cough
- difficulty swallowing
- dizziness
- hives, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- tightness in the chest
- unusual tiredness or weakness
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:
Less common
- Body aches or pain
- cough producing mucus
- difficulty with breathing
- ear congestion
- excess air or gas in the stomach or bowels
- fever
- full feeling
- headache
- loss of voice
- muscle aches
- passing gas
- pressure in the stomach
- sneezing
- sore throat
- stuffy or runny nose
- swelling of abdominal or stomach area
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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