Instructions Oftalek solution for injection 10 mg/ml ampoule 1 ml in blister No. 10
Composition
active ingredient: methylethylpyridinol hydrochloride;
1 ml of solution contains 10 mg of methylethylpyridinol hydrochloride;
excipients: diluted hydrochloric acid, water for injections
Dosage form
Solution for injection.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
Capillary stabilizing agents.
ATX code C05C X.
Pharmacological properties
Pharmacodynamics. Oftalek stabilizes the cell membrane, inhibits platelet and neutrophil aggregation, reduces the total coagulation index, prolongs blood clotting time, reduces blood viscosity, has fibrinolytic activity, increases the content of cyclic nucleotides in tissues, reduces the permeability of the vascular wall. Oftalek also has angioprotective properties, protects the retina from damage under the influence of high-intensity light, improves microcirculation.
Pharmacokinetics. Oftalek is excreted from the body mainly with urine and in small quantities - in unchanged form.
With retrobulbar administration, Oftalek appears in the blood almost instantly; during the first 2 hours its concentration decreases sharply, and after 24 hours the drug is absent in the blood. In the tissues of the eye, the concentration of Oftalek is higher than in the blood.
Clinical characteristics.
Indication
Subconjunctival and intraocular hemorrhages of various genesis.
Angioretinopathy (including diabetic retinopathy).
Central and peripheral chorioretinal dystrophies.
Thrombosis of the central retinal vein and its branches.
Complicated myopathy.
Angiosclerotic macular degeneration (dry form).
Choroid detachment in glaucoma patients in the postoperative period.
Dystrophic diseases of the cornea.
Injuries, burns of the cornea.
Protection of the cornea (when using contact lenses) and retina from exposure to high-intensity light (sunlight, laser radiation during laser coagulation).
Contraindication
Increased individual sensitivity to the drug.
Interaction with other drugs and other types of interactions.
No negative effects have been described when using Oftalek against the background of therapy with other drugs. α-tocopherol acetate potentiates the antioxidant effect of Oftalek.
Application features
In some cases, especially in predisposed patients, in patients with bronchial asthma with increased sensitivity to sulfites, severe hypersensitivity reactions may develop.
Use during pregnancy or breastfeeding
The use of the drug is contraindicated during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Caution should be exercised when driving or operating other machinery, as the drug may cause drowsiness and increase blood pressure.
Method of administration and doses
Oftalek solution is administered subconjunctivally or parabulbarly. If necessary, retrobulbar administration is possible. Subconjunctivally, 0.2 - 0.5 ml (2 - 5 mg) is administered, parabulbarly - 0.5 - 1 ml (5 - 10 mg) of a 1% solution. The drug is used for 10 - 30 days once a day or every other day. If necessary, treatment can be repeated 2 - 3 times a year. Retrobulbarly, 0.5 - 1 ml of the drug is administered once a day for 10 - 15 days.
To protect the retina during laser coagulation (especially during laser coagulation that limits or destroys the tumor), 0.5–1 ml of Oftalek is administered parabulbarly or retrobulbarly 24 hours and 1 hour before the procedure, and then in the same doses (0.5 ml of a 1% solution) once a day for 2–10 days.
Children
The drug is not used in children.
Overdose
Cases of overdose have not been described. In case of overdose, side effects of the drug may be increased, blood clotting disorders may occur. Treatment: discontinue the drug, symptomatic therapy.
Adverse reactions
Short-term excitement, drowsiness, increased blood pressure, allergic reactions (skin rashes, itching, redness), local reactions - pain, burning sensation and compaction of paraorbital tissues (resolves on its own).
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25°C. Keep out of the reach of children.
Incompatibility.
Do not mix Oftalek solution in the same syringe with other drugs.
Packaging
In 1 ml ampoules, 10 or 100 ampoules in a pack or 5 ampoules in a blister, 2 blisters in a pack.
Vacation category
According to the recipe.
Manufacturer/Applicant
JSC "Lekhim-Kharkiv".
Location of the manufacturer and its business address/location of the applicant and/or the applicant's representative
61115, Ukraine, Kharkiv, 36, 17th Party Congress St.
