Travatan eye drops 40 µg/ml 2.5ml, 3pcs

Composition

Pharmacological action

Pharmacodynamics

Travoprost, a synthetic analog of PGF2a, is a highly selective agonist of prostaglandin FP receptors and reduces the risk of cancer. IOP by increasing the outflow of aqueous humor through the trabecular meshwork and uveoscleral pathways.

IOP decreases approximately 2 hours after application, and the maximum effect is achieved after 12 hours. Significant reduction IOP may persist for 24 hours after a single dose of the drug.

Pharmacokinetics

Travoprost is absorbed through the cornea of the eye, where travoprost is hydrolyzed to a biologically active form-free travoprost acid.

Cmax of_travoprost free acid in blood plasma is reached within 10-30 minutes after topical application and is 25 pg / ml or less.

Travoprost free acid is rapidly eliminated from the plasma, and within an hour the concentration decreases below the detection threshold (less than 10 pg / ml). T_1/2 of travoprost free acid in humans could not be determined due to its low plasma concentration and rapid elimination from the body after topical application of the drug.

Metabolism is the main route of elimination of travoprost and travoprost free acid. The pathways of systemic metabolism are parallel to the pathways of endogenous PHF2a metabolism, which are characterized by the reduction of double bond 13-14, oxidation of the 15th hydroxyl group, and beta-oxidative cleavage of the upper side chain link. Travoprost free acid and its metabolites are mainly excreted by the kidneys.

No dose adjustment is required in patients with mild to severe hepatic impairment, or in patients with mild to severe renal impairment (with creatinine clearance below 14 ml / min).

Indications

Reduction of elevated intraocular pressure in patients with:

— open-angle glaucoma—

– increased ophthalmotonus.

Contraindications

-pregnancy;

– lactation (breastfeeding);

– children and adolescents under 18 years of age;

– hypersensitivity to the components of the drug.

With caution, the drug should be prescribed to patients with aphakia; pseudophakia in case of rupture of the posterior lens capsule or anterior intraocular lens; the risk of developing cystic macular edema; acute inflammatory phenomena of the visual organ, as well as patients with the risk of developing iritis, uveitis.

Side effects

According to clinical studies the most common adverse events were conjunctival injection and hyperpigmentation of the iris, the frequency of occurrence were, respectively,20% and 6%.

The frequency of adverse reactions is given in accordance with the following classification: very often (≥1/10), often (from ≥1/100 to <1/10), infrequently (≥1/1,000 to <1/100), rarely (from ≥1/10,000 to <1/1000), very rare (<1/10 000), the frequency is unknown. In each group of adverse events by frequency, adverse events are presented in order of decreasing severity. Data on adverse events were obtained during clinical studies and post-marketing surveillance.

Infectious and parasitic diseases:  rarely – herpetic keratitis, an infectious lesion caused by Herpes simplex.

From the immune system:  infrequently – hypersensitivity, seasonal allergies.

Mental disorders:  frequency unknown-depression, anxiety.

Nervous system disorders:  infrequently-headache, dizziness; rarely-dysgeusia.

From the side of the visual organ:  very often – conjunctival injection; often – hyperpigmentation of the iris, eye pain, eye discomfort, dry eye syndrome, eye irritation; infrequently – corneal erosion, uveitis, iritis, keratitis, spot keratitis, photophobia, blepharitis, eye discharge, erythema of the eyelids, periorbital edema, itching of the eyelids, decreased visual acuity, blurred vision, lacrimation, conjunctivitis, ectropion, cataracts, crusts on the edges of the eyelids, increased eyelash growth, discoloration of the eyelashes, asthenopia; rarely – photopsia, eczema of the eyelids, conjunctival edema, the appearance of iridescent circles around light sources, conjunctival folliculosis, eye hypesthesia, meibomitis, pigment dispersion in the anterior chamber of the eye, mydriasis, thickening of the eyelashes; frequency unknown – macular edema, occlusion of the eyeballs.

Hearing disorders and labyrinth disorders:  frequency unknown-vertigo, tinnitus.

From the cardiovascular system:  infrequently-palpitation sensation; rarely-irregular heartbeat, decreased heart rate; rarely-decreased diastolic blood pressure, increased systolic blood pressure, hypotension, hypertension; frequency unknown-chest pain, bradycardia, tachycardia.

Respiratory system disorders:  infrequently-dyspnoea, asthma, nasal congestion, throat irritation; rarely-respiratory function disorders, oropharyngeal pain, cough, dysphonia; frequency unknown – worsening of the course of bronchial asthma.

From the digestive system:  rarely-constipation, dry mouth, exacerbation of stomach ulcers, gastrointestinal disorders; frequency unknown-diarrhea, abdominal pain, nausea.

Skin and subcutaneous tissue disorders:  infrequently-increased skin pigmentation in the periorbital area, skin discoloration, change in the structure of downy hair, hypertrichosis; rarely-allergic dermatitis, contact dermatitis, erythema, rash, change in the color of downy hair, madarosis; frequency unknown-itching, abnormal growth of downy hair.

Musculoskeletal disorders:  rarely-musculoskeletal pain; frequency unknown-arthralgia.

