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Reltone (ursodiol capsules) 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, or idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of Reltone beyond 24 months is not established.
Reltone is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
Therapy with Reltone is for patients with specific situations and gallstone types, and other therapies should be considered when selecting treatment. Dissolving a gallstone with Reltone takes months of therapy. In some patients, gallstones do not completely dissolve. Up to half (50%) of patients whose stones dissolve on bile acid therapy have stones return within 5 years. It has not been established if Reltone is safe to use for longer than 24 months.
Your healthcare provider should check the levels of certain liver enzymes when you first start taking Reltone and at times as you continue taking it. Tell your healthcare provider if you have liver disease.
Reltone will not dissolve gallstones that are:
Reltone should not be used by people who have a strong medical reason to have surgery to remove the gallbladder. These reasons may include sudden, persistent swelling of the gallbladder (unremitting acute cholecystitis); infected bile ducts (cholangitis); blocked bile ducts (biliary obstruction); inflamed pancreas caused by gallstones (gallstone pancreatitis); or an abnormal connection between organs (biliary-gastrointestinal fistula).
Do not use Reltone if you have an allergy to bile acids.
When Reltone is used for dissolving gallstones, the most common side effects (more frequent than placebo by ≥3%) include diarrhea, indigestion, inflamed throat (pharyngitis), and arthritis. When Reltone is used for preventing gallstones, the most common side effects (more frequent than placebo by ≥3%) include back pain, diarrhea, constipation, nausea, and dizziness.
Using Reltone when pregnant is not recommended. Using the correct dose of Reltone is important, especially for elderly people. It is unknown if Reltone is safe or effective in children.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information enclosed.
Please click here for Prescribing Information of Reltone®
REFERENCES:
1. Stokes CS, Gluud LL, Casper M, Lammert F. Ursodeoxycholic acid and diets higher in fat prevent gallbladder stones during weight loss: a meta-analysis of randomized controlled trials. Clin Gastroenterol Hepatol. 2014;12(7):1090-e61. doi:10.1016/j.cgh.2013.11.031
2. European Association for the Study of the Liver (EASL). EASL Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones. J Hepatol. 2016;65(1):146-181. doi:10.1016/j.jhep.2016.03.005
3. Mechanick JI, Apovian C, Brethauer S, et al. Clinical practice guidelines for the perioperative nutrition, metabolic, and nonsurgical support of patients undergoing bariatric procedures – 2019 update: cosponsored by American Association of Clinical Endocrinologists/American College of Endocrinology, The Obesity Society, American Society for Metabolic & Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists – executive summary. Endocr Pract. 2019;25(12):1346-1359. doi:10.4158/GL-2019-0406
4. He L, Wang J, Ping F, et al. Association of glucagon-like peptide-1 receptor agonist use with risk of gallbladder and biliary diseases: a systematic review and meta-analysis of randomized clinical trials. JAMA Intern Med. 2022;182(5):513-519. doi:10.1001/jamainternmed.2022.0338
5. Reltone. Prescribing information. Intra-Sana
Laboratories LLC; 2021.
Therapy with Reltone is for patients with specific situations and gallstone types, and other therapies should be considered when selecting treatment. Dissolving a gallstone with Reltone takes months of therapy. In some patients, gallstones do not completely dissolve. Up to half (50%) of patients whose stones dissolve on bile acid therapy have stones return within 5 years. It has not been established if Reltone is safe to use for longer than 24 months.
Your healthcare provider should check the levels of certain liver enzymes when you first start taking Reltone and at times as you continue taking it. Tell your healthcare provider if you have liver disease.
Reltone will not dissolve gallstones that are:
Reltone should not be used by people who have a strong medical reason to have surgery to remove the gallbladder. These reasons may include sudden, persistent swelling of the
gallbladder (unremitting acute cholecystitis); infected bile ducts (cholangitis); blocked bile ducts (biliary obstruction); inflamed pancreas caused by gallstones (gallstone pancreatitis); or an abnormal connection between organs (biliary-gastrointestinal fistula).
Do not use Reltone if you have an allergy to bile acids.
When Reltone is used for dissolving gallstones, the most common side effects (more frequent than placebo by ≥3%) include diarrhea, indigestion, inflamed throat (pharyngitis), and arthritis. When Reltone is used for preventing gallstones, the most common side effects (more frequent than placebo by ≥3%) include back pain, diarrhea, constipation, nausea, and dizziness.
Using Reltone when pregnant is not recommended. Using the correct dose of Reltone is important, especially for elderly people. It is unknown if Reltone is safe or effective in children.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information enclosed.
