Emoxypine®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EMOXIPIN® (EMOXIPIN®)

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.

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

Pharmacokinetics.

Emoxypine® is excreted from the body mainly in the urine and in insignificant amounts in unchanged form.

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

Clinical characteristics.

Indications.

Subconjunctival and intraocular hemorrhage of various etiologies.

Angioretinopathy (including diabetic retinopathy).

Central and peripheral choroidal retinal dystrophy.

Thrombosis of the central retinal vein and its branches.

Complicated myopia.

Angiosclerotic macular dystrophy (dry form).

Detachment of the vascular membrane in glaucoma patients in the postoperative period.

Corneal dystrophic disorders.

Corneal injuries and burns.

Corneal protection (during contact lens use) and retinal protection against high-intensity light (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 Emoxypine® in combination with other medicinal products. α-Tocopherol acetate potentiates the antioxidant effect of Emoxypine®.

Special precautions for use.

During administration of the medicinal product Emoxypine®, the condition of the blood coagulation system and arterial pressure should be monitored.

Use during pregnancy or breastfeeding.

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

Ability to affect reaction rate when driving or operating machinery.

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

Administration and Dosage

Emoxypine® solution is administered subconjunctivally or peribulbarly. If necessary, retrobulbar administration is possible. Subconjunctivally, 0.2–0.5 mL (2–5 mg), and peribulbarly, 0.5–1 mL (5–10 mg) of the 1% solution are administered. The drug is used for 10–30 days, once daily or every other day. If necessary, treatment can be repeated 2–3 times per year. Retrobulbar administration consists of 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), 0.5–1 mL of Emoxypine® is administered 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 is not used in children.

Overdose

Cases of overdose have not been reported. In case of overdose, adverse effects of the drug may be intensified, and blood coagulation may be impaired. Treatment: discontinue the drug and administer symptomatic therapy.

Adverse reactions.

Short-term excitement, drowsiness, increased blood pressure, allergic reactions (skin rashes, itching, redness), local reactions – pain, burning sensation, and periorbital tissue induration (resolves spontaneously).

Shelf life. 3 years.

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

Incompatibility.

Emoxypine® solution must not be mixed in the same syringe with other drugs.

Packaging. In 1 mL ampoules, 10 or 100 ampoules per pack, or 5 ampoules per blister, 2 blisters per pack.

Prescription status. Prescription only.

Manufacturer.

JSC "Lechim-Kharkiv".

Manufacturer's address and place of business.

36 Severina Pototskogo St., Kharkiv, 61115, Ukraine.

Marketing authorization holder. LLC "ZDRAVO".

Address of the marketing authorization holder.

54/19 Avtozavodska St., lit. A, office, Kyiv, 04114, Ukraine.