Ursodiol

Warnings and Precautions (

Ursodiol tablets, 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (PBC).

• Recommended adult dosage
  : 13-15 mg/kg/day administered in two to four divided doses with food. (
  2.1 General Dosing Information

  The recommended adult dosage for ursodiol tablets, 250 mg and 500 mgin the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient's need at the discretion of the physician.
  )
• Scored ursodiol tablets, 500 mg tablet
  : scored tablet can be broken in halves to provide recommended dosage. (
  2.3 Scoring the Ursodiol Tablets, 500 mg

  The Ursodiol 500 mg scored tablet can be broken in halves to provide recommended dosage.

  To break ursodiol 500 mg scored 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 scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets.

  [see How Supplied/Storage and Handling (16)].
  ,
  16 HOW SUPPLIED/STORAGE AND HANDLING

  16.1 Ursodiol Tablets, USP 250 mg

  Ursodiol Tablets USP, 250 mg are White to off-white, oval, biconvex, film coated tablets debossed with "1127" on one side and plain on other side and are supplied as follows:

  NDC 70771-1407-1 in bottles of 100 tablets with child-resistant closure

  NDC 70771-1407-5 in bottles of 500 tablets

  16.2 Ursodiol Tablets, USP 500 mg

  Ursodiol Tablets USP, 500 mg are White to off-white, oval, biconvex, film coated tablets debossed with "1128" on one side and breakline on other side. and are supplied as follows:

  NDC 70771-1408-1 in bottles of 100 tablets with child-resistant closure

  NDC 70771-1408-5 in bottles of 500 tablets

  Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

  Half-tablets (scored ursodiol 500 mg tablets broken in half) maintain acceptable quality for up to 28 days when stored in the current packaging (bottles) at 20ºC to 25ºC (68ºF to 77ºF). Due to the bitter taste, the halved segments should be stored separately from the whole tablets

  [see Dosage and Administration (2.2)].
  )

• Ursodiol Tablets, USP 250 mg: 250 mg tablet
• Ursodiol Tablets, USP 500 mg: 500 mg scored tablet

Available published data on the use of ursodiol in pregnant women derived from randomized controlled trials, observational studies, and case series collected over several decades have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Most of the reported exposures to ursodiol occurred in the second and third trimester of pregnancy. In animal reproduction studies, ursodiol had no adverse effects on embryo-fetal development when administered at doses greater than human therapeutic doses

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

No adverse effects on embryo-fetal development were observed with oral administration of ursodiol to pregnant rats and rabbits during organogenesis at doses up to 22 and 7 times, respectively, the maximum recommended human dose (based on body surface area).