OFTALEK

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT OFTALEK (OFTALEK)

Composition:

Active substance: methylethylpiridinol hydrochloride;

1 ml of solution contains methyl ethyl pyridinol hydrochloride 10 mg;

Excipients: diluted hydrochloric acid, water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Capillary stabilizing agents. ATC code C05C X.

Pharmacological Properties.

Pharmacodynamics.

Oftalek stabilizes the cell membrane, inhibits platelet and neutrophil aggregation, reduces the overall coagulation index, prolongs blood clotting time, decreases blood viscosity, has fibrinolytic activity, increases the content of cyclic nucleotides in tissues, and reduces vascular wall permeability. Oftalek also has angioprotective properties, protects the retina from damage caused by high-intensity light, and improves microcirculation.

Pharmacokinetics.

Oftalek is excreted from the body mainly in the urine and in insignificant amounts unchanged.

After retrobulbar administration, Oftalek appears in the blood almost immediately; its concentration sharply decreases within the first 2 hours, and after 24 hours, the drug is no longer detectable in the blood. The concentration of Oftalek in ocular tissues is higher than in the blood.

Clinical characteristics.

Indications.

Subconjunctival and intraocular hemorrhages of various origins.

Angioretinopathies (including diabetic retinopathy).

Central and peripheral choroidal-retinal dystrophies.

Central retinal vein thrombosis and its branches.

Complicated myopia.

Angiosclerotic macular dystrophy (dry form).

Choroidal detachment in patients with glaucoma in the postoperative period.

Corneal dystrophic disorders.

Corneal trauma, corneal burns.

Corneal protection (during contact lens use) and retinal protection from high-intensity light exposure (sunlight, laser radiation during laser coagulation).

Contraindications.

Hypersensitivity to the drug.

Interaction with other medicinal products and other forms of interaction.

No negative effects have been reported when using Ophthalek concurrently with other medicinal products. α-tocopherol acetate potentiates the antioxidant effect of Ophthalek.

Special precautions for use.

In individual cases, especially in predisposed patients and in patients with bronchial asthma with increased sensitivity to sulfites, severe hypersensitivity reactions may occur.

Use during pregnancy or breastfeeding.

The use of the drug is contraindicated during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Caution should be exercised when driving or operating machinery, as the drug may cause drowsiness and increased blood pressure.

Administration and Dosage.

Oftalek solution should be administered subconjunctivally or peribulbarly. Retrobulbar administration may be performed if necessary. Subconjunctivally, administer 0.2–0.5 ml (2–5 mg); peribulbarly, 0.5–1 ml (5–10 mg) of the 1% solution. The drug should be used for 10–30 days, once daily or every other day. If necessary, treatment can be repeated 2–3 times per year. Retrobulbar administration: 0.5–1 ml of the drug once daily for 10–15 days.

For retinal protection during laser coagulation (especially during laser coagulation that limits or destroys a tumor), administer 0.5–1 ml of Oftalek peribulbarly or retrobulbarly 24 hours and 1 hour before the procedure, followed by the same doses (0.5 ml of 1% solution) once daily for 2–10 days.

Children.

The drug should not be used in children.

Overdose.

Cases of overdose have not been reported. In case of overdose, an intensification of the drug's adverse effects and impairment of blood coagulation may occur. Treatment: discontinue the drug, symptomatic therapy.

Adverse reactions.

Transient excitation, drowsiness, increased blood pressure, allergic reactions (skin rashes, itching, redness), local reactions – pain, burning sensation, and induration of periorbital tissues (resolves spontaneously).

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Incompatibility.

Oftalek solution must not be mixed in the same syringe with other medicinal products.

Packaging.

1 ml in an ampoule; 10 or 100 ampoules per pack, or 5 ampoules in a blister, 2 blisters per pack.

Prescription status.

Prescription only.

Manufacturer.

Private Joint-Stock Company "Lekhim-Kharkiv".

Manufacturer's address and location of its business activities.

36 Severina Pototskogo Street, Kharkiv, Kharkiv region, 61115, Ukraine.