Ursodeoxycholic acid (Tablets, Capsules) Instructions for Use
ATC Code
A05AA02 (Ursodeoxycholic acid)
Active Substance
Ursodeoxycholic acid (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Hepatoprotective agent with choleretic and cholelitholytic action
Pharmacotherapeutic Group
Preparations affecting the digestive tract and metabolism; preparations for the treatment of liver and biliary tract diseases; preparations for the treatment of gallbladder diseases; bile acid preparations
Pharmacological Action
Hepatoprotector. Ursodeoxycholic acid is a bile acid. It reduces the cholesterol content in bile primarily by dispersing cholesterol and forming a liquid crystalline phase. It affects the enterohepatic circulation of bile salts, reducing the intestinal reabsorption of endogenous, more hydrophobic and potentially toxic compounds.
In vitro studies have shown that Ursodeoxycholic acid has a direct hepatoprotective effect and reduces the hepatotoxicity of hydrophobic bile salts.
It affects immunological reactions by reducing the pathological expression of HLA class I antigens on hepatocytes and suppressing the production of cytokines and interleukins.
Ursodeoxycholic acid reduces the lithogenic index of bile by increasing its bile acid content. It promotes partial or complete dissolution of cholesterol gallstones when taken orally. It has a choleretic effect.
Pharmacokinetics
After oral administration, Ursodeoxycholic acid is rapidly absorbed in the jejunum and the proximal part of the ileum by passive diffusion, and in the distal part of the ileum by active transport. Approximately 60-80% is absorbed.
After absorption, the bile acid is almost completely conjugated in the liver with glycine and taurine and excreted in the bile. Up to 60% is metabolized during the first pass through the liver.
Depending on the daily dose, the type of disease, or the condition of the liver, a greater or lesser amount of ursodeoxycholic acid accumulates in the bile. Under the action of intestinal bacteria, Ursodeoxycholic acid is partially broken down to form 7-keto-lithocholic and lithocholic acids.
The T1/2 of ursodeoxycholic acid is 3.5-5.8 days.
Indications
Cholesterol gallstones in the gallbladder and common bile duct in patients when surgical or endoscopic treatment is not possible. Cholesterol stones of the gallbladder and common bile duct with a diameter of no more than 1.5-2 cm after extracorporeal lithotripsy or mechanical lithotripsy. Primary biliary cirrhosis (before the formation of advanced fibrosis and cirrhotic transformation of the liver). Chronic active hepatitis with cholestatic syndrome. Acute hepatitis, cystic fibrosis, congenital biliary atresia. Biliary reflux esophagitis and gastritis. Biliary dyspeptic syndrome in cholecystopathy and biliary dyskinesia. Prevention and treatment of cholestatic syndrome caused by the use of hormonal contraceptives. To normalize liver function in patients receiving cytostatic therapy, as well as in patients with alcoholic liver disease, non-alcoholic steatohepatitis. Liver and other organ transplantation (adjuvant therapy).
