Actigall

Name: Actigall

Is ursodiol safe to take if I'm pregnant or breastfeeding?

The are no adequate studies in pregnant women.

It is not known whether ursodiol is secreted in breast milk.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

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 this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

It is best to take ursodiol with meals, unless otherwise directed by your doctor.

Take this medicine 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.

If you are using Urso Forte® tablets:

  • You may break the tablets into halves. To break the tablet easily, place it 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 it.
  • Due to the bitter taste, store the half-tablets or segments separately from the whole tablets. Half-tablets can be used for up to 28 days when kept in the medicine bottle.

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 forms (capsules or tablets):
    • For gallstone disease:
      • Adults and children 12 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 8 to 10 milligrams (mg) per kilogram (kg) of body weight per day, divided into two or three doses.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • For prevention of gallstones during rapid weight loss:
      • Adults—300 milligrams (mg) two times a day.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • For primary biliary cirrhosis:
      • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 13 to 15 milligrams (mg) per kilogram (kg) of body weight per day, divided into two to four doses. Your doctor may adjust your dose as needed.
      • Children—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.

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 immediately 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
  • skin rash or itching over the entire body
  • stomach pain
  • vomiting
  • weakness
Less common
  • Black, tarry stools
  • chest pain
  • chills or fever
  • cough
  • pinpoint red spots on the skin
  • severe or continuing stomach pain
  • sore throat or swollen glands
  • sores, ulcers, or white spots on the lips or in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known
  • Clay-colored stools
  • dark urine
  • difficulty with swallowing
  • headache
  • hives or welts
  • hoarseness
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • nausea
  • redness of the skin
  • slow or irregular breathing
  • tightness in the chest
  • unpleasant breath odor
  • yellow eyes or skin

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
  • general feeling of discomfort or illness
  • heartburn
  • loss of voice
  • muscle aches
  • muscle or bone pain
  • pain, swelling, or redness in the joints
  • runny nose
  • sweating
  • trouble sleeping
Less common
  • Diarrhea
Rare
  • Worsening psoriasis
Incidence not known
  • Acid or sour stomach
  • belching bloating or swelling of face, arms, hands, lower legs, or feet
  • difficulty with moving
  • rapid weight gain
  • stomach discomfort or upset
  • tingling of the hands or feet
  • unusual weight gain or loss

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.

How do I store and/or throw out Actigall?

All products:

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Tablets:

  • If you break the tablet in half, store the half-tablets apart from the whole tablets.

Uses of Actigall

Actigall is a prescription medication used to dissolve small gallstones (non-surgically) and to prevent gallstone formation in very overweight patients experiencing rapid weight loss. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Actigall Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • antacids containing aluminum such as Amphojel, Gaviscon, Maalox, and Mylanta
  • cholestryramine (Questran)
  • clofibrate (Atromid-S)
  • colestipol (Colestid)
  • medications that lower cholesterol levels
  • medications that contain estrogen, including birth control pills

This is not a complete list of Actigall drug interactions. Ask your doctor or pharmacist for more information.

Actigall and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Actigall crosses into human milk. Because many medications can cross into human milk, caution should be exercised when Actigall is administered to a nursing mother.

For Healthcare Professionals

Applies to ursodiol: oral capsule, oral tablet

Gastrointestinal

Very common (10% or more): Abdominal pain (up to 43.2%), diarrhea (up to 27.1%), constipation (up to 26.4%), nausea (up to 17.4%), dyspepsia (up to 16.8%), vomiting (up to 13.7%)
Common (1% to 10%): Flatulence (up to 7.7%), cholecystitis (5.2%), gastrointestinal disorder (3.9%), esophagitis (1.7%), peptic ulcer (1.3%)
Postmarketing reports: Abdominal discomfort, abdominal pain, diarrhea, constipation, dyspepsia, nausea, vomiting[Ref]

Nervous system

Very common (10% or more): Headache (up to 24.8%), dizziness (16.5%)
Common (1% to 10%): Insomnia (1.9%)
Postmarketing reports: Dizziness, headache[Ref]

Other

Very common (10% or more): Viral infection (up to 19.4%)
Common (1% to 10%): Fatigue (up to 7.8%), influenza-like symptoms (6.5%), chest pain (3.2%), asthenia (1.7%)
Postmarketing reports: Malaise, peripheral edema, pyrexia[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 15.5%), sinusitis (up to 11%)
Common (1% to 10%): Pharyngitis (up to 8.4%), coughing (7.1%), bronchitis (6.5%), rhinitis (5.2%)
Postmarketing reports: Cough[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 11.8%)
Common (1% to 10%): Arthralgia (7.7%), musculoskeletal pain (5.9%), arthritis (5.8%), myalgia (5.8%)
Postmarketing reports: Myalgia[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection (6.5%), dysmenorrhea (5.6%)[Ref]

Dermatologic

Common (1% to 10%): Alopecia (5.3%), skin rash (2.6%)
Postmarketing reports: Alopecia, pruritus, rash[Ref]

Hypersensitivity

Common (1% to 10%): Allergy (5.2%)
Postmarketing reports: Drug hypersensitivity (including facial edema, urticaria, angioedema, laryngeal edema)[Ref]

Hematologic

Common (1% to 10%): Leukopenia (2.6%), thrombocytopenia (1.3%)[Ref]

Metabolic

Common (1% to 10%): Anorexia (1.7%), elevated blood glucose (up to 1.3%)[Ref]

Renal

Common (1% to 10%): Elevated creatinine (1.3%)[Ref]

Hepatic

Postmarketing reports: Jaundice (or aggravation of preexisting jaundice), increased ALT, increased AST, increased blood alkaline phosphatase, increased blood bilirubin, increased gamma-glutamyltransferase, increased hepatic enzymes, abnormal liver function test, increased transaminases[Ref]

Some side effects of Actigall may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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