Viberzi, the American retail name for Eluxadoline is an oral medication that is prescribed as a treatment for abdominal pain and diarrhea in patients suffering from IBS-D or Irritable Bowel Syndrome with dominant diarrhea. Its approval and medicinal application have been passed in 2015 in the USA that have been revolutionary in the spectrum of medical sciences as one of the most widely used and effective treatments, especially for acute IBS-D. However, this medicine should not be taken without consulting a doctor due to risks of side effects ranging from minor to serious conditions. 

Prescription Name and Overview

Viberzi is sold for oral administration in quantities of 75 mg and 100 mg dosages as tablets. Used extensively as a treatment in patients with irritable bowel syndrome. The 75 mg tablets are shaped like a capsule with a pale-yellow coating. On the other hand, a 100 mg Viberzi is a capsule-shaped tablet bearing pinkish-orange hue. 

There have been considerable clinical trials with Viberzi for IBS treatment with varied results in patients with different medical history. However, like any other medication, Viberzi too has its placebo-controlled effects on patients that have been studied and passed as an effective treatment. Its reactive progression with other physiological features and organs has shown a limitless list of effective progress.

Generic Name and Overview

Eluxadoline being the main active ingredient of Viberzi finds effective use in patients suffering from irritable bowel syndrome and acute diarrhea. Eluxadoline is a local reactor that acts along the enteric nervous system without having any adverse consequence on our central nervous system. 

Although Viberzi works wonders in stabilizing acute IBS, its use and qualitative effect or drawbacks are still under scrutiny. As long as limited doses work best for treating a condition like so, minor side effects can be over-ruled in patients with no association with a medical history that might aggravate with the administration or long-term use of Viberzi.

OTC Name and Overview

Eluxadoline is sold under the OTC name Viberzi for use as a medicine.

         Manufacturer

Allergen plc based out of Dublin, Ireland is one of the biggest names in the pharmaceutical industry that has been manufacturing medical revolutions for the global mass. Their commitment and hard work have led to the manufacturing of Viberzi as one of their products with extensive availability in the United States. 

         Labeled Indications

Viberzi is prescribed to patients suffering from irritable bowel syndrome with predominant diarrhea. As per labeled indications and instructions, there are a few guidelines of dosage that should be studied before the initiation of the course.

Dosage:

As per usual recommendation, 100 mg Viberzi is taken orally twice daily along with food depending on the physiologies of the patients. 

On the other hand, 75 mg Viberzi dosage is recommended to be taken twice daily with food if the patient has the following dependencies:

•   Patients who unable to make progress or tolerate the 100 mg dosage, 75 mg should be the prescribed limit
•   Patients who are already taking OATP1B1 inhibitors
•   Patients who have moderate or mild hepatic impairment

If severe constipation is seen in patients taking Viberzi, discounting the medication is recommended.

In case a patient misses a dose, the following dose should be taken in the next regular time without taking two tablets to make up for the missed dose.

Strength and Dosage:

•   100 mg – tablets capsule-shaped with a pinkish-orange color and ‘FX100’ stamped on either side. Each of these tablets contains a quantitative measurement of 100 mg eluxadoline
•   75 mg – tablets capsule-shaped with a pale yellow color and ‘FX75’ stamped on either side. Each of these tablets contains a quantitative measurement of 75 mg eluxadoline

Storage:

Physical storage of Viberzi is assigned between 20°C to 25°C (68°F to 77°F) but the permissible temperature being 15°C to 30°C (59°F to 86°F) as per the global standards of controlled room temperature.

             Active Ingredients

The only active ingredient in the composition of Viberzi is a mu-opioid agonist and delta-opioid receptor antagonist eluxadoline. It is a local reactor acting along the enteric nervous system without instigating any adverse effects on the CNS (Central Nervous System).

Other inactive ingredients in the composition of 100 mg and 75 mg Viberzi are:

•   silicified microcrystalline cellulose, 
•   Magnesium stearate,
•   crospovidone, 
•   Opadry II 
•   Colloidal silica, 
•   mannitol

What Is It Used For?

Viberzi, the American retail name for Eluxadoline is an oral medication that is prescribed as a treatment for abdominal pain and diarrhea in patients suffering from IBS-D or Irritable Bowel Syndrome with dominant diarrhea.

        How Does it Work?

Eluxadoline in Viberzi is a mu-opioid agonist and delta-opioid receptor antagonist. It is a local reactor acting along the enteric nervous system without instigating any adverse effects on the CNS (Central Nervous System). In medical terms, Ki or the binding laterals for human mu and delta opioid receptors are 1.8 nM and 430 nM respectively. 

The working principle of Viberzi shows effective results in patients suffering from diarrhea and IBS-D abdominal pain. Viberzi reduces pain and brings the condition under control by making stool less watery. Viberzi is the only prescription medication for patients with conditions of diarrhea and IBS-D. By reducing the verve sensitivity in the intestine and by slowing down the movement of stool along the colon, Viberzi works like a wonder drug. 

        What are the Approved Uses?

The approved uses of Viberzi in the scope of medical treatments work in patients with abdominal or stomach disorders namely IBS-D or Irritable Bowel Syndrome with Diarrhea.

It is always best advised to consult a doctor before starting a course of Viberzi. Oral administration, twice daily with food works the best. However, dosage may change depending on the patient’s receptive powers or other associated medical complications. Overusing the medication may lead to aggravated side effects. With an edge for addictive intake of the drug, it is best advised to follow the doctor’s instructions without going by instincts for best results.

