Cudevita^® (Capsules) Instructions for Use

Marketing Authorization Holder

Pik-Pharma, LLC (Russia)

Manufactured By

Pik-Pharma Pro LLC (Russia)

ATC Code

C01EB09 (Ubidecarenone)

Active Substance

Ubidecarenone (Rec.INN registered by WHO)

Dosage Form

Cudevita®

Capsules 30 mg: 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 1, yellow in color; the capsule contents are a light orange powder.

Excipients: medium-chain triglycerides – 7.2 mg, gelatin – 143.1 mg, sucrose – 47.7 mg, corn starch – 72 mg, colloidal silicon dioxide – 6 mg.

Capsule body composition: titanium dioxide 2%, yellow iron oxide 0.6286%, gelatin up to 100%.
Capsule cap composition: titanium dioxide 1%, yellow iron oxide 0.6286%, gelatin up to 100%.

10 pcs. – blister packs (6) – cardboard packs.
15 pcs. – blister packs (4) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves tissue metabolism and energy supply, reducing tissue hypoxia

Pharmacotherapeutic Group

Cardiotonic agent of non-glycoside structure

Pharmacological Action

Ubidecarenone (coenzyme Q₁₀, ubiquinone) is a natural substance that is a vitamin-like coenzyme.

Ubidecarenone is an endogenous substrate involved in electron transfer in the transport chain of redox processes, in the energy metabolism process, and in the oxidative phosphorylation reaction in the mitochondrial respiratory chain of cells.

It participates in cellular respiration processes by increasing the synthesis of adenosine triphosphoric acid.

It has a clinically significant antioxidant effect.

It protects cell membrane lipids from peroxidation, preventing the formation of free radicals, thereby slowing down the aging process.

It reduces the area of myocardial damage under conditions of ischemia and reperfusion.

Ubidecarenone does not prolong the QT interval and improves exercise tolerance.

Due to endogenous synthesis, 100% satisfaction of the body’s need for coenzyme Q10 occurs only up to the age of 20.

The concentration of coenzyme Q10 decreases in elderly patients, as well as in various diseases in both adults and children.

Pharmacokinetics

C_max averages 0.7 µg/ml after oral administration of a 120 mg dose. T_max in blood plasma is 7 hours after oral administration. T_1/2 is 3.5 hours.

With long-term use (from 4 to 12 weeks), it accumulates mainly in the liver and heart.

Indications

Prevention and as part of complex therapy for various diseases of the cardiovascular system

• Coronary artery disease, chronic heart failure (functional class II-III according to the NYHA classification);
• Arterial hypertension;
• Myocardial infarction (during restorative therapy);
• Period of preparation for heart surgery (coronary artery bypass grafting, for heart defects);
• Prevention and as part of complex therapy for migraine;
• For the prevention and replenishment of coenzyme Q10 deficiency;
• To improve adaptation to increased physical exertion in athletes.

ICD codes

Dosage Regimen

For prevention for all declared indications, adults and children over 12 years of age should take 30 mg (1 capsule) once daily after meals in the first half of the day.

As part of complex therapy for the treatment of chronic heart failure and coronary artery disease, 150 mg (5 capsules) are prescribed, divided into 3-5 doses per day after meals.

In complex therapy for arterial hypertension, myocardial infarction (during restorative therapy), during preparation for heart surgery (coronary artery bypass grafting, for heart defects), migraine, for replenishing coenzyme Q10 deficiency and improving adaptation to increased physical exertion in athletes, adults and children over 12 years of age are prescribed from 30 mg (1 capsule) to 90 mg (3 capsules) per day.

The duration of the course of drug use is 1-3 months.

Increasing the duration of the therapy course and repeated courses are as recommended by a doctor.

Adverse Reactions

Allergic reactions (skin rash, itching), nausea, diarrhea, heartburn, epigastric pain are possible.

Contraindications

• Hypersensitivity to the drug components;
• Acute glomerulonephritis;
• Gastric and duodenal ulcer (in the acute stage);
• Severe bradycardia (heart rate less than 50 beats/min);
• Age under 12 years;
• Fructose intolerance and glucose/galactose malabsorption syndrome or sucrase/isomaltase deficiency.

If you have one of the listed diseases, be sure to consult your doctor before taking the drug.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Renal Impairment

Contraindicated in acute glomerulonephritis.

Pediatric Use

Contraindicated under 12 years of age.

Overdose

No overdose data available.

Drug Interactions

Concomitant use of lipid-lowering agents (statins, fibrates), warfarin, beta-blockers (atenolol, metoprolol, propranolol), tricyclic antidepressants may lead to a decrease in the plasma concentration of ubidecarenone.

Ubidecarenone may enhance the effect of diltiazem, metoprolol, enalapril, and nitrates.

Storage Conditions

Store in a dry place, protected from light and out of reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date.

Dispensing Status

Over-the-counter.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.