Reltone (ursodiol)

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

Moderate Interaction: Assess the risk to the patient and take action as needed.

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)

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 no contraindication contraindications for this drug.

• Biliary obstruction

There are no moderate contraindications for this drug.

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.

Rare or 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

More Frequent

• Acute abdominal pain
• Diarrhea
• Pruritus of skin
• Skin rash

Less Frequent

• Alopecia
• Arthritis
• Constipation
• Cough
• Dizziness
• Dyspepsia
• Nausea
• Pharyngitis
• Upper respiratory infection
• Urinary tract infection

Rare or Very Rare

• Anorexia
• Esophagitis
• Fever
• Headache disorder
• Malaise
• Myalgia
• Peripheral edema
• Vomiting

No enhanced messaging available.

Safety and efficacy have not been established in pediatric patients.

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.

Select dosage with caution.

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.