Composition, form of production and packaging
Eye drops 1 ml
timolol (in the form of maleate) 5 mg
travoprost 40 mcg
2.5 ml - dropper plastic Drop Tainer (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
Travoprost, a synthetic analogue of prostaglandin F2-alpha, is a highly selective agonist of prostaglandin FP receptors and reduces intraocular pressure by increasing the outflow of aqueous humor. The main mechanism of action of the drug is associated with an increase in out-scleral outflow. Has no significant effect on the production of aqueous humor.
Timolol is a non-selective beta-adrenergic blocker without sympathomimetic activity, does not have a direct depressive effect on the myocardium, does not have membrane-stabilizing activity. With topical application reduces intraocular pressure by reducing the formation of watery moisture and a slight increase in its outflow.
Intraocular pressure decreases approximately 2 hours after application, and the maximum effect is achieved after 12 hours. A significant decrease in intraocular pressure can persist for 24 hours after a single application of the drug.
Travoprost and timolol are absorbed through the cornea of вЂ‹вЂ‹the eye. In the cornea, the hydrolysis of the grasshoproot occurs to a biologically active form, the acid of travoprost.
Travoprost after local application is rapidly excreted from the plasma for an hour - the concentration in the blood plasma drops below the detection threshold - less than 0.01 ng / ml (it can vary from 0.011 to 0.02 ng / ml). C max timolol in blood plasma is 0.692 ng / ml and remains until the detection threshold for 12 hours, and Timaxol's timax is reached within one hour after topical application. T 1/2 of timolol is 4 hours after topical application of DuoTrava. Travoprost is excreted as inactive metabolites mainly with bile (61%). The free acid of travoprost and its metabolites are excreted by the kidneys. Less than 2% of travoprost is found in the urine as a free acid.
Timolol and the resulting metabolites are excreted mainly by the kidneys. About 20% of timolol is excreted unchanged, the rest - in the form of metabolites.
- Decreased increased intraocular pressure in open-angle glaucoma and intraocular hypertension in patients resistant to monotherapy with beta-blockers and or prostaglandin analogues.
The drug is instilled in 1 drop in the conjunctival sac of the eye 1 time / day, in the evening or in the morning at the same time.
To reduce the risk of developing systemic side effects, it is recommended after the installation of the drug to squeeze the nasolacrimal canal by pressing in the area of вЂ‹вЂ‹its projection at the inner corner of the eye.
If the dose has been missed, then the treatment should be continued with the next dose. The daily dose of the drug should not exceed 1 drop in the conjunctival sac of the eye 1 time / day.
Local. In 10% of cases, eye irritation and conjunctival hyperemia are observed. In 1-10% of cases - spot keratitis, effusion to the anterior chamber of the eye, pain and itching in the eyes, photophobia, conjunctival hemorrhages, corneal erosion, a feeling of discomfort and foreign body sensations, decreased visual acuity, visual impairment, blurred vision, dry eyes , development of allergic conjunctivitis, increased lacrimation, eyelid irritation, erythema eyelids, dermatitis of the eyelids, hyperpigmentation of the skin (periorbital), asthenopia, darkening, thickening and lengthening of eyelashes, blepharitis.
In 0.1-1% of cases - soreness, itching and edema of the eyelids, allergic reactions, edema of the conjunctiva, keratitis.
Systemic side effects. In 1-10% of cases - general anxiety, dizziness, headache, increase or decrease in blood pressure, bradycardia, arrhythmia, bronchospasm, urticaria, pain in the extremities.
In 0.1-1% of cases - dyspnea, cough, irritation of the larynx, increase in the level of alanine aminotransferase and aspartate aminotransferase, contact dermatitis, changes in urine color, thirst, and postnasal edema syndrome. Possible side effects (frequency unknown) are: corneal damage, tachycardia, chest pain.
Travoprost: macular edema, uveitis, iritis, conjunctivitis, conjunctival follicles, crust formation on the edges of the eyelids, increased iris pigmentation, bronchial asthma, skin peeling.
Timolol: diplopia, conjunctivitis, ptosis of the century, hypoglycemia, depression, cerebrovascular disorders, cerebral ischemia, syncope, paresthesia, myasthenia gravis, cardiac arrest, arrhythmias, heart failure, atrioventricular blockade, palpitation, respiratory failure, nasal congestion, diarrhea, nausea, rash , alopecia, chest pain, asthenia.
