Travapress Duo drops 5mg / ml + 0.04mg / ml, 2.5ml

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BIDL3181962
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Expiration Date: 11/2025

Russian Pharmacy name:

Травапресс Дуо капли 5мг/мл+0,04мг/мл, 2,5мл

Travapress Duo drops 5mg / ml + 0.04mg / ml, 2.5ml; 'Reduction of increased intraocular pressure in open-angle glaucoma and intraocular hypertension in patients resistant to monotherapy with beta-blockers or prostaglandin analogues.

Locally 1 time / day, at the same time.

To reduce the risk of systemic side effects, it is recommended, after using the agent, to clamp the nasolacrimal canal by pressing in the area of ??its projection at the inner corner of the eye.

The tool can be used in combination with other topical ophthalmic drugs to reduce intraocular pressure. In this case, the interval between their application should be at least 5 minutes.

Eye drops in the form of a clear, colorless solution.

1 ml timolol maleate 6.8 mg,?

which corresponds to the content of timolol 5 mg

travoprost 0.04 mg

Excipients: boric acid - 3 mg, sodium chloride - 2.5 mg, mannitol - 3 mg, macrogol glyceryl hydroxystearate (Collifor RH40) - 1 mg, propylene glycol - 7.5 mg, 1M hydrochloric acid solution or 1M sodium hydroxide solution - up to pH 6.8 ± 0.1 , purified water - up to 1 ml.

  • Hypersensitivity to the components of the product;

  • hypersensitivity to the group of beta-blockers;

  • reactive airway disease, including bronchial asthma (including history), as well as severe COPD;

  • sinus bradycardia, SSS, including sinoatrial block, II or III degree AV block without a pacemaker;

  • decompensated chronic heart failure, cardiogenic shock;

  • severe allergic rhinitis;

  • corneal dystrophy;

  • pregnancy, breastfeeding period;

  • age up to 18 years.

  • With caution Neovascular, angle-closure (narrow-angle) glaucoma, pigmentary and congenital glaucoma, open-angle glaucoma with pseudophakia, pseudoexfoliative glaucoma, acute inflammatory diseases of the organ of vision, in patients with pseudoaphakia with rupture of the posterior lens capsule, or in patients with an anterior chamber lens development of cystic macular edema, iritis, uveitis; in patients with atopy or with severe anaphylactic reactions to various allergens in history; in patients with diabetes mellitus of a labile course and a tendency to hypoglycemia; in patients with hyperthyroidism, Prinzmetal's angina; in patients who are planned to undergo surgical interventions.

pharmachologic effect

Combined product for use in ophthalmology, the action of which is due to the properties of the components that make up its composition Travoprost, a synthetic analogue of prostaglandin F2?, 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 travoprost is associated with an increase in uveoscleral outflow. Does not significantly affect the production of aqueous humor. Timolol is a non-selective blocker of ?-adrenergic receptors without sympathomimetic activity, does not have a direct depressive effect on the myocardium, and does not have membrane stabilizing activity. When applied topically, it reduces intraocular pressure by reducing the formation of aqueous humor and a slight increase in its outflow.Due to the complementary mechanisms of action of both components, the decrease in intraocular pressure under the influence of the combination is more significant than with the action of each of these components separately. 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 agent.

Pharmacokinetics

Travoprost and timolol are absorbed through the cornea of ??the eye. In the cornea, travoprost is hydrolyzed to a biologically active form - travoprost freebord acid. The free acid of travoprost is rapidly excreted from the plasma within an hour - the concentration in the blood plasma decreases below the detection threshold - less than 0.01 ng / ml (it can vary from 0.01 to 0.03 ng / ml). Cmax of timolol in blood plasma is 1.34 ng / ml and remains up to the detection threshold for 12 hours, and Tmax of timolol is reached within 0.69 hours after topical application. T1 / 2 of timolol is 4 hours after topical application of the agent. Metabolism is the main pathway for the elimination of travoprost and free acid and travoprost. The pathways of systemic metabolism are parallel to the pathways of metabolism of endogenous prostaglandin F2?, which are characterized by the restoration of the double bond 13-14,oxidation of the 15-hydroxyl group and ?-oxidative cleavage of the upper side chain unit. The free acid of travoprost and its metabolites are excreted by the kidneys. Less than 2% of travoprost is found in 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.

