Urso (Ursodiol) – Patient Information Guide for Australia
Basic Product Information
| International Nonproprietary Name (INN) | Ursodeoxycholic Acid |
|---|---|
| Australia Brand Names | Urso, Ursosan, Ursodiol, Actigall |
| ATC Code | A05AA02 |
| Available Forms and Strengths | Capsules (250 mg, 500 mg), Tablets (250 mg), Oral Suspension (various strengths) |
| Manufacturers | Arrow Pharma, Aspen Pharmacare, Sigma Pharmaceuticals, Teva, and other registered suppliers |
| Prescription Status | Prescription Only Medicine (Schedule 4, S4) |
| Regulatory Authority | Therapeutic Goods Administration (TGA) |
Mechanism of Action
For Everyone: Urso (ursodiol) is a naturally occurring bile acid that helps to dissolve certain types of gallstones and improves bile flow in the liver. It works by reducing the amount of cholesterol released by the liver and absorbed in the gut, making gallstones less likely to form or helping existing stones to dissolve over time. It also reduces inflammation in the bile ducts.
For Healthcare Professionals: Ursodiol modulates the enterohepatic circulation of bile acids, reduces hepatic secretion of cholesterol, and stabilises hepatocyte membranes. It displaces more hydrophobic, hepatotoxic bile acids and has immunomodulatory effects in cholestatic liver disorders.
Pharmacokinetics
- Absorption: Ursodiol is partially absorbed from the small intestine (around 60%).
- Metabolism: Extensively metabolised in the liver, conjugated to glycine or taurine, then secreted in bile.
- Elimination: Excreted mainly in faeces (via bile) with a small fraction lost in urine.
- Duration of action: Steady-state plasma concentrations reached after 3–6 weeks of continuous therapy.
- Half-life: Around 3.5–5.8 days.
Use in Everyday Life and Best Practices
Dosing: Your doctor will prescribe the correct dose for your condition. For most adults, the typical starting dose is 8–10 mg per kg of body weight per day, usually divided into two or three doses. In Australia, this can mean 500–1,000 mg per day depending on your weight and medical need.
- Always take ursodiol exactly as prescribed, and do not stop unless advised by your healthcare provider.
- Swallow capsules/tablets whole, with a glass of water; do not crush or chew.
- If using a suspension, shake the bottle well before each dose, and use a proper oral syringe or measuring spoon.
- Treatment courses can last several months or longer, especially for dissolving gallstones.
- Attend all scheduled follow-up appointments and blood tests to monitor your liver function and progress.
Australian Context: Ursodiol is not a substitute for a healthy Australian diet, moderate exercise, and regular GP check-ups. Continue with a diet low in saturated fats and cholesterol, high in fibre, which supports the medication's effect.
Dosing in the Morning vs Evening
- Morning: Taking ursodiol in the morning suits patients with complex dosing schedules. It may help with remembering to take your dose if linked with breakfast.
- Evening: Some people experience less stomach upset or nausea when taking this medication in the evening, possibly with dinner.
- Tips: Most importantly, take your doses at the same time each day for maximum effect. Setting a daily alarm or linking with routine meals may be helpful.
- Consistency: Take all doses evenly spaced throughout the day as prescribed (for example, after breakfast and dinner).
Taking with Food or on an Empty Stomach
Ursodiol can be taken with or without food, but taking it with meals—especially with a small amount of dietary fat—may help reduce stomach upset and may support better absorption. In line with common English eating habits, taking ursodiol with breakfast or dinner is typical. Avoid taking with a high-fat meal, as very rich or greasy foods may worsen digestive symptoms for some people.
Interaction Warnings
| Interaction | Details |
|---|---|
| Food | No significant food interactions; take with or without food as recommended for comfort. |
| Alcohol | Limit or avoid excessive alcohol, as it can worsen liver function and counteract ursodiol’s effects. |
| Antacids | Certain antacids (esp. aluminium-based) may reduce absorption; separate doses by 2 hours. |
| Bile Acid Sequestrants | Drugs like cholestyramine or colestipol can interfere with absorption; take ursodiol at least 2 hours before or 4 hours after these medications. |
| Oestrogen/Hormone Therapy | Oral contraceptives or hormone replacement therapy can increase cholesterol in bile, potentially reducing ursodiol's effectiveness. |
| Ciprofloxacin, Dapsone | May change bile acid metabolism. Monitor with specialist oversight. |
| Immunosuppressants (e.g. ciclosporin) | Possible alteration in metabolism; monitor blood levels and side effects. |
| Other Medicines | Always inform your healthcare provider and pharmacist about all prescription, non-prescription, and complementary medicines you are taking. |
Indications
| Indication | Status in Australia | Notes |
|---|---|---|
| Dissolution of radiolucent cholesterol gallstones | Approved | For patients who are not surgical candidates or prefer medical management |
| Primary biliary cholangitis (PBC) | Approved | First-line therapy |
| Primary sclerosing cholangitis | Off-label | Specialist discretion; evidence is less robust |
| Cystic fibrosis–related liver disorders | Off-label | Paediatric and respiratory/hepatologist specialist management |
| Prevention of gallstones with rapid weight loss | Approved/specialist use | After bariatric surgery or very low-calorie diets (VLCDs) |
Dosing According to Clinical Indications
| Indication | Adults | Paediatrics | Elderly |
|---|---|---|---|
| Gallstone Dissolution | 8–10 mg/kg/day in 2–3 divided doses | 8–20 mg/kg/day, specialist discretion | As per adult dosing; monitor liver function |
| Primary Biliary Cholangitis | 13–15 mg/kg/day in 2–3 divided doses | Same as adult, specialist adjustment | Same; monitor liver/kidney function |
| Prevention (Post-bariatric Surgery) | 500–1,200 mg/day | Individualised | Same as adults; assess comorbidity risks |
Safety Profile and Side Effects
| Frequency | Possible Side Effects |
|---|---|
| Common (1–10%) |
|
| Uncommon (0.1–1%) |
|
| Rare (less than 0.1%) |
|
Warnings: Ursodiol should not be used if you are allergic to bile acids or have certain types of gallstones (calcified/radiopaque stones), acute inflammation of the gallbladder or bile ducts, or blockage of bile drainage. Always inform your doctor about your full medical history.
