Neocatachrom (Drops) Instructions for Use

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Manufactured By

Dosfarm, LLP (Kazakhstan)

ATC Code

S01XA (Other preparations for the treatment of eye diseases)

Active Substances

Nicotinamide (Rec.INN registered by WHO)

Cytochrome C (Grouping name)

Adenosine (Rec.INN registered by WHO)

Dosage Form

Neocatachrom

Eye drops 2 mg+20 mg+0.675 mg/1 ml: 10 ml dropper bottle 1 pc.

Dosage Form, Packaging, and Composition

Eye drops as a clear red solution.

Excipients: sorbitol – 10 mg, sodium dihydrogen phosphate dihydrate – 4.415 mg, disodium hydrogen phosphate dihydrate – 2.847 mg, sodium succinate – 1 mg, benzalkonium chloride – 0.04 mg, water for injections – up to 1 ml.

10 ml – polyethylene dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug used for cataracts

Pharmacotherapeutic Group

Tissue repair stimulant

Pharmacological Action

A combined drug that improves the energy metabolism of the lens.

Cytochrome C plays an important role in biochemical redox processes in the tissues of the eyeball and is an antioxidant.

Adenosine is a precursor of ATP and is involved in the metabolic processes of the lens.

Nicotinamide stimulates the synthesis of nicotinamide dinucleotide, a cofactor of dehydrogenases.

Pharmacokinetics

Absorption and Distribution

When applied topically, cytochrome C is not absorbed into the systemic circulation.

Adenosine penetrates the cornea well.

Metabolism and Excretion

Cytochrome C is completely metabolized in the body by the same pathways as amino acids, and the heme is broken down to bilirubin, which is excreted in the bile.

Adenosine is metabolized in almost all tissues to form inosine, xanthine, and urate, which are excreted in the urine. The ribose, which is part of the adenosine molecule, is metabolized to glyceraldehyde-3-phosphate, then to pyruvate, and is finally broken down in the Krebs cycle. The T_1/2 of adenosine from plasma is less than 1 min.

Nicotinamide is partially metabolized to nicotinic acid. Both compounds are methylated to form N-methylnicotinamide, which is further broken down in the liver. Unchanged Nicotinamide and metabolites are excreted in the urine.

Indications

Cataracts of various origins.

ICD codes

Dosage Regimen

Instill the solution topically into the conjunctival sac.

Apply 1-2 drops into the affected eye(s).

Administer the drops three times daily.

The duration of treatment is determined by the attending physician.

Wash hands thoroughly before the procedure.

Avoid contact between the dropper tip and the eye, eyelids, or any other surfaces to prevent contamination of the solution.

Keep the bottle tightly closed when not in use.

Use the preparation regularly to achieve the desired therapeutic effect.

If you wear soft contact lenses, remove them before instillation.

You may reinsert contact lenses 15 minutes after applying the drops.

Do not use the solution if it changes color or becomes cloudy.

Discard the bottle 4 weeks after first opening.

Write the date of opening on the bottle label for reference.

Adverse Reactions

From the organ of vision: short-term sensation of burning and tingling in the eyes, allergic conjunctivitis, contact dermatitis.

Systemic reactions: very rarely – short-term nausea, arterial hypotension, dizziness, shortness of breath; sensation of heat and pulsation in the temples, fainting (due to the vasodilating effect of nicotinic acid).

Contraindications

Childhood and adolescent age under 18 years; hypersensitivity to the components of the drug, pregnancy, lactation (breastfeeding).

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and during breastfeeding.

Pediatric Use

The drug is contraindicated for use in children and adolescents under the age of 18 years.

Geriatric Use

The drug can be used in elderly patients according to indications.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

During treatment, patients should avoid driving vehicles and other activities requiring high concentration and speed of psychomotor reactions.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.