Oftan^® Catachrom (Drops) Instructions for Use

Marketing Authorization Holder

Santen, Oy (Finland)

Quality Control Release

SANTEN, OY (Finland)

Labeled By

Manufacturing Packaging Farmaca, MPF B.V. (Netherlands)

Manufactured By

NEXTPHARMA, OY (Finland)

Contact Information

SANTEN LLC (Russia)

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

Oftan® Catachrom

Eye drops 675 mcg+2 mg+20 mg/1 ml: bottle 10 ml with dropper cap

Dosage Form, Packaging, and Composition

Eye drops as a clear red solution.

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

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

Clinical-Pharmacological Group

Drug used for cataracts

Pharmacotherapeutic Group

Agents used in ophthalmology; other agents used in ophthalmology

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 one to two drops into the conjunctival sac of the affected eye(s) three times daily.

Ensure the dropper tip does not contact the eye, eyelids, or any other surface to prevent contamination of the solution.

For the first use of a new bottle, turn the cap while pressing down firmly, then open the bottle.

If you use other topical ophthalmic medications, administer them concomitantly with an interval of at least 15 minutes between applications.

Remove soft contact lenses prior to instillation due to the presence of the preservative benzalkonium chloride; you may reinsert lenses 15 minutes after applying the drops.

Continue treatment as directed by your physician; the therapeutic effect on cataract progression is typically observed with prolonged, regular use.

After opening the bottle, discard any unused solution after one month to ensure sterility and efficacy.

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

• Children and adolescents under 18 years of age (due to the lack of data on the efficacy and safety of the drug use in children and adolescents);
• Hypersensitivity to the drug components.

Use in Pregnancy and Lactation

There is insufficient experience with the use of Oftan^® Catachrom during pregnancy and lactation (breastfeeding).

Oftan^® Catachrom may be used during pregnancy and lactation as prescribed by a doctor in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus or breastfed infant.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age (due to the lack of data on the efficacy and safety of the drug use in children and adolescents).

Special Precautions

During treatment with Oftan^® Catachrom, soft contact lenses should not be worn, as the preservative may deposit in them and have an adverse effect on eye tissues. Before using Oftan^® Catachrom, contact lenses should be removed and reinserted 15 minutes after instillation of the drug.

Effect on the ability to drive vehicles and mechanisms

Patients who experience short-term eye irritation after instillation of the drug should avoid driving vehicles, working with machinery, machine tools, or any other equipment requiring good visual acuity immediately after using the eye drops.

Overdose

No data on overdose of Oftan^® Catachrom are available.

Drug Interactions

No clinically significant interaction of Oftan^® Catachrom with other drugs has been identified.

Storage Conditions

The drug should be stored out of the reach of children at a temperature from 8°C (46.4°F) to 15°C (59°F).

Shelf Life

Shelf life – 3 years.

After opening the dropper bottle, the eye drops should be used within 1 month.

Dispensing Status

The drug is available without a prescription.

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.