Side effect

From the immune system: infrequently - hypersensitivity reactions; possibly - systemic allergic reactions, including angioedema, urticaria, local and generalized rash, pruritus, anaphylactic shock. From the side of the psyche: rarely - nervousness; possibly insomnia, nightmares, memory loss; frequency unknown - depression. From the nervous system: infrequently - dizziness, headache; possibly - cerebral ischemia, aggravation of the signs and symptoms of myasthenia gravis; the frequency is unknown - stroke, fainting, paresthesia. From the side of the organ of vision: very often - conjunctival hyperemia; often - punctate keratitis, eye pain, visual disturbances, blurred vision, dry eye syndrome, itchy eyes, eye discomfort, eye irritation (burning sensation, stabbing sensation, itching, lacrimation, conjunctival injection);infrequently - keratitis, iritis, conjunctivitis, inflammation of the anterior chamber of the eye, blepharitis, photophobia (photophobia), decreased visual acuity, asthenopia, eye edema, erythema of the eyelids, increased eyelash growth, eye allergies, conjunctival edema, eyelid edema; rarely - corneal erosion, meibomitis, subconjunctival hemorrhage, the formation of crusts at the edges of the eyelids, trichiasis, distichiasis; possibly - uveitis, disorders of the conjunctiva, folliculosis of the conjunctiva, hyperpigmentation of the iris, detachment of the vitreous body in the postoperative period of fistulizing operations of the organ of vision, decreased sensitivity of the cornea, diplopia; frequency unknown - macular edema, ptosis, corneal pathology. From the side of the cardiovascular system: infrequently - bradycardia, arterial hypertension, arterial hypotension; rarely - arrhythmia, heart rhythm disturbances;possibly - chest pain, congestive heart failure, AV block, cardiac arrest, Raynaud's syndrome, cold extremities; frequency unknown - heart failure, tachycardia, chest pain, palpitations, peripheral edema. From the respiratory system: infrequently - shortness of breath, postnasal syndrome; rarely - dysphonia, bronchospasm, cough, throat irritation, pharyngeal-laryngeal pain, nasal discomfort; possibly - bronchospasm (mainly in patients with existing bronchospastic diseases); frequency unknown - bronchial asthma. From the digestive system: possibly - dysgeusia, dyspepsia, diarrhea, dry mouth, abdominal pain, vomiting; frequency unknown - dysgeusia. From the liver and biliary tract: rarely - an increase in the activity of ALT and AST. On the part of the skin and subcutaneous tissues:infrequently - contact dermatitis, hypertrichosis; rarely - skin discoloration, alopecia, periocular hyperpigmentation of the skin; possibly - peeling of the skin, psoriasiform rash or aggravation of the course of psoriasis; frequency unknown - skin rash. From the musculoskeletal system: rarely - pain in the limbs. From the urinary system: rarely - chromaturia. From the side of metabolism: hypoglycemia is possible. On the part of the reproductive system: possibly - sexual dysfunction, decreased libido. General reactions: rarely - thirst, increased fatigue; possibly asthenia.From the urinary system: rarely - chromaturia. From the side of metabolism: hypoglycemia is possible. From the reproductive system: possibly - sexual dysfunction, decreased libido. General reactions: rarely - thirst, increased fatigue; possibly asthenia.From the urinary system: rarely - chromaturia. From the side of metabolism: hypoglycemia is possible. On the part of the reproductive system: possibly - sexual dysfunction, decreased libido. General reactions: rarely - thirst, increased fatigue; possibly asthenia.

