Hymecromone (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

A05AX02 (Hymecromone)

Active Substance

Hymecromone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug with choleretic and spasmolytic action

Pharmacotherapeutic Group

Means for the treatment of diseases of the liver and biliary tract; agents for the treatment of diseases of the biliary tract; other agents for the treatment of diseases of the biliary tract

Pharmacological Action

A drug with choleretic and spasmolytic action.

It enhances the formation and secretion of bile.

It exerts a pronounced spasmolytic effect on the sphincter of Oddi and thereby relieves symptoms arising from bile stasis.

Pharmacokinetics

It has a high degree of absorption, weakly binds to plasma proteins.

C_max is achieved in 2-3 hours, T_1/2 is 1 hour.

It is excreted by the kidneys.

Indications

Biliary dyskinesia, chronic cholecystitis, and cholangitis.
Lack of appetite, nausea, and constipation caused by reduced bile secretion.

Use for the symptomatic management of functional biliary disorders associated with impaired bile formation and outflow.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
K81.1	Chronic cholecystitis
K82.8	Other specified diseases of gallbladder and cystic duct (including dyskinesia)
K83.0	Cholangitis

ICD-11 code	Indication
DC12.1	Chronic cholecystitis
DC13	Cholangitis
DC1Z	Diseases of gallbladder and biliary tract, unspecified
DD94	Functional disorder of the gallbladder

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.

Administer orally. For adults, take 200-400 mg three times daily, up to a maximum of 800 mg per dose, 30 minutes before meals. Continue treatment for 2-3 weeks as directed.

For pediatric patients, the total daily dose is 200-600 mg, divided into multiple administrations. Adjust the dosing schedule based on the patient’s age and clinical response.

Adverse Reactions

Possible adverse reactions include allergic manifestations such as skin rash or urticaria. With long-term use, gastrointestinal disturbances like diarrhea, flatulence, and abdominal pain may occur.

Headache and ulceration of the gastrointestinal mucosa have also been reported. Discontinue use if severe adverse reactions develop and seek medical attention.

Contraindications

Hypersensitivity to hymecromone or any component of the formulation.
Complete or partial obstruction of the biliary tract.
Severe renal failure or severe hepatic failure.
Active inflammatory bowel diseases, including ulcerative colitis and Crohn’s disease.
Active peptic ulcer of the stomach or duodenum.
Hemophilia or other severe coagulation disorders.
Children under 7 years of age due to lack of sufficient safety data.

Use in Pregnancy and Lactation

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 obstruction of the biliary tract, hepatic failure.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

Contraindicated in children under 7 years of age.

Geriatric Use

Can be used in elderly patients according to the indications.

Special Precautions

Hymecromone should be prescribed with caution in obstruction of the biliary tract, renal/hepatic failure, ulcerative colitis, Crohn’s disease, peptic ulcer of the stomach and duodenum, hemophilia.

It does not reduce the secretory function of the digestive glands and does not impair intestinal absorption.

The intravenous dosage form of hymecromone is used as a means of regulating bile secretion after operations on the gallbladder and biliary tract, as well as during diagnostic procedures.

Drug Interactions

Morphine and other opioid analgesics weaken the choleretic and spasmolytic effect of hymecromone; avoid concurrent use.

Concomitant administration with metoclopramide leads to a mutual weakening of the therapeutic effects of both drugs; consider an alternative prokinetic agent.

It enhances the anticoagulant effect of indirect coagulants (e.g., warfarin), increasing the risk of bleeding; monitor prothrombin time and INR closely.

Overdose

Symptoms of overdose may include severe diarrhea, abdominal cramping, and exacerbation of known adverse reactions such as headache and gastrointestinal discomfort.

There is no specific antidote. Institute supportive measures and symptomatic treatment. Gastric lavage may be considered if ingestion was recent. Ensure adequate hydration, especially if diarrhea is severe.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Hymecromone [Lekvalis, LLC (Russia)]
Tablets 200 mg: 20, 50, or 100 pcs.

