URSOLIGN

URSOLIGN is an FDA-registered drug product whose active ingredient is URSODIOL. It is labelled by Pangea Pharmaceuticals, LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 81279-130, application ANDA210344, label effective 20260612. It is one of 20 FDA drug label records sharing the active ingredient URSODIOL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing URSODIOL are most often described in connection with: ursolign indicated, radiolucent noncalcified, gallbladder stones, greatest diameter, elective cholecystectomy, undertaken except, presence increased, surgical risk. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE URSOLIGN TM is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of URSOLIGN TM beyond 24 months is not established. URSOLIGN TM is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

DOSAGE AND ADMINISTRATION Gallstone Dissolution The recommended dose for URSOLIGN TM capsules 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 URSOLIGN TM capsules therapy to monitor gallstone response. If gallstones appear to have dissolved, URSOLIGN TM capsules 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 URSOLIGN TM therapy, the likelihood of success is greatly reduced. Gallstone Prevention The recommended dosage of URSOLIGN TM for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).

CONTRAINDICATIONS URSOLIGN TM will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Hence, patients with such stones are not candidates for URSOLIGN TM therapy. Patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for URSOLIGN TM therapy. Allergy to bile acids.

WARNINGS Enteroliths in Patients with Risk for Intestinal Stenosis or Stasis There have been rare postmarketing reports of ursodiol-treated patients who developed enteroliths (bezoars) resulting in obstructive symptoms that required surgical intervention. These patients had medical conditions that predisposed them to intestinal stenosis or stasis (e.g., surgical enteroanastomoses, Crohn's disease). If a patient presents with obstructive gastrointestinal symptoms, hold URSOLIGN TM until a clinical evaluation has been conducted.

ADVERSE REACTIONS GALLSTONE DISSOLUTION Ursodiol Placebo 8 - 10 mg/kg/day (N = 155) (N = 159) N (%) N (%) Body as a Whole Allergy 8 (5.2) 7 (4.4) Chest Pain 5 (3.2) 10 (6.3) Fatigue 7 (4.5) 8 (5.0) Infection Viral 30 (19.4) 41 (25.8) Digestive System Abdominal Pain 67 (43.2) 70 (44.0) Cholecystitis 8 (5.2) 7 (4.4) Constipation 15 (9.7) 14 (8.8) Diarrhea 42 (27.1) 34 (21.4) Dyspepsia 26 (16.8) 18 (11.3) Flatulence 12 (7.7) 12 (7.5) Gastrointestinal Disorder 6 (3.9) 8 (5.0) Nausea 22 (14.2) 27 (17.0) Vomiting 15 (9.7) 11 (6.9) Musculoskeletal System Arthralgia 12 (7.7) 24 (15.1) Arthritis 9 (5.8) 4 (2.5) Back Pain 11 (7.1) 18 (11.3) Myalgia 9 (5.8) 9 (5.7) Nervous System Headache 28 (18.1) 34 (21.4) Insomnia 3 (1.9) 8 (5.0) Respiratory System Bronchitis 10 (6.5) 6 (3.8) Coughing 11 (7.1) 7 (4.4) Pharyngitis 13 (8.4) 5 (3.1) Rhinitis 8 (5.2) 11 (6.9) Sinusitis 17 (11.0) 18 (11.3) Upper Respiratory Tract Infection 24 (15.5) 21 (13.2) Urogenital System Urinary Tract Infection 10 (6.5) 7 (4.4) GALLSTONE PREVENTION URSOLIGN TM Placebo 600 mg (N = 322) (N = 325) N (%) N (%) Body as a Whole Fatigue 25 (7.8) 33 (10.2) Infection Viral 29 (9.0) 29 (8.9) Influenza-like Symptoms 21 (6.5) 19 (5.8) Digestive System Abdominal Pain 20 (6.2) 39 (12.0) Constipation 85 (26.4) 72 (22.2) Diarrhea 81 (25.2) 68 (20.9) Flatulence 15 (4.7) 24 (7.4) Nausea 56 (17.4) 43 (13.2) Vomiting 44 (13.7) 44 (13.5) Musculoskeletal System Back Pain 38 (11.8) 21 (6.5) Musculoskeletal Pain 19 (5.9) 15 (4.6) Nervous System Dizziness 53 (16.5) 42 (12.9) Headache 80 (24.8) 78 (24.0) Respiratory System Pharyngitis 10 (3.1) 19 (5.8) Sinusitis 17 (5.3) 18 (5.5) Upper Respiratory Tract Infection 40 (12.4) 35 (10.8) Skin and Appendages Alopecia 17 (5.3) 8 (2.5) Urogenital System Dysmenorrhea 18 (5.6) 19 (5.8) The nature and frequency of adverse experiences were similar across all groups. The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level: Postmarketing Experience The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post-approval use of ursodiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disorders : enteroliths (bezoars) To report SUSPECTED ADVERSE REACTIONS, contact Pangea Pharmaceuticals at 855-892-8224 or got to www.pangeapharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 20 drug label records with URSODIOL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is URSOLIGN used for?
INDICATIONS AND USAGE URSOLIGN TM is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of URSOLIGN TM …

Who makes URSOLIGN?
Pangea Pharmaceuticals, LLC is the labeler of record for URSOLIGN. 20 FDA label records share the active ingredient URSODIOL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does URSOLIGN come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is URSOLIGN prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing URSODIOL?
Yes. 20 FDA drug label records list URSODIOL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has URSOLIGN been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.