Why is this medication prescribed?

Actigall (Generic Ursodiol) is a medication primarily prescribed for two main purposes:

•  Treatment of Gallstones: Ursodiol is used to dissolve small cholesterol gallstones in patients who are unable or unwilling to undergo surgery to remove the gallbladder (cholecystectomy). It works by reducing the production of cholesterol in the liver and by slowly dissolving the cholesterol that makes up gallstones. It is also used to prevent the formation of gallstones in overweight patients who are undergoing rapid weight loss, which is a risk factor for gallstone development.
• Primary Biliary Cirrhosis (PBC): Ursodiol is used to treat primary biliary cirrhosis, a chronic disease that slowly destroys the bile ducts in the liver. By improving bile flow and reducing the toxic effects of bile acids, Ursodiol can slow the progression of this disease.

How should this medicine be used?

Here’s a general overview of how it’s used:

• Dosage: The dosage of Ursodiol varies depending on the condition being treated. For gallstone dissolution, the typical dose is around 8-10 mg/kg/day, usually divided into two or three doses. For primary biliary cirrhosis, the dosage is typically higher, around 13-15 mg/kg/day, also divided into multiple doses.
• Administration: Ursodiol should be taken with food to improve absorption. The tablets should be swallowed whole and not crushed or chewed.
• Duration: Treatment for gallstones may take several months, and it’s essential to follow the prescribed duration even if symptoms improve. Regular monitoring through ultrasound or other imaging may be necessary to assess the effectiveness of the treatment.
• Consistency: For best results, it’s important to take Ursodiol regularly, as missing doses can reduce its effectiveness.

It’s essential to follow your healthcare provider’s instructions regarding the dosage and duration of treatment with Ursodiol. Regular follow-ups are important to monitor the progress and to check for any potential side effects.

Other uses for this medicine

• Liver Disease: Besides PBC, it’s sometimes used for other liver-related conditions based on specific medical advice.
• Other Liver Conditions: It may be used for other specific liver diseases based on your healthcare provider’s recommendations.

What special precautions should I follow?

When using Actigall, there are several precautions you should take to ensure safe and effective use:

• Allergies: Inform your doctor if you have any allergies, particularly to Ursodiol or other bile acids.
• Liver Problems: If you have a history of liver disease other than those being treated with Ursodiol, your doctor needs to know.
• Gallbladder Issues: Ursodiol is not suitable for patients with certain types of gallbladder problems, such as calcified gallstones or non-functioning gallbladders.
• Intestinal Problems: Conditions like Crohn’s disease, which affect bile absorption, can influence the effectiveness of Ursodiol.
• Pregnancy: If you are pregnant or planning to become pregnant, discuss the risks and benefits of taking Ursodiol with your doctor.
• Breastfeeding: It’s not known if Ursodiol passes into breast milk, so you should consult your doctor before breastfeeding while on this medication.
• Cholestyramine or Colestipol: These medications can bind to Ursodiol in the intestine and reduce its absorption, so they should be taken several hours apart.
• Estrogenic Hormones and Oral Contraceptives: These can increase cholesterol secretion into bile, potentially reducing the effectiveness of Ursodiol in dissolving gallstones.
• Antacids: Certain antacids containing aluminum may also interfere with Ursodiol absorption.
• Regular Testing: Periodic liver function tests and imaging studies like ultrasound are often necessary to monitor the effectiveness and safety of the treatment.
• Symptoms: Report any new or worsening symptoms to your doctor immediately, particularly signs of liver problems like yellowing of the skin or eyes (jaundice), dark urine, or severe abdominal pain.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose and continue your regular schedule. Do not double the dose to catch up.
• Cholesterol Intake: Following a diet low in cholesterol and fat can help enhance the effectiveness of Ursodiol in treating gallstones.

By following these precautions and working closely with your healthcare provider, you can help ensure that your treatment with Actigall is as safe and effective as possible.

What special dietary instructions should I follow?

• Dietary Adjustments: To enhance the effectiveness of Ursodiol, you may be advised to follow a diet low in cholesterol and fats. High-fat and high-cholesterol foods can contribute to the formation of gallstones.
• Take with Food: Ursodiol is better absorbed when taken with food. Make sure to take your doses with meals to improve absorption and effectiveness.

What should I do if I forget a dose?

• Take it as Soon as You Remember: If you forget a dose, take it as soon as you remember, unless it’s close to the time for your next dose.
• Skip the Missed Dose: If it’s almost time for your next scheduled dose, skip the missed dose. Do not take two doses at once to make up for a missed one.
• Resume Your Regular Schedule: Continue with your regular dosing schedule. Missing occasional doses may reduce the effectiveness of the treatment, so try to take your medication consistently as prescribed.

What side effects can this medication cause?

