Cocarboxylase-biotek

I N S T R U C T I O N for medical use of the medicinal product COCARBOXYLASE-BIOTEK (COCARBOXYLASE-BIOTEK)

Composition:

active substance: cocarboxylase hydrochloride;

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

excipients: sodium citrate, disodium edetate, maleic acid, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear, colorless or almost colorless solution.

Pharmacotherapeutic group. Simple vitamin B1 preparations.

ATC code A11D A.

Pharmacological Properties

Pharmacodynamics. Cocarboxylase is a non-protein component (coenzyme) of enzymes that regulate metabolic processes. It is formed in the body from thiamine through phosphorylation. It plays an especially important role in carbohydrate metabolism, particularly in the oxidative decarboxylation of keto acids (pyruvic acid, α-ketoglutaric acid), as well as in the pentose phosphate pathway of glucose breakdown. It reduces the levels of lactic and pyruvic acids in the body, improves glucose utilization, enhances nutrition of nervous tissue, and promotes normalization of cardiovascular system function.

Cocarboxylase should not be used for the treatment of vitamin B1 hypovitaminosis or avitaminosis, as its biological properties do not fully correspond to those of thiamine.

Pharmacokinetics. It is not stored in the body. It is excreted in the urine.

Clinical characteristics

Indications. Use as part of complex therapy for:

• pathological processes involving carbohydrate metabolism disorders;
• complications caused by diabetes mellitus;
• heart diseases accompanied by rhythm disorders (extrasystoles);
• peripheral neuritis.

Contraindications. 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.

Special precautions for use.

When conducting combination therapy, it should be taken into account that cocarboxylase may enhance the cardiotonic effect of cardiac glycosides.

This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding. The efficacy and safety of the medicinal product “Cocarboxylase-Biotek” during pregnancy or breastfeeding have not been established; therefore, the drug is not recommended for use during these periods.

Effect on the ability to drive or operate machinery. Since the medicinal product may cause weakness, impaired consciousness, or sluggishness in some patients, its use is not recommended when driving or operating machinery.

Administration and Dosage

The drug is usually used as a component of complex therapy. It is administered intramuscularly, less frequently subcutaneously or intravenously. When administered intravenously by bolus injection, the solution volume should be adjusted to 10–20 ml; for infusion, to 200–400 ml, using 0.9% sodium chloride solution or 5% glucose solution. The dose is determined individually, depending on the nature of the disease and the patient's condition severity. Adults should receive a single dose of 50–100 mg once daily. If necessary, the stated dose may be repeated after 1–2 hours. Subsequently, maintenance therapy should be initiated — 50 mg once daily. The treatment course lasts 15–30 days.

Children should receive the drug subcutaneously or intramuscularly: from birth to 3 months of age — 25 mg once daily; from 4 months to 7 years — 25–50 mg once daily; from 8 to 18 years — 50–100 mg once daily. If necessary, the indicated daily doses may be divided into two administrations.

Children. May be used from birth. The drug should not be administered intravenously.

Overdose. Manifests as an exacerbated form of adverse reactions. Discontinuation of the drug is recommended, along with symptomatic treatment aimed at normalizing respiration and cardiovascular function.

Adverse Reactions

Immune system disorders: hypersensitivity reactions, including: pruritus, urticaria, angioneurotic edema, dyspnea, eyelid swelling, skin hyperemia, acrocyanosis, anaphylactic shock.

Cardiovascular system disorders: arterial hypotension, arterial hypertension.

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

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

Reporting of adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the drug. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.

Shelf life: 2 years.

Storage conditions: Store in the original packaging, protected from light, at a temperature between 2 and 8 °C. Keep out of reach of children.

Incompatibilities: The drug solution should not be mixed with other medicinal products, except those specified in the section “Method of administration and dosage”.

Packaging: 2 ml in ampoules. 5 ampoules per blister pack, 1 or 2 blisters per cardboard box.

Prescription status: Prescription only.

Manufacturer: JSC "Lekhim-Kharkiv"

Manufacturer's address and place of business: 36 Severina Pototskogo Street, Kharkiv, 61115, Ukraine.

Marketing Authorization Holder: LLC "FC "Biotech"

Address of the Marketing Authorization Holder: 7 Poшtovyi Lane, Kharkiv, 61001, Ukraine.