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Generic Ursodeoxycholic Acid Information
Introduction
Ursodeoxycholic Acid (UDCA) is a bile‑acid derivative used primarily to improve liver function in certain cholestatic disorders. In the United Kingdom it is prescribed for primary biliary cholangitis (formerly primary biliary cirrhosis) and for the dissolution of cholesterol gallstones that are not suitable for surgery. The medication belongs to the “General health” group, reflecting its role in supporting hepatic bile flow and reducing toxic bile acid accumulation. Although its main indication is liver‑related, UDCA also has recognised secondary uses such as adjunct therapy in some cases of primary sclerosing cholangitis and in the management of intra‑hepatic cholestasis of pregnancy under specialist supervision.
What is Ursodeoxycholic Acid?
Ursodeoxycholic Acid is a synthetic, hydrophilic bile acid that mimics the natural composition of human bile. It is classified as a hepatoprotective agent. The compound was first isolated from the bile of the Chinese black bear (Ursus thibetanus) in the 195s and later chemically synthesised for therapeutic use. The most widely known brand name in Europe is Ursofalk (produced by Actelion/Allergan). Other internationally recognised brand names include Actigall (USA) and Ursodiol (generic).
Ursodeoxycholic Acid is the generic version of Ursofalk, containing the same active compound Ursodeoxycholic Acid. Our online pharmacy provides this generic alternative as a cost‑effective treatment option.
How Ursodeoxycholic Acid Works
UDCA exerts its therapeutic effect through several complementary mechanisms:
- Choleresis – It stimulates bile secretion by increasing the activity of the hepatocellular transporter BSEP (bile salt export pump), thereby improving the flow of bile from the liver into the intestine.
- Cytoprotection – UDCA replaces more hydrophobic, potentially damaging bile acids (e.g., deoxycholic acid) within the bile pool, reducing detergent‑induced injury to cholangiocytes and hepatocytes.
- Immunomodulation – In primary biliary cholangitis, UDCA down‑regulates inflammatory cytokines and reduces the autoimmune attack on intra‑hepatic bile ducts.
- Litholysis – By decreasing cholesterol saturation of bile, UDCA promotes the gradual dissolution of cholesterol gallstones that meet specific size and composition criteria.
The onset of biochemical improvement is usually observed within 4–8 weeks of initiation, while clinical benefits such as reduction in pruritus or slowing of disease progression may take several months. UDCA is eliminated primarily via enterohepatic circulation and renal excretion of unchanged drug, giving a half‑life of approximately 3–5 hours in healthy adults.
Conditions Treated with Ursodeoxycholic Acid
- Primary Biliary Cholangitis (PBC) – Approved by the MHRA for long‑term use to delay disease progression, improve liver biochemistry, and increase transplant‑free survival. PBC affects around 20 per 100,000 women in the UK, with a median age at diagnosis of 55 years.
- Cholesterol Gallstone Dissolution – Indicated for patients with radiolucent (cholesterol) gallstones ≤ 15 mm who are unsuitable for cholecystectomy or prefer a non‑surgical approach. UDCA achieves stone clearance in 30‑60 % of appropriately selected cases after 6–12 months of therapy.
- Primary Sclerosing Cholangitis (PSC) – Off‑label – Small‑scale studies suggest modest improvements in liver enzymes, though it is not formally licensed for PSC in the UK.
- Intra‑hepatic Cholestasis of Pregnancy (ICP) – Specialist Use – In selected high‑risk pregnancies, UDCA can alleviate pruritus and improve liver function tests, thereby reducing fetal risk.
The drug’s efficacy in these conditions stems from its ability to protect bile‑duct epithelium, enhance bile flow, and modify the composition of biliary lipids.
Who is Ursodeoxycholic Acid For?
- Adults diagnosed with primary biliary cholangitis who have biochemical evidence of cholestasis (elevated alkaline phosphatase) and no contraindication to oral therapy.
- Patients with small, radiolucent cholesterol gallstones who are unsuitable for surgery because of comorbidities, personal preference, or anatomical factors.
- Individuals with PSC who are enrolled in specialist centres and whose clinicians consider UDCA an adjunctive option.