- bronchial asthma;
- history of bronchial asthma;
severe chronic obstructive pulmonary disease;
- hyperreactivity of the bronchi;
- sinus bradycardia;
- atrioventricular blockade of II-III degree;
Decompensated chronic heart failure;
- cardiogenic shock;
- Allergic rhinitis of severe course;
- corneal dystrophy;
- hypersensitivity to a group of beta-blockers;
- the period of breastfeeding;
- children's age till 18 years;
hypersensitivity to the components of the drug.
Neovascular, closed-angle, narrow-angle glaucoma, pigmented and congenital glaucoma, open-angle glaucoma with pseudo-aphasia, pseudo-reflexive glaucoma;ophthalmic inflammatory diseases; aphakia, pseudofakia with a rupture of the posterior capsule of the lens, patients at risk of developing cystoid macular edema, iritis, uveitis.
PREGNANCY AND LACTATION
Contraindicated during pregnancy and during breastfeeding.
APPLICATION FOR CHILDREN
Contraindicated in children under 18 years.
Patients with atopy or with severe anaphylactic reactions to various allergens in a history who receive beta-blockers may be resistant to conventional doses of epinephrine in the treatment of anaphylactic reactions.
Travoprost and timolol may undergo systemic absorption. Timolol with local use can cause the same side effects from the cardiovascular and respiratory systems, as well as systemic beta-blockers. It is necessary to monitor the patient's condition before and during therapy with timolol. Cases of severe respiratory and cardiovascular disorders, including death from bronchospasm in patients with bronchial asthma and death from heart failure with timolol, are described.
Beta-blockers should be used with caution in patients with a tendency to hypoglycemia or diabetes (especially with diabetes mellitus), because these drugs can mask the symptoms of acute hypoglycemia.
Beta-adrenoblockers can mask symptoms of hyperthyroidism and cause peripheral and central circulatory disorders and hypotension, as well as worsening of the condition with Prinzmetal angina pectoris.
Before the planned operation, beta-blockers should be gradually (not instantaneously!) Canceled 48 hours before the general anesthesia, tk. during general anesthesia, they can reduce the sensitivity of the myocardium to sympathetic stimulation necessary for the work of the heart.
Travoprost can cause a gradual change in eye color by increasing the amount of brown pigment in melanocytes. Before starting treatment, patients should be informed about the possibility of changing eye color. Treatment of only one eye can lead to permanent heterochromia. Long-term effects on melanocytes and the effects of this effect are currently unknown. The change in the color of the iris of the eyes is slow and may go unnoticed for a number of months or years. This effect is revealed mainly in patients with mixed iris coloration, for example, blue-brown, gray-brown, green-brown or yellow-brown; However, it can also be observed in patients with brown eyes. Typically, brown pigmentation spreads concentrically around the pupil to the periphery of the iris of the eyes, while the entire iris or parts of it can acquire a more intense brown color. After the drug was discontinued, there was no further increase in the amount of brown pigment, but the already developed color change may be irreversible.
The drug can cause darkening, thickening and lengthening of eyelashes / or an increase in their number; rarely - darkening of the skin of the eyelids. The mechanism of these changes is not currently established.
The drug contains a preservative of benzalkonium chloride, which can be absorbed by contact lenses. Before using the drug, the lens should be removed and installed back no earlier than 15 minutes after the drug is used. If the patient after the application of the drug temporarily reduces the clarity of vision, until it is restored, it is not recommended to drive and engage in activities that require increased attention.
Do not touch the tip of the dropper bottle to any surface to avoid contamination of the dropper and its contents. The bottle must be closed after each use.
Symptoms: irritation of the mucous membrane of the eye, hyperemia of the conjunctiva or episcleras, bradycardia, lowering of arterial pressure, bronchospasm and cardiac arrest.
Treatment: immediate cleansing of the groove with water and symptomatic therapy is recommended. Hemodialysis is ineffective.
Studies on interactions with other drugs have not been conducted.
There is a possibility of intensifying the hypotensive effect and / or development of severe bradycardia with simultaneous use of timolol with calcium channel blockers for oral administration, guanethidine, beta-adrenoblockers, antiarrhythmics, cardiac glycosides and parasympathomimetics.
The development of hypertension after a sharp abolition of clonidine can be enhanced with simultaneous reception of beta-blockers.
Beta-blockers can increase the hypoglycemic effect of antidiabetics. Beta-blockers can mask symptoms of hypoglycemia.
DuoTrav can be used in combination with other local ophthalmic drugs to reduce intraocular pressure. In this case, the interval between their use should be at least 5 minutes.
It is not recommended simultaneous use of two local beta-blockers or two local analogues of prostaglandins!
TERMS OF RELEASE FROM PHARMACY
TERMS AND CONDITIONS OF STORAGE
At a temperature of 2-25 В° C, out of reach of children. Shelf life - 3 years.