Choludexan (Ursodeoxycholic Acid) 300 mg, 20 capsules

The instruction for medical use





of HOLUDEKSAN medicine



the Trade name

Holudeksan



Mezhdunarodnoye the unlicensed

name Ursodeoksikholevaya acid



the Dosage form

gelatin capsules of 300 mg



Structure

One capsule contains

active agent ursodeoksikholiyevy acid of 300 mg,

excipients: the starch corn (granulated), starch corn, magnesium stearate, potassium sorbate, aerosil 200,

structure of a cover of the capsule: gelatin, titan dioxide (E171), karmoizin (E122), ponso 4R (E124).



The description

the Solid gelatin capsules, size No. 0, the body of pink color, a cap of red color filled with the granulated powder of white or almost white color.



Pharmacotherapeutic group

Drugs for treatment of diseases of a liver and biliary tract. Drugs of bile acids.

The code of automatic telephone exchange A05AA02





The pharmacological



Pharmacokinetics At properties oral administration ursodeoksikholevy acid is quickly soaked up in a small intestine and in an upper part of an ileal gut owing to passive, and in terminal department of an ileal gut of active transport. Extent of absorption makes 60-80%. After a resorption in intestines, it is almost completely conjugated in a liver with amino acids glycine and taurine, and after that it is again removed with bile. The effect of primary passing through a liver is 60%. In intestines partially there is a bacterial decomposition on 7-keto-lithocholic acid. Lithocholic acid of a gepatotoksichn and in an experiment is capable to cause damage of a parenchyma of a liver. At the person only its insignificant part rezorbirutsya, this part is sulphated and thus detoksitsirutsya in a liver, then is again removed with bile and is final with a stake. Elimination half-life of ursodeoksikholevy acid makes 3.5 - 5.8 days.



Holudeksan's pharmacodynamics has membrane stabilizing and gepatoprotektivny effect, protecting hepatocytes from action of disturbing factors. Has immunomodulatory activity, reduces expressiveness of immunopathological reactions in a liver. Stimulating at a cholestasia an exocytosis in hepatocytes by activation of Sa2 + - a dependent protein kinase, Holudeksan reduces concentration of bile acids, toxic for hepatocytes (cholic, lithocholic, deoxycholic, etc.). slows down absorption of lipophilic bile acids in intestines (apparently, at the expense of the competitive mechanism), raises their fractional turn at pechenochno intestinal circulation, induces a cholepoiesis with the high content of bicarbonates that leads to increase in a passage of bile and stimulates removal of toxic bile acids through intestines. Substituting unpolar bile acids, forms the non-toxic mixed micelles. Reducing synthesis of cholesterol in a liver and also its absorption in intestines, Holudeksan reduces a bile litogennost, reduces holato the cholesteric index, promotes dissolution of cholesteric concrements and prevents formation of new.



Indications

- uncomplicated cholelithiasis with cholesteric stones (at impossibility of their removal surgical or endoscopic by methods)

- a chronic acute hepatitis of virus, toxic and any other etiology

- an alcoholic liver disease

- primary biliary cirrhosis

- primary sclerosing cholangitis

- dyskinesia of biliary tract

- a biliary reflux gastritis and a reflux esophagitis

- prevention of damages of a liver when using hormonal contraceptives and tsitostatik

- prevention of a recurrence of a lithogenesis after cholecystectomia.



The route of administration and

Holudeksan's doses appoint inside once a day before going to bed or two times a day.

The capsule is swallowed entirely, without chewing, washing down with enough liquid.

The dosing mode

- at treatment of acute, chronic diseases of a liver, including cirrhosis, in a dose of 10-15 mg/kg of body weight 2 times a day, are continuously long (from 6 months to several years),

- for dissolution of gallstones in a dose of 10-15 mg/kg of body weight, accept all daily dose 1 time before going to bed, duration - 12 months. If in 12 months from an initiation of treatment the reduction of gallstones is not observed, administration of drug is considered inexpedient,

- for prevention of a repeated cholelithiasis the administration of drug in a dose on 300 mg 2 times a day within several months is recommended (on average 3 months),

- for treatment biliary the reflux of gastritis and a reflux of an esophagitis are appointed on 300 mg (1 capsule) of Holudeksan before going to bed. Treatment duration usually is 10 14 days up to 6 months.

Duration of treatment is defined by the doctor depending on clinical and laboratory tool changes.



Side effects

Seldom

- nausea, vomiting, an abdominal pain, diarrhea (can be dose-dependent), constipations, passing (tranzitorny) increase in activity of hepatic transaminases

- exacerbation of earlier being available psoriasis

- an alopecia

- allergic reactions (itching)

Very seldom

- calcination of gallstones



of the Contraindication

- hypersensitivity to any component of drug

- acute inflammatory diseases of a gall bladder, bile ducts and intestines

- a nonfunctioning gall bladder (including an empyema of a gall bladder)

- cholelithiasis with the high content of Sa2 + and not cholesteric stones

- it is bilious - zheludochno, intestinal fistula

- cirrhosis in a decompensation stage

- a liver and/or renal failure

- acute and chronic pancreatitis in an aggravation stage

- pregnancy and the period of a lactation

- children's and teenage age up to 18 years



Medicinal interactions

the Antacids containing ions of aluminum and ion-exchange resins (Colestyraminum) reduce drug absorption.

Hypolipidemic means (especially Clofibratum), are oestrogenic, Neomycinum or progestins increase bile saturation by cholesterol and can reduce ability of drug to dissolve cholesteric bilious concrements.



Special instructions

For successful dissolution of gallstones they have to be purely cholesteric and not give a shadow on the roentgenogram, no more than 15-20 mm in size.

Function of a gall bladder has to remain completely kept, and filling with its stones no more, than half. The passability of a vesical channel has to be kept, and the general bile duct is free from stones.

For the purpose of control of efficiency of treatment it is recommended to spend each 6 months of X-ray the cholecystography or ultrasound examination of biliary tract.

During treatment it is necessary to carry out dynamic control of level of transaminase, gamma glutamiltraspeptitazy, bilirubin and alkaline phosphatase at least 1 time a month if the activity them is increased, the dose is recommended to be lowered. Treatment should be stopped if indicators are not normalized within 1 month.

After full dissolution of concrements the drug use is recommended about 3 months to promote dissolution of concrements of the small sizes.



The overdose

In general overdose is improbable as absorption of ursodezoksikholevy acid decreases at increase in a dose and it mostly is excreted with a stake.





A form of release and packing

On 10 capsules in blister strip packaging from a film of polyvinylchloride and aluminum foil.

On 2 planimetric packs together with the instruction for use in the state and Russian languages place in a pack from cardboard.





To Store storage conditions at a temperature from +15 to + 25C.

To store out of children's reach!





3 years

not to apply a period of storage after an expiration date.



Prescription status

According to the prescription





of Proizvoditel Sigma Pharmasjyutikal Industries

Mubarak Indasstrial City, Egypt

it Is made for UORLD MEDITSIN, Great Britain

(WORLD MEDICINE, Great Britain)

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from the consumer on quality of products (goods)

of RK, Almaty, Suyunbaya 222 St. of B

Ph. / fax: 8 (7272) 529090

www.worldmedicine.kz