URSODIOL

URSODIOL- ursodiol tablet, film coated
Impax Generics

1 INDICATIONS AND USAGE

Ursodiol tablets are indicated for the treatment of patients with primary biliary cirrhosis (PBC).

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

The recommended adult dosage for ursodiol in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient’s need at the discretion of the physician.

2.2 Liver Function Tests

Liver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter [see Warnings and Precautions (5.1) ].

2.3 Scoring the Ursodiol Tablet USP, 500 mg

The ursodiol 500 mg scored tablet can be broken in halves to provide recommended dosage.

To break ursodiol scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets. [see How Supplied/Storage and Handling (16.2) ].

3 DOSAGE FORMS AND STRENGTHS

  • Ursodiol: 250 mg tablet
  • Ursodiol: 500 mg scored tablet

4 CONTRAINDICATIONS

Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation.

5 WARNINGS AND PRECAUTIONS

Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant, should receive appropriate specific treatment.

5.1 Abnormal Liver Function Tests

Liver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter. This monitoring will allow the early detection of a possible deterioration of the hepatic function. Treatment discontinuation should be considered if the above parameters increase to a level considered clinically significant in patients with stable historical liver function test levels.

Caution has to be exercised to maintain the bile flow of the patients taking ursodiol.

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The following table summarizes the adverse reactions observed in two placebo-controlled clinical trials.

ADVERSE REACTIONS VISIT AT 12 MONTHS VISIT AT 24 MONTHS
UDCA
n (%)
Placebo
n (%)
UDCA
n (%)
Placebo
n (%)
Note: Those adverse reactions occurring at the same or higher incidence in the placebo as in the UDCA group have been deleted from this table (this includes diarrhea and thrombocytopenia at 12 months, nausea/vomiting, fever and other toxicity).
UDCA = Ursodeoxycholic acid = Ursodiol
Diarrhea 1 (1.32)
Elevated creatinine 1 (1.32)
Elevated blood glucose 1 (1.18) 1 (1.32)
Leukopenia 2 (2.63)
Peptic ulcer 1 (1.32)
Skin rash 2 (2.63)
Thrombocytopenia 1 (1.32)

In a randomized, cross-over study in sixty PBC patients, seven patients (11.6%) reported nine adverse reactions: abdominal pain and asthenia (1 patient), nausea (3 patients), dyspepsia (2 patients) and anorexia and esophagitis (1 patient each). One patient on the twice a day regimen (total dose 1000 mg) withdrew due to nausea. All of these nine adverse reactions except esophagitis were observed with the twice a day regimen at a total daily dose of 1000 mg or greater. However, an adverse reaction may occur at any dose.

6.2 Postmarketing Experience

The following adverse reactions, presented by system organ class in alphabetical order, have been identified during postapproval 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: abdominal discomfort, abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting.
  • General disorders and administration site conditions: malaise, peripheral edema, pyrexia.
  • Hepatobiliary disorders: jaundice (or aggravation of preexisting jaundice).
  • Immune System Disorders: Drug hypersensitivity to include facial edema, urticaria, angioedema and laryngeal edema.
  • Abnormal Laboratory Tests: ALT increased, AST increased, blood alkaline phosphatase increased, blood bilirubin increased, γ-GT increased, hepatic enzyme increased, liver function test abnormal, transaminases increased.
  • Musculoskeletal and connective tissue disorders: myalgia
  • Nervous system disorders: dizziness, headache.
  • Respiratory, thoracic and mediastinal disorders: cough.
  • Skin and subcutaneous tissue disorder: alopecia, pruritus, rash.
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