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Ursodeoxycholic acid

Biliary Liver Cirrhosis, Cholelithiasis

DRUG STATUS

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Approvals

US(FDA), UK(BNF)

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Essential Medicine

NO

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Teratogenicity

Unlisted

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Pharmaceutical Class

Bile Acid

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Drug Ingredient

Ursodeoxycholic acid

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Summary

  • Ursodeoxycholic Acid (UDCA) is primarily used to treat liver conditions like primary biliary cholangitis and gallstones. It's also used for certain liver diseases such as nonalcoholic fatty liver disease and to prevent gallstones in those with risk factors.

  • UDCA works by reducing cholesterol production in the liver and improving bile flow. This helps dissolve gallstones and prevents toxic bile acids buildup. It also protects liver cells, promoting liver health.

  • The typical dosage for adults ranges from 10 to 15 mg per kilogram of body weight per day, divided into two to four doses. It's often taken with food to improve absorption. Capsules should be swallowed whole.

  • Common side effects include diarrhea, nausea, vomiting, stomach pain, constipation, and heartburn. Rarely, it can cause skin irritation, rashes, and inflammation in the lungs.

  • UDCA can cause severe diarrhea, nausea, and vomiting. It can also cause liver damage in patients with advanced cirrhosis or other severe liver diseases. It can increase the risk of bleeding, especially in patients with bleeding disorders or those taking blood-thinning medications.

Indications and Purpose

What is Ursodeoxycholic acid used for?

Ursodiol tablets help people with a liver disease called primary biliary cholangitis (PBC). PBC damages the liver's bile ducts. Ursodiol helps slow down this damage, making the liver work better and improving symptoms. The tablets come in two strengths, 250 mg and 500 mg.

How does Ursodeoxycholic acid work?

Ursodiol is a medicine that helps your liver handle cholesterol. It works in a few ways: it lowers cholesterol production in your liver, prevents your intestines from absorbing as much cholesterol, and helps dissolve cholesterol already in your bile (a liver fluid). Your body gets used to the medicine within about three weeks. Most of the medicine leaves your body through your bowel movements, but more goes into your urine if you have a serious liver problem. If you take it regularly, a good portion of it will be found in your bile and blood.

Is Ursodeoxycholic acid effective?

Ursodiol is a medicine that helps people with a liver disease called primary biliary cholangitis (PBC). A study showed it works better than a dummy pill (placebo). Fewer people taking ursodiol had their treatment fail, and it took longer for their treatment to fail.

How does one know if Ursodeoxycholic acid is working?

A study showed that a medicine called ursodiol helped people with a liver disease called primary biliary cholangitis (PBC). Fewer people taking ursodiol had their disease get worse compared to those taking a sugar pill (placebo). The medicine also slowed down the progression of the disease. Doctors regularly checked liver blood tests to monitor how well the medicine was working.

Directions for Use

What is the usual dose of Ursodeoxycholic acid?

Ursodiol is a medicine. The amount you take depends on why you're taking it. For PBC, a liver disease, your doctor will figure out your dose based on your weight, aiming for a daily total of 13 to 15 milligrams per kilogram of body weight, split into 2 to 4 doses with meals. If you're taking it to dissolve gallstones, the dose is lower – 8 to 10 milligrams per kilogram of body weight daily, in 2 or 3 doses. For preventing gallstones during quick weight loss, your doctor might prescribe 600 milligrams daily. This information is for adults only; there's no information for children. Your doctor will decide the best dose for you.

How do I take Ursodeoxycholic acid?

Ursodiol is a medicine taken in divided doses with food. Your doctor will figure out the right amount for you based on your weight, and it might need to be adjusted. It's important to get your liver checked regularly while taking it. Some other medicines can affect how well it works, so tell your doctor about everything you're taking. You can break the tablets in half if needed.

For how long do I take Ursodeoxycholic acid?

Ursodiol treatment needs regular liver tests. These tests happen monthly for the first three months, then every six months after that. Your doctor decides how much Ursodiol you take, and they'll adjust the dose if needed. There's no set time for how long you'll need to take it.

How long does it take for Ursodeoxycholic acid to start working?

It takes about three weeks for the medicine ursodiol to reach a consistent level in your bile (a fluid in your liver). However, a study showed that it takes much longer, about two years, to see the full benefit of the medicine in preventing treatment failure. This means that while the medicine is working in your body after three weeks, the best results take much longer to appear.

How should I store Ursodeoxycholic acid?

Keep Ursodiol tablets in a cool, dry place (between 68°F and 77°F). If you break a tablet in half, use that half within 28 days and keep it in the original bottle, separate from the whole tablets.

Warnings and Precautions

Who should avoid taking Ursodeoxycholic acid?

Ursodiol is a medicine that shouldn't be used if you have a completely blocked bile duct or are allergic to it. Your liver function will be checked regularly with blood tests for the first three months, then less often. The medicine should be stopped if the tests show problems. If you have problems with your intestines, you might need to stop taking it and see a doctor. Some other medicines can affect how well ursodiol works.

Can I take Ursodeoxycholic acid with other prescription drugs?

Drugs affecting lipid metabolism (e.g., estrogens) may counteract the effects of ursodiol by promoting cholesterol gallstone formation. Close monitoring is advised when these drugs are used together. 

Can I take Ursodeoxycholic acid with vitamins or supplements?

Bile acid sequestering agents (like cholestyramine) and aluminum-based antacids may interfere with the absorption of ursodiol, reducing its effectiveness.

Can Ursodeoxycholic acid be taken safely while pregnant?

Doctors don't recommend Ursodiol during pregnancy, even though animal studies and a small number of human cases haven't shown any clear problems for the baby. However, because there haven't been many studies, they can't say for sure it's completely safe.

Can Ursodeoxycholic acid be taken safely while breastfeeding?

We don't know for sure if the medicine ursodiol passes into breast milk. Because many medicines *do* pass into breast milk, it's best to be careful if you're breastfeeding. While there haven't been many reports of problems in babies, we need more information. Doctors will need to consider the benefits of breastfeeding against any possible risks to the baby from the medicine or the mother's health problem.

Is Ursodeoxycholic acid safe for the elderly?

Older people should take Ursodiol carefully. Studies haven't shown big problems with safety or how well it works in older adults, but it's possible some older people might need a lower dose or might be more sensitive to its effects. Their doctor should start them on a low dose and watch them closely.

Is it safe to exercise while taking Ursodeoxycholic acid?

Exercising while taking ursodiol is typically safe and can help improve overall health. However, individuals should listen to their bodies and consult their healthcare provider before starting any new exercise regimen to ensure it's appropriate for their health status while on this medication.

Is it safe to drink alcohol while taking Ursodeoxycholic acid?

Moderate alcohol consumption may increase the risk of liver damage when combined with ursodiol. It's best to consult your healthcare provider regarding alcohol use while on this medication.