Taophtal^® (Drops) Instructions for Use

Marketing Authorization Holder

Triangle, LLC (Russia)

Manufactured By

Obnovlenie Pfc, JSC (Russia)

ATC Code

S01XA (Other preparations for the treatment of eye diseases)

Active Substance

Taurine (Rec.INN registered by WHO)

Dosage Form

Taophtal®

Eye drops 40 mg/1 ml: tube-droppers 5 ml, 10 ml, 15 ml, 20 ml or 25 ml

Dosage Form, Packaging, and Composition

Eye drops in the form of a transparent, colorless or slightly yellowish solution.

Excipients: hyetellose (hydroxyethylcellulose), methylparahydroxybenzoate (methylparaben, E218), purified water.

5 ml – polyethylene tube-droppers (1) – cardboard boxes.
10 ml – polyethylene tube-droppers (1) – cardboard boxes.
15 ml – polyethylene tube-droppers (1) – cardboard boxes.
20 ml – polyethylene tube-droppers (1) – cardboard boxes.
25 ml – polyethylene tube-droppers (1) – cardboard boxes.

Clinical-Pharmacological Group

A drug that stimulates regeneration processes for topical use in ophthalmology

Pharmacotherapeutic Group

Agents used in ophthalmology; other agents used in ophthalmology

Pharmacological Action

Taurine is a natural product of the metabolism of sulfur-containing amino acids: cysteine, cysteamine, methionine.

Taurine has osmoregulatory and membrane-protective properties, has a positive effect on the phospholipid composition of cell membranes, normalizes the metabolism of calcium and potassium ions in cells, and improves nerve impulse conduction conditions.

It stimulates reparative and regenerative processes in diseases of a dystrophic nature and/or diseases accompanied by a sharp disruption of the metabolism of eye tissues.

Pharmacokinetics

When administered intraocularly, the maximum accumulation of taurine in the retina is observed after 20-30 minutes.

Upon instillation, penetration into the eye tissues is slower. Taurine is excreted by the kidneys unchanged.

Indications

Dystrophic diseases of the retina, including hereditary tapetoretinal degeneration; corneal dystrophy; cataract (senile, diabetic, traumatic, radiation); corneal injury (as a stimulator of reparative processes); primary open-angle glaucoma (in combination with beta-blockers for topical use in ophthalmology).

ICD codes

Dosage Regimen

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

Use the solution 2-4 times daily.

The specific frequency and duration of therapy are determined by the treating ophthalmologist based on the diagnosed condition.

For dystrophic lesions of the retina and cornea, the treatment course typically lasts up to three months.

For cataracts, the treatment course is typically three months; courses may be repeated at intervals determined by the physician.

For corneal injuries, use for the duration required for complete epithelialization.

For primary open-angle glaucoma, use as an adjunct to beta-blocker therapy for at least one month.

Before use, wash hands thoroughly.

Remove the protective cap.

Avoid contact between the dropper tip and any surface, including the eye, to prevent contamination.

Tilt head back, pull lower eyelid down to form a pouch, and instill prescribed number of drops.

Close eye gently and apply light pressure to the inner corner of the eye (nasolacrimal duct) for 1-2 minutes to minimize systemic absorption.

If using other topical ophthalmic agents, maintain an interval of at least 10-15 minutes between instillations.

Apply eye ointments last.

Adverse Reactions

Possible allergic reactions.

Contraindications

Age under 18 years (efficacy and safety have not been established); hypersensitivity to taurine.

Use in Pregnancy and Lactation

Use during breastfeeding is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or child.

Pediatric Use

Contraindicated under 18 years of age (efficacy and safety have not been established).

Geriatric Use

Can be used in elderly patients.

Special Precautions

If it is necessary to use other ophthalmic agents simultaneously, the interval between the use of taurine and other drugs should be at least 10-15 minutes. Eye ointments should be applied last.

Drug Interactions

In patients with glaucoma, with the simultaneous use of taurine with timolol maleate, an enhancement of the hypotensive action was noted due to an increase in the outflow facility coefficient and a decrease in the production of aqueous humor.

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.