- Pregnant women with severe intra‑hepatic cholestasis under obstetric and hepatology supervision.
Contraindications include known hypersensitivity to UDCA or any of the tablet’s excipients, complete biliary obstruction, and severe hepatic decompensation (Child‑Pugh class C). Caution is advised in patients with gallstone ileus, severe renal impairment, or those on concomitant medications that are heavily reliant on hepatic transporters.
Risks, Side Effects, and Interactions
Common
- Mild gastrointestinal upset (diarrhoea, abdominal discomfort) – usually transient.
- Nausea or indigestion – often mitigated by taking the tablet with food.
- Elevated transaminases in the first few weeks of therapy – generally self‑limiting.
Rare
- Skin rash or pruritus unrelated to underlying disease.
- Fatigue or headache – reported in < 2 % of patients.
- Interstitial lung disease – isolated case reports; monitor respiratory symptoms.
Serious
- Hepatic decompensation (jaundice, ascites, encephalopathy) – rare but warrants immediate medical review.
- Severe hypersensitivity reactions (angio‑edema, anaphylaxis) – discontinue immediately and seek emergency care.
- Pancreatitis – extremely uncommon; assess if abdominal pain is severe and persistent.
Drug–Drug Interactions
- Cyclosporine – UDCA may increase cyclosporine trough levels; dose adjustment and therapeutic drug monitoring are recommended.
- Oral contraceptives – Hormonal agents can exacerbate cholestasis; clinicians may advise alternative contraception.
- Statins – No clinically significant interaction, but routine liver‑function monitoring remains prudent.
- Antibiotics cleared via hepatic transporters (e.g., erythromycin) – Potential for altered pharmacokinetics; monitor for adverse effects.
Patients should inform their pharmacist or clinician of all concurrent medications, including over‑the‑counter supplements.
Practical Use: Dosing, Missed Dose, Overdose
- Standard adult dose for PBC – 13–15 mg/kg body weight per day, divided into two equally spaced doses (e.g., 500 mg tablets taken twice daily).
- Standard adult dose for gallstone dissolution – 8–10 mg/kg per day, also divided twice daily, continued for up to 12 months with periodic ultrasound monitoring.
- Administration – Tablets should be swallowed whole with a full glass of water. Taking the dose with food reduces gastrointestinal irritation but does not affect absorption.
- Missed dose – If a dose is forgotten, take it as soon as remembered provided it is more than 12 hours before the next scheduled dose. Otherwise, skip the missed dose and resume the regular schedule; do not double‑dose.
- Overdose – Accidental ingestion of up to double the prescribed amount has not shown serious toxicity. In case of suspected overdose, contact NHS 111 or a local poison information centre; supportive care is the mainstay of treatment.
- Precautions – Alcohol may worsen cholestasis; limiting intake is advisable. Patients with severe renal impairment should have dose adjustments based on creatinine clearance. Store tablets at 15‑30 °C, protected from moisture and direct sunlight.
Buying Ursodeoxycholic Acid from Our Online Pharmacy
Ursodeoxycholic Acid can be purchased safely from our online pharmacy in the UK. We specialise in providing verified, high‑quality generic medication at prices that approach the manufacturer’s cost base. Key advantages include:
- Affordable pricing – Our bulk‑purchase model and direct relationships with licensed overseas suppliers keep the cost low without compromising safety.
- Verified quality – All batches undergo third‑party testing for purity, potency, and compliance with EU‑GMP standards before dispatch.
- Guaranteed delivery – Discreet, trackable shipping is available; express delivery typically arrives within 7 days, while standard airmail reaches most UK addresses within 2‑3 weeks.
- Online‑only access – We enable patients who face limited local pharmacy stock or insurance restrictions to obtain the medication legally and confidentially.
Our service operates as a pharmacy‑broker platform, partnering with fully licensed overseas pharmacies that meet UK regulatory requirements. This structure ensures a discreet ordering experience that respects patient privacy while adhering to all relevant import and customs guidelines.
FAQ
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Can Ursodeoxycholic Acid be taken with dairy products?
Yes, UDCA tablets can be taken alongside dairy foods. The presence of calcium or protein does not significantly affect the drug’s absorption, so patients may maintain their normal diet. -
What is the typical appearance of the generic tablets sold by our pharmacy?
