Ursodil, Ursodeoxycholic Acid

Ursodil is used for the treatment of gallbladder stones. Ursodil is known as a hepatoprotective medication which works by reducing the amount of cholesterol in the blood. Ursodil also works to dissolve gall bladder stones which are made out of mainly cholesterol

Generic Ursocol

Ursodeoxycholic Acid

Ursodil

10

Zydus Cadila

Tablet, Sustained Release Tablet

150 mg, 300 mg, 500 mg

India

Ursodil, Ursodeoxycholic Acid

Introduction

"Known as Ursodil in terms of being medically referred to as Ursodeoxycholic Acid (UDCA), this substance holds a place in modern medicine for its valuable role in treating liver ailments. This piece explores the background of the compound, along with its characteristics and importance, in today's treatments."


Overview of Ursodeoxycholic Acid (Ursodil)

Ursodeoxycholic acid occurs naturally in bile in small amounts and is used as a medication to change the bile's makeup, lower cholesterol levels, and break down gallstones. Its medicinal benefits also include treating long-term liver conditions such as cirrhosis.

Brief History and Discovery

Ursodeoxycholic acid was found in the 1900s after being extracted from bear bile, which was used in Chinese medicine for many years. Its evolution from a treatment to an application represents notable progress in studying biliary pharmacology.

Importance in Modern Medicine

UDCA has become essential in the field of gastroenterology as it offers a surgical solution for gallstone issues and serves as a treatment for different liver conditions related to cholestasis. Its effectiveness in enhancing liver enzymes and safeguarding liver cells from bile acid-induced cell death highlights its significance in therapy.

Composition and Properties

Chemical Structure and Properties

Acid's unique trait is its water-loving quality, which sets it apart from natural bile acids. Its ability to replace bile acids in the liver plays a role in alleviating cell damage associated with cholestatic diseases.

Pharmaceutical Formulations Available

  • Capsules
  • Tablets
  • Oral suspensions

Ursodeoxycholic Acid Generic Name

Ursodeoxycholic Acid is known by its various names and is well known in the field of pharmacology for its effectiveness in treating liver and bile duct disorders.

Ursodeoxycholic Acid Alternative

Other options aside from UDCA are medicines such as acid and different types of bile acid sequestrants, which also alter the composition of bile but vary in their intended uses and potential side effects.

Ursodeoxycholic Acid vs Tudca

A compound called Tauroursodeoxycholic acid (known as TUDCA, for short), a type of UDCA combined with taurine for absorption and effectiveness in safeguarding ng cells in brain-related uses, is more potent than the original form.

Ursodeoxycholic Acid vs Ursodiol

In the field, ursodiol and ursodeoxycholic acid are often referred to interchangeably as they are the bile acids mainly used for dissolving gallstones and treating liver conditions.

Obeticholic Acid vs Ursodeoxycholic Acid

A new treatment called acid works by activating the farnesoid X receptor. It has a unique way of treating conditions, like nonalcoholic steatohepatitis (nash), which UDCA may not effectively address.

Ursodeoxycholic Acid and Cholestyramine

Cholestyramine is commonly combined with UDCA to act as a bile acid sequestrant, lowering cholesterol levels to treat hyperlipidemia and biliary blockages—a strategy in therapy that emphasizes synergy.

Ursodeoxycholic Acid Uses

Primary Indications

In the field of medicine, the Gallstone Treatment Approach:

  • UDCA alters the content of bile to lower cholesterol levels and aid in breaking down gallstones made of cholesterol without the need for surgery. This method is especially beneficial for individuals who're not candidates, for gallbladder removal surgery.
  • Chronic liver diseases have benefitted from the use of UDCA in treating conditions like cholangitis (known as PBC) as it slows down the advancement of the disease and improves liver function tests while also reducing inflammation and fibrosis in the liver.

Secondary Indications

In addition to its purposes, UDCA also shows flexibility in treating liver-related issues.

Off-label Uses of Ursodil

Exploring Non-approved Applications

Ursodeoxycholic acid (UDCA), commonly referred to as Ursodil, is widely recognized for its efficacy in treating gallstones and chronic liver ailments; however, it also shows promise in unapproved or off-label uses. These innovative applications leverage UDCA's effects on cells and its ability to modulate the system to offer fresh strategies for addressing various health issues.

Research and Studies Supporting Off-label Use

New studies support the use of UDCA for purposes not approved by authorities.