ICD codes
| ICD-10 code | Indication |
| B17.9 | Acute viral hepatitis, unspecified |
| E84 | Cystic fibrosis |
| K23.8 | Disorders of esophagus in diseases classified elsewhere |
| K70 | Alcoholic liver disease |
| K71 | Toxic liver disease |
| K73.9 | Unspecified chronic hepatitis |
| K74.3 | Primary biliary cirrhosis |
| K76.0 | Fatty (change of) liver, not elsewhere classified |
| K80 | Cholelithiasis [cholelithiasis] (including biliary colic) |
| K81.1 | Chronic cholecystitis |
| K82.8 | Other specified diseases of gallbladder and cystic duct (including dyskinesia) |
| K83.9 | Disease of biliary tract, unspecified |
| Q44.2 | Atresia of bile ducts |
| Y42.4 | Oral contraceptives |
| Y43.1 | Antineoplastic antimetabolites |
| Y43.2 | Antineoplastic natural products |
| Y43.3 | Other antineoplastic drugs |
| Z94.4 | Presence of transplanted liver |
| ICD-11 code | Indication |
| 1E50.0 | Acute hepatitis A |
| 1E50.1 | Acute hepatitis B |
| 1E50.2 | Acute hepatitis C |
| 4A85.00 | Drug hypersensitivity-induced liver disease |
| CA25.Z | Cystic fibrosis, unspecified |
| DA22.Z | Gastro-esophageal reflux disease, unspecified |
| DA24.Z | Unspecified esophagitis |
| DA42.Z | Gastritis, unspecified |
| DA51.Z | Duodenitis, unspecified |
| DA7Z | Diseases of stomach or duodenum, unspecified |
| DB92.0 | Non-alcoholic fatty liver disease without steatohepatitis |
| DB92.Y | Other specified non-alcoholic fatty liver disease |
| DB92.Z | Non-alcoholic fatty liver disease, unspecified |
| DB94.Z | Alcoholic liver disease, unspecified |
| DB95.Z | Drug-induced or toxic liver disease, unspecified |
| DB96.1Z | Primary biliary cholangitis, unspecified |
| DB97.2 | Chronic hepatitis, not elsewhere classified |
| DC10.Z | Acquired structural (organic) changes of gallbladder or bile ducts, unspecified |
| DC11.Z | Cholelithiasis, unspecified |
| DC12.1 | Chronic cholecystitis |
| DC14.Z | Diseases of the biliary tract, unspecified |
| DC1Z | Diseases of gallbladder and biliary tract, unspecified |
| DD94 | Functional disorder of the gallbladder |
| LB20.21 | Biliary atresia (atresia of bile ducts) |
| PL00 | Drugs, medicaments or biological substances causing injury or harm in therapeutic use |
| QB63.3 | Presence of transplanted liver |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer orally with a small amount of water. Take with food to improve tolerability and enhance bile acid incorporation.
For cholesterol gallstone dissolution, the typical adult dose is 10-12 mg/kg body weight per day, administered as a single evening dose or in two divided doses. Continue treatment until stones are dissolved, confirmed by ultrasound, plus an additional 3 months. Assess dissolution progress via ultrasound or oral cholecystography after 6-10 months of therapy.
For primary biliary cholangitis (PBC), the recommended adult dose is 13-15 mg/kg body weight per day, administered in two to four divided doses. Titrate the dose gradually over the first few months to the recommended dose to improve gastrointestinal tolerability. Treatment is typically long-term.
For other cholestatic liver diseases and hepatopathies, the usual adult dose ranges from 10-15 mg/kg per day in divided doses. Adjust the dose based on clinical response and biochemical markers.
In pediatric patients, calculate the dose based on body weight. Use only dosage forms appropriate for the child’s age and ability to swallow. Adhere strictly to age-specific contraindications listed in the product labeling for the specific formulation.
For biliary reflux gastritis/esophagitis, the typical adult dose is 250 mg per day, administered in the evening. The duration of treatment is usually 10-14 days, which may be repeated.
Divide the total daily dose if it exceeds one tablet or capsule. Do not crush or chew enteric-coated tablets. Swallow capsules whole.
Monitor liver function tests (ALT, AST, ALP, GGT, bilirubin) every 4 weeks for the first 3 months of treatment, then every 3 months thereafter. In patients with PBC, monitor for clinical signs of decompensation, especially in late-stage disease.
Reduce the dose if persistent diarrhea occurs. Discontinue therapy if diarrhea persists despite dose reduction. In gallstone dissolution therapy, discontinue if no reduction in stone size is observed after 12 months of treatment.
Adverse Reactions
From the digestive system: frequently – unformed stools or diarrhea; very rarely when treating primary biliary cirrhosis – acute pain in the right upper quadrant of the abdomen.
From the liver and biliary tract: very rarely – calcification of gallstones, when treating advanced stages of primary biliary cirrhosis – decompensation of liver cirrhosis, which disappears after discontinuation of ursodeoxycholic acid.
From the skin and subcutaneous tissues: very rarely – allergic reactions, urticaria.
