Ursomaxe Arlico treats gallbladder stones, cholecystic liver disease (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Ursodeoxycholic Acid

Ingredient

Composition information	Content
Ursodeoxycholic Acid	200mg

Uses

indications

Ursomaxe 200mg Arlico 3x10 is indicated in the following cases:

Cholesterol gallbladder stones: Small or asymptomatic gallbladder stones, no contrast, with a diameter of less than 15mm, the gallbladder is still working normally (confirmed by gallbladder X-ray), in patients with stones but are contraindicated for surgery.

Pediatric: Muscoviscidose in children from 6 to 18 years old. This is a natural bile acid present in the composition of people's bile fluid but exists at a low rate compared to the total amount of bile acid.

Ursodeoxycholic acid increases the ability to dissolve cholesterol in bile fluid in humans, converts insoluble bile (easy to create stones) into soluble bile fluid. Many acting mechanisms have been shown to explain the effect of ursodeoxycholic acid: reduce cholesterol secretion in bile fluid by reducing the absorption of cholesterol in the intestine and its synthesis in the liver; Increasing the amount of bile acid has the effect of dissolving cholesterol in the form of micelle; Beat the gallstones by forming a concentrated crystalline liquid at the gallbladder and improving the regular bile regulation and the emptiness in the gallbladder.

Children: Hepatic disorders due to pathology of mucus damage. There has been data on the use of drugs that lasted more than 10 years, extracted from clinical reports, related to Ursodeoxycholic acid treatment for children suffering from liver diseases due to mucus damage.

These data shows that Ursodeoxycholic acid can reduce the production of bile ducts, stop tissue damage and even reverse the liver changes if used in the early stages of the disease. Ursodeoxycholic acid treatment must be started when the diagnosis is set, for the optimal treatment effect.

Dynamic pharmacokinetics

After drinking, ursodeoxycholic acid is easy to absorb in the small intestine. Ursodeoxycholic acid connects 96-98% plasma protein. After that, ursodeoxycholic acid was excreted in bile in the form of a combined (with glycin and taurin) and entered the gut cycle. Ursodeoxycholic acid is partially metabolized by intestinal bacteria and its derivatives are eliminated through feces.

Before taking Ursomaxe Arlico treats gallbladder stones, cholecystic liver disease (3 blisters x 10 tablets)

How to use

Take oral use.

Dosage

adults

Cholesterol gallbladder stones:

The average dosage is recommended as 10 mg/kg (during or after dinner) to limit the process of creating gallbladder stones, the treatment time for the dispersion of stones is at least 4 to 6 months, depending on the original size of the stone, and may last up to 24 months, without interruption.

Must maintain treatment for 3 to 4 months after confirming the stones are completely dissolved with ultrasound. However, the treatment time must not exceed 2 years. Dosage can be adjusted when the doctor judges it is necessary.

Chronic cholestatic liver disease:

The optimal dose is 13 to 15 mg/kg/day. Recommendation to increase the dose gradually to reach the maximum dose after 4 and 8 weeks of treatment.

In the case of cholestatic liver disease that complications of pathology of mucus damage, the optimal dose is 20 mg/kg/day. Dosage is divided into 2 to 3 times a day, drink while eating.

Children

Liver disorders due to mucus damage to children from 6 to 18 years old:

Take 20 mg/kg/day divided into 2 to 3 times.

Dosage can increase to 30 mg/kg/day, if necessary.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

In case of overdose, diarrhea may occur. In general, other symptoms of ursodexolic overdose are negligible because the absorption of ursodeoxycholic acid decreases when increasing the dose.

Management: There is no specific treatment when overdose. In case of diarrhea, it can be treated by restoring water and electrolyte balance. However, there is also advice to use Colestyramin because it has the ability to chelate bile acids.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using Ursomaxe 200mg Arlico 3X10, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Digestive: Fertilizer, diarrhea.

Very rare, ADR

Digestive: serious pain in the lower right flank (while the treatment of raw bile fibrosis), calcification of gallbladder stones, loss of cirrhosis (while the treatment of primary fibrosis in the progressive stage) and partially recovered after treatment.

Skin and subcutaneously: urticaria.

Not determined frequency

Skin and subcutaneous organization: a lot of itching.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Ursomaxe 200mg Arlico 3X10 contraindicated in the following cases:

Hypersensitivity to Ursodeoxycholic, with bile acids or any ingredients of the drug.

