Composition
Active ingredient: Hymecromone – 400,00 mg; excipients: potato starch-90.00 mg, gelatin-6.00 mg; sodium lauryl sulfate-2.00 mg; magnesium stearate-2.00 mg
Pharmacological action
Pharmacotherapy group: Choleretic agent. ATX code: A 05 AH 02Pharmacological properties
Pharmacodynamics
Mechanism of action
Hymecromone is a coumarin derivative. Choleretic drug. Increases the formation and excretion of bile. It has a selective antispasmodic effect on the bile ducts and sphincter Oddi (does not reduce peristalsis of the gastrointestinal tract (GIT)) and blood pressure (BP). Reduces bile stagnation, prevents the crystallization of cholesterol and thereby the development of gallstones.
Pharmacokinetics
Suction
When taken orally, it is easily absorbed from the digestive tract. The maximum concentration in the blood serum is reached in 2-3 hours. The elimination half-life is about 1 hour.
Distribution
In the blood plasma, it binds to plasma proteins. The volume of distribution is 20.8±11.4 l. There are no data on the excretion of hymecromone in breast milk.
Metabolism
Hymecromone is mainly metabolized in the liver to glucuronide and sulfate metabolites.
Deduction
Hymecromone is excreted by the kidneys (about 93% in the form of glucuronide,1.4% in the form of sulfate,0.3% in unchanged form).
Indications
Biliary dyskinesia and Oddi sphincter, stone-free chronic cholecystitis, cholangitis, bile duct dysfunction in patients with uncomplicated cholelithiasis, condition after surgical interventions on the gallbladder and biliary tract. Decreased appetite, nausea, constipation, vomiting (due to bile hyposecretion).
Use during pregnancy and lactation
Use during pregnancy
There are insufficient data on the use of Hymecromone in pregnant women. There are no data on the effect of Hymecromone on the fetus when using the drug during pregnancy. As a precautionary measure, it is recommended to avoid using Odeston Forte during pregnancy.
Use during breastfeeding
There are no data on the excretion of hymecromone in breast milk.
However, the risk to newborns and children cannot be excluded. If it is necessary to use the drug, the question of stopping breastfeeding should be decided.
Fertility
No effect on fertility was observed in preclinical studies.
Contraindications
- Hypersensitivity to hymecromone or any excipient of the drug;
- Obstruction of the biliary tract;
- Renal / hepatic insufficiency
- Peptic ulcer of the stomach and duodenum 12;
- Hemophilia;
- Ulcerative colitis, Crohn’s disease;
- Children under 18 years of age (for this dosage).
With caution
The drug should be discontinued if symptoms of renal/hepatic insufficiency occur.
Side effects
Odeston Forte is usually well tolerated.
The adverse reactions listed below are listed by body system and by frequency of occurrence. The frequency of occurrence is determined as follows:  very common (≥1/10), common (≥1/100 and <1/10), infrequent (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (
Frequency of adverse reactions
Disorders of the digestive system Occasionally: diarrhea, flatulence, a feeling of fullness or pressure in the stomach. Unknown: abdominal pain, ulceration of the gastrointestinal mucosa.
Immune system disorders Rarely: allergic reactions.
Disorders of the nervous systemnotable: headache.
Skin and subcutaneous tissue disorders Rare: skin rash and other allergic skin reactions.
Interaction
Morphine weakens the effect of hymecromone. When taken together with metoclopramide, the effect of both drugs is weakened. Enhances the effects of indirect anticoagulants.
How to take, course of use and dosage
Inside,30 minutes before meals; adults – 400 mg 3 times a day. The daily dose is 1200 mg.
The course of treatment is 2 weeks.
Take the whole tablet.
If you miss a dose, you should take the drug as soon as possible or, if the time for the next dose is approaching, do not take the missed dose. Do not take a double dose at once.
Special instructions
The drug should not be used if symptoms of renal or hepatic insufficiency develop.
Special precautions when disposing of an unused medicinal product
Medicines should not be disposed of in sewers or household waste containers.
Ask your pharmacist for instructions on how to dispose of unused medication.
These activities will help protect the environment.
Influence on the ability to drive vehicles and mechanisms
Odeston Forte does not affect the ability to drive vehicles and engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Form of production
Tablets,400 mg. 10 tablets in a PVC/Al. 3 blister or 5 blisters together with the instructions for use in a cardboard pack.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of the reach of children.
Shelf
life is 2 years.
Do not use after the expiration date indicated on the package
Active ingredient
Gimecromon
Dosage form
Tablets
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