  • Studies conducted in settings to test the effectiveness of UDCA in alleviating symptoms of bile reflux gastritis showed promising initial findings suggesting possible advantages in decreasing inflammation of the stomach lining.
  • Research on the inflammatory properties of UDCA indicates potential therapeutic benefits in autoimmune conditions, like ulcerative colitis, that might not respond well to conventional therapies.

Research like this showcases the investigation into the pharmacological effects of UDCA and offers a broader range of potential treatment options.

Ursodeoxycholic Acid for Bile Reflux

UDCA's effectiveness in treating bile reflux is attributed to its impact on bile acids. By modifying their structure and decreasing their properties, UDCA can alleviate the effects of bile reflux on the stomach lining, providing relief from persistent gastritis and related issues.

Ursodeoxycholic Acid for Dogs

UDCA is not only used in medicine but also in veterinary care to treat liver diseases in dogs, such as chronic hepatitis and gallstones. It has beneficial effects on liver function and the well-being of the animals prescribed by veterinarians.


Ursodeoxycholic Acid in Ulcerative Colitis

Although UDCA is not commonly used for treating colitis, it has been under clinical evaluation for its ability to regulate immune responses and lessen inflammation in the colon. This unconventional application is based on the acid's ability to mitigate bile acid toxicity and its overall anti-inflammatory characteristics, which present a strategy for addressing this condition.

As healthcare professionals uncover and confirm UDCA's range of capabilities, integrating it into treatment plans highlights its adaptability and lasting significance in medicine.


Ursodeoxycholic Acid Mechanism of Action

How Ursodil Works in the Body

Ursodil mainly works by changing the composition of bile in the body to its name, Ursodeoxycholic acid (UDCA). Its primary role is to replace more harmful bile acids with a gentler and less toxic UDCA. This leads to better bile flow and protection against liver cell damage caused by bile acids.



Effect on Gallstone Solubilization

UDCA is commonly used to treat cholesterol gallstones, playing a role in their management by undergoing a process for this purpose.

  • Reducing the amount of cholesterol in bile by limiting the production and release of cholesterol in the liver and decreasing the absorption of cholesterol in the intestines.
  • UDCA helps to enhance the solubility of cholesterol in the bile which aids in the breakdown of cholesterol gallstones, in the gallbladder.

UDCA's ability makes it a valuable choice for individuals who are not keen on or unable to have surgery for gallstones.

Impact on Liver Function and Bile Composition

The impact of UDCA on liver function and bile composition is complex and varied.

  • It helps enhance liver enzyme levels and liver function tests by decreasing liver enzyme leakage and improving liver cell survival.
  • By changing the makeup of the bile substance itself,​ UDCA lessens the effects of bile acids, helping to relieve issues like cholestasis that hinder bile flow.

These combined impacts help reduce symptoms and slow down the advancement of diseases in liver conditions such as Primary Biliary Cholangitis (PBC).

Ursodeoxycholic Acid Half Life

The way UDCA moves through the body is interesting – it doesn't stick around for long in the blood and usually hangs out for about 3 to 6 hours before disappearing! The cool part: even though it exits the bloodstream quickly, its impact lingers on in the liver thanks to enterohepatic recirculation. This recirculation magic keeps UDCA in the liver, where it does its thing—tweaking bile makeup and safeguarding liver cells while sparking cell regrowth.

Dosage and Administration

The dosing of Ursodeoxycholic Acid (UDCA) or UDCA differs depending on the medical condition being addressed.


Maximum Dose of Ursodeoxycholic Acid

It is advised not to exceed the UDCA dosage of 15-20 mg/kg/day of body weight, as going beyond this limit does not offer treatment advantages and could cause unwanted side effects.

Maximum Dose of Ursodeoxycholic Acid in Pregnancy

During pregnancy, it's important to be cautious when using UDCA and only do so when absolutely necessary. Generally, not going over the 10-15 mg/kg/day dosage limit is recommended for the safety of both the mother and the baby.

Ursodeoxycholic Acid Dosage for Adults

In adults receiving UDCA treatment for liver conditions, the dosage may differ based on liver function and the specific condition being addressed.

Ursodeoxycholic Acid Dose in Neonates

In babies with liver conditions, UDCA is given at a dose of 20-.30 mg/kg/day. This increased dosage is necessary because newborns metabolize quickly and require more medication per weight than adults.