Application during pregnancy and lactation

Pregnancy

Travoprost has a negative pharmacological effect both on the course of pregnancy and on the fetus or newborn. The product has reproductive toxicity. Data on the use of the drug or its components in pregnant women are absent or limited. Epidemiological studies with oral use of beta-blockers did not reveal effects associated with malformations, but indicate the risk of intrauterine growth retardation. In addition, signs and symptoms of beta-adrenergic receptor blocking (eg, bradycardia, hypotension, respiratory depression, hypoglycemia) have been observed in newborns with the use of systemic beta-blockers by the mother before delivery. The use of the drug during pregnancy is contraindicated.If the drug is used before childbirth, careful monitoring of the condition of the newborn in the first days of life should be carried out.

Breastfeeding period

It is not known whether travoprost is excreted in human breast milk. Timolol is excreted in breast milk, which can potentially lead to the development of serious adverse reactions in a breastfed infant. However, when using timolol in therapeutic doses, it is unlikely that a sufficient amount of the drug will be present in breast milk for the development of symptoms of ?-adrenergic receptor blockade in a child.

The use of the drug during breastfeeding is not recommended.

Women with preserved reproductive potential

It is not recommended to use the remedy in women with preserved reproductive potential, except when using reliable contraception.

Application for violations of liver function

The drug is approved for use in case of impaired liver function

Application for impaired renal function

The drug is approved for use in case of impaired renal function

Application in children

The safety and effectiveness of the drug in children and adolescents aged 18 years have not been established. No data available. Contraindicated for use in children and adolescents under the age of 18 years.

special instructions

Like other topical ophthalmic agents, travoprost and timolol are absorbed into the systemic circulation. Due to the presence of timolol in the composition of the drug, which has a beta-adrenergic blocking effect, the development of the same types of adverse reactions from the cardiovascular system, lungs and other organs is possible as when using systemic beta-blockers.

Heart disorders

In patients with diseases of the cardiovascular system (for example, ischemic heart disease, Prinzmetal angina pectoris, heart failure) and arterial hypotension, it is necessary to critically assess the feasibility of using beta-blockers and consider the use of other active substances. In patients with diseases of the cardiovascular system, the presence of signs of a worsening of the course of these diseases and the development of adverse reactions should be assessed. Since beta-blockers have a negative effect on the timing, they should be used with caution in patients with grade I AV block.

Vascular disorders

In patients with severe disorders or diseases of the peripheral circulation (i.e., severe forms of the disease or Raynaud's syndrome), treatment should be carried out with caution.

Breathing disorders

The patient's condition should be monitored before and during therapy with timolol. After using some ophthalmic drugs from the group of beta-blockers, cases of respiratory reactions have been described, including death from bronchospasm in patients suffering from bronchial asthma. In patients with mild to moderate COPD, the drug should be used with caution and only if the intended benefit outweighs the potential risk.

Hypoglycemia / Diabetes Mellitus

In patients prone to the development of spontaneous hypoglycemia, as well as in patients with a labile course of diabetes mellitus, beta-blockers should be used with caution, since they can mask the signs and symptoms of acute hypoglycemia.

Hyperthyroidism

Beta-blockers can mask the signs of hyperthyroidism.

Muscle weakness

It has been reported that beta-blockers can potentiate muscle weakness, which is consistent with certain symptoms of myasthenia gravis (eg, diplopia, ptosis, and generalized muscle weakness).

Corneal diseases

Beta-blockers for ophthalmic use can cause dry eyes. In patients with corneal diseases, the drug should be used with caution.

Detachment of the choroid

In patients who used drugs that suppress the production of aqueous humor (for example, timolol and acetazolamide), cases of detachment of the choroid were noted after fistulizing the organ of vision.

Other beta-blockers

When using timolol in patients who are already using systemic beta-blockers, it is possible to increase the effect on intraocular pressure or other known effects of systemic beta-blockers. The response to therapy in these patients must be carefully monitored. The use of two topical beta-blockers is not recommended.

Skin contact

Prostaglandins and prostaglandin analogs are biologically active substances that can be absorbed through the skin. Women during pregnancy, as well as women planning to become pregnant, should take appropriate precautions to avoid direct skin contact. If a significant portion of the product does come into contact with the skin (which is unlikely), the affected area should be rinsed immediately with water.