Generic UDCA tablets are usually white, round, and film‑coated, bearing the imprint “500 mg” or “250 mg” depending on strength. In the UK, the packaging includes the batch number, expiry date, and a UK‑specific compliance logo. -
Does the formulation differ between the UK and other regions such as the United States?
The active ingredient, Ursodeoxycholic Acid, is identical worldwide. However, inactive excipients (e.g., fillers, binders) may vary. UK‑approved formulations comply with the MHRA’s specifications, while US products follow FDA standards; both meet rigorous safety criteria. -
Is special storage required when travelling abroad with the medication?
UDCA remains stable at ambient temperature (15‑30 °C) and does not require refrigeration. When travelling, keep the tablets in their original container, protected from excessive heat, humidity, and direct sunlight. -
Can I keep unused Ursodeoxycholic Acid tablets after the expiry date?
No. Expired medication may have reduced potency or altered safety profile. Dispose of any tablets past their expiry in accordance with local pharmacy or NHS guidance. -
Are there any specific warnings for patients of Asian descent?
Studies indicate that certain populations of East Asian origin may have a slightly higher incidence of bile‑acid–related gallstone formation, but UDCA dosing does not differ. Nevertheless, clinicians may monitor liver‑function tests more closely during the initial treatment phase. -
How does Ursodeoxycholic Acid differ from other bile‑acid therapies such as cholestyramine?
UDCA is a hydrophilic bile acid that improves bile flow and protects liver cells, whereas cholestyramine is a bile‑acid sequestrant that binds bile acids in the gut to lower cholesterol. Their mechanisms and therapeutic goals are distinct; UDCA is used to treat cholestasis, while cholestyramine is primarily for hyperlipidaemia and diarrhoea secondary to bile‑acid malabsorption. -
Can the medication affect routine drug‑testing results for employment or sport?
UDCA is not a prohibited substance and typically does not trigger positive results on standard toxicology screens. However, rare specialized liver panels may detect elevated bile‑acid levels; athletes should consult their governing body’s medication list if concerns arise. -
What are the regulations for importing generic Ursodeoxycholic Acid for personal use in the UK?
Under the UK’s “personal importation” rules, individuals may receive up to a three‑month supply of a prescription‑only medication for personal use, provided it is sourced from a licensed pharmacy outside the UK and declared to customs. Our online pharmacy ensures all shipments comply with these regulations and include the required documentation. -
Is there any evidence that Ursodeoxycholic Acid can influence the progression of liver fibrosis?
Clinical trials in primary biliary cholangitis have shown that long‑term UDCA therapy can slow the rise in serum fibrosis markers and improve histologic scores in a subset of patients. While not a definitive antifibrotic agent, it contributes to disease stabilisation when started early. -
Do different strengths of UDCA tablets have the same inactive ingredients?
Generally, manufacturers use comparable excipients across strengths to maintain tablet integrity, but minor variations (e.g., different amounts of microcrystalline cellulose) may exist. All ingredients are listed on the product leaflet supplied with the medication.
Glossary
- Bile Acid
- A component of bile that aids digestion of fats; UDCA is a naturally occurring, less toxic bile acid used therapeutically.
- Choleresis
- The stimulation of bile production and secretion from the liver, a key effect of UDCA that helps clear accumulated bile acids.
- Enterohepatic Circulation
- The recycling loop where bile acids are secreted into the intestine, reabsorbed, and returned to the liver; UDCA participates in this cycle, extending its therapeutic reach.
- Hydrophilic
- Having an affinity for water; UDCA’s hydrophilic nature makes it less damaging to cell membranes compared with more lipophilic bile acids.
⚠️ Disclaimer
The information provided about Ursodeoxycholic Acid is for general knowledge only. It does not replace professional medical consultation. All treatment decisions should be made under the supervision of a qualified healthcare provider. We assume all readers are responsible adults capable of making informed decisions about their health. Our online pharmacy offers access to Ursodeoxycholic Acid for individuals who may have limited availability through traditional pharmacies, prescription‑based insurance schemes, or who are seeking affordable generic alternatives. Always consult your doctor before starting, changing, or discontinuing any medication.