Cholecystitis or acute biliary paths.

Colecular clogging (bile duct clogged or gallbladder).

Patients often suffer from bile cramps.

Calculated gallbladder stones, contrast.

Patients with decline in gallbladder contractions.

Failure after surgery to connect bile ducts or no good drainage back to the intestine in children with congenital bile stenosis.

Lactating women, pregnant women or pregnancy.

Patients with chronic liver disease, stomach ulcers, duodenum or colon.

Be cautious when using

Ursodeoxycholic acid treatment must be monitored by a doctor.

It is recommended to avoid Ursodeoxycholic acid for patients who often suffer from bile cramps, in cases of bile bacteria infections, severe pancreatic damage or intestinal diseases that affect the intestinal cycle of bile acid (such as ileum cutting and ileum opened, local intensive ileitis).

During the first 3 months of treatment, the doctor needs to monitor the parameters of the liver function such as ALT (GPT), AST (GOT) and Y-AG every 4 weeks, then every 3 months. In addition to showing or not responding in patients treated with raw cholestitis, monitoring may also allow early detection of liver function decline may occur, especially for patients with raw bile inflammation in the progressive stage.

Be cautious when indicated to treat gallbladder stones:

To assess the progress of treatment and screening for calculating gallbladder stones, depending on the size of the stones, it is necessary to check the gallbladder (by X-ray of the gallbladder), overall and (with ultrasound) the contrast clusters in the standing and lying position, 6 to 10 months after the beginning of treatment. The cause often suffer from bile cramps, do not prescribe ursodeoxycholic acid.

When indicating the treatment of raw bile inflammation at the stage of progress:

In rare cases, it is possible to occur in compensatory cirrhosis, partially recovery after stopping treatment. In this case, Ursodeoxycholic acid dose needs to decrease to the point of only 1 200mg of tablets per day. Then, increase the dose gradually again. In the case of persistent diarrhea, stop treatment.

The ability to drive and operate machinery

Ursodeoxycholic acid does not affect or affect the ability to drive and operate machinery.

Pregnancy

There is no adequate data on the use of ursodeoxycholic acid, especially in the first three months of pregnancy. Animal studies have provided evidence of teratogenic effects in the early stages of pregnancy. Do not use ursodeoxycholic acid during pregnancy. Treatment should be stopped immediately during pregnancy and need to consult a doctor.

Lactation period

Based on some cases recorded in breastfeeding women, ursodexolic acid ratio in breast milk is very small, which can be unwanted effects that do not occur in infants. Ursodeoxycholic acid should not be used in nursing women. If treated with ursodeoxycholic acid is necessary, stop breastfeeding.

Drug interaction

Ursodeoxycholic acid is not used simultaneously with Colestyramin, Colestipol or antacids containing aluminum hydroxyd and/or smectit (aluminum oxid), because these drugs are linked to ursodeoxycholic acid in the intestine and prevent its absorption and inhibition of its effectiveness. When necessary to use the above active ingredients, be aware of the drug at least 2 hours ago and after taking ursodeoxycholic acid.

Ursodeoxycholic acid is likely to affect the absorption of ciclosporin in the intestine. In patients treated with ciclosporin, the doctor must monitor the concentration of this drug in the blood and adjust the dose as needed.

Ursodeoxycholic acid reduces the peak concentration (CMAX) and the area under the curve (AUC) of nitrendipine, a calcium inhibitor in healthy volunteers. Closely monitor effectively when using nitrendipine and ursodeoxycholic acid simultaneously. Increasing nitrendipine dose may be necessary. There are also reports on drug interaction that reduces the effectiveness of DASSone treatment.

These detectors clinically, as well as in vitro data, can show the ability to ursodeoxycholic acid is a cytochrom P450 3A enzyme induction. However, the induction phenomenon is not recorded in a medical interactive study well designed with Budesonid, a substrate of Cytochrome P450 3A. estrogen and drugs that lower blood cholesterol, such as clofibro, increase the secretion of liver cholesterol and may thus increase the risk of gallbladder stones. This shows the opposite of the effect of ursodeoxycholic acid that is indicated to dissolve the gallbladder stones. Avoid coordinating with drugs that increase the elimination of cholesterol through bile (such as estrogen, oral hormone oral contraceptives, blood lipid medications) or drugs that can cause liver damage.

Storage

Store in closed packaging, temperatures below 30 ° C, avoiding light and moisture.

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