Quinagut^® (Drops) Instructions for Use

Marketing Authorization Holder

Pharmactive, LLC (Russia)

Manufactured By

Ferment Firm, LLC (Russia)

ATC Code

S01XA (Other preparations for the treatment of eye diseases)

Active Substance

Azapentacene (USP United States Pharmacopeia)

Dosage Form

Quinagut®

Ophthalmic drops 0.015%: bottle 5 ml 1 pc.

Dosage Form, Packaging, and Composition

Ophthalmic drops in the form of a transparent solution from pink to dark red color.

Excipients : boric acid – 6.3 mg, sodium borate (sodium tetraborate decahydrate) – 0.3 mg, potassium chloride – 7.15 mg, methylparaben – 0.065 mg, propylparaben – 0.035 mg, thimerosal – 0.002 mg, sodium hydroxide and/or concentrated hydrochloric acid – to adjust pH to 7.1-7.8, purified water – up to 1 ml.

5 ml – dark glass bottles (1) – cardboard packs.
5 ml – colorless glass bottles (1) with a pipette or dropper cap – cardboard packs.

Clinical-Pharmacological Group

Drug used for cataracts

Pharmacotherapeutic Group

Remedy for cataracts

Pharmacological Action

A synthetic phenoxazone derivative used for cataracts. The main action of azapentacene is to inhibit the reaction between quinone derivatives and soluble proteins, which leads to lens opacification.

It slows down the degeneration of the lens, preventing or slowing the development of cataracts. According to the “quinoid” theory of cataract development, the SH-radical of the soluble protein contained in the eye lens undergoes degeneration and oxidation under the influence of a quinoid substance formed due to impaired metabolism of aromatic amino acids such as tryptophan and tyrosine.

Azapentacene has a high affinity for the SH-radical of the soluble protein contained in the eye lens, protecting it from the negative effects of the quinoid substance. Furthermore, it has been established that Azapentacene is able to increase the activity of the proteolytic enzyme present in the intraocular fluid of the anterior chamber of the eye.

Indications

Cataract (senile, traumatic, congenital, secondary). Prevention of cataract.

ICD codes

Dosage Regimen

Instill 1-2 drops into the conjunctival sac of the affected eye(s).

Administer 3-6 times per day at approximately regular intervals.

Continue treatment for a long time, typically for several months.

Do not discontinue therapy prematurely, even if an improvement in visual acuity occurs quickly after initiation.

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

If using other topical ophthalmic medications, maintain an interval of at least 5-10 minutes between instillations.

After instillation, apply gentle pressure to the lacrimal sac (at the inner corner of the eye) for one to two minutes to reduce systemic absorption.

Patients experiencing temporary blurred vision after instillation should not drive vehicles or operate machinery until their vision clears completely.

Adverse Reactions

Local reactions very rarely – burning, itching in the eyelid area.

Contraindications

Advanced cataract (requiring surgical intervention); severe eye diseases (e.g., corneal ulcer); hypersensitivity to azapentacene.

Use in Pregnancy and Lactation

There is insufficient experience with the use of azapentacene during pregnancy and lactation. Use is possible in cases where the expected therapeutic benefit for the mother outweighs the potential risk of side effects in the fetus or child.

Use in Hepatic Impairment

Use is possible because systemic absorption of the active substance is low.

Use in Renal Impairment

Use is possible because systemic absorption of the active substance is low.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Azapentacene is intended for topical use as an instillation into the conjunctival sac; do not administer subconjunctivally or into the anterior chamber of the eye.

It is recommended to continue treatment for a long time, for several months, even if improvement in visual acuity occurs quickly after the start of treatment.

Use in pediatrics

Experience with the use of azapentacene in children is insufficient. The use of azapentacene in children is possible when the expected therapeutic effect outweighs the potential risk of possible side effects.

Effect on ability to drive vehicles and operate machinery

Patients who experience temporary blurred vision after instillation are not recommended to drive a car or operate complex machinery requiring clear vision immediately after instillation of azapentacene.

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

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.