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Drug overview for RELTONE (ursodiol):
Generic name: ursodiol (UR-soe-DYE-ol)
Drug class: Gallstone Solubilizing Agents
Therapeutic class: Gastrointestinal Therapy Agents
Ursodiol, a naturally occurring bile acid, is used for its cholelitholytic or anticholestatic action.
No enhanced Uses information available for this drug.
Generic name: ursodiol (UR-soe-DYE-ol)
Drug class: Gallstone Solubilizing Agents
Therapeutic class: Gastrointestinal Therapy Agents
Ursodiol, a naturally occurring bile acid, is used for its cholelitholytic or anticholestatic action.
No enhanced Uses information available for this drug.
DRUG IMAGES
RELTONE 400 MG CAPSULE
RELTONE 200 MG CAPSULE
The following indications for RELTONE (ursodiol) have been approved by the FDA:
Indications:
Biliary calculus
Cholelithiasis prevention
Professional Synonyms:
Cholelithiasis prophylaxis
Cholelithiasis
Indications:
Biliary calculus
Cholelithiasis prevention
Professional Synonyms:
Cholelithiasis prophylaxis
Cholelithiasis
The following dosing information is available for RELTONE (ursodiol):
No enhanced Dosing information available for this drug.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| RELTONE 200 MG CAPSULE | Maintenance | Adults take 4 mg/kg by oral route 2 times per day |
| RELTONE 400 MG CAPSULE | Maintenance | Adults take 4 mg/kg by oral route 2 times per day |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| URSODIOL 200 MG CAPSULE | Maintenance | Adults take 4 mg/kg by oral route 2 times per day |
| URSODIOL 400 MG CAPSULE | Maintenance | Adults take 4 mg/kg by oral route 2 times per day |
The following drug interaction information is available for RELTONE (ursodiol):
There are 0 contraindications.
There are 0 severe interactions.
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Ursodiol/Bile Acid Sequestrants SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Bile acid sequestrants may bind to ursodiol in the gastrointestinal tract, preventing its absorption.(1) CLINICAL EFFECTS: Simultaneously administering ursodiol and a bile acid sequestrant may decrease the effectiveness of ursodiol.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Separate the administration time of ursodiol and bile acid sequestrants by as much time as possible.(2) DISCUSSION: In a study in 5 healthy subjects, simultaneous administration of cholestyramine (4 grams daily) and ursodiol (12.5 mg/kg daily) decreased ursodiol levels by 60%. Separation of the dosage times by 5 hours decreased this effect.(2) In a study in 5 healthy subjects, simultaneous administration of colestimide (1.5 grams) and ursodiol (200 mg) decreased ursodiol by more than 50% in 4 of the 5 subjects.(3) |
CHOLESTYRAMINE, CHOLESTYRAMINE LIGHT, COLESEVELAM HCL, COLESTID, COLESTIPOL HCL, PREVALITE, QUESTRAN, QUESTRAN LIGHT, WELCHOL |
The following contraindication information is available for RELTONE (ursodiol):
Drug contraindication overview.
Hypersensitivity or intolerance to ursodiol, bile acids, or any component of the formulation. Complete biliary obstruction. Do not use for dissolution of calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Do not use in patients with compelling reasons for cholecystectomy, including unremitting cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula.
Hypersensitivity or intolerance to ursodiol, bile acids, or any component of the formulation. Complete biliary obstruction. Do not use for dissolution of calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Do not use in patients with compelling reasons for cholecystectomy, including unremitting cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula.
There are 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Biliary obstruction |
There are 0 moderate contraindications.
The following adverse reaction information is available for RELTONE (ursodiol):
Adverse reaction overview.
Capsules (gallstone dissolution): Abdominal pain, diarrhea, viral infection, headache, dyspepsia, upper respiratory tract infection, nausea, sinusitis, constipation, vomiting, pharyngitis, arthralgia, flatulence, back pain, cough, bronchitis, urinary tract infection, arthritis, myalgia, allergy, cholecystitis, rhinitis, fatigue. Capsules (prevention of gallstone formation): Constipation, diarrhea, headache, nausea, dizziness, vomiting, upper respiratory tract infection, back pain, viral infection, fatigue, influenza-like symptoms, abdominal pain, musculoskeletal pain, dysmenorrhea, alopecia, sinusitis, flatulence. Tablets (PBC): Abdominal discomfort, abdominal pain, alopecia, diarrhea, nausea, pruritus, rash.
Capsules (gallstone dissolution): Abdominal pain, diarrhea, viral infection, headache, dyspepsia, upper respiratory tract infection, nausea, sinusitis, constipation, vomiting, pharyngitis, arthralgia, flatulence, back pain, cough, bronchitis, urinary tract infection, arthritis, myalgia, allergy, cholecystitis, rhinitis, fatigue. Capsules (prevention of gallstone formation): Constipation, diarrhea, headache, nausea, dizziness, vomiting, upper respiratory tract infection, back pain, viral infection, fatigue, influenza-like symptoms, abdominal pain, musculoskeletal pain, dysmenorrhea, alopecia, sinusitis, flatulence. Tablets (PBC): Abdominal discomfort, abdominal pain, alopecia, diarrhea, nausea, pruritus, rash.