Contraindications
Hypersensitivity to ursodeoxycholic acid and other bile acids; X-ray positive (high calcium content) gallstones, impaired contractility of the gallbladder, acute inflammatory diseases of the gallbladder and bile ducts, decompensated liver cirrhosis, severe hepatic and/or renal failure, occlusion of the biliary tract (occlusion of the common bile duct or cystic duct), frequent episodes of biliary colic; unsuccessful portoenterostomy or cases of no restoration of normal bile flow in children with biliary atresia; pediatric age – depending on the dosage form.
Use in Pregnancy and Lactation
Ursodeoxycholic acid should not be used during pregnancy.
Use of the drug by women of childbearing potential is only possible if they use reliable methods of contraception. It is recommended to use non-hormonal contraceptives or oral contraceptives with low estrogen content, since hormonal oral contraceptives may enhance gallstone formation. Possible pregnancy should be excluded before starting treatment.
Use during breastfeeding is possible if indicated, at recommended doses.
Use in Hepatic Impairment
Contraindicated in some liver diseases.
Use in Renal Impairment
Contraindicated in severe renal failure.
Pediatric Use
Contraindicated in cases of unsuccessful portoenterostomy or in the absence of restoration of normal bile flow in children with biliary atresia.
Use in children is possible if indicated, at doses and in dosage forms appropriate for age and body weight. It is necessary to strictly follow the instructions in the ursodeoxycholic acid drug labels regarding contraindications for use in children of different ages for specific dosage forms of ursodeoxycholic acid.
Special Precautions
Treatment with ursodeoxycholic acid should be carried out under medical supervision. During the first 3 months of treatment, liver function tests should be monitored: transaminases, ALP and GGT in blood serum every 4 weeks, and then every 3 months. Monitoring these parameters allows for the detection of liver dysfunction at an early stage. This also applies to patients in the late stages of primary biliary cirrhosis. Furthermore, this allows for quick determination of whether a patient with primary biliary cirrhosis is responding to the treatment.
When using ursodeoxycholic acid to dissolve cholesterol gallstones, in order to assess treatment progress and for the timely detection of signs of stone calcification depending on their size, the gallbladder should be visualized (oral cholecystography) with examination of opacities in the standing and supine positions (ultrasound) 6-10 months after the start of treatment. If the gallbladder cannot be visualized on X-rays or in cases of stone calcification, weak gallbladder contractility, or frequent colic attacks, ursodeoxycholic acid should not be used.
When treating patients in the late stages of primary biliary cirrhosis, cases of decompensation of liver cirrhosis have been very rarely reported. After discontinuation of therapy, partial regression of decompensation manifestations was observed.
In patients with diarrhea, the dose of ursodeoxycholic acid should be reduced. If diarrhea persists, treatment should be discontinued.
Drug Interactions
With simultaneous use, cholestyramine, colestipol, and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce the absorption of ursodeoxycholic acid in the intestine and thus reduce its effectiveness. If it is necessary to use these agents simultaneously, they should be taken at least 2 hours before taking ursodeoxycholic acid.
With simultaneous use, Ursodeoxycholic acid may enhance the absorption of cyclosporine from the intestine. The concentration of cyclosporine in the blood should be monitored and its dose adjusted if necessary when using this combination.
A case of decreased plasma concentration of ciprofloxacin in a patient receiving ursodeoxycholic acid has been described.
With simultaneous use, hypolipidemic drugs (especially clofibrate), estrogens, neomycin, or progestins increase the saturation of bile with cholesterol and may reduce the ability of ursodeoxycholic acid to dissolve cholesterol gallstones.
With simultaneous use, Ursodeoxycholic acid reduces the Cmax and AUC of nitrendipine. An increase in the dose of nitrendipine may be required.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Capsules 250 mg: 10, 30, 50, or 100 pcs.
