TAUFON-DARNITSA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TAUFON-DARNITSA (TAUFON-DARNITSA)

Composition:

Active substance: taurine;

1 ml of solution contains 40 mg of taurine;

Excipients: methylparahydroxybenzoate (E 218), water for injections.

Pharmaceutical form. Eye drops, solution.

Main physicochemical characteristics: clear, colorless, odorless liquid.

Pharmacotherapeutic group. Ophthalmological agents. Other ophthalmological preparations. ATC code S01X A.

Pharmacological properties.

Pharmacodynamics.

Taufon-Darnytsia contains taurine – a sulfur-containing amino acid formed in the body during the conversion of cysteine. Taurine participates in the synthesis of structural material, thereby stimulating reparative and regenerative processes in eye diseases of dystrophic nature and/or pathological conditions accompanied by severe disturbances in ocular tissue metabolism, including eye injuries. It promotes normalization of cell membrane functions, optimization of energy and metabolic processes, maintenance of stable electrolyte composition of cell cytoplasm, and inhibition of synaptic transmission.

Pharmacokinetics.

After instillation, the drug penetrates into ocular tissues, where it exerts its specific effect. When used in therapeutic doses, the drug is practically not absorbed into the systemic circulation.

Clinical characteristics.

Indications.

• Dystrophic lesions of the cornea and retina, including hereditary tapetoretinal degenerations;
• cataracts (age-related, diabetic, traumatic, radiation);
• as a means of stimulating reparative processes in corneal injuries;
• open-angle glaucoma (as an additional agent).

Contraindications.

Hypersensitivity to taurine or to any of the excipients.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with timolol eye drops, the reduction of intraocular pressure and arterial pressure is enhanced.

When administering several locally-acting ophthalmic medicinal products, they should be applied at 10–15 minute intervals. Ophthalmic ointments should be applied last.

Special precautions for use

In open-angle glaucoma, the medicinal product should be used in combination with timolol, administered 20–30 minutes before instilling timolol.

Excipients: The medicinal product contains methylparahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed).

Use during pregnancy or breast-feeding

The efficacy and safety of the medicinal product during pregnancy or breast-feeding have not been studied.

Effect on the ability to drive and use machines

The effect of the medicinal product on the human body during driving or operating machinery has not been studied.

As with other topically applied ophthalmic medicinal products, transient blurred vision or other visual disturbances may affect the ability to drive or operate machinery. If blurred vision occurs after instillation, patients should wait until vision clears before driving or operating machinery.

Method of Administration and Dosage

Administer Taufon to adults.

Immediately before use, hold the tube-dropper in the palm of the hand to warm it to body temperature. To open the tube-dropper, rotate the cap until it completely separates from the body. Apply gentle pressure to the body of the tube-dropper to instill the solution into the eye.

Treatment of cataract: administer 2–3 drops 2–4 times daily. Treatment duration is 3 months. Repeat the course after a 1-month interval.

Injuries: use 2–3 drops 2–4 times daily for 1 month.

Treatment of tapetoretinal degeneration and other retinal dystrophic disorders, penetrating corneal injuries: administer 0.3 mL of 4% solution subconjunctivally once daily for 10 days. Repeat the treatment course after 6–8 months.

Open-angle glaucoma: instill 2–3 drops into the conjunctival sac twice daily, 20–30 minutes prior to timolol administration. The treatment duration is determined individually by the physician.

Children

The efficacy and safety of the drug in children have not been studied.

Overdose.

Cases of overdose have not been reported.

Side effects.

Allergic reactions, conjunctival hyperemia, itching, burning, and stinging in the eyes may occur in individual patients.

Shelf life. 3 years.

After opening the bottle, the medicinal product should not be stored for more than 28 days.

Storage conditions.

Store in the original packaging at a temperature not exceeding 15 °C. Do not freeze. Keep out of reach of children.

Packaging.

5 ml or 10 ml in a bottle; 1 bottle per carton.

Prescription status. By prescription only.

Manufacturer.

JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and location of business activity.

13, Boryspylska Street, Kyiv, 02093, Ukraine.