        Production Anecdotes / History

Used extensively in adults suffering from Irritable Bowel Syndrome with diarrhea, Viberzi is an important drug in the spectrum of prescription medicines. It is considered as a controlled medicine because the active ingredient eluxadoline may lead to drug abuse and dependence if used more than what is required during the period of treatment. It is still under research whether the use of Viberzi is safe for children. The associated side effects can reflex in its aggravated form in patients who are 65 or older.

Precautions

It is best advised not to take Viberzi if the patient has the following conditions:

•   Medical history relating to gallbladder like a blockage or sphincter of Oddi
•   Intake of excessive alcohol regularly
•   Blockage or inflammation in the pancreas
•   Allergic reactions to Viberzi
•   Any liver complications
•   Chronic constipation
•   Bowel blockage

Other than these known precautionary effects of Viberzi, its unknown areas of ill-effects during pregnancy are still not known. Consulting a doctor irrespective of any health-related issues is a must before starting a course of Viberzi.

Long-term Use Considerations

Long-term use of Viberzi is strictly prohibited once IBS-D is fully treated.

Drug Interactions

Drug interaction of Viberzi encompasses a large scope of due to each patient’s medical history. Drug interactions vary depending on the physiology of each patient that paves the way for serious side effects. 

    Can Interact with the Following

High concentrations of eluxadoline are observed along with the administration of inhibitors of transporter protein OATP1B1 like:

•   Cyclosporine
•   Gemfibrozil
•   Certain antiretrovirals
•   Rifampin
•   Eltrombopag

Concurrent use of eluxadoline with the following drugs that might cause constipation sometimes cause adverse effects:

•   Opioids
•   Alosetron
•   Anticholinergics
•   Bismuth subsalicylate

Eluxadoline is responsible for increasing the concentration of certain drugs that are substrates of BCRP and OATP1B1. Administration of Viberzi along with rosuvastatin increases the risk of rhabdomyolysis.

    Can’t Interact with the Following

No studies have been concluded on Viberzi’s interaction with the following:

•   Oral Contraceptives
•   Probenecid
•   Midazolam

When To Stop Taking

•   After effective treatment of Irritable Bowel Syndrome with diarrhea, administration and use of Viberzi should be stopped immediately. 
•   Patients who show an aversion towards both the dosage quantities of Viberzi should discontinue the course. 
•   Taking of Viberzi should also be immediately cut short and medical help should be sought if abdominal conditions are worsened. If there is pain around the upper right side of the stomach that moves towards the back and the shoulder with nausea and vomiting tendencies, medicine course should be stopped.
•   In some patients, one or two might cause allergic reactions ranging from minor to serious conditions. Symptoms like swelling of tongue, lips, mouth, face, breathing difficulties, rash, itching or hives call for immediate medical help.
•   One of the biggest side effects of Viberzi is constipation, sometimes leading to severe cases. If severe constipation is experienced during the course of Viberzi, immediate medical consultation is a must.

Long-Term Side Effects

Adverse long-term side effects due to the use of Viberzi include the following:

•   Pancreatitis

Although rare, pancreatitis is one of the major effects of Viberzi who look 100 mg pills twice daily during clinical studies. However, among the patients who contracted pancreatitis, 60% were excessive drinkers and the rest with biliary sludge. Their pancreatic complications stopped eventually after discontinuation of Viberzi with most patients recovering within a week.

•   Sphincter of Oddi Spasm

The occurrence of Oddi Spasm presented acute abdominal pain due to excessive secretion of hepatic enzymes. 

•   Hypersensitivity Reactions

Serious allergic reactions may occur in some people depending on their physiological conditions.

•   Constipation

One of the major and most conspicuous side effects of Viberzi intake is constipation and in some cases leading to severe conditions where hospitalization is required.

FDA Warnings (History Of)

As per reports released by the U.S Food and Drug Administration (FDA), the use of Viberzi has ruled its use as a risk for patients without a gallbladder. Such patients have a tremendous high tendency to develop pancreatitis that might result in hospitalization or death. Caused due to the spasm of digestive muscles in the small intestine, the safety concerns relating to the use of Viberzi is still under medical scrutiny.

For a patient looking to take a course of Viberzi to cure IBS-D should consult a medical practitioner irrespective of whether they have any other medical conditions and history. Particularly for those without a gallbladder, intake of Viberzi is a risk. If there are symptoms of abdominal pain, a visit to the doctor is indispensable.

Viberzi was first approved for use as an OTC medicine by the FDA in May 2017. However, by February 2017, FDA has received 120 reports of severe cases of fatal pancreatitis. A shocking number that jolted the FDA’s decision on approving the medicine, FDA urges patients as well as medical practitioners to report any side effect due to the use of Viberzi.

Other Common Side Effects

Common side effects due to the use of Viberzi include the following:

•   Constipation
•   Abdominal pain
•   Nausea
•   Upper respiratory tract infection
•   Vomiting
•   Stuffy or runny nose
•   Bloating
•   Bronchitis
•   Dizziness
•   Gas
•   Rash or other allergic reactions
•   Fatigue

Lawsuits

Lawsuit claims against Viberzi claim that manufacturers have failed to produce enough side effect warnings of pancreatitis, especially in patients without a gallbladder. Potentially fatal, such a condition has been reported multiple times by patients who took Viberzi over the course of their treatment. An alarming report by 120 patients who developed pancreatitis has been made in a matter of less than two years of the medicine’s approval by the FDA. However, there are risks of severe side-effects even in patients who have gallbladders. Lawsuits are customized as per the reported files and the prerequisites are extensively researched before any further legal steps can be taken. Medical research on the effects of Viberzi is still under extensive clinical study with the manufacturers sitting amidst the dusty air of uncertainty.