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Ursodex
Last reviewed: 03.07.2025
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The bile acid-based product Ursodex belongs to the category of drugs that are prescribed for the treatment of liver and biliary system diseases.
Indications Ursodex
Ursodex may be prescribed for the following therapeutic purposes:
- for softening radiologically negative cholesterol gallstones with a diameter of no more than 1.5 cm (in patients with a functional biliary system);
- for the treatment of inflammatory processes in the stomach with bile reflux;
- for the treatment of primary biliary cirrhosis, provided there is no state of decompensation.
Release form
Pharmacodynamics
A small amount of the active ingredient Ursodex is normally found in human bile secretions. After taking Ursodex, the concentration of cholesterol in bile decreases, cholesterol absorption in the small intestine and its release into bile decreases.
Apparently, during the distribution of cholesterol and the formation of liquid crystalline structures, incomplete dissolution of cholesterol, which is located in the hepatobiliary system, begins.
Taking into account the latest revisions by scientists, it is believed that the active ingredient Ursodex in liver and biliary system diseases demonstrates the effect by relative replacement of lipophilic toxic bile acids with hydrophilic non-toxic protective acid. At the same time, the producing property of liver cells improves, and immune-regulating processes are normalized.
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Pharmacokinetics
After oral administration, the active ingredient Ursodex is rapidly absorbed in the small intestine, in the upper ileum by passive transport and in the terminal ileum by active transport.
The absorption rate can usually range from 60 to 80%.
After the assimilation process is complete, the bile acid undergoes almost complete hepatic conjugation, with the participation of the amino acid complex taurine and glycine. After this, the acid is excreted with bile secretions.
First-pass clearance rates through the liver may be approximately 60%.
Dosing and administration
To soften cholesterol stones, take:
- weight less than 60 kg – three tablets of 150 mg;
- weight from 60 to 80 kg – from 4 to five tablets of 150 mg;
- weight from 80 to 100 kg – three tablets of 300 mg;
- weight over 100 kg – 3 to 4 tablets of 300 mg.
Ursodex should be taken once a day, at night. The duration of therapy can be ½-1 year. If after a year of taking it, no positive dynamics are detected, then Ursodex is canceled.
The quality of therapy is checked every six months of treatment, using ultrasound or X-ray examination. In addition, it is important to check for the absence of calcification - otherwise, treatment is stopped.
- For the treatment of the inflammatory process in the stomach with bile reflux, one tablet of Ursodex 300 mg is prescribed daily at night. Therapy in this case can last up to 2 weeks, which is decided in each case separately.
- To eliminate the symptoms of primary biliary cirrhosis, the dosage is determined taking into account the patient's weight:
- weight from 47 to 62 kg – daily amount of Ursodex 12-16 mg/kg;
- weight from 63 to 78 kg – daily amount of Ursodex 13-16 mg/kg;
- weight from 79 to 93 kg – daily amount of Ursodex 13-16 mg/kg;
- weight from 94 to 109 kg – daily amount of Ursodex 14-16 mg/kg;
- weight from 110 kg – the daily amount of Ursodex is determined individually.
During the first three months, Ursodex 300 mg is taken, dividing the daily amount into three times (morning, afternoon and night). When the liver's performance improves, you can switch to a once-daily regimen at night.
At the beginning of treatment, patients may observe a worsening of the clinical picture. If this happens, the dosage is slightly reduced, gradually increasing the daily amount of the medication to the required amount according to the scheme.
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Use Ursodex during pregnancy
The periods of bearing a child and breastfeeding are considered contraindications to the prescription of the drug Ursodex.
Contraindications
Ursodex should not be prescribed:
- in case of exacerbation of the inflammatory process in the biliary system;
- in case of obstruction of the bile ducts;
- during the process of bearing and feeding a child;
- in the presence of calcifications;
- with impaired contractility of the gallbladder;
- for regular attacks of biliary colic.
Side effects Ursodex
Taking Ursodex in some cases may be accompanied by adverse effects, such as:
- diarrhea, pain in the liver projection area;
- formation of calcifications in the biliary system;
- development of the decompensation stage in the presence of liver cirrhosis;
- allergic rash (like urticaria).
Overdose
Most often, an overdose of Ursodex is accompanied by the appearance of diarrhea, although in general this phenomenon occurs only in a small number of patients. The fact is that large quantities of the drug are intensively excreted with feces, which virtually reduces the likelihood of a toxic effect on the body to zero.
If the patient experiences diarrhea due to an overdose, then the intake of Ursodex should be reduced or stopped.
There is no need for any special measures in case of overdose. In case of diarrhea, take the appropriate drugs, paying attention to the stability of the water-electrolyte balance in the patient's body.
Interactions with other drugs
Ursodex should not be used in combination with medications such as Cholestyramine, Cholestipol, antacids containing aluminum oxides or hydroxides. The listed medications envelop the components of Ursodex in the intestinal cavity, which leads to poor absorption and reduced effectiveness. If such a combination cannot be avoided, it is necessary to wait 180 minutes between taking the above medications.
Ursodex may increase the absorption of cyclosporine. Therefore, in patients undergoing treatment with cyclosporine, it is necessary to check the content of this drug in the blood and, if necessary, adjust it.
In some patients, Ursodex may impair the absorption of Ciprofloxacin.
The combination of Ursodex and drugs whose metabolism involves cytochrome P450 3A4 should be monitored and controlled (sometimes dosage adjustment may be required).
Storage conditions
Store Ursodex out of the reach of children, at temperatures not exceeding +25°C.
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Shelf life
Attention!
To simplify the perception of information, this instruction for use of the drug "Ursodex" translated and presented in a special form on the basis of the official instructions for medical use of the drug. Before use read the annotation that came directly to medicines.
Description provided for informational purposes and is not a guide to self-healing. The need for this drug, the purpose of the treatment regimen, methods and dose of the drug is determined solely by the attending physician. Self-medication is dangerous for your health.