Actigall

Name: Actigall

Notes

Do not share this medication with others.Laboratory and/or medical tests (e.g., liver function tests, bilirubin level) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Actigall (ursodiol)?

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb ursodiol.

If you also take cholestyramine or colestipol, avoid taking ursodiol at the same time. Ask your doctor how many hours apart you should take your medicines.

What are some things I need to know or do while I take Actigall?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Actigall while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Actigall) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

  • To gain the most benefit, do not miss doses.
  • Keep taking Actigall as you have been told by your doctor or other health care provider, even if you feel well.
  • Some other drugs may need to be taken at some other time than this medicine. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than Actigall.

Tablets:

  • Take with food.
  • Some products may be broken in half. If you are not sure if you can break this product in half, talk with the doctor.
  • If you break the tablet in half, use the other half of the tablet for the next dose, as told by the doctor. Throw away half-tablets not used within 28 days.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Actigall Dosage and Administration

Gallstone Dissolution

The recommended dose for Actigall treatment of radiolucent gallbladder stones is 8 - 10 mg/kg/day given in 2 or 3 divided doses.

Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of Actigall therapy to monitor gallstone response. If gallstones appear to have dissolved, Actigall therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of Actigall therapy, the likelihood of success is greatly reduced.

Gallstone Prevention

The recommended dosage of Actigall for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).

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Actigall 
ursodiol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52544-930
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
URSODIOL (URSODIOL) URSODIOL 300 mg
Product Characteristics
Color PINK (pink) , WHITE (opaque white) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code Actigall;300;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:52544-930-01 100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019594 12/31/1987
Labeler - Actavis Pharma, Inc. (119723554)
Revised: 08/2015   Actavis Pharma, Inc.

Actigall Drug Class

Actigall is part of the drug class:

  • Bile acid preparations

Actigall Precautions

Serious side effects have been reported with Actigall including the following:

  • frequent urination or pain when you urinate
  • cough with fever

Actigall can cause dizziness. Do not drive or operate heavy machinery until you know how Actigall affects you.

Do not take Actigall if you:

  • are allergic to Actigall or to any of its ingredients
  • are allergic to bile acids
  • have calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones
  • have compelling reasons for a cholecystectomy (surgical removal of the gall bladder) such as unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula

Actigall Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • how you respond to this medication
  • your weight

The recommended dosage of Actigall for the treatment of gallstones is 8-10 mg/kg/day divided in 2 or 3 doses. 

The recommended dosage of Actigall for the prevention of gallstones in patients undergoing rapid weight loss is 300 mg 2 times a day.

Pregnancy & Lactation

Pregnancy Category: B

Lactation: unknown if excreted in breast milk; use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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