DuoTrav, eye drops, 2.5ml

Composition

1 ml of the solution contains:

Main active substances:

travoprost-40 mcg;

timolol-5 mg;

Auxiliary components:

benzalkonium chloride,

boric acid,

disodium edetate,

macrogol glycerylhydroxystearate,

mannitol,

trometamol and / or hydrochloric acid,

purified water.

Pharmacological action

The properties of the drug are due to the action of the components of travoprost and timolol included in it.

Travoprost is a highly selective agonist of prostaglandin FP receptors, is a synthetic analog of prostaglandin F2-alpha, and is able to reduce intraocular pressure by improving the outflow of aqueous humor (increasing uveoscleral outflow). It does not significantly affect the production of watery moisture.

Timolol is a non-selective beta-adrenergic blocker. It does not exhibit sympathomimetic activity, does not have a membrane-stabilizing effect, and does not have a depressing effect on the myocardium. When applied topically, timolol reduces intraocular pressure, suppressing the formation of watery moisture, and also slightly activates its outflow.

A decrease in intraocular pressure occurs approximately two hours after application, the peak effect is observed after 12 hours. With a single application of the drug, a significant reduction in blood pressure persists for 24 hours.

Pharmacokinetics

Travoprost and timolol are absorbed through the cornea of the eye. In the cornea, herbogrost is hydrolyzed to a biologically active form – travoprost acid.

Travoprost after topical application is rapidly eliminated from the plasma within an hour -the concentration in the blood plasma decreases below the detection threshold-less than 0.01 ng / ml (can vary from 0.011 to 0.02 ng/ml). The cmax of timolol in blood plasma is 0.692 ng / ml and remains up to the detection threshold for 12 hours, and the Tmax of timolol is reached within an hour after topical application. T1 / 2 of timolol is 4 hours after topical application of Duotrav. Travoprost is mainly excreted as inactive metabolites in the bile (61%). Travoprost free acid and its metabolites are excreted by the kidneys. Less than 2% of travoprost is found in the urine as free acid.

Timolol and the resulting metabolites are mainly excreted by the kidneys. About 20% of timolol is excreted unchanged, with the remainder as metabolites.

Indications

• Lowering of intraocular pressure.
• Therapy of open-angle glaucoma.

Use during pregnancy and lactation

It is contraindicated in pregnant women and during breastfeeding, children and adolescents under 18 years of age.

Contraindications

• Hypersensitivity to the components.
• Bronchial asthma (and a history of it), COPD, bronchial hyperreactivity.
• Atrioventricular block, chronic heart failure (in the stage of decompensation), cardiogenic shock.
• Severe course of allergic rhinitis.
• Corneal dystrophy.
• Individual intolerance to beta-blockers.
• The period of pregnancy and lactation.
• Under 18 years of age.

DuoTrav is prescribed with caution when:

Neovascular, closed-angle, narrow-angle glaucoma, pigmented or congenital glaucoma, open-angle glaucoma accompanied by pseudoaphakia, pseudoexfoliative glaucoma; ophthalmic inflammatory diseases; aphakia and pseudophakia with rupture of the posterior lens capsule, as well as patients with a probability of developing cystic macular edema, uveitis or iritis.

Beta-blockers are also prescribed with caution in patients with diabetes mellitus or a tendency to hypoglycemia, since these drugs mask the symptoms of acute hypoglycemia.

In addition, they can mask the signs of hyperthyroidism and provoke central and peripheral circulatory disorders, hypotension. Beta-blockers are being phased out (gradually!) before elective surgery, because together with general anesthesia, they can reduce the sensitivity of the myocardium to sympathetic stimulation, which is necessary for cardiac activity.

Side effects

Local effects:

Conjunctival hyperemia, eye irritation. Pinpoint keratitis, anterior eye chamber effusions, pain and itching at the site of application, photophobia, conjunctival hemorrhages, discomfort in the eye, corneal erosion, decreased visual acuity, blurred vision, dry eyes, allergic conjunctivitis, increased lacrimation, eyelid erythema, eyelid irritation, eyelid dermatitis, priorbital hyperpigmentation of the skin, asthenopia, changes in the color and length of eyelashes, blepharitis, allergic reactions.

System effects:

General anxiety, headache, dizziness, high or low blood pressure, arrhythmia, bradycardia, bronchospasm, urticaria, joint pain.

