About this Medication
- How does this medication work? What will it do for me?
- How should I use this medication?
- What form(s) does this medication come in?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
How does this medication work? What will it do for me?
Eluxadoline belongs to the class of medications called opioid receptor agonist/antagonists. It works in the bowel to regulate muscle activity and slow the rate that material passes through the digestive system.
This medication is used to treat irritable bowel syndrome with diarrhea in adults (IBS-D).
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
How should I use this medication?
The recommended adult dose of this medication is 100 mg taken by mouth 2 times daily. People over the age of 65 years should be started at a dose of 75 mg 2 times daily. Eluxadoline should be taken with food.
Depending on how well the medication is tolerated, your doctor may decrease the dose.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, and it is less than 4 hours since the missed dose, take it as soon as possible and continue with your regular schedule. If it is more than 4 hours since the missed dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
What form(s) does this medication come in?
Each pale yellow-to-light tan, capsule-shaped tablet debossed with "FX75" on one side, contains 75 mg of eluxadoline. Nonmedicinal ingredients: colloidal silica, crospovidone, mannitol, magnesium stearate, silicified microcrystalline cellulose, and Opadry II (iron oxide red, iron oxide yellow, polyethylene glycol, partially hydrolyzed polyvinyl alcohol, talc, and titanium dioxide).
Each pink-orange-to-peach, capsule-shaped tablet, debossed with "FX100" on one side contains 100 mg of eluxadoline. Nonmedicinal ingredients: colloidal silica, crospovidone, mannitol, magnesium stearate, silicified microcrystalline cellulose, and Opadry II (iron oxide red, iron oxide yellow, polyethylene glycol, partially hydrolyzed polyvinyl alcohol, talc, and titanium dioxide).
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to eluxadoline or any ingredients of the medication
- have or may have a biliary duct blockage
- do not have a gallbladder
- consume more than 3 alcoholic drinks daily
- are alcoholic, have an alcohol addiction, or abuse alcohol
- have a history of inflammation of the pancreas (pancreatitis)
- have decreased liver function
- have a history of chronic or severe constipation
- have or have had an obstruction of the digestive tract
- are taking certain medications:
- HIV protease inhibitors (e.g., atazanavir, lopinavir, ritonavir, saquinavir)
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- abdominal pain
- nausea and vomiting (accompanied by other symptoms)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- severe constipation
- symptoms of pancreatitis (e.g., abdominal pain, nausea, vomiting)
- symptoms of a serious allergic reaction (such as fever, swollen glands, yellowing of skin or eyes, or flu-like symptoms with skin rash or blistering)
- symptoms of spasm of the sphincter of Oddi (e.g., new or worsening belly pain, nausea, vomiting, or sudden pain in the upper right abdomen)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Constipation: Eluxadoline may cause severe constipation in some people. If you experience symptoms of severe constipation such as difficulty passing stool, sudden stomach pain, nausea, vomiting, or a bloated stomach, contact your doctor immediately.
Dependence and drug abuse: Although this medication primarily works in the digestive tract, it can cause euphoria (a false sense of extreme well-being). It is possible to develop a psychological need for this medication.
Drowsiness/reduced alertness: Eluxadoline may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by this medication.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Pancreatitis: Eluxadoline can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.
If you have a history of pancreatitis, gallstones, alcoholism, or high triglycerides, you may be more at risk of experiencing this.
Sphincter of Oddi: The sphincter of Oddi is a muscular valve that controls the passage of digestive juices from the pancreas and gall bladder to the small intestine. In uncommon instances, this muscle can spasm, increasing the risk of inflammation of the pancreas or decreased liver function. If you experience symptoms of spasm of the sphincter of Oddi, such as nausea, vomiting, and sudden pain in the upper right hand side of the abdomen, possibly radiating toward the back, get medical help immediately.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if eluxadoline passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: People over the age of 65 years may experience more side effects from this medication.
What other drugs could interact with this medication?
There may be an interaction between eluxadoline and any of the following:
- antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- hepatitis C antivirals (e.g., dasabuvir, ombitasvir, paritaprevir, ritonavir)
- HIV protease inhibitors (e.g., atazanavir, lopinavir, ritonavir, saquinavir)
- monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
- narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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