Ursodeoxycholic Acid Dose for Dogs

Canine liver diseases are usually treated with a dose of 10-15 mg/kg/day of body weight, as recommended by veterinarians, to address issues like hepatitis and gallbladder disorders in dogs.

Dose of Ursodeoxycholic Acid in Jaundice

When it comes to managing jaundice linked to liver issues, the dose of UDCA can vary between 10 and 15 mg/kg/day. It can be adjusted based on how the patient is responding and how their bile flow is improving.

Methods of Administration

UDCA is available in forms such as tablets, capsules, and liquid suspensions, allowing for various ways of taking it.

  • You can take tablets and capsules with water and choose to take them with or without food; it's suggested to take them with meals to improve absorption and minimize stomach issues.
  • Liquid medications are an option, for individuals who struggle with swallowing tablets or need to make dosage adjustments; this is particularly important, in cases involving children or animals.

Ursodeoxycholic Acid Side Effects

Common Side Effects

Individuals receive ursodeoxycholic acid (UDCA) well, with only a few experiencing mild side effects primarily related to the gastrointestinal system.

  • Minor digestive problems, such as feeling queasy or having a stomach and discomfort in the abdomen area, can arise as side effects of your treatment but usually get better on their own without needing to stop the therapy.

Potential Allergic Reactions

Although uncommonly seen in practice, there have been reported cases of individuals experiencing hypersensitivity reactions to UDCA. Symptoms associated with responses may include:

  • Skin irritation
  • The sensation of pruritus is commonly known as itching.
  • Skin rash is known as urticaria, also commonly referred to as hives.

If individuals encounter these signs, they must promptly consult a healthcare professional, as stopping the medication might be necessary.


Serious Side Effects

Some serious adverse effects linked to UDCA require attention.

  • Liver Function Impairment Concerns: In some instances, that's uncommon but significant nonetheless. UDCA can unexpectedly aggravate liver function in individuals with progressed liver conditions. It is advised to monitor liver enzymes to catch any decline in liver function.
  • Severe allergic reactions can be very serious and require emergency attention. Anaphylactic reactions are rare but critical cases that may present symptoms such as difficulty breathing and swelling of the face and throat.

Long-term Side Effects of Ursodeoxycholic Acid

Extended use of UDCA in therapy may result in a range of side effects, especially when administered at dosages.

  • The chances of developing calcified gallstones are higher when the root cause of stone formation remains unresolved.
  • Over time, there is a chance that the effectiveness might diminish, which may require changes in the dosage or treatment method used. Regularly check in with healthcare professionals.

Staying vigilant is crucial for handling and reducing the dangers of extended UDCA use.

Interactions with Other Medications

Ursodeoxycholic Acid Drug Interactions

When taking acid (UDCA), it's essential to be aware of how it may affect the medications you are taking, as it could change their effectiveness or raise the chances of experiencing unwanted side effects. Here are some significant interactions to watch out for:

  • Cholestyramine and similar bile acid sequestrants may hinder the absorption of UDCA and reduce its efficacy. To avoid this issue, it is recommended that UDCA be taken 4 to 6 hours after using these agents.
  • Aluminum-infused antacids and bile acid sequestrants impact the absorption of UDCA; spacing out the times of administration can alleviate this issue.
  • Some medications used to lower lipids might also interfere with the effectiveness of UDCA in breaking down cholesterol gallstones.

Impact on Other Therapeutic Agents

UDCA might. Reduce the effectiveness of medications by influencing liver enzyme activity and bile production.

  • Improved liver function and increased enzyme activity can result in the absorption and effectiveness of medications processed by the liver.
  • Changes in how the body eliminates drugs may mean that dosage adjustments are needed.

Guidelines for Avoiding Harmful Interactions

To avoid any effects when combining UDCA with drugs, it is essential to take precautions.

  • Ensure to inform your healthcare provider about all the medications you currently take when they prescribe UDCA.
  • Keep an eye on your therapy regimen when you begin or end any medication while taking UDCA.
  • Change the timing of your medication to prevent any conflicts with the absorption process when taking bile acid sequestrants and antacids.

Contraindications and Precautions

Absolute Contraindications

Patients should steer clear of using UDCA under the following circumstances:

Precautions in Specific Populations

Certain groups of people need to be taken into account when recommending UDCA.

