Odeston^® (Tablets) Instructions for Use

Marketing Authorization Holder

Adamed Pharma, S.A. (Poland)

Contact Information

ADAMED RUSHA LLC (Russia)

ATC Code

A05AX02 (Hymecromone)

Active Substance

Hymecromone (Rec.INN registered by WHO)

Dosage Form

Odeston^®

Tablets 200 mg: 20, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a yellowish tint, round, flat-cylindrical, with a bevel and an engraving on one side with the letters “Ch”.

	1 tab.
Hymecromone	200 mg

Excipients: potato starch – 45 mg, gelatin – 3 mg, sodium lauryl sulfate – 1 mg, magnesium stearate – 1 mg.

10 pcs. – blisters (2) – cardboard packs with first opening control.
10 pcs. – blisters (5) – cardboard packs with first opening control.
10 pcs. – blisters (10) – cardboard packs with first opening control.

Clinical-Pharmacological Group

Drug with choleretic and spasmolytic action

Pharmacotherapeutic Group

Choleretic agent

Pharmacological Action

Choleretic drug. Increases the formation and secretion of bile. It has a selective antispasmodic effect on the bile ducts and the sphincter of Oddi. The drug does not reduce gastrointestinal motility and blood pressure.

It reduces bile stasis, prevents cholesterol crystallization and, thus, the development of cholelithiasis.

Pharmacokinetics

Absorption and Distribution

After oral administration, it is easily absorbed from the digestive tract. C_max in blood serum is reached in 2-3 hours. Weakly binds to plasma proteins.

Elimination

T_1/2 is about 1 hour. Hymecromone is excreted by the kidneys (about 93% as glucuronate, 1.4% as sulfonate, 0.3% unchanged).

Indications

biliary dyskinesia and sphincter of Oddi dyskinesia of the hyperkinetic type;
non-calculous chronic cholecystitis, cholangitis, cholelithiasis;
condition after surgical interventions on the gallbladder and biliary tract;
decreased appetite, nausea, constipation, vomiting (against the background of bile hyposecretion).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
K59.0	Constipation
K80	Cholelithiasis [cholelithiasis] (including biliary colic)
K81.1	Chronic cholecystitis
K82.8	Other specified diseases of gallbladder and cystic duct (including dyskinesia)
K83.0	Cholangitis
K83.4	Spasm of sphincter of Oddi
K83.8	Other specified diseases of biliary tract
K91.5	Postcholecystectomy syndrome
R11	Nausea and vomiting

ICD-11 code	Indication
DB32.1	Slow-transit constipation
DC10.Z	Acquired structural (organic) changes of gallbladder or bile ducts, unspecified
DC11.Z	Cholelithiasis, unspecified
DC12.1	Chronic cholecystitis
DC13	Cholangitis
DC14.1	Postcholecystectomy syndrome
DC14.2	Dyskinesia of the sphincter of Oddi
DC14.Z	Diseases of the biliary tract, unspecified
DC1Z	Diseases of gallbladder and biliary tract, unspecified
DD91.1	Functional constipation
DD94	Functional disorder of the gallbladder
DD95	Functional disorder of the sphincter of Oddi
DE2Z	Diseases of the digestive system, unspecified
MD90	Nausea or vomiting

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Take orally 30 minutes before meals.

Adults are prescribed 200-400 mg 3 times/day. The daily dose is 1200 mg. The course of treatment is 2-3 weeks.

Children from 7 years old – 200 mg (1 tablet) 1-3 times/day. The daily dose is 600 mg. The course of treatment is 2-3 weeks.

In case of a missed dose, the drug should be taken as soon as possible. If it is almost time for the next dose, the missed dose should not be taken. A double dose of the drug should not be taken at once.

Adverse Reactions

From the digestive system: diarrhea, flatulence, abdominal pain, ulceration of the gastrointestinal mucosa.

Other: allergic reactions, headache.

Contraindications

hypersensitivity to the components of the drug;
obstruction of the biliary tract;
renal failure;
hepatic failure;
ulcerative colitis;
Crohn’s disease;
gastric and duodenal ulcer;
hemophilia;
children under 7 years of age.

Use in Pregnancy and Lactation

There are no data on the safety of hymecromone use during pregnancy and lactation.

The use of Odeston^® during pregnancy and lactation (breastfeeding) is permissible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus or child.

Use in Hepatic Impairment

Contraindicated in hepatic failure.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

Contraindicated in children under 7 years of age.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

There have been no reports of overdose with Odeston^® to date.

Drug Interactions

With simultaneous use, morphine, which causes spasm of the sphincter of Oddi, weakens the effect of Odeston^®.

With simultaneous use of Odeston^® with metoclopramide, a mutual weakening of the effect is noted.

Odeston^® enhances the effects of indirect anticoagulants.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 4 years.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer