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Drugs reference index «Actigall»

Actigall
Actigall


Actigall

Generic Name: ursodiol (Oral route)

ur-soe-DYE-ol

Commonly used brand name(s):

In the U.S.

  • Actigall
  • Urso
  • Urso 250
  • Urso Forte

Available Dosage Forms:

  • Tablet
  • Capsule

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Bile Acid

Uses For Actigall

Ursodiol is used in the treatment of gallstone disease. It is taken by mouth to dissolve the gallstones.

Ursodiol is used in patients with gallstones who do not need to have their gallbladders removed or in those in whom surgery should be avoided because of other medical problems. However, ursodiol works only in those patients whose gallstones are made of cholesterol and works best when these stones are small and of the “floating” type.

Ursodiol is also used to help prevent gallstones in patients who are on rapid weight-loss programs.

Ursodiol is also used in patients with cirrhosis of the liver. Cirrhosis causes a patient's liver to have problems and not work properly.

Ursodiol is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, ursodiol is used in certain patients with the following medical conditions:

  • Chronic liver disease
  • Liver transplant (to help reduce the risk of rejection)

Before Using Actigall

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ursodiol in the pediatric population. Safety and efficacy have not been established .

Geriatric

No information is available on the relationship of age to the effects of ursodiol in geriatric patients .

Pregnancy

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Ascites (accumulation of fluid in the abdominal cavity) or
  • Bleeding varices (veins that enlarge and bleed) or
  • Hepatic encephalopathy (brain disease due to liver failure) or
  • Liver damage (from not having a certain chemical in your liver to break down a substance called lithocholate) or
  • Liver problems—May make these conditions worse .
  • Biliary tract problems or
  • Pancreatitis (inflammation of pancreas)—These conditions may make it necessary to have surgery since treatment with ursodiol would take too long.

Proper Use of ursodiol

This section provides information on the proper use of a number of products that contain ursodiol. It may not be specific to Actigall. Please read with care.

Take ursodiol with meals for best results, unless otherwise directed by your doctor.

Take ursodiol for the full time of treatment, even if you begin to feel better. If you stop taking this medicine too soon, the gallstones may not dissolve as fast or may not dissolve at all.

It is thought that body weight and the kind of diet the patient follows may affect how fast the stones dissolve and whether new stones will form. However, check with your doctor before going on any diet.

Ursodiol forte tablet can be broken in halves to provide recommended dosage. To break the tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the groove then apply gentle pressure until it breaks apart. Swallow each segment with water. Do not chew .

Half-tablets can be used for up to 28 days when kept in the medicine bottle. Due to the bitter taste, segments should be stored separately .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules or tablets):
    • For gallstone disease:
      • Adults and children 12 years of age and older—The dose is based on body weight and must be determined by your doctor. The usual dose is 8 to 10 milligrams (mg) per kilogram (kg) (3.6 to 4.5 mg per pound) of body weight a day, divided into two or three doses. Each dose is usually taken with a meal.
      • Children up to 12 years of age—Use and dose must be determined by your doctor.
    • For prevention of gallstones during rapid weight loss:
      • Adults—Oral, 300 mg two times a day.
      • Children up to 12 years of age—Use and dose must be determined by your doctor.
    • For cirrhosis of the liver:
      • Adults—The dose is based on body weight and must be determined by your doctor. The usual dose is 13 to 15 milligrams (mg) per kilogram (kg) (5.85 to 6.75 mg per pound) of body weight a day, divided into two to four doses. Each dose should be taken with a meal.
      • Children up to 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

If you miss a dose of this medicine, take it as soon as possible or double your next dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Actigall

It is important that your doctor check your progress at regular visits. Laboratory tests will have to be done every few months while you are taking this medicine to make sure that the gallstones are dissolving and your liver is working properly.

Do not take aluminum-containing antacids (e.g., ALternaGEL®, Maalox®), cholestyramine (Questran®), colestipol (Colestid®), clofibrate (Atromid-S®), or estrogen or birth control pills while taking ursodiol. To do so may keep ursodiol from working properly. Before using these medicines, check with your doctor first .

Check with your doctor immediately if severe abdominal or stomach pain, especially toward the upper right side, or severe nausea and vomiting occur. These symptoms may mean that you have other medical problems or that your gallstone condition needs your doctor's attention.

Actigall Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common
  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • dizziness
  • fast heartbeat
  • frequent urge to urinate
  • indigestion
  • lower back or side pain
  • severe nausea
  • shortness of breath
  • skin rash or itching over the entire body
  • stomach pain
  • vomiting
  • weakness
  • wheezing
Less common
  • Black, tarry stools
  • blood in vomit
  • chest pain
  • chills
  • cough
  • fever
  • painful or difficult urination
  • severe or continuing stomach pain
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • swollen glands
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

  • Diarrhea

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Back pain
  • body aches or pain
  • congestion
  • constipation
  • cough producing mucus
  • difficulty in breathing
  • dryness or soreness of throat
  • ear congestion
  • general feeling of discomfort or illness
  • hair loss
  • headache
  • heartburn
  • loss of appetite
  • loss of voice
  • muscle aches and pains
  • muscle or bone pain
  • muscle stiffness
  • nasal congestion
  • nausea
  • pain, swelling, or redness in joints
  • runny nose
  • shivering
  • sneezing
  • sweating
  • tightness in chest
  • trouble in swallowing
  • trouble sleeping
  • voice changes
Less common or rare
  • Worsening psoriasis

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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  • Actigall Prescribing Information (FDA)
  • Actigall MedFacts Consumer Leaflet (Wolters Kluwer)
  • Actigall Detailed Consumer Information (PDR)
  • Actigall Concise Consumer Information (Cerner Multum)
  • Ursodiol Prescribing Information (FDA)
  • Ursodiol Professional Patient Advice (Wolters Kluwer)
  • Urso Prescribing Information (FDA)

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