Marketing Authorization Holder
Jivdhara Pharma, Private Limited (India)
Manufactured By
NPC Scan Biotek, LLC (Russia)
Dosage Form
 |
Ursodeoxycholic acid | Capsules 250 mg: 10, 30, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #0; body and cap white or almost white; capsule contents – powder or a mixture of granulated and non-granulated powder, white or almost white.
| 1 caps. | |
| Ursodeoxycholic acid | 250 mg |
Excipients: corn starch – 119.5 mg, sodium carboxymethyl starch – 2.5 mg, sodium lauryl sulfate – 1 mg, talc – 1.5 mg, magnesium stearate – 0.3 mg, colloidal silicon dioxide – 1.2 mg.
Composition of the gelatin capsule (cap and body): gelatin – up to 100%, sodium lauryl sulfate – 0.1%, purified water – 14.5%, titanium dioxide (E171) – 3.3%.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
Capsules 250 mg: 5, 6, 10, 12, 15, 18, 20, 24, 25, 30, 35, 36, 40, 42, 45, 48, 50, 54, 60, 70, 75, 80, 90, 100, 105, 120, 125, 135, 140, 150, 160, 175, 180, 200, 225 or 250 pcs.
Marketing Authorization Holder
Bright Way, LLC (Russia)
Manufactured By
Velpharm, LLC (Russia)
Dosage Form
|
Ursodeoxycholic acid | Capsules 250 mg: 5, 6, 10, 12, 15, 18, 20, 24, 25, 30, 35, 36, 40, 42, 45, 48, 50, 54, 60, 70, 75, 80, 90, 100, 105, 120, 125, 135, 140, 150, 160, 175, 180, 200, 225 or 250 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard, gelatinous, #0, white; capsule contents – white or almost white powder.
| 1 caps. | |
| Ursodeoxycholic acid | 250 mg |
Excipients: titanium dioxide, gelatin.
Capsule composition: titanium dioxide, gelatin.
5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (3) – cardboard packs.
5 pcs. – contour cell packs (4) – cardboard packs.
5 pcs. – contour cell packs (5) – cardboard packs.
5 pcs. – contour cell packs (6) – cardboard packs.
5 pcs. – contour cell packs (7) – cardboard packs.
5 pcs. – contour cell packs (8) – cardboard packs.
5 pcs. – contour cell packs (9) – cardboard packs.
5 pcs. – contour cell packs (10) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
6 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (3) – cardboard packs.
6 pcs. – contour cell packs (4) – cardboard packs.
6 pcs. – contour cell packs (5) – cardboard packs.
6 pcs. – contour cell packs (6) – cardboard packs.
6 pcs. – contour cell packs (7) – cardboard packs.
6 pcs. – contour cell packs (8) – cardboard packs.
6 pcs. – contour cell packs (9) – cardboard packs.
6 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
15 pcs. – contour cell packs (1) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (3) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (5) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.
15 pcs. – contour cell packs (7) – cardboard packs.
15 pcs. – contour cell packs (8) – cardboard packs.
15 pcs. – contour cell packs (9) – cardboard packs.
15 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (7) – cardboard packs.
20 pcs. – contour cell packs (8) – cardboard packs.
20 pcs. – contour cell packs (9) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
25 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (2) – cardboard packs.
25 pcs. – contour cell packs (3) – cardboard packs.
25 pcs. – contour cell packs (4) – cardboard packs.
25 pcs. – contour cell packs (5) – cardboard packs.
25 pcs. – contour cell packs (6) – cardboard packs.
25 pcs. – contour cell packs (7) – cardboard packs.
25 pcs. – contour cell packs (8) – cardboard packs.
25 pcs. – contour cell packs (9) – cardboard packs.
25 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars – cardboard packs.
20 pcs. – jars – cardboard packs.
30 pcs. – jars – cardboard packs.
40 pcs. – jars – cardboard packs.
50 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
70 pcs. – jars – cardboard packs.
80 pcs. – jars – cardboard packs.
90 pcs. – jars – cardboard packs.
100 pcs. – jars – cardboard packs.
Capsules 250 mg: 30, 40, 50, 60, 90, 100 or 120 pcs.