  • Despite being mainly safe for them, older individuals may need dosage modifications, considering their liver function and overall well-being.
  • For women and nursing mothers considering using UDCA treatment, medication should only be considered if the benefits outweigh the risks to the baby's health or well-being. While data indicates a level of risk involved in using UDCA during pregnancy or breastfeeding, it is recommended to proceed with caution.
  • Children are not fully guaranteed safety and effectiveness when it comes to using UDCA in treating liver diseases; however, it has been administered to patients under close medical monitoring.

Special Considerations

Administration to Elderly Patients

When giving Ursodeoxycholic Acid (UDCA ) to patients, healthcare providers need to take into account the changes in the body that come with age, which could impact how the drug is processed and eliminated.

  • Commence therapy at reduced dosages to account for declines in liver and kidney function.
  • Keep an eye on liver function tests and how the patient responds clinically to make necessary dose adjustments.
  • Watch out for any reactions that might show up noticeably in this group.

Safety in Pregnancy and Nursing

UDCA falls into FDA pregnancy category B, which suggests no risk to humans. However, it is advisable to use it under guidance.

  • Use it when necessary and weigh the advantages against any risks to the unborn child.
  • NursinÉ¡ mothers should be careful as it is uncertain whether UDCA is passed into breast milk.

It's important to discuss this with healthcare professionals to make sure you're using the product safely during these times.


Pediatric Use and Considerations

The use of UDCA in children may not have documentation as it does for adults; however, it is administered in situations under the supervision of specialists.

  • It is mainly utilized in conditions affecting the liver's bile flow, such as atresia and liver issues linked to fibrosis.
  • Dosages must be calculated considering the individual's weight and the particular medical condition being addressed.
  • Regularly monitoring growth and development along with liver function is essential for ensuring the effectiveness of long-term usage.


Overdosage

Symptoms of Overdosage

Consuming UDCA can have severe health consequences and usually shows symptoms such as:

  • Experiencing diarrhea could result in dehydration and disruptions in levels.
  • Signs of liver enzymes suggest liver damage.


Emergency Management and Antidotes

In case of an overdose situation arising suddenly on the scene where a person has taken medication or substances

  • Provide supportive care as necessary.
  • There is currently no known antidote for UDCA in treatment strategies, as the primary focus is to stabilize the patient while addressing issues related to dehydration and electrolyte imbalances.
  • Keep a watch, on the patients liver function and overall condition until they are stable.

Handling and Storage

Proper Storage Conditions


It is important to store ursodeoxycholic acid (UDCA) throughout its shelf life to maintain its effectiveness.

  • Please store this product in a place with an average room temperature between 20 °C and 25°C (68°F and 77°F).
  • Try to keep the medication from getting damaged by too much heat and moisture.
  • Remember to keep the container tightly sealed to shield it from light and moisture when not in use.


Handling Precautions to Ensure Safety

It's essential to handle UDCA to keep it safe and protect the person handling it.

  • Consider wearing gloves when touching the skin to prevent contamination or transmission of germs. This is particularly important in healthcare environments.
  • Remember to steer of breathing, in any dust that may come from the tablets or capsules while you're handling them out.
  • Don't swallow or inhale any crushed tablets or capsule contents to avoid any reactions from exposure.

Important Precautions and Warnings

Critical Warnings Regarding Liver Disease

Though UDCA is mainly utilized in the treatment of liver conditions, it comes with cautions:

  • It's not recommended for individuals with liver disease to take UDCA if there are signs of bile duct blockage since it could potentially exacerbate the situation.
  • It's a good idea to monitor your liver function tests to catch any signs of liver health decline while undergoing treatment.

Safety Guidelines for Long-term Use

Regular supervision is necessary when using UDCA for a period of time to avoid any issues.

  • Regularly check liver function through blood tests to detect any signs of harm or adverse reactions at an early stage.
  • It is important to ensure that patients follow the dosage and administration guidelines to prevent the over- or under-administration of medication.
  • Consider the necessity of therapy weighing the advantages of treatment against any possible drawbacks.
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Ursodil, Ursodeoxycholic Acid FAQ

Can Ursodeoxycholic Acid cause kidney problems

Ursodeoxycholic Acid has the potential to lead to kidney issues, like injury or impairment; however, these side effects are uncommon.

Can Ursodeoxycholic Acid cause itching

Yes indeed! Ursodeoxycholic Acid can lead to itching as a side effect.

