Ukrliv (ursodeoxycholic acid) oral suspension 250 mg/5 ml. 30 ml. vial

Description

Ukrliv (ursodeoxycholic acid) oral suspension 250 mg/5 ml. 30 ml. vial 

Composition

active substance: ursodeoxycholic acid (ursodeohucholic acid);

5 ml of suspension contain ursodeoxycholic acid 250 mg;

Excipients: microcrystalline cellulose – sodium carboxymethylcellulose, benzoic acid (E 210), xylitol, glycerin, sodium saccharin, sodium chloride, citric acid, monohydrate; sodium citrate, flavoring lemon, purified water.

Dosage form

The suspension is oral.

Main physical and chemical properties: viscous white suspension with lemon scent.

Pharmacotherapeutic group

Drugs used to treat the liver and biliary tract. Means used in biliary pathology. ATX code A05A A02.

Drugs used in case of liver disease, lipotropic substances. ATX code A05B.

Pharmacological properties

A medicine used for diseases of the hepatobiliary system. Reduces the saturation of bile with cholesterol, slowing down its absorption in the small intestine and its secretion into bile.

Indications

Ukrliv oral suspension is applied:

• for the symptomatic treatment of PBC (primary biliary cirrhosis) in the absence of a decompensated course of liver cirrhosis;
• for dissolving cholesterol (X-ray) gallstones with a diameter of not more than 15 mm in patients with a functioning gallbladder, even if there are gallstones (s);
• for the treatment of hepatobiliary disorders in children aged 6 years and older suffering from cystic fibrosis.

Contraindications

You cannot use Ukrliv oral suspension:

• with allergies to components;
• a blockage of the bile duct (blockage of the common bile duct / bladder duct);
• with cirrhosis of the liver in the stage of decompensation;
• patients with a gallbladder that cannot be visualized by X-ray methods, with impaired contractility of the gallbladder, with calcified stones, in the presence of frequent biliary colic;
• with acute inflammation of the bile ducts / gallbladder;
• with an unsuccessful result of portoenterostomy;
• in the absence of an adequate outflow of bile in children with atresia of the bile ducts.

Application during pregnancy and lactation

Not enough data. The results of animal studies have demonstrated the toxicity of this drug for pregnant women, especially in the early stages.
It is important to rule out pregnancy before starting treatment.
The content of ursodeoxycholic acid in milk during breastfeeding was extremely low, therefore, the development of adverse events in a child receiving such milk is not expected.

Method of administration and dosage

For various indications, the following daily doses are recommended.

To dissolve cholesterol gallstones

Approximately 10 mg UDCA / kg body weight per day.

• Body weight from 5 to 7 kg – ¼ measuring spoon – 1.25 ml;
• Body weight from 8 to 12 kg – ½ measuring spoon – 2.50 ml;
• Body weight from 13 to 18 kg – ¾ (= ¼ + ½) measuring spoon – 3.75 ml;
• Body weight from 19 to 25 kg – 1 measuring spoon – 5.00 ml;
• Body weight from 26 to 35 kg – 1 ½ measuring spoon – 7.50 ml;
• Body weight from 36 to 50 kg – 2 measuring spoon – 10.00 ml;
• Body weight from 51 to 65 kg – 2 ½ measuring spoon – 12.50 ml;
• Body weight from 66 to 80 kg – 3 measuring spoon – 15.00 ml;
• Body weight from 81 to 100 kg – 4 measuring spoon – 20.00 ml;
• Body weight over 100 kg – 5 measuring spoon – 25.00 ml.

1 measuring spoon (= 5 ml of suspension) contains 250 mg of UDCA.

Ukrliv oral suspension should be taken in the evening before bedtime. The suspension should be taken regularly.

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

The success of the treatment should be checked every 6 months by ultrasound or X-ray examination. With the help of additional research, you need to check whether the calcification of the stones over time. If this happens, treatment should be stopped.

For the symptomatic treatment of primary biliary cirrhosis (PBC)

The daily dose depends on body weight and is approximately 14 ± 2 mg UDCA / kg body weight.

In the first 3 months of treatment, Ukrliv should be taken during the day, dividing the daily dose into several doses. If liver function improves, the daily dose can be taken once in the evening.

1 measuring spoon (= 5 ml of suspension) contains 250 mg of UDCA.

You can use a plastic disposable syringe without a needle to measure doses.

The drug Ukrliv should be taken in accordance with the table. 2 dosing regimens. It is necessary to adhere to the regularity of reception.

The use of Ukrliv oral suspension in PBC may be unlimited in time.

Clinical symptoms, such as pruritus, may rarely worsen at the start of treatment in patients with PBC. If this happens, therapy should be continued, first taking a reduced daily dose of Ukrliv suspension, then gradually increasing the dose (increasing the daily dose daily) until the indicated dosing regimen is reached.

For the treatment of hepatobiliary disorders in cystic fibrosis

For children with cystic fibrosis aged 1 month to 18 years, the dosage is 20 mg / kg / day and is divided into 2-3 doses, followed by increasing the dose to 30 mg / kg / day if necessary.

Children weighing less than 10 kg are very rarely affected. In such cases, it is recommended to use disposable syringes for oral administration.

Single doses for children weighing up to 10 kg should be taken with a syringe from the included measuring spoon to a volume of 1.25 ml. To do this, use a disposable syringe with a volume of 2 ml with a gradation of 0.1 ml.

Please note that disposable syringes are not included in the package.

To enter the required dose with a syringe

1. Shake the suspension before opening the vial / jar.

2. Pour a small amount of suspension into a measuring spoon.

3. Draw a little more suspension into the syringe than needed.

4. Press the syringe plunger with your finger to remove air bubbles from the suspension.

5. Check the volume of the suspension in the syringe, adjust if necessary.

6. Carefully insert the contents of the syringe directly into the child’s mouth.

Do not draw the suspension into the syringe directly from the vial / jar. Do not pour unused suspension from a measuring spoon or syringe back into the vial / jar.

Dosage regimen for children weighing less than 10 kg: 20 mg UDCA / kg / day

(volume measuring device – disposable syringe)

Dosage regimen for children weighing more than 10 kg: 20-25 mg UDCA / kg / day (volume measuring device – measuring spoon)

Children

For the dissolution of cholesterol gallstones and symptomatic treatment of PBC

There are no age restrictions for the use of this drug.

For the treatment of hepatobiliary disorders in cystic fibrosis

Use for children from 1 month.

Overdose

Diarrhea is a sign of an overdose. If diarrhea occurs, the dose is reduced, and if the diarrhea is persistent, treatment is stopped. Treatment involves restoring fluid and electrolyte balance.

Side effects:

• on the digestive side: diarrhea, pasty stools, severe pain in the abdomen / right hypochondrium;
• co side of the liver / gallbladder: decompensation of liver cirrhosis, calcification of gallstones;
• from the side of the immune system: manifestations of allergies, including urticaria;
• during the first three months of therapy, liver function monitoring is required every 4 weeks.