DuoTrav, eye drops 2.5ml

The properties of the drug are due to the action of its constituents travoprost and timolol.

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 aqueous outflow (increase uveoscleral outflow). It has no significant effect on aqueous humor production.

Timolol is a non-selective beta-adrenoreceptor blocker. It does not exhibit sympathomimetic activity, has no membrane stabilizing effect and has no depressant effect on the myocardium. When used topically, timolol reduces intraocular pressure by inhibiting the formation of aqueous humor, and slightly activates its outflow.

The decrease in intraocular pressure occurs approximately two hours after administration, with peak effect observed after 12 hours. A significant decrease in pressure is maintained for 24 hours after a single use of the drug.

Pharmacokinetics

Travoprost and timolol are absorbed through the cornea. In the cornea there is hydrolysis of travoprost to the biologically active form – acid travoprost.

Travoprost after topical administration is rapidly eliminated from plasma within one hour – plasma concentration decreases below the detection threshold – less than 0.01 ng/ml (can vary from 0.011 to 0.02 ng/ml). The plasma Cmax of timolol is 0.692 ng/ml and persists to the detection threshold for 12 h, and the Tmax of timolol is reached within one hour after topical administration. The T1/2 of timolol is 4 h after topical administration of DuoTrav. Travoprost is excreted as inactive metabolites mainly in the bile (61%). Free acid of travoprost and its metabolites are excreted by the kidneys. Less than 2% of hervoprost is detected in the urine as free acid.

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

Indications

Active ingredient

Composition

1 ml of the solution contains:

Main active ingredients:

Travoprost – 40 mcg;

Timolol – 5 mg;

Associate components:

benzalkonium chloride,

boric acid,

dietate disodium,

macrogoal glyceryl hydroxystearate,

mannitol,

tromethamol and/or hydrochloric acid,

purified water.

How to take, the dosage

Duotrav is administered 1 drop conjunctivally once a day, at a specific time: in the morning or in the evening.

In order to reduce the risk of systemic side effects after instillation of Duotrav, it is recommended that the nasolacrimal ducts be briefly squeezed by applying pressure to the inner corner of the eye.

If a dose is missed, treatment continues with the next dose. The daily dose (1 drop in one eye) should not be exceeded.

Interaction

There have been no studies on interaction with other drugs.

There is a possibility of increased hypotensive effect and/or development of marked bradycardia when using timolol simultaneously with oral calcium channel blockers, guanethidine, beta-adrenoblockers, antiarrhythmic drugs, cardiac glycosides and parasympathomimetics.

The development of hypertension after abrupt withdrawal of clonidine may increase with concomitant administration of beta-adrenal blockers.

Beta-adrenoblockers may increase the hypoglycemic effect of antidiabetic agents. Beta-adrenoblockers may mask the symptoms of hypoglycemia.

DuoTrav may be used in combination with other topical ophthalmic drugs to reduce intraocular pressure.

In this case, the interval between applications should be at least 5 minutes. The simultaneous use of two local beta-adrenoblockers or two local prostaglandin analogues is not recommended.

Special Instructions

Anaphylactic reactions

Patients with atopy or a history of severe anaphylactic reactions to various allergens receiving beta-adrenoblockers may be resistant to the usual doses of adrenaline in the treatment of anaphylactic reactions.

Systemic effects

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

Beta-adrenoblockers should be prescribed with caution in patients with a predisposition to hypoglycemia or diabetes (especially labile diabetes) because these drugs may mask symptoms of acute hypoglycemia.

Beta-adrenoblockers can mask symptoms of hyperthyroidism and cause peripheral and central circulatory disturbances and hypotension, as well as worsening in Prinzmetal angina. Prior to elective surgery, beta-adrenoblockers should be gradually (not overnight!) withdrawn 48 hours prior to general anesthesia, because during general anesthesia they may decrease myocardial sensitivity to sympathetic stimulation necessary for cardiac function.

Local effects

Travoprost may cause a gradual change in eye color by increasing the amount of brown pigment in melanocytes. Patients should be advised of the possibility of eye discoloration before starting treatment. Treatment of only one eye may lead to permanent heterochromia.

The long-term effects on melanocytes and the consequences of these effects are currently unknown. The change in iris color occurs slowly and may go undetected for a number of months or years. This effect is predominantly seen in patients with mixed iris coloration, such as blue-brown, gray-brown, green-brown, or yellow-brown; however, it can also be seen in patients with brown eyes.

Brown pigmentation usually spreads concentrically around the pupil to the periphery of the iris, and all or parts of the iris may become more intense brown. No further increase in brown pigment has been observed after withdrawal of the drug, but the color change that has already developed may be irreversible.

The drug may cause darkening, thickening and lengthening of the eyelashes and/or an increase in their number; rarely, darkening of the eyelid skin. The mechanism of these changes is currently unknown.

The drug contains the preservative benzalkonium chloride which may be absorbed by the contact lenses. Before using the drug the lenses shall be taken off and put back on not earlier than 15 minutes after application of the drug. If after the use of the drug the patient’s vision is temporarily reduced, until its recovery it is not recommended to drive a car and engage in activities requiring high attention.

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

Contraindications

DuoTrav is prescribed with caution in:

Neovascular, closed-angle, narrow-angle glaucoma, pigmented or congenital glaucoma, open-angle glaucoma accompanied by pseudoaphakia, pseudoexfoliative glaucoma; Inflammatory ophthalmic diseases; aphakia and pseudophakia with rupture of the posterior lens capsule; and patients at risk for cystic macular edema, uveitis, or iritis.

Beta-adrenoblockers are also used with caution in patients with diabetes mellitus or a history of hypoglycemia, as these agents mask the symptoms of severe hypoglycemia.

In addition, they may mask symptoms of hyperthyroidism and induce central and peripheral circulatory disturbances and hypotension. Beta-adrenoblockers are withdrawn (gradually!) before planned surgical interventions, 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, ocular irritation. Dot keratitis, effusion into the anterior ocular chamber, pain and itching at the site of application, photophobia, conjunctival hemorrhages, feeling of discomfort in the eye, corneal erosion, decreased visual acuity, feeling of shroud before the eyes, visual disturbances, Dry eyes, allergic conjunctivitis, increased lacrimation, erythema of the eyelids, eyelid irritation, dermatitis, orbital skin hyperpigmentation, asthenopia, changes in color and lash length, blepharitis, allergic reactions.

Systemic effects:

General restlessness, headache, dizziness, increased or decreased blood pressure, arrhythmia, bradycardia, bronchospasm, urticaria, joint pain.

Dyspnea, laryngeal irritation, cough, increased alanine aminotransferase or aspartate aminotransferase levels, contact dermatitis, feeling thirsty, color changes in urine, postnasal drip syndrome. Corneal lesions, chest pain, tachycardia.

Overdose

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

Treatment: immediate pasal irrigation with water and symptomatic therapy are recommended. Hemodialysis is ineffective.

Pregnancy use