There are 13 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Angioedema Facial edema Gastrointestinal concretion Hyperbilirubinemia Increased alanine transaminase Increased alkaline phosphatase Increased aspartate transaminase Jaundice Laryngeal edema Leukopenia Thrombocytopenic disorder Urticaria |
There are 22 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Diarrhea Pruritus of skin Skin rash |
Alopecia Arthritis Constipation Cough Dizziness Dyspepsia Nausea Pharyngitis Upper respiratory infection Urinary tract infection |
| Rare/Very Rare |
|---|
|
Anorexia Esophagitis Fever Headache disorder Malaise Myalgia Peripheral edema Vomiting |
The following precautions are available for RELTONE (ursodiol):
Safety and efficacy have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Available data on use of ursodiol in pregnant women have not identified a drug-associated risk of major birth defects, spontaneous abortion, or other adverse maternal or fetal outcomes; most of the reported exposures occurred in the second and third trimesters of pregnancy. Reproduction studies in animals have revealed no adverse embryofetal developmental effects. The manufacturer of ursodiol capsules states that although fetal harm seems unlikely, the possibility cannot be ruled out and therefore the drug is not recommended for use during pregnancy.
Ursodiol is naturally present in human milk. There are no reports of adverse effects of the drug on breast-fed infants, but the reports are extremely limited. It is not known whether ursodiol affects milk production. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for ursodiol and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.
No substantial differences in safety and efficacy for gallstone dissolution have been observed in geriatric patients relative to younger adults, but increased sensitivity and small differences in efficacy cannot be ruled out.
The following prioritized warning is available for RELTONE (ursodiol):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for RELTONE (ursodiol)'s list of indications:
| Biliary calculus | |
| K80 | Cholelithiasis |
| K80.0 | Calculus of gallbladder with acute cholecystitis |
| K80.00 | Calculus of gallbladder with acute cholecystitis without obstruction |
| K80.01 | Calculus of gallbladder with acute cholecystitis with obstruction |
| K80.1 | Calculus of gallbladder with other cholecystitis |
| K80.10 | Calculus of gallbladder with chronic cholecystitis without obstruction |
| K80.11 | Calculus of gallbladder with chronic cholecystitis with obstruction |
| K80.12 | Calculus of gallbladder with acute and chronic cholecystitis without obstruction |
| K80.13 | Calculus of gallbladder with acute and chronic cholecystitis with obstruction |
| K80.18 | Calculus of gallbladder with other cholecystitis without obstruction |
| K80.19 | Calculus of gallbladder with other cholecystitis with obstruction |
| K80.2 | Calculus of gallbladder without cholecystitis |
| K80.20 | Calculus of gallbladder without cholecystitis without obstruction |
| K80.21 | Calculus of gallbladder without cholecystitis with obstruction |
| K80.3 | Calculus of bile duct with cholangitis |
| K80.30 | Calculus of bile duct with cholangitis, unspecified, without obstruction |
| K80.31 | Calculus of bile duct with cholangitis, unspecified, with obstruction |
| K80.32 | Calculus of bile duct with acute cholangitis without obstruction |
| K80.33 | Calculus of bile duct with acute cholangitis with obstruction |
| K80.34 | Calculus of bile duct with chronic cholangitis without obstruction |
| K80.35 | Calculus of bile duct with chronic cholangitis with obstruction |
| K80.36 | Calculus of bile duct with acute and chronic cholangitis without obstruction |
| K80.37 | Calculus of bile duct with acute and chronic cholangitis with obstruction |
| K80.4 | Calculus of bile duct with cholecystitis |
| K80.40 | Calculus of bile duct with cholecystitis, unspecified, without obstruction |
| K80.41 | Calculus of bile duct with cholecystitis, unspecified, with obstruction |
| K80.42 | Calculus of bile duct with acute cholecystitis without obstruction |
| K80.43 | Calculus of bile duct with acute cholecystitis with obstruction |
| K80.44 | Calculus of bile duct with chronic cholecystitis without obstruction |
| K80.45 | Calculus of bile duct with chronic cholecystitis with obstruction |
| K80.46 | Calculus of bile duct with acute and chronic cholecystitis without obstruction |
| K80.47 | Calculus of bile duct with acute and chronic cholecystitis with obstruction |
| K80.5 | Calculus of bile duct without cholangitis or cholecystitis |
| K80.50 | Calculus of bile duct without cholangitis or cholecystitis without obstruction |
| K80.51 | Calculus of bile duct without cholangitis or cholecystitis with obstruction |
| K80.6 | Calculus of gallbladder and bile duct with cholecystitis |
| K80.60 | Calculus of gallbladder and bile duct with cholecystitis, unspecified, without obstruction |
| K80.61 | Calculus of gallbladder and bile duct with cholecystitis, unspecified, with obstruction |
| K80.62 | Calculus of gallbladder and bile duct with acute cholecystitis without obstruction |
| K80.63 | Calculus of gallbladder and bile duct with acute cholecystitis with obstruction |
| K80.64 | Calculus of gallbladder and bile duct with chronic cholecystitis without obstruction |
| K80.65 | Calculus of gallbladder and bile duct with chronic cholecystitis with obstruction |
| K80.66 | Calculus of gallbladder and bile duct with acute and chronic cholecystitis without obstruction |
| K80.67 | Calculus of gallbladder and bile duct with acute and chronic cholecystitis with obstruction |
| K80.7 | Calculus of gallbladder and bile duct without cholecystitis |
| K80.70 | Calculus of gallbladder and bile duct without cholecystitis without obstruction |
| K80.71 | Calculus of gallbladder and bile duct without cholecystitis with obstruction |
| K80.8 | Other cholelithiasis |
| K80.80 | Other cholelithiasis without obstruction |
| K80.81 | Other cholelithiasis with obstruction |
Formulary Reference Tool