Marketing Authorization Holder
B-PHARM, LLC (Russia)
Manufactured By
Biopharmkombinat, LLC (Russia)
Dosage Form
|
Ursodeoxycholic acid | Capsules 250 mg: 30, 40, 50, 60, 90, 100 or 120 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Ursodeoxycholic acid | 250 mg |
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (9) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
10 pcs. – blister packs (12) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.
Capsules 250 mg: 10, 20, 30, 50, or 100 pcs.
Marketing Authorization Holder
OHFK, JSC (Russia)
Dosage Form
|
Ursodeoxycholic acid | Capsules 250 mg: 10, 20, 30, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size 0, white body and cap; capsule contents – white powder.
| 1 caps. | |
| Ursodeoxycholic acid | 250 mg |
Excipients: corn starch – 72.8 mg, anhydrous colloidal silicon dioxide – 1.6 mg, magnesium stearate – 0.6 mg.
Capsule shell composition: titanium dioxide (E171) – 1.92 mg, gelatin – 94.08 mg.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
Capsules 250 mg: 5, 6, 10, 12, 15, 18, 20, 24, 25, 30, 40, 50, 60, or 100 pcs.
Marketing Authorization Holder
Rif LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Ursodeoxycholic acid | Capsules 250 mg: 5, 6, 10, 12, 15, 18, 20, 24, 25, 30, 40, 50, 60, or 100 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size 0, opaque white body, opaque light gray cap; capsule contents – a mixture of powder and granules white or almost white; compaction of the capsule contents into lumps that are easily destroyed when pressed is allowed.
| 1 caps. | |
| Ursodeoxycholic acid | 250 mg |
Excipients: corn starch – 73 mg, colloidal silicon dioxide – 5 mg, magnesium stearate – 2 mg.
Capsule body composition: titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition titanium dioxide – 2%, iron oxide black dye – 0.05%, gelatin – up to 100%.
5 pcs. – blister packs (1) – cardboard packs.
5 pcs. – blister packs (2) – cardboard packs.
5 pcs. – blister packs (3) – cardboard packs.
5 pcs. – blister packs (4) – cardboard packs.
5 pcs. – blister packs (5) – cardboard packs.
5 pcs. – blister packs (10) – cardboard packs.
6 pcs. – blister packs (1) – cardboard packs.
6 pcs. – blister packs (2) – cardboard packs.
6 pcs. – blister packs (3) – cardboard packs.
6 pcs. – blister packs (4) – cardboard packs.
6 pcs. – blister packs (5) – cardboard packs.
6 pcs. – blister packs (10) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
10 pcs. – jarsx (1) – cardboard packs.
20 pcs. – jarsx (1) – cardboard packs.
30 pcs. – jarsx (1) – cardboard packs.
40 pcs. – jarsx (1) – cardboard packs.
50 pcs. – jarsx (1) – cardboard packs.
100 pcs. – jarsx (1) – cardboard packs.
x with first opening control
Capsules 250 mg: 5, 6, 10, 12, 15, 18, 20, 24, 25, 30, 40, 50, 60, or 100 pcs.
Marketing Authorization Holder
Rif LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Ursodeoxycholic acid | Capsules 250 mg: 5, 6, 10, 12, 15, 18, 20, 24, 25, 30, 40, 50, 60, or 100 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard, gelatin, size 0; opaque white body; opaque light gray cap; capsule contents – a mixture of powder and granules white or almost white; compaction of the capsule contents into lumps that are easily destroyed when pressed is allowed.
| 1 caps. | |
| Ursodeoxycholic acid | 250 mg |
Excipients: corn starch – 73 mg, colloidal silicon dioxide – 5 mg, magnesium stearate – 2 mg.
Capsule cap composition: titanium dioxide -2%, iron oxide black dye – 0.05%, gelatin – up to 100%.
Capsule body composition titanium dioxide – 2%, gelatin – up to 100%.
5 pcs. – blister packs (1) – cardboard packs.
5 pcs. – blister packs (2) – cardboard packs.
5 pcs. – blister packs (3) – cardboard packs.
