Oftan Timolol eye drops 5mg/ml, 5ml

Composition

Active ingredients: timolol maleate 6.84 mg, equivalent to timolol 5 mg. Auxiliary substances: benzalkonium chloride, sodium hydrophosphate, sodium hydrophosphate dodecahydrate, sodium hydroxide, water for injection.

Pharmacological action

 The main Active ingredient is timolol, a substance from the group of non-selective beta-blockers. Timolol blocks beta-adrenergic receptors, without simultaneously exerting a pronounced sympathomimetic effect. The mechanism of antihypertensive action of Timolol eye drops is associated with inhibition of the production of intraocular fluid (aqueous humor) in the anterior chamber of the eye, as well as with facilitating the outflow of aqueous humor from the eye chambers. The drug does not affect the size of the pupil and the ability of the eye to accommodate, so it does not interfere with visual acuity and does not impair the quality of twilight vision.

The drug reduces both elevated and normal intraocular pressure, regardless of the presence or absence of glaucoma in the patient.

A pronounced hypotensive effect develops on average 30 minutes after a single application of eye drops, its maximum is 1-2 hours after instillation of the solution into the conjunctival sac, the pressure remains reduced for 24 hours after a single application of the drug.

Timolol is well tolerated, causes a small number of side effects, when used according to the instructions, it has almost no effect on the heart rate.

Indications

To reduce intraocular pressure and prevent the development of complications in patients with increased ophthalmotonus and primary open-angle glaucoma, as well as secondary glaucoma (including post-traumatic, uveal and aphakic).

The drug can be prescribed in the complex therapy of closed glaucoma (when prescribed with mitotics), as an auxiliary drug for congenital glaucoma or in the case of acute increase in intraocular pressure.

Use during pregnancy and lactation

There is no sufficient experience with the use of the drug during pregnancy and lactation, but it has been established that timolol penetrates the placental barrier and is excreted in breast milk. As prescribed by the attending physician Oftan® Timolol can be used during pregnancy and lactation in cases where the expected therapeutic effect for the mother justifies the potential risk to the fetus and child.

If the drug was used immediately before delivery or during breastfeeding, then newborns should be carefully monitored for several days after birth and during the entire period of treatment of nursing mothers with Oftan® Timolol.

 Use in children

Due to the lack of data on efficacy and safety, the use of the drug in children and adolescents under 18 years of age is contraindicated.

Contraindications

Timolol should not be prescribed for the treatment of patients under 18 years of age, suffering from bronchial asthma, chronic obstructive pulmonary diseases, sinus bradycardia, atrioventricular block II-III stages, chronic heart failure in the stage of decompensation, cardiogenic shock, corneal dystrophic changes. Do not use if hypersensitivity to any of the components of the drug occurs.

Special care should be taken when using Timolol in patients with hypotension, sinoatrial blockades of stage II – III, atrophic rhinitis, pulmonary insufficiency, severe cerebrovascular disorders, diabetes mellitus, myasthenia gravis, thyrotoxic goiter, pheochromocytoma, Raynaud’s syndrome, during pregnancy or breastfeeding.

Concomitant use of other beta-blockers and psychoactive drugs that increase the release of epinephrine.

Side effects

 From the side of the organ of vision: blurred vision, irritation and hyperemia of the conjunctiva, burning and itching of the eyes, lacrimation, edema of the corneal epithelium, point surface keratopathy, corneal hypersthesia, dry eye syndrome, blepharitis, conjunctivitis and keratitis. With prolonged use, ptosis may develop and rarely diplopia. When performing fistulizing (penetrating) anti-glaucoma operations, vascular detachment may develop in the postoperative period.

From the cardiovascular system: bradycardia, bradiarrhythmia, decreased blood pressure, collapse, heart block, transient cerebral circulatory disorders, exacerbation of chronic heart failure, chest pain.

From the digestive system: nausea, diarrhea.

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

From the central nervous system and peripheral nervous system: headache, dizziness, weakness, confusion, hallucinations, insomnia, onyrodinia, anxiety, mood changes, paresthesia.

From the skin: alopecia, psoriasis-like rashes and exacerbation of psoriasis.

From the genitourinary system: Peyronie’s disease, decreased potency.

Allergic reactions: generalized or local rash, pruritus.

Other services: myasthenia gravis, ringing in the ears.

Interaction

Concomitant use of Oftan Timolol with eye drops containing epinephrine may cause dilation of the pupil.

With simultaneous use of eye drops containing epinephrine and pilocarpine, it is possible to increase the decrease in intraocular pressure.

Hypotension and bradycardia may worsen when Oftan Timolol is co-administered with calcium antagonists, reserpine, and systemic beta-blockers.

Inhibitors of the CYP2D6 isoenzyme, such as quinidine and cimetidine, can increase the concentration of timolol in plasma.

Concomitant use with insulin or oral antidiabetic agents may result in hypoglycemia.

Timolol enhances the effect of muscle relaxants, so it is necessary to cancel the drug 48 hours before the planned surgical intervention under general anesthesia. These data may also apply to medications that were used shortly before.

How to take, course of use and dosage

At the beginning of treatment,1-2 drops are prescribed in the affected eye 2 times a day.

If intraocular pressure normalizes with regular use, the dose should be reduced to 1 drop 1 time / day in the morning.

Treatment with Oftan Timolol is usually carried out for a long time. A break in treatment or a change in the dosage of the drug is carried out only on the instructions of the attending physician.

Overdose

Symptoms: it is possible to develop systemic effects characteristic of beta-blockers (dizziness, headache, arrhythmia, bradycardia, bronchospasm, nausea and vomiting).

Treatment: immediately flush eyes with water or saline, symptomatic therapy.

Special instructions

Visual disturbances, dizziness and fatigue may occasionally occur when using Oftan Timolol eye drops.

Monitoring the effectiveness of the drug is recommended to be carried out approximately 3-4 weeks after the start of therapy (not earlier than 1-2 weeks). With prolonged use of timolol, the effect may weaken.

When combined with beta-blockers, calcium channel blockers, excessive pressure reduction may occur. When using the drug Oftan Timolol at least 1 time in 6 months, the function of lacrimation, the integrity of the cornea, and the field of vision should be monitored.

Oftan Timolol contains the preservative benzalkonium chloride, which can cause eye irritation, be absorbed by soft contact lenses, causing discoloration, and have an adverse effect on eye tissue. Contact lenses should be removed before applying the drug and, if necessary, re-installed no earlier than 15 minutes after instillation.

When transferring patients to timolol treatment, correction of refractive changes caused by previously used myotics may be required.

With caution, Oftan Timolol is prescribed to patients with impaired liver function, kidney function, and diabetes mellitus.

In case of an upcoming surgical intervention under general anesthesia, it is necessary to cancel the drug 48 hours before the operation, since timolol enhances the effect of muscle relaxants and general anesthetics.

Do not put two different beta-blockers in the same eye.

Influence on the ability to drive motor vehicles and manage mechanisms

During treatment, care should be taken when driving vehicles and when working with complex equipment that requires increased concentration of attention, speed of psychomotor reactions and good vision (within 30 minutes after instillation in the eye), because the drug can reduce blood pressure, cause fatigue and dizziness.

Form of production

Eye drops in the form of a clear colorless solution.

Storage conditions

At a temperature of 15-25 °C

Shelf life

3 years

Active ingredient

Timolol

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Purpose

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

Indications

Glaucoma