Exinta^® (Drops) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

S03D (Other drugs for the treatment of eye and ear diseases)

Active Substance

Aminobenzoic acid (Rec.INN registered by WHO)

Dosage Form

Exinta®

Eye drops 0.007%: 5 ml bottle.

Dosage Form, Packaging, and Composition

Eye drops as a transparent, colorless or yellowish, or brownish solution.

Excipients: sodium chloride – 9 mg, 1M sodium hydroxide solution – to adjust pH to 3.5-5.0, water for injections – up to 1 ml.

5 ml – low-density polyethylene bottles^× (1) with a dropper – cardboard packs.
5 ml – polyethylene terephthalate bottles^× (1) with a dropper – cardboard packs.
5 ml – high-density polyethylene dropper bottles^× (1) with a dropper cap – cardboard packs.
5 ml – dark glass bottles^× (1) – cardboard packs.

^× with a medical nozzle and a protective cap, supplied with or without a finger rest nozzle; in a foil film bag or without it.

Clinical-Pharmacological Group

Antiviral and immunomodulatory drug for topical use in ophthalmology. Interferon synthesis inducer

Pharmacotherapeutic Group

Antiviral agent for topical application

Pharmacological Action

Antiviral agent for topical application.

Aminobenzoic acid is an interferon inducer, has antioxidant, immunomodulatory, radioprotective effects, and accelerates corneal regeneration.

Pharmacokinetics

When instilled into the conjunctival sac, Aminobenzoic acid is rapidly absorbed and exhibits a therapeutic effect.

Indications

As monotherapy and as part of combination therapy for viral eye lesions: conjunctivitis, keratoconjunctivitis, keratouveitis caused by herpes virus (Herpes simplex, Herpes zoster), adenoviruses; keratopathies of infectious, post-traumatic, and postoperative origin.

ICD codes

Dosage Regimen

Instill 1-2 drops into the conjunctival sac of the affected eye(s) 6-8 times daily.

Ensure even distribution throughout the day for consistent therapeutic effect.

After clinical recovery is achieved, continue therapy for a consolidation period of 7 days.

During this period, administer 2 drops into the conjunctival sac 3 times daily.

This post-recovery regimen is critical to prevent viral recurrence.

Do not touch the dropper tip to any surface to avoid contamination.

If using other topical ophthalmic agents, maintain an interval of at least 15 minutes between instillations.

Consult a physician if no improvement is observed within the initial days of treatment.

Adverse Reactions

Local reactions conjunctival hyperemia, local allergic reactions.

Contraindications

Hypersensitivity to aminobenzoic acid.

Use in Pregnancy and Lactation

The drug can be used if the expected benefit of therapy for the mother outweighs the potential risk to the fetus or breastfed infant.

Special Precautions

Do not use simultaneously with sulfonamide drugs and their derivatives (sulfacetamide sodium).

Drug Interactions

In combination with nucleoside analogues (including acyclovir, ganciclovir), antimicrobial agents (fluoroquinolones), and antibiotics (polymyxin B), the therapeutic effect of these drugs is enhanced.

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

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.