Reltone 400 mg 400 mg/1
Ursodiol · CAPSULE · Intra-Sana Laboratories
Reltone 400 mg is a capsule containing ursodiol at 400 mg/1, taken oral. Manufactured by Intra-Sana Laboratories.
Key Facts
- Brand Name
- Reltone 400 mg
- Generic Name
- Ursodiol
- NDC Code (Product)
80056-144- Manufacturer
- Intra-Sana Laboratories
- Strength
- 400 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA205789
- Drug Class
- Bile Acid [EPC]
- Marketing Start
- 07/01/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 1. Reltone™ 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 Reltone™ beyond 24 months is not established. 2. Reltone™ is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
Dosage & Administration
DOSAGE AND ADMINISTRATION Gallstone Dissolution The recommended dose for Reltone™ 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 Reltone™ therapy to monitor gallstone response. If gallstones appear to have dissolved, Reltone™ 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 Reltone™ therapy, the likelihood of success is greatly reduced. Gallstone Prevention The recommended dosage of Reltone™ for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day.
Contraindications
CONTRAINDICATIONS 1. Reltone™ will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Hence, patients with such stones are not candidates for Reltone™ therapy. 2. Patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for Reltone™ therapy. 3. Allergy to bile acids.
Drug Interactions
Drug Interactions Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of ursodiol by reducing its absorption. Aluminum-based antacids have been shown to adsorb bile acids in vitro and may be expected to interfere with ursodiol in the same manner as the bile acid sequestering agents. Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the effectiveness of ursodiol.
Adverse Reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Intra-Sana Laboratories at 1-702-980-8963 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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: 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…
Frequently Asked Questions
What is Reltone 400 mg used for?
Reltone 400 mg contains Ursodiol. It is a capsule taken oral. Consult your doctor for specific uses.
Is Reltone 400 mg a controlled substance?
Reltone 400 mg is not classified as a controlled substance by the DEA.
What is the generic name for Reltone 400 mg?
The generic name for Reltone 400 mg is Ursodiol. There are 11 other brand versions of Ursodiol.
What is the NDC code for Reltone 400 mg 400 mg/1?
The NDC (National Drug Code) for Reltone 400 mg 400 mg/1 is 80056-144, listed by Intra-Sana Laboratories.