Guidelines for Proper Use
- Take ursodiol at exactly the same times each day to maintain even levels in your blood.
- If you forget a dose, take it as soon as you remember (unless it is near your next dose).
- Never take two doses together to make up for a missed dose.
- Ursodiol works gradually; it may take several months before full benefits are seen. Follow your healthcare team’s instructions closely.
- Regular blood tests to monitor liver enzymes and function are a part of safe treatment.
- Consult your pharmacist if you need advice on timing, drug interactions, or side effect management.
Storage: Store at room temperature away from children, heat, and moisture.
Alternative Treatment Options
- Surgical removal of gallbladder (cholecystectomy): Most common and definitive treatment for gallstones.
- Chenodeoxycholic acid (CDCA): Less commonly used due to more frequent side effects and less favourable safety profile than ursodiol.
- Diet and lifestyle changes: May help prevent gallstones, but ineffective for treating established stones.
- Supportive therapies: For PBC and PSC, additional medicines may be prescribed by a specialist, including obeticholic acid, fibrates, or immunomodulators (not all on PBS).
Advantages of Urso: Non-invasive, established safety in long-term use, preferred first choice for PBC in Australia.
Disadvantages: Not suitable for all gallstone types or acute disease, slow onset of action compared to surgery.
Legal, Registration, and Reimbursement Status in Australia
- Ursodiol is registered and approved in Australia by the TGA (Therapeutic Goods Administration).
- It is a Schedule 4 medicine—available only by prescription from your doctor.
- Some indications (e.g., PBC) are listed on the Pharmaceutical Benefits Scheme (PBS), reducing out-of-pocket costs. Availability for other uses (such as gallstone dissolution) may not be subsidised—ask your doctor or pharmacist for details.
- Private prescriptions may be required for off-label or non-PBS-subsidised indications.
Latest Research & Clinical Guidance (2022–2025)
- Australian consensus guidelines (2023) continue to recommend ursodiol as first-line therapy for primary biliary cholangitis. [Australasian Society for Clinical Hepatology]
- A 2024 meta-analysis of over 10,000 patients shows that long-term ursodiol therapy is safe and effective in reducing disease progression in PBC.
- Emerging evidence supports its role in preventing gallstones after rapid weight loss (2022–2024 studies).
- Research is ongoing into newer bile acid modulators for unclear cholestatic liver diseases, but ursodiol remains established frontline therapy.
- For primary sclerosing cholangitis, ursodiol should be used only under specialist care as evidence for benefit is still uncertain (Cochrane review, 2023).
Availability and Delivery
| Pack Size | Form | Indicative Price (AUD) | Estimated Delivery (Sydney) | Estimated Delivery (Melbourne) | Estimated Delivery (Brisbane) | Estimated Delivery (Perth) |
|---|---|---|---|---|---|---|
| 100 capsules | 250 mg | $55–$80 | 1–2 business days | 1–2 business days | 1–2 business days | 2–4 business days |
| 50 tablets | 500 mg | $60–$95 | 1–2 business days | 1–2 business days | 1–2 business days | 2–4 business days |
| Oral suspension, 250 mL | 250 mg/5mL | $70–$110 | 1–3 business days | 1–3 business days | 2–4 business days | 3–6 business days |
Most community pharmacies can obtain ursodiol promptly from wholesalers. Prescription is required for purchase and delivery in Australia. Prices may vary depending on brand and PBS coverage.
Frequently Asked Questions (FAQ)
- Can I drink alcohol while taking Urso?
Moderate social alcohol intake is not strictly contraindicated, but heavy drinking can worsen liver damage and reduce treatment effectiveness. Always discuss your alcohol use with your GP or specialist. - How long does it take for Urso to work?
For gallstone dissolution, it may take 6–24 months for stones to dissolve, depending on their size and type. Benefits for PBC are usually seen within a few months, but blood tests track your response. - What should I do if I miss a dose?
Take the missed dose as soon as you remember, unless it's nearly time for your next dose. Do not double up doses. Consistency is important for maximum benefit. - Can I take Urso if I am pregnant or breastfeeding?
Urso is not routinely used in pregnancy unless the potential benefits outweigh risks. Consult your specialist for personalised advice. Limited data exist for breastfeeding; discuss with your doctor or pharmacist. - Is it safe to use Urso with other medications?
Urso has some drug interactions—see above for detail. Always let your pharmacist and doctor know all medicines and supplements you take.
Disclaimer: This information is for patient education in Australia and should not replace professional medical advice. Always consult your doctor or pharmacist for personalised guidance and before starting or stopping any medicine.