Marketing Authorization Holder

Lekvalis, LLC (Russia)

Manufactured By

Interpharma, LLC (Russia)

Dosage Form

Hymecromone

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

Dosage Form, Packaging, and Composition

Tablets from almost white to white, round, flat-cylindrical, with a bevel on the edges on both sides and a score on one side.

	1 tab.
Hymecromone	200 mg

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

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Hymecromone [Rif LLC (Russia)]
Tablets 200 mg

Marketing Authorization Holder

Rif LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Hymecromone

Tablets 200 mg

Dosage Form, Packaging, and Composition

Tablets

	1 tab.
Hymecromone	200 mg

10 pcs. – contour cell packs – cardboard packs (10 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (2 pcs.) – cardboard packs (20 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (4 pcs.) – cardboard packs (40 pcs.) – Over-the-Counter
25 pcs. – contour cell packs – cardboard packs (25 pcs.) – Over-the-Counter
25 pcs. – contour cell packs (2 pcs.) – cardboard packs (50 pcs.) – Over-the-Counter
25 pcs. – contour cell packs (3 pcs.) – cardboard packs (75 pcs.) – Over-the-Counter
25 pcs. – contour cell packs (4 pcs.) – cardboard packs (100 pcs.) – Over-the-Counter
30 pcs. – contour cell packs – cardboard packs (30 pcs.) – Over-the-Counter
30 pcs. – contour cell packs (2 pcs.) – cardboard packs (60 pcs.) – Over-the-Counter
30 pcs. – contour cell packs (3 pcs.) – cardboard packs (90 pcs.) – Over-the-Counter
30 pcs. – contour cell packs (4 pcs.) – cardboard packs (120 pcs.) – Over-the-Counter

Hymecromone [Pharmproekt, JSC (Russia)]
Tablets 200 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 84, 90, 98, 100, 112, 126, or 140 pcs.

Marketing Authorization Holder

Pharmproekt, JSC (Russia)

Dosage Form

Hymecromone

Tablets 200 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 84, 90, 98, 100, 112, 126, or 140 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel.

	1 tab.
Hymecromone	200 mg

Excipients: potato starch, povidone K30, sodium lauryl sulfate, magnesium stearate.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (6) – cardboard packs.
7 pcs. – contour cell packs (7) – cardboard packs.
7 pcs. – contour cell packs (8) – cardboard packs.
7 pcs. – contour cell packs (9) – cardboard packs.
7 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (3) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – contour cell packs (5) – cardboard packs.
14 pcs. – contour cell packs (6) – cardboard packs.
14 pcs. – contour cell packs (7) – cardboard packs.
14 pcs. – contour cell packs (8) – cardboard packs.
14 pcs. – contour cell packs (9) – cardboard packs.
14 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – polymer bottles (1) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.
50 pcs. – polymer bottles (1) – cardboard packs.
100 pcs. – polymer bottles (1) – cardboard packs.

Hymecromone Renewal [Obnovlenie Pfc, JSC (Russia)]
Tablets 200 mg
Tablets 400 mg

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Forms

	Hymecromone Renewal	Tablets 200 mg
		Tablets 400 mg

Dosage Form, Packaging, and Composition

Tablets

	1 tab.
Hymecromone	200 mg

10 pcs. – contour cell packs (10 pcs.) – cardboard packs (100 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (2 pcs.) – cardboard packs (20 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (5 pcs.) – cardboard packs (50 pcs.) – Over-the-Counter
15 pcs. – contour cell packs (2 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
15 pcs. – contour cell packs (4 pcs.) – cardboard packs (60 pcs.) – Over-the-Counter
15 pcs. – contour cell packs (6 pcs.) – cardboard packs (90 pcs.) – Over-the-Counter
15 pcs. – contour cell packs (8 pcs.) – cardboard packs (120 pcs.) – Over-the-Counter

Tablets

	1 tab.
Hymecromone	400 mg

Medixlife (Author)

View all posts Profile link