Cikadoks (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

ATC Code

C01CX (Other cardiotonic agents)

Active Substance

Cytochrome C

Cytochrome C (Grouping name)

Dosage Form

Cikadoks

Lyophilizate for solution for intravenous and intramuscular administration 10 mg: vial 5 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of a solution for intravenous and intramuscular administration in the form of a light red-brown lyophilized mass.

Excipients: sodium chloride – 37 mg, sodium hydroxide 0.1 M or hydrochloric acid 0.1 M – to pH 6-7.

10 mg – vials (5) – contour cell packaging (1) – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Metabolic agent

Pharmacological Action

Cytoprotector. It is a high-molecular-weight iron-porphyrin compound that is isolated as a purified crystalline substance, for example, from the myocardium of cattle. It is a conjugated protein, structurally similar to hemoglobin, consisting of heme and a single peptide chain (apocytochrome C).

Cytochrome C plays a crucial role in biochemical oxidation-reduction processes in almost all aerobic organisms. These reactions occur with the participation of two mitochondrial enzymes: cytochrome oxidase and cytochrome reductase. Heme exhibits properties of either an electron donor or an electron acceptor. It has high chemical activity in the utilization of oxygen radicals, such as superoxide or hydrogen peroxide, which is a strong oxidizing agent. Heme metabolites act as “traps” for the peroxyl radical.

Pharmacokinetics

It is rapidly and completely absorbed by any route of administration. It penetrates well into the cells of organs and tissues.

Indications

In complex therapy as a means of improving tissue respiration in conditions accompanied by impaired oxidation-reduction processes in the body: neonatal asphyxia; severe injuries; before and after surgery (to prevent shock), during remission of bronchial asthma with respiratory failure, in patients with COPD and heart failure; in viral hepatitis complicated by hepatic coma; in poisoning with hypnotic drugs and carbon monoxide.

ICD codes

Dosage Regimen

Administer intramuscularly or intravenously.

Determine the dose and regimen individually based on the clinical indication and the patient’s age.

For adults, the typical single dose is 10 mg.

For intramuscular administration, reconstitute the lyophilisate with 4-5 ml of water for injection or 0.9% sodium chloride solution.

For intravenous administration, first reconstitute the lyophilisate with 5 ml of water for injection or 0.9% sodium chloride solution.

Further dilute the reconstituted solution in 100-200 ml of 0.9% sodium chloride solution or 5% glucose solution for infusion.

Administer the intravenous infusion slowly, at a rate of 20-30 drops per minute.

The frequency of administration is typically once or twice daily.

The standard course of treatment lasts from 10 to 14 days; the duration may be adjusted based on clinical response.

In pediatric practice, use the drug according to indications and in age-appropriate doses.

For neonatal asphyxia, administer a single dose of 1-2 mg intramuscularly or intravenously.

In severe conditions, such as poisoning or hepatic coma, the dose and frequency may be increased as determined by the physician.

Before initiating therapy and each repeated course, perform a mandatory intradermal sensitivity test.

Adverse Reactions

With rapid administration, chills with fever and allergic reactions are possible.

With prolonged use, changes in the peripheral blood picture, indicators of the blood coagulation system, and liver function are possible.

Contraindications

Hypersensitivity to cytochrome C; pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

It can be used in children according to the indications in the recommended doses. It is necessary to strictly follow the instructions in the cytochrome C drug instructions for use in children.

Special Precautions

Before use, a test should be performed to determine individual sensitivity to it. For this purpose, 0.1 ml of the solution (0.25 mg) is administered intradermally. If no reaction (facial redness, skin itching, urticaria) is observed within 30 minutes, then treatment with cytochrome C can be started. Before prescribing a repeat course, the biological test must be repeated.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.