Medichronal®-darnitsa

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MEDICHRONAL®-DARNITSA (MEDICHRONAL-DARNITSA)

Composition:

Pack No. 1:

Active ingredient: 1 sachet contains: glucose monohydrate 17.5 g;

Excipient: povidone;

Pack No. 2:

Active ingredients: 1 sachet contains: glycine 7 g; sodium formate 3.5 g;

Excipient: povidone.

Pharmaceutical form. Granules.

Main physicochemical properties: white granules or white with a yellowish tint, odorless.

Pharmacotherapeutic group. Agents used in alcohol dependence.

ATC code N07BB.

Pharmacological Properties

Pharmacodynamics

The medicinal product Medikhronal®-Darnytsia is a combination agent that promotes reduction of accumulation in the body of toxic metabolites of alcohol, particularly acetaldehyde (a product of ethanol oxidation).

The medicinal product exerts a detoxifying effect, improves metabolic processes in the body, enhances synthesis of catecholamines, especially norepinephrine, which improves neuromediation processes, stimulates the limbic-reticular complex, and increases functional activity of the cerebral cortex.

The medicinal product Medikhronal®-Darnytsia has a positive effect on liver function and also improves sleep and general well-being.

Reduction of symptoms of acute alcohol intoxication and symptoms of mild to moderate severity abstinence syndrome occurs as early as 20–30 minutes after administration of the medicinal product.

Pharmacokinetics

Aminoacetic acid is rapidly absorbed in the gastrointestinal tract. It has nearly 100% bioavailability. It readily penetrates into most body fluids and tissues. It is degraded in the liver by the enzyme glycine oxidase.

Sodium formate is rapidly absorbed in the gastrointestinal tract. In systemic circulation and body tissues, it reacts with acetaldehyde to form conjugates that participate in the tricarboxylic acid cycle, thereby increasing the formation of macroergic compounds.

Clinical characteristics.

Indications.

Alcohol intoxication, withdrawal syndrome; to enhance the effectiveness of other therapeutic methods; prevention of intoxication; secondary prevention of alcoholism.

Contraindications.

Hypersensitivity to the components of the medicinal product; severe forms of diabetes mellitus, arterial hypotension.

Interaction with other medicinal products and other types of interactions.

The active substance of the medicinal product, glycine, reduces the toxicity of anticonvulsants, antipsychotics, and antidepressants.

When the medicinal product is taken concomitantly with tranquilizers, sedatives, and antipsychotics, the central nervous system depressant effect is enhanced.

Medikhronal®-Darnitsia can be combined with other agents used for the treatment of alcohol dependence, except disulfiram. Disulfiram may be used after completing treatment courses with Medikhronal®-Darnitsia, if necessary.

Special precautions for use.

Medikhronal®-Darnytsia can be used both as monotherapy and as part of combination therapy. When prescribing treatment, an individualized approach should be applied, which may involve adjustments in treatment duration or an increase in the number of repeated courses within a year.

Patients predisposed to arterial hypotension require monitoring of arterial pressure (AP) levels and, if necessary, dose adjustment of the medicinal product (administration in lower doses and under conditions of regular arterial pressure monitoring). If AP decreases below the usual level, administration of the medicinal product should be discontinued.

Since the medicinal product contains glucose, a contraindication for its use includes conditions associated with hyperglycemia.

Use during pregnancy or breastfeeding.

The effects of the medicinal product on the body during pregnancy or breastfeeding have not been thoroughly studied; therefore, use of the medicinal product is not recommended.

Ability to affect reaction speed when driving or operating machinery.

Caution should be exercised when driving vehicles or operating complex machinery during treatment.

Method of Administration and Dosage

Medikhronal®-Darnytsia should be administered orally to adults after meals, dissolving the contents of both packets in 200 mL of warm water. The single dose is 28.5 g (total weight of components from both packets). To improve taste, the contents of the packets may be dissolved in non-carbonated beverages (juice, compote, etc.).

For relief of acute alcohol intoxication, administer the medicinal product 1–2 times on the first day (every 10–12 hours) at a dose of 28.5 g; during the following 2–3 days, administer 28.5 g once daily.

In combination with other medicinal agents for the treatment of chronic alcoholism and for secondary prevention, the drug should be administered daily at a dose of one package (28.5 g) for 7 days, in three courses separated by 3-day intervals between courses. To prevent relapses, a repeated 30-day treatment course with Medikhronal®-Darnytsia is recommended 1–1.5 months after completing the initial course. Alternatively, from 1 to 3 repeated short-term preventive courses (each lasting 7–14 days) may be administered during the year.

For prevention of intoxication, a single dose (contents of packets No. 1 and No. 2) should be taken 30 minutes before consuming alcoholic beverages.

Children

Studies on the efficacy and safety of the medicinal product in children have not been conducted.

Overdose

There is no information on clinical manifestations of overdose.

Symptoms
In case of overdose, gastrointestinal disturbances (nausea, bloating, diarrhea) and increased intensity of adverse reactions may occur.

Treatment
Symptomatic therapy.

Side effects.

All components of the medicinal product Medikhronal®-Darnytsia are natural metabolites, therefore it is well tolerated. In individual cases, the following adverse reactions are possible:

Gastrointestinal disorders: nausea;

Nervous system disorders: headache, tension, irritability, impaired concentration;

Immune system disorders: hypersensitivity reactions, including rash, itching, urticaria.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

Granules in sachet No. 1 and sachet No. 2; sachet No. 1 and sachet No. 2 in a carton; 7 sachets No. 1 and 7 sachets No. 2 per carton; 21 sachets No. 1 and 21 sachets No. 2 per carton.

Supply category. Over-the-counter (without prescription).

Manufacturer. JSC "Pharmaceutical company "Darnitsya".

Manufacturer's location and address of the place of business.

13, Boryspylska Street, Kyiv, 02093, Ukraine.