Actigall

The active ingredient in Actigall is ursodiol or ursodeoxycholic acid. It is a bile acid that prevents and helps dissolve certain gallstones. It works to lower the cholesterol content of bile and bile stones by reducing the production and secretion of cholesterol from your liver and the reabsorption of cholesterol by your intestines. It also keeps bile flow moving and maintains liver function in people who have a certain type of liver disease called primary biliary cirrhosis.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Actigall. However, the following is a synopsis of the general guidelines for the use of Actigall:

• If necessary, the scored pill may be divided in half to deliver the precise dosage that your doctor has prescribed. The remaining half-tablet can be kept for up to 28 days at room temperature. You should immediately drink the half-tablet with water. The half-tablet may have a bitter taste, so avoid chewing it.
• It may be more difficult for your body to absorb Actigall if you take it with any antacids.
• Before beginning Actigall, it is essential to discuss any bile acid allergies with your doctor. If you are allergic to bile acids, you should not use this prescription.
• You may need gallbladder ultrasound exams or frequent blood tests to check your liver function while on Actigall.

The most common side effects of Actigall include:

• Headaches.
• Dizziness.
• Skin rash.
• Back pain.
• Hair loss or thinning.
• Bladder infection.
• Muscle pain.
• Abdominal pain.
• Constipation.

Some individuals may experience serious side effects while using Actigall. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe allergic reactions (facial, lips, tongue, or throat swelling, sore throat, hives, and trouble breathing).
• Liver problems (jaundice or yellowing of your skin and eyes, dark urine, clay-colored stools, fatigue, or stomach pain).

These are not all of the possible side effects of Actigall. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Actigall, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Fluid buildup in the stomach cavity (ascites).
• Bleeding varices (enlarged and bleeding veins).
• Gastrointestinal issues, such as Crohn's disease.
• Liver failure-related brain illness (hepatic encephalopathy).
• Liver injury.
• Liver transplant.
• Obstruction of the biliary tract.
• Pancreatitis.

• An allergy to bile acids.
• Calcified gallstones.
• Certain bile duct problems, like cholangitis or a blockage.
• Gallbladder inflammation (cholecystitis).

Although it may take several months for Actigall to completely dissolve your gallstones, you may get some symptom relief after just a few weeks of treatment. Even after Actigall treatment, it's possible that some of your gallstones won't dissolve entirely. Additionally, years after finishing Actigall, your gallstones can return. If this drug is not appropriate for you, you and your healthcare practitioner should talk about the risks and benefits of the treatment. You should also look into alternative therapies.

When Actigall is taken with other prescription drugs, over-the-counter medications, vitamins, and dietary supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Aluminum-based antacids
• Estrogen-containing medications, including oral contraceptives
• Cholestyramine
• Colesevelam
• Colestipol
• Cyclosporine
• Magaldrate

Typical dosage for Actigall (ursodiol):

Gallstone dissolution using capsules: Body weight determines the dosage. Take two or three divided doses of 8–10 mg/kg each day.

Preventing gallstones: Take 300 mg orally twice daily, for a daily total of 600 mg.

Tablets:

Biliary cirrhosis primary: Body weight determines the dosage. Take two or four split doses of 13–15 mg/kg per day with food.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

Store the medication at room temperature and keep it out of reach of children.

Teva Pharmaceuticals is the company that manufactures Actigall.

There are several lower-cost generic versions of Actigall available.

Even if you start to feel better, continue taking this medication for the duration of your treatment. The gallstones might not dissolve at all or might not dissolve as quickly if you stop taking this medication too soon.

Available data have not identified a drug-associated risk of major birth defects, miscarriage, or other harmful outcomes when Actigall is used during pregnancy. However, talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

There are no reports of adverse effects of ursodiol on breastfed children, and it is not known its effects on milk production. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.