Shortness of breath, irritation of the larynx, cough, increased levels of alanine aminotransferase or aspartate aminotransferase, contact dermatitis, thirst, change in urine color, postnasal congestion syndrome. Corneal damage, chest pain, tachycardia.

Interaction

Interaction studies with other drugs have not been conducted.

There is a possibility of increasing the hypotensive effect and/or the development of severe bradycardia when timolol is co-administered with oral calcium channel blockers, guanethidine, beta-blockers, antiarrhythmic drugs, cardiac glycosides and parasympathomimetics.

The development of hypertension after abrupt withdrawal of clonidine may increase with simultaneous use of beta-blockers.

Beta-blockers may enhance the hypoglycemic effect of antidiabetic agents. Beta-blockers can mask the symptoms of hypoglycemia.

DuoTrav can be used in combination with other topical ophthalmic medications to reduce intraocular pressure.

In this case, the interval between their use should be at least 5 minutes. Simultaneous use of two local beta-blockers or two local prostaglandin analogues is not recommended.

How to take, course of use and dosage

DuoTrav is prescribed 1 drop conjunctivally once a day, at a certain time: in the morning or in the evening.

To reduce the risk of systemic side effects after instillation of Duotrav, it is recommended to briefly pinch the nasolacrimal canals by pressing into the inner corner of the eye.

If you miss a dose of the drug, treatment continues with the next dose. Do not exceed the daily dose (1 drop-in one eye).

Overdose

Symptoms: irritation of the eye mucosa, hyperemia of the conjunctiva or episclera, bradycardia, decreased blood pressure, bronchospasm and cardiac arrest.

Treatment: it is recommended to immediately flush the groove with water and conduct symptomatic therapy. Hemodialysis is ineffective.

Special instructions

Anaphylactic reactions

Patients with a history of atopic or severe anaphylactic reactions to various allergens who are receiving beta-blockers may be resistant to conventional doses of epinephrine in the treatment of anaphylactic reactions.

System effects

Travoprost and timolol may be subject to systemic absorption. Timolol, when used topically, can cause the same side effects from the cardiovascular and respiratory systems as systemic beta-blockers. The patient’s condition should be monitored before and during timolol therapy. Cases of severe respiratory and cardiovascular disorders have been described, including death from bronchospasm in patients with asthma and death from heart failure when using timolol.

Beta-blockers should be used with caution in patients with a tendency to hypoglycemia or diabetes (especially with labile diabetes), since these drugs can mask the symptoms of acute hypoglycemia.

Beta-blockers can mask the symptoms of hyperthyroidism and cause peripheral and central circulatory disorders and hypotension, as well as deterioration in Prinzmetal angina. Before elective surgery, beta-blockers should be taken gradually (not simultaneously!) they are canceled 48 hours before general anesthesia, because during general anesthesia they can reduce the sensitivity of the myocardium to sympathetic stimulation necessary for heart function.

Local action

Travoprost can cause a gradual change in eye color due to an increase in the amount of brown pigment in melanocytes. Before starting treatment, patients should be informed about the possibility of changing eye color. Treating only one eye can lead to permanent heterochromia.

The long-term effect on melanocytes and the consequences of this effect are currently unknown. The change in the color of the iris of the eye is slow and can go unnoticed for a number of months or years. This effect is mainly found in patients with mixed iris color, such as blue-brown, gray-brown, green-brown or yellow-brown; however, it can also be observed in patients with brown eyes.

Usually, brown pigmentation spreads concentrically around the pupil to the periphery of the iris, and the entire iris or parts of it may turn a more intense brown color. After discontinuation of the drug, there was no further increase in the amount of brown pigment, but the color change that has already developed may be irreversible.

The drug may cause darkening, thickening and lengthening of the eyelashes/or an increase in their number; rarely – darkening of the skin of the eyelids. The mechanism for these changes is not currently established.

The product contains the preservative benzalkonium chloride, which can be absorbed by contact lenses. Before using the drug, the lenses should be removed and replaced no earlier than 15 minutes after using the drug. If the patient’s visual clarity is temporarily reduced after using the drug, it is not recommended to drive a car or engage in activities that require increased attention until it is restored.

Do not touch the tip of the dropper bottle to any surface to avoid contamination of the dropper bottle and its contents. The bottle must be closed after each use.

Form of production

Eye drops.

Storage conditions

At a temperature of 2-25 °C

Shelf life

3 years

Active ingredient

Travoprost, Timolol

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Purpose

For adults as directed by your doctor

Indications

Glaucoma