Ocumed, eye drops 0.5% 5ml

Composition

1 ml of eye drops contains 0.5% :

Active ingredient:

timolol (in maleate form)  5 mg;

Auxiliary substances:

benzalkonium chloride (0.1 mg / ml),

sodium hydrophosphate,

sodium dihydrogen phosphate,

d/i water.

Pharmacological action

When applied topically, timolol in the form of eye drops lowers normal and elevated intraocular pressure, reducing the formation of intraocular fluid. The drug does not affect accommodation, does not change the size of the pupil. Timolol maleate quickly penetrates through the cornea, after 1-2 hours it is maximally concentrated in the watery moisture of the anterior chamber of the eye. In small amounts, it enters the systemic bloodstream and is excreted by the kidneys.

The effect of timolol begins 20 minutes after instillation, the effect of reducing intraocular pressure reaches a maximum in 1-2 hours and persists throughout the day. In newborns and young children, the concentration of timolol in plasma is significantly higher than in adults.

Pharmacokinetics

Suction

When applied topically, timolol quickly penetrates the cornea.

After instillation of eye drops, the_cmax of timolol in the aqueous humor of the anterior chamber of the eye is reached in 1-2 hours.

A small amount enters the systemic circulation by absorption through the vessels of the conjunctiva, nasal mucosa and lacrimal tract.

Deduction

Timolol metabolites are mainly excreted by the kidneys.

Pharmacokinetics in special clinical cases

In newborns and young children_{, cmax} in blood plasma significantly exceeds that in adults.

Indications

Okumed eye drops are used for ophthalmohypertension (increased intraocular pressure), as well as for open-angle glaucoma, secondary glaucoma.

The drug is effective if other therapeutic measures are insufficient in the treatment of congenital glaucoma, as well as in angle – closure glaucoma-as an additional tool for lowering intraocular pressure in combination with drugs that constrict the pupil.

Use during pregnancy and lactation

There is no sufficient experience with the use of the drug during pregnancy and lactation (breastfeeding), so the drug can only be prescribed in cases where the intended benefit of therapy for the mother exceeds the potential risk to the fetus or child.

It was found that timolol penetrates the placental barrier and is excreted in breast milk.

Breast-feeding should be discontinued during treatment.

Use in pediatrics

There is no sufficient experience in using the drug in children, so the drug can only be prescribed in cases where the intended benefit of therapy exceeds the potential risk of side effects.

Contraindications

Ocumed eye drops are not recommended for use with hypersensitivity to the components of the drug. The drug should not be used for such diseases in the anamnesis as bronchial asthma, severe chronic obstructive pulmonary diseases, atrioventricular block of II or III degree, sinus bradycardia, acute heart failure, severe chronic heart failure of III – IV functional class, cardiogenic shock. Okumed is contraindicated in allergic reactions with skin rashes, atrophic rhinitis, dystrophic diseases of the cornea. Do not prescribe the drug to newborns.

With caution, eye drops are used for heart failure of functional class 1-11, arterial hypotension, sinoatrial blockade, pulmonary or cerebrovascular insufficiency, diabetes mellitus or hypoglycemia, thyrotoxicosis, pheochromocytoma, Raynaud’s syndrome, myasthenia gravis, as well as with simultaneous treatment with other beta-blockers. Also, with caution, Okumed is prescribed to children.

Side effects

From the side of the visual organ: irritation and hyperemia of the conjunctiva, skin of the eyelids, burning and itching in the eyes, lacrimation or decreased lacrimation, photophobia, edema of the corneal epithelium, point surface keratopathy, corneal hypesthesia, diplopia, ptosis, dry eyes, short-term visual acuity, blepharitis, conjunctivitis, keratitis. When performing surgical interventions for glaucoma, detachment of the choroid of the eye may develop in the postoperative period.

From the cardiovascular system: chest pain, heart failure, bradycardia, bradiarrhythmia, decreased blood pressure, collapse, AV block, cardiac arrest, transient disorders of cerebral circulation.

From the respiratory system: rhinitis, shortness of breath, bronchospasm, pulmonary insufficiency.

From the central nervous system and peripheral nervous system: headache, dizziness, weakness, depression, paresthesia, myasthenia gravis, drowsiness, hallucinations, ringing in the ears, slowing down the speed of psychomotor reaction.

From the digestive system: nausea, vomiting, diarrhea.

Allergic reactions: urticaria, eczema.

Other services: nosebleeds, decreased potency, alopecia.

Interaction

When Ocumed eye drops are used together with epinephrine-containing eye drops, pupil dilation may occur. It is not recommended to instill two beta-blockers in the eyes due to the risk of side effects, so the drug is not used with drops containing epinephrine and pilocarpine.

When used concomitantly with calcium antagonists (verapamil, diltiazem, nifedipine, nimodipine, amlodipine, cinnarizine, etc. ) or reserpine, there may be a slowing of the heart rate and an increased decrease in blood pressure.

Use with insulin or oral medications to treat diabetes may cause hypoglycemia.

It is not recommended to use Okumed with neuroleptics and tranquilizers, as well as to take alcohol because of the danger of a sharp decrease in blood pressure.

48 hours before the operation, under general anesthesia, the drug should be discontinued.

How to take, course of use and dosage

Adults and children over 10 years of age are recommended to instill 1 drop of 0.25% solution into the conjunctival sac 2 times a day. If this dosage is ineffective, take 1 drop of 0.5% solution also 2 times a day.

When intraocular pressure is normalized, apply a maintenance dosage – 1 drop of 0.25% solution 1 time a day.

Children under 10 years of age instill 1 drop of 0.25% solution 2 times a day.

Treatment is carried out for a long time, and the doctor should change the dosage or recommend a break in taking the drug.

Overdose

In case of overdose, the effects typical for beta-blockers may develop – headache, dizziness, nausea, vomiting, heart rhythm disorders.

Immediately flush your eyes with water or 0.9% sodium chloride solution. Further treatment is symptomatic.

Special instructions

The patient should be warned about the need for regular measurement of intraocular pressure and corneal examination, as well as about the need to stop using the drug and consult a doctor if side effects occur.

When wearing soft contact lenses, Okumed eye drops should not be used, as the preservative contained in them can be deposited in soft contact lenses and have an adverse effect on the eye tissue.

Hard contact lenses should be removed before instillation of the drug and re-installed after 15 minutes.

When transferring patients to treatment with Okumed, refractive correction may be necessary (after the effects of previously used myotics disappear).

Okumed should be discontinued 48 hours prior to general anesthesia surgery.

Okumed should not be used simultaneously with antipsychotic (neuroleptics) and anxiolytic (tranquilizers) drugs.

During the period of use of the drug, it is not recommended to drink alcohol (a sharp decrease in blood pressure is possible).

Influence on the ability to drive motor vehicles and manage mechanisms

Immediately after using the drug, visual clarity may decrease and psychomotor reactions may slow down, which may reduce the ability to engage in potentially dangerous activities that require increased attention.

Form of production

Okumed. Eye drops.

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Timolol

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Purpose

For adults as prescribed by a doctor, Pregnant women as prescribed by a doctor, Children as prescribed by a doctor

Indications

Glaucoma