Visomitin^® (Drops) Instructions for Use

Marketing Authorization Holder

Mitotech LLC (Russia)

Manufactured By

Framon, CJS (Russia)

Or

Firn M, LLC (Russia)

Quality Control Release

Research Institute of Mitoengineering of Moscow State University, LLC (Russia)

Contact Information

MITOTECH LLC (Russia)

ATC Code

S01XA (Other preparations for the treatment of eye diseases)

Active Substance

Plastoquinonyldecyltriphenylphosphonium bromide (Grouping name)

Dosage Form

Visomitin®

Eye drops 0.155 mcg/ml: 5 ml or 10 ml bottle with dropper cap

Dosage Form, Packaging, and Composition

Eye drops transparent or slightly opalescent, colorless or slightly colored.

Excipients: benzalkonium chloride – 0.1 mg, hypromellose – 2 mg, sodium chloride – 9 mg, sodium dihydrogen phosphate dihydrate – 0.81 mg, disodium hydrogen phosphate dodecahydrate – 1.16 mg, sodium hydroxide 1M solution – to adjust pH to 6.0-7.0, purified water – up to 1 ml.

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

Clinical-Pharmacological Group

Keratoprotector with antioxidant properties

Pharmacotherapeutic Groups

• Antioxidant agent
• Keratoprotective agent

Pharmacological Action

Plastoquinonyldecyltriphenylphosphonium bromide (PDTP) is a derivative of plastoquinone, which is linked via a linker chain (C10) to a triphenylphosphine residue. When used in low (nanomolar) concentrations, PDTP exhibits high antioxidant activity. It has a stimulating effect on the process of corneal epithelialization and helps to increase the stability of the tear film.

One of the causes of age-related cataract development is the damaging effect of ultraviolet radiation, which initiates photooxidation processes leading to the denaturation of the main structural components of the lens – crystallins. The primary protection of eye tissues from ultraviolet radiation is the tear fluid, which absorbs ultraviolet light in the range of 240-320 nm and neutralizes it due to the components of the antioxidant activity of the tear fluid. According to preclinical studies, the anti-cataract effect of the drug Visomitin^® is associated with an increase in the expression level of the main lens proteins, α-crystallins. According to clinical studies in patients with age-related cataracts who used the drug Visomitin^®, an increase in the antioxidant activity of tears was noted.

Pharmacokinetics

Preclinical studies in animals have shown that when using Visomitin^® eye drops as instillations, PDTP is not detected in the blood.

After oral administration of PDTP to healthy volunteers, the T_1/2 from plasma is approximately 45 min.

Indications

As part of complex therapy

• Dry eye syndrome/corneal-conjunctival xerosis (poor tolerance to wind, air conditioning, smoke, sensation of a foreign body, pain, burning, dryness in the eyes, fluctuating visual acuity, lacrimation, redness of the eyes in the area not covered by the eyelids);
• Initial stage of age-related cataract (gradual blurring and decrease in visual acuity).

ICD codes

Dosage Regimen

Dry eye syndrome

Prescribe 1-2 drops of the drug into the conjunctival sac 3 times/day. According to clinical studies, the therapeutic effect is achieved within the first 2-4 weeks of use. The therapeutic effect is stable when used for 6 weeks.

If there is no effect within the first 2 weeks of treatment, a specialist examination is necessary.

Initial stage of age-related cataract

Prescribe 1-2 drops of the drug into the conjunctival sac 3 times/day. The duration of the treatment course is 6 months. The diagnosis of “initial stage of age-related cataract” must be established by a specialist.

If improvement does not occur after treatment, or symptoms worsen, or new symptoms appear, the patient should consult a doctor.

The drug should be used only according to the indications, method of administration, and doses specified in the instructions for use.

Adverse Reactions

Classification of adverse reactions by organs and systems with indication of their frequency: very common (≥10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000), including isolated reports; frequency unknown (frequency cannot be estimated from the available data).

From the organ of vision common – short-term pain and burning after instillation; uncommon – temporary appearance of a veil before the eyes.

Other common – allergic reactions (itching, redness and swelling of the eyelids and conjunctiva).

If side effects listed in the instructions develop, or they worsen, or any other side effects not listed in the instructions are noted, the patient must inform the doctor.

Contraindications

• Age under 18 years (lack of clinical study data);
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

There are no data on the safety of using the drug Visomitin^® during pregnancy. Studies of generative function and teratogenic effect in rats did not reveal signs of impaired fertility or fetal developmental defects due to PDTP. The use of the drug Visomitin^® during pregnancy is possible if the intended benefit to the mother outweighs the potential risk to the fetus. If a woman is pregnant or suspects she could be pregnant, or is planning a pregnancy, she should consult a doctor.

It is not known whether PDTP is excreted in breast milk. Relevant studies in breastfeeding women have not been conducted.

Pediatric Use

The use of the drug is contraindicated under the age of 18 years.

Special Precautions

Visomitin^® eye drops contain benzalkonium chloride as a preservative and are not recommended for use while wearing contact lenses. Before instilling the eye drops, contact lenses should be removed and reinserted no earlier than 15 minutes after applying the drug.

The bottle must be closed after each use.

Do not touch the eyes with the tip of the pipette during instillation.

The active substance of the drug Visomitin^® is very sensitive to light: the bottle should not be stored in an illuminated place between uses.

Patients using the drug Visomitin^® to relieve symptoms of dry eye syndrome and for maintenance therapy of cataracts without a prescription should consult a doctor in the following cases

• Use of the drug to relieve symptoms of dry eye syndrome for 6 weeks or more;
• Presence of purulent discharge from the eyes;
• Redness of the areas of the eye covered by the eyelids;
• Sudden (from one day to one month) deterioration of vision;
• Appearance of new symptoms or change in previously observed symptoms related to the organ of vision.

Patients who have been suffering from recurring symptoms of dry eye syndrome or progressive vision deterioration due to cataracts for a long time should regularly undergo an examination by an ophthalmologist.

Effect on ability to drive vehicles and mechanisms

If short-term blurred vision occurs after applying the drug, it is not recommended to drive vehicles or engage in activities requiring clear visual perception until vision is restored.

Overdose

When using the drug Visomitin^® in accordance with the instructions, overdose is unlikely. With excessive use, an increase in side effects is possible.

Treatment symptomatic therapy.

Drug Interactions

No adverse interactions of the drug Visomitin^® with other medicinal products have been previously noted.

If necessary, it can be used simultaneously with other eye drops; the break between instillations should be at least 15 minutes.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature from 2°C (35.6°F) to 8°C (46.4°F).

Shelf Life

The shelf life is 2 years. Do not use after the expiration date printed on the package.

The opened bottle should be stored protected from light at a temperature from 2°C (35.6°F) to 8°C (46.4°F); use within 1 month.

Dispensing Status

The drug is dispensed 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.