PMS-Ursodiol 500mg 50 tablets — Made in Canada — Free Delivery

Product description 

PMS-Ursodiol tablets are used for the following indications:

• to dissolve X-ray negative cholesterol gallstones no larger than 15 mm in diameter in patients with a functioning gallbladder, despite the presence of gallstone(s) in it(s);
• for the treatment of gastritis with bile reflux;
• for the symptomatic treatment of primary biliary cirrhosis (PBC) in the absence of decompensated liver cirrhosis;
• for the treatment of hepatobiliary disorders in cystic fibrosis in children aged 6 to 18 years.

Compound

Active ingredient - ursodeoxycholic acid (ursodeoxycholic acid) (one tablet contains ursodeoxycholic acid 500 mg).

Excipients: sodium starch glycolate (type A), povidone, sodium lauryl sulfate, microcrystalline cellulose, polyethylene glycol, magnesium stearate, tablet shell (hydroxypropyl methylcellulose, polyethylene glycol).

Contraindications

• hypersensitivity to any substance that is part of the drug;
• acute inflammation of the gallbladder or bile ducts;
• blockage of the bile duct (blockage of the common bile duct or duct);
• frequent episodes of hepatic colic;
• radiopaque calcified gallstones;
• violation of the contractility of the gallbladder;
• cirrhosis of the liver in the stage of decompensation;
• failure of portoenterostomy or lack of adequate bile outflow in children with bile duct atresia.

Mode of application

The drug is administered orally.

There are no age restrictions on the use of the drug. For patients who weigh less than 47 kg or who have difficulty swallowing tablets, ursodeoxycholic acid in the form of a suspension should be used.

To dissolve cholesterol gallstones

Use approximately 10 mg ursodeoxycholic acid/kg, which is equivalent to:

for patients weighing up to 60 kg - 500 mg;

61-80 kg - 750 mg;

81-100 kg - 1000 mg;

more than 100 kg - 1250 mg.

Tablets should be swallowed whole with water, 1 time per day in the evening before bedtime.

Tablets should be taken regularly.

The time required for gallstones to dissolve is usually 6-24 months. If a decrease in the size of gallstones is not observed after 12 months of administration, therapy should not be continued.

The success of the treatment should be checked every 6 months by ultrasound or X-ray. In additional studies, it is necessary to check whether stones have calcified over time. If this happens, treatment should be discontinued.

For the treatment of gastritis with bile reflux

Take 250 mg once a day with some liquid in the evening before bedtime.

Usually, for the treatment of gastritis with bile reflux, the drug should be taken for 10-14 days. The duration of treatment depends on the condition of the patient. The doctor must decide on the duration of treatment in each case individually.

For the symptomatic treatment of primary biliary cirrhosis (PBC)

The daily dose depends on body weight and varies from 750 mg to 1750 mg (14±2 mg ursodeoxycholic acid/kg body weight).

In the first 3 months of treatment, the drug should be taken by distributing the daily dose into 3 doses during the day. With improvement in liver function, the dose can be taken 1 time per day in the evening.

Tablets should be swallowed whole with liquid. It is necessary to observe the regularity of reception.

The use of this drug in primary biliary cirrhosis can be unlimited in time.

In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may increase. If this happens, therapy should be continued, taking 250 mg per day, and then gradually increase the dose (increasing the daily dose by 250 mg every week) until the prescribed dosing regimen is reached.

Application to children

Children with cystic fibrosis aged 6 to 18 years. The dose is 20 mg / kg / day and is divided into 2-3 doses, followed by an increase in dose to 30 mg / kg / day, if necessary.

For the dissolution of cholesterol gallstones and the symptomatic treatment of PBC: there are no fundamental age restrictions for the use of ursodeoxycholic acid in children, but children weighing less than 47 kg and / or children who have difficulty swallowing are recommended to use ursodeoxycholic acid in the form of a suspension.

Application features

pregnant

Animal studies have not shown an effect of ursodeoxycholic acid on fertility. Data on the effect on human fertility are not available.

There are insufficient data on the use of ursodeoxycholic acid in pregnant women. The results of animal studies indicate reproductive toxicity in the early stages of pregnancy. The drug should not be used by pregnant women unless necessary. Women of childbearing age should only take the drug if they are using reliable contraception.

It is recommended to use non-hormonal contraceptives or low-estrogen oral contraceptives. Patients who receive this drug should use effective non-hormonal contraception to dissolve gallstones, since hormonal oral contraceptives can increase gallstone formation. Before starting treatment, the possibility of pregnancy should be excluded.

According to several recorded cases of the use of the drug by breastfeeding, the content of ursodeoxycholic acid in milk was extremely low, therefore, the development of any adverse events in infants should not be expected.

Drivers

There was no effect on the ability to drive vehicles or work with other mechanisms.

Overdose

In case of overdose, diarrhea is possible. Other symptoms of overdose are unlikely because the absorption of ursodeoxycholic acid decreases with increasing dose and therefore most of the dose is excreted in the feces.

If diarrhea occurs, the dose should be reduced, and if diarrhea persists, therapy should be discontinued.

Treatment is symptomatic and involves restoring fluid and electrolyte balance.

Side effects

From the gastrointestinal tract: dyspepsia; noted nausea and abdominal pain, cases of anorexia, esophagitis, peptic ulcer; diarrhea, pasty stools, severe abdominal pain localized in the right hypochondrium.

From the side of the liver and gallbladder: in the treatment with ursodeoxycholic acid, calcification of gallstones can be observed.

During therapy of advanced stages of primary biliary cirrhosis, decompensation of liver cirrhosis may be observed, which partially regressed after discontinuation of treatment.

From the skin: cases of itching and rash on the skin.

Metabolic disorders: cases of increased creatinine and increased blood glucose.

Violation of the general nature: asthenia, pain in the sternum and peripheral edema.

From the side of the cardiovascular system: increased blood pressure.

From the hemopoietic system: cases of leukopenia.

Hypersensitivity reactions: rarely possible allergic reactions, including rash, urticaria.

Storage conditions

Store at a temperature not exceeding 30 ° C, out of the reach of children.

Shelf life - 5 years.