COCARBOXYLASE-FORTE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT COCARBOXYLASE-FORTE (COCARBOXYLASE-FORTE)

Composition:

Active substance: cocarboxylase;

1 tablet contains 25 mg or 50 mg of thiamine pyrophosphate chloride aminoacetate-magnesium (II) potassium salt trihydrate, calculated as 100% substance;

Excipients: lactose monohydrate; microcrystalline cellulose; sugar powder; calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: white-colored, round-shaped tablets with a biconvex surface and a score line on one side.

Pharmacotherapeutic group.

Simple vitamin B1 preparations. ATC code: A11DA.

Pharmacological Properties.

Pharmacodynamics.

Thiamine pyrophosphate chloride aminoglycinate-magnesium (II) potassium salt trihydrate is an original coordination compound of cocarboxylase (thiamine pyrophosphate hydrochloride). The presence of magnesium ions and the amino acid glycine in the compound enhances the activity of cocarboxylase towards carbohydrate metabolism enzymes for which it acts as a coenzyme.

In the body, cocarboxylase in complex with protein and magnesium ions is a component of the carboxylase enzyme system, catalyzing the decarboxylation and carboxylation of α-keto acids. Cocarboxylase activates key enzymes of carbohydrate metabolism, resulting in enhanced tissue utilization of glucose. Enhanced glucose metabolism leads to activation of tissue respiration, increased ATP production, and reduced accumulation of lactic acid. This effect improves metabolic processes, particularly in diabetes mellitus. Cocarboxylase promotes more complete utilization of pyruvic acid, resulting in improved nerve fiber function in diabetes and reduction of neuropathic symptoms.

Cocarboxylase-Forte promotes normalization of cellular metabolism under conditions of ischemia and hypoxia. Use of the drug in conditions associated with activation of free radical reactions is accompanied by improvement of antioxidant status.

Pharmacokinetics.

After sublingual (under the tongue) administration, the components of the drug are rapidly absorbed into the bloodstream. Maximum plasma concentration is reached within 0.5–1.5 hours. Metabolites are excreted by the kidneys.

Clinical characteristics.

Indications.

As part of complex therapy:

• diabetes mellitus and its complications;
• liver diseases regardless of etiology, to enhance hepatocyte activity against various pathological influences (viral, inflammatory, toxic);
• hepatic insufficiency;
• ischemic heart disease;
• peripheral neuritis;
• inflammatory and toxic myocardial lesions (myocarditis);
• cardiomyopathies.

Contraindications.

Hypersensitivity to the drug.

Interaction with other medicinal products and other forms of interaction.

When Carboxylase-Forte is used concomitantly with hypoglycemic agents, enhanced activity of the latter should be taken into account.

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

Special precautions for use.

When using the drug Cocarboxylase-Forte in patients with diabetes mellitus, blood glucose levels should be monitored.

During complex therapy, it should be taken into account that cocarboxylase enhances the cardiotonic effect of cardiac glycosides.

The drug Cocarboxylase-Astrafarm should not be administered to patients with rare hereditary disorders of lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Use during pregnancy or breastfeeding.

The efficacy and safety of using cocarboxylase hydrochloride during pregnancy or breastfeeding have not been established; therefore, the drug is not recommended for use during these periods.

Ability to influence reaction rate when driving or operating machinery.

Not studied.

Method of Administration and Dosage

The method and dosage of the drug are determined individually by a physician in each case.

Adults and children aged 12 years and older usually take tablets sublingually, holding them in the mouth until completely dissolved, 3–4 times daily. Alternatively, the drug may be taken orally, 10–15 minutes before meals, 3–4 times daily. The usual duration of treatment is 20–30 days.

Children

The efficacy and safety of cocarboxylase in children under 12 years of age have not been studied; therefore, the drug is not recommended for use in this age group.

Overdose

An overdose may enhance manifestations of increased individual sensitivity to the drug. Symptoms of overdose may present as a more pronounced form of adverse reactions.

Treatment includes discontinuation of the drug; symptomatic therapy aimed at normalizing respiration and cardiovascular function.

Adverse reactions.

Immune system: allergic reactions are possible, including hypersensitivity reactions. Symptoms may range from itching, skin rash, urticaria to development of anaphylactic shock.

In such cases, the dose should be reduced or the drug discontinued. After discontinuation of the drug, all adverse effects rapidly resolve.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding +15 °C.

Keep out of reach of children.

Packaging.

10 tablets in a blister; 3 blisters per pack.

Availability category. Over-the-counter.

Manufacturer.

LLC "AstraPharm".

Manufacturer's location and address of business activity.

Ukraine, 08132, Kyiv region, Kyiv-Sviatoshyn district, city of Vyshneve, Kyivska Street, 6.

Manufacturer.

LLC "Pharmaceutical Company "Farko-S".

Manufacturer's location and address of business activity.

Ukraine, 08290, Kyiv region, city of Irpin, urban-type settlement Hostomel, Sviato-Pokrovska Street, 360.