From the urinary system:  frequency unknown-dysuria, urinary incontinence.

Laboratory data:  frequency unknown-increased total PSA.

Other services:  rarely-asthenia.

Profile of adverse events in pediatric practice

During a 3-month phase III study and a 7-day pharmacokinetic study involving 102 paediatric patients, the adverse event profile was consistent with that of adult patients. Short-term safety profiles in different subpopulations of the pediatric population were also similar.

The most common adverse reactions in the pediatric population were conjunctival injection (16.9%) and increased eyelash growth (6.5%). In a similar 3-month study in adult patients, these adverse events occurred with a frequency of 11.4% and 0.0%, respectively. Additionally, isolated cases of eyelid erythema, keratitis, lacrimation, and photophobia were observed in patients in the pediatric population (n=77) during a 3-month clinical study similar to that in adult patients (n=185), and the overall incidence of adverse events was 1.3% compared to 0.0% in the adult population.

Interaction

No clinically significant drug interaction has been described.

How to take, course of use and dosage

The drug is applied topically.

Assign 1 drop to the conjunctival sac of the eye (eye) 1 time/day, in the evening. To reduce the risk of developing systemic side effects, it is recommended to pinch the nasolacrimal canal after instillation of the drug by pressing in the area of its projection at the inner corner of the eye.

If a dose of the drug was missed, 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.

Travatan® 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.

In the event that the drug Travatan® It is prescribed as a substitute for another ophthalmic drug for the treatment of glaucoma, the latter should be discontinued, and Travatan®should be started the next day.

Dose adjustment in patients with mild to severe hepatic impairment, as well as in patients with impaired renal function, from mild to severe (with creatinine clearance below 14 ml / min) not required.

Overdose

Toxicity in case of overdose with topical application is unlikely.

Treatment:  in case of accidental ingestion – symptomatic and supportive therapy. In case of overdose of the drug with topical application, rinse your eyes with warm water.

Special instructions

Changing eye color

Travatan® it can cause a gradual change in eye color due to an increase in the number of melanosomes (pigment granules) in melanocytes. This effect is detected mainly in patients with mixed color of the iris, for example, blue-brown, gray-brown, green-brown or yellow-brown. This effect was also observed in patients with brown color of the iris.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.

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. Before starting treatment, patients should be informed about the possibility of irreversible changes in eye color. If only one eye is treated, persistent heterochromia may develop. After the end of travoprost therapy, there was no further increase in brown pigmentation of the iris.

Changes in the skin of the periorbital area and eyelids

In controlled clinical trials, darkening of the skin of the periorbital area and/or eyelids was observed with Travatan® in 0.4% of patients. Travatan® may gradually change the lashes in the eye that has been treated; these changes include increasing the length, thickness, increased pigmentation, and / or increasing the number of lashes. The mechanism of these changes, as well as their impact on the long-term safety of the drug, is currently not established.

When using prostaglandin analogues, changes in the orbital region and eyelids were noted, including a deepening of the eyelid groove. Information about such changes in the periocular region was obtained during studies on monkeys and was not observed during clinical studies in humans, which allows us to consider this effect as species-specific.

No experience with Travatan® in the treatment of inflammatory diseases of the visual organ, neovascular glaucoma, angle-closure glaucoma, in patients with narrow-angle glaucoma or congenital glaucoma. Limited data are available on the use of the drug in the treatment of ocular manifestations of thyroid diseases, open-angle glaucoma with concomitant pseudophakia, pigmented glaucoma, pseudoexfoliative glaucoma.

Patients with aphakia

Macular edema was observed during treatment with prostaglandin F2a analogues.

Skin contact

It is necessary to avoid contact of the drug with the skin, because in experiments on rabbits, percutaneous absorption of travoprost was demonstrated.

Contact Lenses

Before using Travatan® contact lenses should be removed and replaced no earlier than 15 minutes after applying the drug.

Auxiliary substances

The drug contains propylene glycol, which can cause skin irritation.

The drug contains macrogol glycerylhydroxystearate, which can cause reactions from the skin.

Use in pediatrics

Information on the efficacy and safety of the drug in the age group from 2 months to 3 years and older is limited. Information on the use of the drug in patients under 2 months of age is not available. In patients over 3 years of age who most often receive antihypertensive therapy due to primary congenital glaucoma, surgical treatment (trabeculotomy/goniotomy) remains the first-line therapy. There is no information on the long-term safety of the drug in the pediatric population.

Security measures

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.

Influence on the ability to drive motor vehicles and manage mechanisms

Temporary blurred vision or other visual disturbances after using the drug may affect the ability to drive a car or operate mechanisms. If blurred vision occurs after instillation of the drug, then before driving vehicles or operating mechanisms, the patient should wait for the restoration of visual clarity.

Storage conditions

The drug should be stored out of the reach of children at a temperature of 2° to 30°C. Shelf life – 2 years. Do not use after the expiration date indicated on the package.

After opening the bottle, the eye drops should be used for 4 weeks.

Active ingredient

Travoprost

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Purpose

For adults as directed by your doctor

Indications

Glaucoma