Anaphylactic reactions

The use of timolol in patients with atopy or a history of severe pathological reactions to various allergens can provoke more severe reactions in response to the administration of various allergens. Such patients may be poorly responsive to the usual doses of epinephrine to control anaphylactic reactions. Effects on the eyes This remedy can gradually change the color of the eyes by increasing the number of melanosomes (pigment granules) in the melanocytes. Before starting treatment, patients should be informed about the possibility of permanent changes in eye color. Treatment of only one eye can lead to permanent heterochromia. The long-term effects on melanocytes and the consequences of this effect are currently unknown. The color change in the iris is slow and may not be noticeable for months or years.Eye color changes are predominantly observed in patients with mixed iris color (blue-brown, gray-brown, yellow-brown or green-brown), a similar effect was observed in patients with brown eyes. Typically, brown pigmentation around the pupil extends concentrically to the periphery of the iris; in connection with which the entire iris or parts of it acquire a brownish color. After the end of therapy, no further accumulation of brown pigment in the iris was noted. Darkening of the skin of the periorbital region and / or eyelids has been reported with this agent. This remedy can gradually change the condition of the eyelashes in the treated eye (s); these changes include changes in length, thickness, pigmentation and / or number of eyelashes. The mechanism for these changes is currently not clear.During treatment with prostaglandin F2 analogues? noted macular edema. The agent should be used with caution in patients with neovascular, closed-angle (narrow-angle) glaucoma, pigmentary and congenital glaucoma, open-angle glaucoma with pseudophakia, pseudoexfoliative glaucoma, inflammatory diseases of the organ of vision, aphakia, pseudophakia with rupture of the posterior lens capsule of the intracranial lens or anterior chamber patients with risk factors for macular edema, iritis, uveitis. With the use of prostaglandin analogues, changes in the periorbital region and eyelids were noted.pseudoexfoliative glaucoma, inflammatory diseases of the organ of vision, aphakia, pseudophakia with rupture of the posterior lens capsule or anterior chamber intraocular lens, as well as in patients with risk factors for macular edema, iritis, uveitis. With the use of prostaglandin analogues, changes in the periorbital region and eyelids were noted.pseudoexfoliative glaucoma, inflammatory diseases of the organ of vision, aphakia, pseudophakia with rupture of the posterior lens capsule or anterior chamber intraocular lens, as well as in patients with risk factors for macular edema, iritis, uveitis. With the use of prostaglandin analogues, changes in the periorbital region and eyelids were noted.

Anesthesia during surgery

Ophthalmic drugs from the group of beta-blockers can suppress beta-agonistic effects, for example, of adrenaline. The anesthesiologist should be informed if the patient is receiving timolol. Contact lenses Patients should be instructed to remove contact lenses before using this product and wait at least 15 minutes before reusing them.

Influence on the ability to drive vehicles and mechanisms

Temporary blurred vision or other visual impairments after using this product may affect your ability to drive or use machinery. If blurred vision occurs after using the product, then before driving a vehicle or operating machinery, the patient must wait until the clarity of vision is restored.

Drug interactions

During combined treatment with inhibitors of the isoenzyme CYP2D6 (for example, quinidine, fluoxetine, paroxetine) and timolol, there have been cases of increased systemic effect of beta-blockers (for example, decreased heart rate, depression). When using an ophthalmic solution of a beta-blocker simultaneously with calcium channel blockers, beta-blockers, antiarrhythmics (including amiodarone), cardiac glycosides and parasympathomimetics, additive effects may develop, leading to arterial hypotension and (or) severe bradycardia. Against the background of the combined use of beta-blockers and clonidine, rebound arterial hypertension may develop after the abrupt withdrawal of the latter. Beta-blockers can reduce the response to epinephrine, which is used in the treatment of anaphylactic reactions.Particular care should be taken in patients with a history of indications of atopy and anaphylaxis. The simultaneous use of two local beta-blockers or two local analogs of prostaglandins is not recommended. It was reported about the development of mydriasis with the simultaneous use of ophthalmic beta-blockers and adrenaline. Beta-blockers can enhance the effect of hypoglycemic drugs.

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