5 pcs. – blister packs (4) – cardboard packs.
5 pcs. – blister packs (5) – cardboard packs.
5 pcs. – blister packs (10) – cardboard packs.
6 pcs. – blister packs (1) – cardboard packs.
6 pcs. – blister packs (2) – cardboard packs.
6 pcs. – blister packs (3) – cardboard packs.
6 pcs. – blister packs (4) – cardboard packs.
6 pcs. – blister packs (5) – cardboard packs.
6 pcs. – blister packs (10) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
Capsules 250 mg: 10, 20, 25, 50 or 100 pcs.
Marketing Authorization Holder
Citypharm LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Ursodeoxycholic acid | Capsules 250 mg: 10, 20, 25, 50 or 100 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard, gelatin, size 0; white, cylindrical in shape, with hemispherical ends; capsule contents – a mixture of powder and granules white or almost white; compaction of the capsule contents into lumps that are easily destroyed when pressed is allowed.
| 1 caps. | |
| Ursodeoxycholic acid | 250 mg |
Excipients: corn starch – 73 mg, colloidal silicon dioxide – 5 mg, magnesium stearate – 2 mg.
Capsule composition: titanium dioxide -2%, gelatin – up to 100%.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
25 pcs. – jars – cardboard packs.
50 pcs. – jars – cardboard packs.
100 pcs. – jars – cardboard packs.
Capsules 250 mg: 50 or 100 pcs.
Marketing Authorization Holder
HLS Pharma, LLC (Russia)
Manufactured By
Shreya Life Sciences, Pvt.Ltd. (India)
Dosage Form
|
Ursodeoxycholic acid | Capsules 250 mg: 50 or 100 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard opaque gelatin, size 0, white body and cap; capsule contents – powder or microgranules, or a mixture of powder and microgranules, white.
| 1 caps. | |
| Ursodeoxycholic acid | 250 mg |
Excipients: corn starch – 73 mg, colloidal silicon dioxide – 5 mg, magnesium stearate – 2 mg.
Capsule composition body – 58.6 mg (sodium lauryl sulfate – 0.1%, titanium dioxide (E171) – 3.3%, purified water – 14.5%, gelatin – up to 100%); cap – 38.4 mg (sodium lauryl sulfate – 0.1%, titanium dioxide (E171) – 3.3%, purified water – 14.5%, gelatin – up to 100%).
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
50 pcs. – plastic jars (1) – cardboard packs.
Capsules 250 mg
Capsules 500 mg
Marketing Authorization Holder
Abc Farmaceutici, S.p.A. (Italy)
Dosage Forms
|
Ursodeoxycholic acid ABC | Capsules 250 mg |
| Capsules 500 mg |
Dosage Form, Packaging, and Composition
Capsules
| 1 caps. | |
| Ursodeoxycholic acid | 250 mg |
15 pcs. – blisters (2 pcs.) – cardboard packs (30 pcs.) – Prescription only
20 pcs. – blisters – cardboard packs (20 pcs.) – Prescription only
20 pcs. – blisters (3 pcs.) – cardboard packs (60 pcs.) – Prescription only
25 pcs. – blisters – cardboard packs (25 pcs.) – Prescription only
25 pcs. – blisters (2 pcs.) – cardboard packs (50 pcs.) – Prescription only
25 pcs. – blisters (3 pcs.) – cardboard packs (75 pcs.) – Prescription only
25 pcs. – blisters (4 pcs.) – cardboard packs (100 pcs.) – Prescription only
5 pcs. – blisters (2 pcs.) – cardboard packs (10 pcs.) – Prescription only
Capsules
| 1 caps. | |
| Ursodeoxycholic acid | 500 mg |
15 pcs. – blisters (2 pcs.) – cardboard packs (30 pcs.) – Prescription only
20 pcs. – blisters – cardboard packs (20 pcs.) – Prescription only
20 pcs. – blisters (3 pcs.) – cardboard packs (60 pcs.) – Prescription only
25 pcs. – blisters – cardboard packs (25 pcs.) – Prescription only
