Cytochrome C (Solution, Lyophilisate, Drops) Instructions for Use

Instructions
Dosage forms

ATC Code

C01CX (Other cardiotonic agents)

Active Substance

Cytochrome C

Cytochrome C (Grouping Name)

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 as either an electron donor or 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 a violation of oxidation-reduction processes in the body: asphyxia of newborns; severe injuries; before and after surgery (to prevent shock), during remission of bronchial asthma with the presence of respiratory failure, in patients with COPD and heart failure; in viral hepatitis complicated by hepatic coma; in case of poisoning with hypnotic drugs and carbon monoxide.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
B19.0	Unspecified viral hepatitis with hepatic coma
I50.0	Congestive heart failure
J44	Other chronic obstructive pulmonary disease
J45	Asthma
J96	Respiratory failure, not elsewhere classified
P21	Birth asphyxia
T14.9	Injury, unspecified
T42	Poisoning by antiepileptic, sedative-hypnotic and antiparkinsonism drugs
T58	Toxic effect of carbon monoxide
Z51.4	Preparatory procedures for subsequent treatment or examination, not elsewhere classified
Z98.8	Other specified postprocedural states

ICD-11 code	Indication
1E5Z	Unspecified viral hepatitis
BD10	Congestive heart failure
CA22.Z	Chronic obstructive pulmonary disease, unspecified
CA23	Asthma
CB41	Respiratory failure
ND56.Z	Unspecified injury of unspecified part of trunk, limb or body region
NE60	Poisoning by drugs, medicaments or biological substances, not elsewhere classified
NE61	Toxic effect of poisonous substances, chiefly nonmedicinal, not elsewhere classified
QB6Z	Surgical or postprocedural conditions, unspecified
QB9A	Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For intramuscular and intravenous administration of the solution or reconstituted lyophilisate, determine the dose individually based on the clinical indication and the patient’s age.

Administer the intravenous infusion slowly to minimize the risk of adverse reactions such as chills and fever.

For ophthalmic use of the drops, instill 1-2 drops into the conjunctival sac of the affected eye(s) 3-4 times daily.

Before initiating parenteral therapy, perform a mandatory intradermal sensitivity test by injecting 0.1 ml (0.25 mg) of the solution.

Observe the test site for at least 30 minutes for signs of a hypersensitivity reaction, including redness, itching, or urticaria.

Do not proceed with treatment if a positive skin reaction occurs.

Repeat the biological test prior to administering any subsequent course of treatment with Cytochrome C.

Monitor peripheral blood counts, coagulation parameters, and liver function tests during prolonged therapy.

Adverse Reactions

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

With prolonged use, changes in the peripheral blood picture, indicators of the blood coagulation system, 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

Can be used in children according to indications in recommended doses. It is necessary to strictly follow the instructions in the cytochrome C drug labels regarding 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 injected 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Cytochrome C [Samson-Med LLC (Russia)]
Lyophilizate for solution for intravenous and intramuscular administration 10 mg: vial 5 pcs.

Marketing Authorization Holder

Samson-Med LLC (Russia)

Dosage Form

Cytochrome C

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

Dosage Form, Packaging, and Composition

Lyophilizate for solution for intravenous and intramuscular administration in the form of a tablet, whole, partially or completely crumbled, from light pink to pinkish-brown in color; in addition to the main color, it may have shades from whitish to bluish; color heterogeneity is allowed; the reconstituted solution is clear, reddish-brown in color.

	1 vial
Cytochrome C*	10 mg

* obtained from the hearts of cattle, horses, and pigs.

Excipients : sodium chloride.

Vials (5) – blisters (1) – cardboard packs.

Cytochrome C [Samson-Med LLC (Russia)]
Solution for intravenous and intramuscular administration 10 mg/4 ml: fl. 5 or 10 pcs.

Marketing Authorization Holder

Samson-Med LLC (Russia)

Dosage Form

Cytochrome C

Solution for intravenous and intramuscular administration 10 mg/4 ml: fl. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration	1 ml	1 vial
Cytochrome C	2.5 mg	10 mg

4 ml – vials (5) – cardboard packs.
4 ml – vials (5) – plastic contour packs (1) – cardboard packs.
4 ml – vials (5) – plastic contour packs (2) – cardboard packs.
4 ml – vials (10) – cardboard packs.

Cytochrome C [Samson-Med LLC (Russia)]
Solution for intravenous and intramuscular administration 2.5 mg/ml