Ursomax

One of the medications recommended for the treatment of hepatobiliary system diseases is Ursomax, which has lipotropic properties.

Indications Ursomax

The medicine Ursomax can be used:

• if it is necessary to remove gallstones of cholesterol etiology that are not detectable by radiography, the diameter of which does not exceed 1.5 cm (a mandatory condition is a functioning gallbladder, regardless of the presence of stones in it);
• as a treatment for gastritis with bile reflux;
• to eliminate painful symptoms in patients with primary biliary cirrhosis (a mandatory condition is the compensated stage of the disease);
• to stabilize liver and biliary system function in children suffering from cystic fibrosis (age 6-18 years).

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Release form

The drug Ursomax is produced in the form of capsules with granulated or powdered contents based on ursodeoxycholic acid.

The capsules are dense (No. 0), white in color, sealed in blister packs of 10 pieces.

The cardboard packaging may contain one, five or ten blister plates (respectively, 10, 50 or 100 capsules).

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Pharmacodynamics

The active ingredient of Ursomax is ursodeoxycholic acid, a substance present in small quantities in human bile.

After taking Ursomax orally, the medication reduces the concentration of the cholesterol component in the bile fluid, limiting its absorption in the digestive system and blocking the entry of cholesterol into the bile. In all likelihood, due to the breakdown of cholesterol and the formation of liquid crystalline forms, a slow decomposition of gallstones occurs.

It is believed that the therapeutic properties of Ursomax in liver pathologies and bile stasis are due to the partial replacement of lipophilic toxic bile acids with a hydrophilic non-toxic acid, which serves as the active ingredient of Ursomax. This leads to an acceleration of the excretory activity of liver cells and activation of immune regulation mechanisms.

Pharmacokinetics

After taking the medicine Ursomax, the active substance is well absorbed in the intestine by means of active and passive transport. The absorption rate is estimated at 60-80%.

After the absorption processes, absolute conjugation of bile acid with a number of amino acids occurs, in particular with glycine and taurine. Excretion occurs through bile.

The clearance indicators during the first pass can be 60%.

Depending on the daily amount of Ursomax and the degree of liver dysfunction, the active ingredient accumulates in bile secretions. A relative decrease in the level of other, more lipophilic, acids is also detected.

Under the influence of microbial flora in the intestine, incomplete degradation of the active ingredient is observed. One of the degradation products is considered hepatotoxic and can lead to changes in the liver parenchyma, which has been confirmed by animal experiments. In humans, only a small amount of the toxic component is absorbed, which is then completely inactivated in the liver.

The biological half-life of the active ingredient Ursomax can be 3.5-5.8 days.

Dosing and administration

Ursomax is prescribed by a doctor if there are appropriate indications. The dosage and duration of therapy depend mainly on the patient's weight and the characteristics of the disease.

• To eliminate gallstones and cholesterol stones, the dosage is determined at the rate of 10 mg Ursomax per kg of the patient's weight. The required number of capsules is swallowed whole, daily, before bedtime, regularly. The duration of treatment can be from six months to a year. If after 12 months of therapy, positive dynamics are not detected, then Ursomax is discontinued. It is important to monitor the dynamics of treatment once every six months, using ultrasound and radiography. At the same time, the probability of calcification of stones should be assessed. If signs of calcification are detected, therapy is terminated.
• In case of inflammation of the mucous tissues of the stomach with reflux of bile, it is enough to take 1 capsule of Ursomax at night, for 10-14 days. The treatment regimen can be adjusted at the discretion of the attending physician.
• In primary biliary cirrhosis, the daily dose of Ursomax should be 12-16 mg per kg of the patient's weight. During the first three months of therapy, Ursomax is taken three times a day. After the patient's condition improves, they switch to the standard dose - once a day, at night.

The capsules are swallowed whole, with liquid. They are taken daily at the same time.

In the primary form of biliary cirrhosis, a worsening of clinical symptoms may initially be observed, such as itching. With such signs, therapy is continued, limiting the intake of Ursomax to once a day. After the patient's condition has normalized, the number of capsules is gradually increased (one capsule is added weekly until the desired therapeutic dosage is reached).

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Use Ursomax during pregnancy

Informative data regarding the possibility of using Ursomax for the treatment of pregnant patients are insufficient. When studying the effects of Ursomax on rodents, reproductive toxicity of the drug was discovered in the early stages of pregnancy. Given this, specialists cannot recommend Ursomax as a drug for use by pregnant patients. Moreover, before starting treatment, all women of childbearing age must exclude pregnancy and resort to using reliable contraception (it is preferable to use non-hormonal oral drugs or drugs with a minimum estrogen content).

Taking Ursomax during breastfeeding is considered acceptable, since the medication is found in trace amounts in breast milk and cannot have any negative impact on the body of a nursing baby.

Contraindications

Not everyone can take Ursomax, as there are a number of contraindications, for example:

• allergic reaction of the body to individual ingredients of Ursomax;
• acute inflammatory process in the biliary system;
• obstruction of the bile ducts or bladder;
• frequent hepatic colic;
• the presence of radiologically detectable calcifications in the gallbladder;
• disorders of the contractile ability of the gallbladder;
• lack of positive results after portoenterostomy, abnormal bile flow in pediatric patients with biliary atresia.

Side effects Ursomax

Ursomax is usually well tolerated by patients of any age. Only in isolated cases may undesirable side effects develop, such as:

• diarrhea or semi-liquid pasty stools;
• severe pain in the liver projection area;
• calcification of bile stones (very rare);
• transition of biliary cirrhosis to a decompensated state, with partial regression after discontinuation of Ursomax;
• allergic manifestations in the form of skin rash.

Overdose

In case of overdose, diarrhea usually occurs: other manifestations are considered unlikely, because an excessive increase in dosage leads to a violation of the absorption of Ursomax. As a result, the excess drug is simply excreted with feces.

If the patient develops diarrhea, the dosage is reduced, and if persistent diarrhea occurs, treatment is stopped completely.

Special measures and drugs in case of overdose of Uromax are not carried out. It is enough to observe the patient's condition and control the stability of water-electrolyte balance in the body.

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Interactions with other drugs

It is contraindicated to take Ursomax in combination with antacid medications, with the medications Colestyramine, Colestipol, Smecta, Phosphalugel or Almagel, since such medications impair the absorption of ursodeoxycholic acid in the intestinal cavity. If a combination of medications cannot be avoided, then a time interval of 120 minutes should be maintained between their use.

Ursomax may affect the absorption of Cyclosporine in the intestinal cavity. With such a combination, the level of Cyclosporine in the bloodstream should be monitored and, if necessary, the dosage should be changed.

In some patients, taking Ursomax may impair the absorption of Ciprofloxacin.

The combination of Ursomax + Rosuvastatin may lead to an increase in the concentration of Rosuvastatin in the blood serum.

Ursomax has been shown to reduce the maximum possible serum concentration of Nitrendipine in patients with adequate liver and kidney function.

Patients should be monitored when treated simultaneously with Ursomax and Nifedipine. In some cases, an increase in the dosage of Nifedipine may be necessary.

There is evidence of a weakening of the therapeutic effect of Dapsone in combination with Ursomax.

Estrogen-based medications, as well as drugs for normalizing cholesterol levels in the circulatory system, can increase the secretion of cholesterol in the liver and increase the risk of the formation of stones in the biliary system.

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Storage conditions

It is recommended to store Ursomax in packaged form, away from children, at temperatures ranging from +18 to +25°C.

Shelf life

Ursomax is stored for up to 3 years, subject to the required conditions.