Cocarboxylase hydrochloride solution for injection 50 mg ampoule 2 ml No. 10

Instructions for Cocarboxylase hydrochloride solution for injection 50 mg ampoule 2 ml No. 10

Composition

active ingredient: cocarboxylase hydrochloride;

1 ampoule (2 ml) contains 50 mg of cocarboxylase hydrochloride;

Excipients: sodium citrate, disodium edetate, maleic acid, water for injection.

Dosage form

Solution for injection.

Main physicochemical properties: transparent colorless or almost colorless solution.

Pharmacotherapeutic group

Simple preparations of vitamin B1. ATX code A11D A.

Pharmacological properties

Pharmacodynamics

Cocarboxylase is a component of the non-protein part (coenzyme) of enzymes that regulate metabolic processes. In the body, it is formed from thiamine as a result of its phosphorylation. It plays a particularly important role in carbohydrate metabolism, in particular in the oxidative decarboxylation of ketoacids (pyruvic, α-ketoglutarate), as well as in the pentose phosphate pathway of glucose breakdown. It reduces the level of lactic and pyruvic acid in the body, improves glucose absorption, trophism of nervous tissue, and contributes to the normalization of the function of the cardiovascular system.

Cocarboxylase should not be used to treat hypovitaminosis and avitaminosis B1, since its biological properties do not fully coincide with those of thiamine.

Pharmacokinetics

It is not deposited in the body. It is excreted in the urine.

Indication

As part of the complex treatment:

pathological processes with impaired carbohydrate metabolism; complications caused by diabetes; heart diseases accompanied by rhythm disturbances (extrasystoles); peripheral neuritis.

Contraindication

Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other types of interactions

Cocarboxylase enhances the cardiotonic effect of cardiac glycosides and improves their tolerability.

Application features

When conducting complex therapy, it is necessary to take into account the property of cocarboxylase to enhance the cardiotonic effect of cardiac glycosides.

Ability to influence reaction speed when driving vehicles or other mechanisms

Not studied.

Use during pregnancy or breastfeeding

The effectiveness and safety of using “Cocarboxylase hydrochloride” for the treatment of pregnant women or during breastfeeding have not been established, therefore, prescribing the drug during these periods is not recommended.

Method of administration and doses

Usually used as a component of complex therapy. The drug is administered intramuscularly, less often subcutaneously or intravenously. With intravenous jet administration, the volume of the solution should be brought to 10–20 ml, with drip administration – to 200–400 ml, adding 0.9% sodium chloride solution or 5% glucose solution. The dose for administration is determined individually, taking into account the nature of the disease and the severity of the patient's condition. Adults should be administered 50–100 mg/day once. The course of treatment is 15–30 days. If necessary, the specified dose can be administered again after 1–2 hours. In the future, you should switch to maintenance therapy – 50 mg 1 time per day.

Children should be administered subcutaneously or intramuscularly: from birth to the third month of life - 25 mg once a day; from 4 months to 7 years - 25–50 mg once a day, 8–18 years - 50–100 mg once a day. If necessary, the indicated daily doses can be administered in two doses.

Children

Use from birth. Do not administer the drug intravenously.

Overdose

Manifested as a more pronounced form of adverse reactions. Discontinuation of the drug and symptomatic treatment aimed at normalizing breathing and cardiovascular system activity are recommended.

Adverse reactions

Immune system: hypersensitivity reactions, including: itching, urticaria, angioedema, shortness of breath, eyelid edema, skin hyperemia, acrocyanosis, anaphylactic shock.

From the cardiovascular system: arterial hypotension, arterial hypertension.

Local reactions: reactions at the injection site, including: hyperemia, itching, swelling at the injection site.

General disorders: weakness, chills, hyperthermia, impaired consciousness, lethargy, back pain.

Expiration date

2 years.

Storage conditions

Store in the original packaging to protect from light at a temperature of 2 to 8 ° C. Keep out of the reach of children.

Packaging

5 ampoules in a blister, 2 blisters in a cardboard pack.

Vacation category

According to the recipe.

Producer

LLC "FZ "BIOPHARMA", Ukraine.

Location of the manufacturer and its business address

Ukraine, 09100, Kyiv region, Bila Tserkva, Kyivska st., 37.