Actipol^® (Solution, Drops) Instructions for Use

Instructions
Dosage forms

ATC Code

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

Active Substance

Aminobenzoic acid (Rec.INN registered by WHO)

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Agents used in ophthalmology; other agents used in ophthalmology

Pharmacological Action

Antiviral agent for topical use.

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

Use as monotherapy or as part of combination therapy for the following conditions:

Viral eye lesions including conjunctivitis, keratoconjunctivitis, and keratouveitis caused by the herpes virus (Herpes simplex, Herpes zoster) or adenoviruses.
Keratopathies of infectious, post-traumatic, and postoperative origin.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
B00.5	Herpetic eye disease
B30.1	Conjunctivitis due to adenovirus (H13.1*)
H13.1	Acute conjunctivitis in diseases classified elsewhere
H16	Keratitis
H19.1	Herpesviral keratitis and keratoconjunctivitis
H22.0	Disorders of iris and ciliary body in infectious diseases classified elsewhere

ICD-11 code	Indication
1D84.0	Conjunctivitis caused by adenovirus
1F00.10	Herpes simplex keratitis
1F00.1Z	Ocular infection caused by herpes simplex virus, unspecified
9A60.Y	Other specified conjunctivitis
9A71	Infectious keratitis
9A7Z	Diseases of the cornea, unspecified
9A94	Certain specified disorders of the iris or ciliary body
9A96.2	Anterior uveitis associated with infection

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Instill the solution into the conjunctival sac.

Apply 1-2 drops 6-8 times per day during the acute phase of treatment.

After clinical recovery is achieved, continue therapy with 2 drops administered 3 times daily for an additional 7 days to consolidate the therapeutic effect and prevent recurrence.

Adverse Reactions

Local reactions may occur, including conjunctival hyperemia and local allergic reactions such as itching, burning, or redness at the application site.

Discontinue use and consult a healthcare professional if any severe or persistent adverse reactions are experienced.

Contraindications

Do not use under the following conditions:

Known hypersensitivity to aminobenzoic acid or any of the excipients in the formulation.
History of severe allergic reactions to the active substance.

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

Concomitant use with nucleoside analogues (e.g., acyclovir, ganciclovir) may result in an enhanced therapeutic effect of these agents.

Similarly, co-administration with certain antimicrobial agents (fluoroquinolones) and antibiotics (polymyxin B) can potentiate their pharmacological activity.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Actipol^® [M.P. Chumakov Institute of Poliomyelitis and Viral Encephalitides Enterprise for the Production of Bacterial and Viral Preparations of the RAMS Federal State Unitary Enterprise (Russia)]
Solution for injection and instillation 140 mcg/2 ml: amp. 1 and 2 ml.

Marketing Authorization Holder

M.P. Chumakov Institute of Poliomyelitis and Viral Encephalitides Enterprise for the Production of Bacterial and Viral Preparations of the RAMS Federal State Unitary Enterprise (Russia)

Trademark Owner

NPMP Akti-M, LLC (Russia)

Dosage Form

Actipol^®

Solution for injection and instillation 140 mcg/2 ml: amp. 1 and 2 ml.

Dosage Form, Packaging, and Composition

Solution for injection and instillation	1 ml	1 amp.
Para-Aminobenzoic acid	70 mcg	140 mcg

Excipients : water for injection, sodium chloride.

1 ml – ampoules (10) – cardboard packs.
1 ml – ampoules (50) – cardboard packs.
2 ml – ampoules (50) – cardboard packs.
2 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

M.P. Chumakov Institute of Poliomyelitis and Viral Encephalitides Enterprise for the Production of Bacterial and Viral Preparations of the RAMS Federal State Unitary Enterprise (Russia)