25 pcs. – blisters (2 pcs.) – cardboard packs (50 pcs.) – Prescription only
25 pcs. – blisters (3 pcs.) – cardboard packs (75 pcs.) – Prescription only
25 pcs. – blisters (4 pcs.) – cardboard packs (100 pcs.) – Prescription only
5 pcs. – blisters (2 pcs.) – cardboard packs (10 pcs.) – Prescription only
Film-coated tablets 250 mg
Film-coated tablets 500 mg
Marketing Authorization Holder
PFKO-1, LLC (Russia)
Manufactured By
Obnovlenie Pfc, JSC (Russia)
Dosage Forms
|
Ursodeoxycholic acid Renewal | Film-coated tablets 250 mg |
| Film-coated tablets 500 mg |
Dosage Form, Packaging, and Composition
Film-coated tablets
| Ursodeoxycholic acid | 250 mg |
10 pcs. – blister packs – cardboard packs (10 pcs.) – Prescription only
10 pcs. – blister packs (10 pcs.) – cardboard packs (100 pcs.) – Prescription only
10 pcs. – blister packs (5 pcs.) – cardboard packs (50 pcs.) – Prescription only
120 pcs. – jars – cardboard packs (120 pcs.) – Prescription only
15 pcs. – blister packs – cardboard packs (15 pcs.) – Prescription only
15 pcs. – blister packs (4 pcs.) – cardboard packs (60 pcs.) – Prescription only
15 pcs. – blister packs (6 pcs.) – cardboard packs (90 pcs.) – Prescription only
15 pcs. – blister packs (8 pcs.) – cardboard packs (120 pcs.) – Prescription only
Film-coated tablets white or almost white, oblong, biconvex, with a score. Surface roughness is allowed. The core on the cross-section is white or almost white. The tablet can be divided into equal doses.
| 1 tab. | |
| Ursodeoxycholic acid | 500 mg |
Excipients: microcrystalline cellulose, mannitol (E421), potato starch, povidone (K-30), sodium carboxymethyl starch, calcium stearate, macrogol 4000 (E1521).
10 pcs. – blister packs (1) – cardboard packs (10 pcs.) – Prescription only
10 pcs. – blister packs (10 pcs.) – cardboard packs (100 pcs.) – Prescription only
10 pcs. – blister packs (5 pcs.) – cardboard packs (50 pcs.) – Prescription only
120 pcs. – jars – cardboard packs (120 pcs.) – Prescription only
15 pcs. – blister packs – cardboard packs (15 pcs.) – Prescription only
15 pcs. – blister packs (4 pcs.) – cardboard packs (60 pcs.) – Prescription only
15 pcs. – blister packs (6 pcs.) – cardboard packs (90 pcs.) – Prescription only
15 pcs. – blister packs (8 pcs.) – cardboard packs (120 pcs.) – Prescription only
Coating composition hypromellose (hydroxypropyl methylcellulose) (E464), titanium dioxide (E171), macrogol 4000 (E1521) or a ready-made film coating of identical composition.
Capsules 250 mg: 10, 20, 50 or 100 pcs.
Marketing Authorization Holder
Vertex, JSC (Russia)
Dosage Form
|
Ursodeoxycholic acid-Vertex | Capsules 250 mg: 10, 20, 50 or 100 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size 0, white; capsule contents – a mixture of powder and granules or a compacted mass white or almost white.
| 1 caps. | |
| Ursodeoxycholic acid | 250 mg |
Excipients: corn starch – 63 mg, povidone K30 – 10 mg, colloidal silicon dioxide – 5 mg, magnesium stearate – 2 mg.
Hard gelatin capsule composition titanium dioxide – 2%, gelatin – up to 100%.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
20 pcs. – blister packs (1) – cardboard packs.
20 pcs. – blister packs (5) – cardboard packs.
50 pcs. – jars (1) with first opening control – cardboard packs.
![Ursodeoxycholic acid [Tablets, Capsules] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Ursodeoxycholic acid [Tablets, Capsules] 2")