Can you drink alcohol with Ursodeoxycholic Acid

Sure thing! It's okay to have a drink or two while you're on Ursodeoxycholic Acid as long as you keep it moderate and check in with your doctor for advice that suits your health needs

Does Ursodeoxycholic Acid cause weight loss

Ursodeoxycholic acid usually doesn't lead to weight loss; it's mainly prescribed for liver and gallbladder issues rather than for managing weight.

Does Ursodeoxycholic Acid dissolve gallstones

Sure thing! Sometimes, Ursodeoxycholic acid can break down cholesterol gallstones.

Is Ursodiol the same as Ursodeoxycholic Acid

Ursodiol and Ursodeoxycholic acid refer to the compound. They are different names for the same compound.

Is Ursodeoxycholic Acid good for fatty liver

Ursodeoxycholic acid is commonly prescribed for managing fatty liver conditions like alcoholic fatty liver disease (NAFLD).

Is Ursodeoxycholic Acid safe in pregnancy

Certainly! Ursodeoxycholic acid is generally deemed safe for consumption during pregnancy when recommended by a physician for conditions.

Is Ursodeoxycholic Acid safe

Certainly! Ursodeoxycholic acid is typically considered safe when taken as directed; nevertheless, it may lead to side effects and may not be appropriate for all individuals.

Is Ursodeoxycholic Acid a steroid

Ursodeoxycholic acid isn't a steroid; instead, it's a bile acid prescribed for liver and gallbladder issues.

How does Ursodeoxycholic Acid work in PBC (Primary biliary cholangitis)

In cholangitis (also known as PBC), Ursodeoxycholic acid functions by decreasing the levels of harmful bile acids in the liver to enhance bile movement and shield liver cells from harm. This contributes to slowing down the advancement of the illness.

How does Ursodeoxycholic Acid work

Ursodeoxycholic Acid lowers cholesterol absorption in the intestines and reduces the concentration of bile cholesterol while aiding in the dissolution of cholesterol gallstones. Its additional benefits include enhancing bile flow and shielding liver cells from harm.

How to take Ursodeoxycholic Acid

It's recommended to take acid by mouth along with food for absorption. As a healthcare professional advises, it's usually split into two or three doses daily.

How Ursodeoxycholic Acid dissolve gallstones

The main function of Ursodeoxycholic Acid is to dissolve gallstones by lowering the amount of cholesterol in bile fluids and breaking down cholesterol crystals over time.

How long does it take for Ursodeoxycholic Acid to work

Ursodeoxycholic acid usually takes 6 months to 2 years to break down gallstones based on their size and structure.

How does Ursodeoxycholic Acid help the liver

Ursodeoxycholic Acid can benefit the liver by enhancing bile flow and reducing its toxicity levels. It also safeguards liver cells and slows the advancement of liver conditions like cholangitis.

What is Ursodeoxycholic Acid

UDCA is a type of bile acid utilized to manage liver and gallbladder conditions such as cholangitis and gallstones by decreasing the harmful effects of bile acid and enhancing bile movement.

What is Ursodeoxycholic Acid used for

Ursodeoxycholic Acid is a medication used to address biliary cholangitis, aid in the dissolution of cholesterol gallstones, and enhance liver function under specific circumstances.

What are the side effects of Ursodeoxycholic Acid?

One reaction to Ursodeoxycholic Acid is stomach upset, which can include queasiness, bellyache, head pain, lightheadedness, and skin irritation.

What are the major side effects of Ursodeoxycholic Acid?

Ursodeoxycholic Acid can have effects such as intense abdominal pain and yellowish skin coloration in rare instances, along with dark-colored urine and deterioration of liver function.

What does Ursodeoxycholic Acid do

The function of acid includes enhancing the movement of bile in the body to break down cholesterol gallstones and safeguard liver cells from harm caused by bile acid toxicity.

What is Ursodeoxycholic Acid used to treat

The usage of acid includes treating biliary cholangitis, managing specific liver conditions, and dissolving cholesterol gallstones.

When should i take Ursodeoxycholic Acid

Make sure to follow your doctor's instructions when taking acid for issues such as gallstones or primary biliary cholangitis, with meals and as directed, for the best results in treatment.

When to take Ursodeoxycholic Acid

Remember to consume Ursodeoxycholic Acid alongside your meals per your doctor's instructions.

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