Actigall (Ursodiol) is generally well-tolerated, but like any medication, it can cause side effects. These can range from mild to more serious. It’s important to be aware of potential side effects and to report any unusual symptoms to your healthcare provider.

Common Side Effects: These side effects are generally mild and may diminish as your body adjusts to the medication:

• Diarrhea: This is one of the most common side effects and may occur particularly when starting the medication.
• Constipation: Some people may experience constipation instead of diarrhea.
• Nausea or Vomiting: Mild gastrointestinal discomfort, including nausea, may occur.
• Indigestion or Stomach Pain: Some patients report mild to moderate indigestion or discomfort in the stomach area.
• Headache: Headaches are a less common but possible side effect.
• Dizziness: You might feel lightheaded or dizzy, especially when getting up quickly from a sitting or lying position.
• Back Pain: Some individuals may experience mild back pain.

Less Common but More Serious Side Effects: These side effects are less common but require immediate medical attention if they occur:

• Severe Abdominal Pain: Intense or persistent abdominal pain could indicate a serious problem, such as gallstone complications.
• Jaundice: Yellowing of the skin or eyes, which may indicate liver problems.
• Severe Diarrhea: While mild diarrhea is common, severe or persistent diarrhea should be reported to your doctor.
• Allergic Reactions: Symptoms of a severe allergic reaction may include rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing. This requires immediate medical attention.
• Chest Pain: Any chest pain should be evaluated promptly by a healthcare professional.
• Dark Urine or Pale Stools: These could be signs of liver dysfunction.
• Unusual Fatigue or Weakness: Persistent tiredness or weakness may indicate an underlying issue that needs to be addressed.

With prolonged use, monitoring for potential liver function changes is important, as long-term use may affect liver enzymes. Regular blood tests are often recommended to ensure liver function remains normal.

If you experience any side effects that are persistent, bothersome, or concerning, contact your healthcare provider for advice. They may adjust your dosage, suggest ways to manage the side effects, or consider an alternative treatment if necessary.

What should I know about storage and disposal of this medication?

Storage and Disposal of Actigall (Ursodiol):

Storage:

• Room Temperature: Store Actigall at room temperature, typically between 68°F to 77°F (20°C to 25°C).
• Avoid Moisture and Heat: Keep the medication away from excessive heat, moisture, and direct sunlight. Do not store it in the bathroom, as humidity can degrade the medication.
• Original Container: Keep Actigall in its original container, tightly closed, and out of reach of children and pets.
• Expiration Date: Check the expiration date on the medication bottle. Do not use the medication if it has expired.

Disposal:

• Do Not Flush: Do not flush Actigall down the toilet or pour it down a drain unless instructed to do so by your pharmacist or local waste disposal company.
• Medication Take-Back Programs: If available, use a medication take-back program for safe disposal. Many pharmacies offer this service.
• Dispose of Safely: If a take-back program is not available, mix the medication with an unappealing substance like coffee grounds or cat litter, place it in a sealed plastic bag, and dispose of it in the household trash.

In case of emergency/overdose

• Signs of Overdose: Overdosing on Actigall may lead to symptoms such as severe diarrhea, abdominal pain, dizziness, and possible liver toxicity.
• Call Emergency Services: If you suspect an overdose, immediately call emergency services (911 in the U.S.) or your local poison control center.
• Contact Poison Control: You can reach the Poison Control Center at 1-800-222-1222 in the U.S. They can provide guidance on what to do next.
• Do Not Induce Vomiting: Unless specifically instructed by a healthcare professional, do not induce vomiting.

What other information should I know?

• Follow Prescribed Dosage: Take Actigall exactly as prescribed by your healthcare provider. Do not take more or less than the prescribed dose.
• Regular Monitoring: Attend all follow-up appointments for blood tests and imaging studies to monitor your liver function and the effectiveness of the treatment.
• Medication Interactions: Keep a list of all your medications, including prescription drugs, over-the-counter medications, and supplements, and share it with your healthcare provider. Actigall can interact with other medications.
• Missed Doses: If you miss a dose, take it as soon as you remember, unless it’s almost time for your next dose. Do not double up on doses.
• Report Side Effects: Inform your doctor about any side effects you experience, especially if they are severe or persistent.
• Pregnancy and Breastfeeding: If you become pregnant while taking Actigall, inform your doctor immediately. Discuss the risks and benefits of continuing treatment during pregnancy or while breastfeeding.
• Do Not Share Medication: Do not share your medication with others, even if they have similar symptoms, as it may not be appropriate for them.
• Alcohol Use: Discuss alcohol use with your doctor, as alcohol can increase the risk of liver damage, especially in patients with liver disease.

Always follow your healthcare provider’s instructions for using, storing, and disposing of Actigall, and consult them if you have any questions or concerns.