Travatan, eye drops 40 mcg/ml 2.5 ml 3 pcs.

Reduction of elevated intraocular pressure in:

– Open-angle glaucoma;

– Increased ophthalmotonus.

Active ingredient

Travoprost

Composition

How to take, the dosage

The drug is used topically.

Prescribe 1 drop into the conjunctival sac of the eye (eye) once a day, in the evening. To decrease the risk of systemic side effects, after instillation of the drug, it is recommended to squeeze the nasolacrimal duct by applying pressure to its projection area at the inner corner of the eye.

If a dose of the drug is 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 once daily.

Travatan® can be used in combination with other topical ophthalmic drugs to reduce intraocular pressure. In this case the interval between their administration should be at least 5 minutes.

If Travatan® is prescribed as a substitute for another ophthalmic glaucoma drug, the latter should be discontinued and Travatan® started the next day.

Dose adjustment is not required in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (with CK values below 14 mL/min).

Interaction

No clinically significant drug interactions have been described.

Special Instructions

Eye color changes

Travatan® may cause a gradual change in eye color by increasing the number of melanosomes (pigment granules) in the melanocytes. This effect is mostly seen in patients with mixed coloration of the iris, such as blue-brown, gray-brown, green-brown, or yellow-brown. This effect has also been noted in patients with brown iris coloration. The brown pigmentation usually spreads concentrically around the pupil to the periphery of the iris, and the entire iris or portions of the iris may become more intense brown.

The long-term effects on melanocytes and the consequences are currently unknown. Changes in iris color occur slowly and may go undetected for months or years. Patients should be informed of the possibility of irreversible discoloration before treatment begins. If only one eye is treated, persistent heterochromia may develop. No further increase in brown iris pigmentation was noted after the end of therapy with travoprost.

In controlled clinical studies, darkening of the periorbital and/or eyelid skin was observed with Travatan® in 0.4% of patients. Travatan® may gradually change the lashes in the treated eye; these changes include increased length, thickness, pigmentation and/or an increase in the number of lashes. The mechanism of these changes, as well as their effect on the long-term safety of the drug, is currently unknown.

In the use of prostaglandin analogues, changes to the orbital area and eyelids, including deepening of the eyelid sulcus, have been noted. This periorbital area change has been reported in monkey studies and has not been seen in human clinical studies, suggesting it is a species-specific effect.

There is no experience with the use of Travatan® in the treatment of inflammatory diseases of the visual organ, neovascular glaucoma, closed angle glaucoma, in patients with narrow angle glaucoma or congenital glaucoma. Limited data are available on the use of the drug in the therapy of ocular manifestations of thyroid disease, open angle glaucoma with concomitant pseudophakia, pigmentary glaucoma, and pseudoexfoliative glaucoma.

Patients with aphakia

In treatment with prostaglandin F2α analogues, macular edema was noted.

Skin contact

Contact of the drug with the skin should be avoided because percutaneous absorption of travoprost has been demonstrated in rabbit experiments.

Contact lenses

Contact lenses should be removed and put back in no earlier than 15 minutes after application of Travatan®.

Excipients

The product contains propylene glycol which may cause skin irritation.

The product contains macrogoal glyceryl hydroxystearate, which may cause skin reactions.

Pediatric use

There is limited information about the efficacy and safety of the drug in the age group of 2 months to 3 years and older. No data are available on the use of the drug in patients less than 2 months of age. In patients over 3 years of age who are more likely to receive hypotensive therapy for primary congenital glaucoma, surgical treatment (trabeculotomy/goniotomy) remains the first-line therapy. There are no data on the long-term safety of the drug in the pediatric population.

Precautionary measures

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.

Impact on driving and operating machinery

Transient blurring of vision or other visual disturbances after use may affect the ability to drive or operate machinery. If blurred vision occurs after dosing the drug, the patient must wait until visual clarity is restored before driving or operating machinery.

Contraindications

– pregnancy;

– lactation period (breast-feeding);

– childhood and adolescence under 18 years of age;

– hypersensitivity to the drug components.

Patients with aphakia; pseudophakia with rupture of the posterior lens capsule or anterior chamber intraocular lens; risk of cystoid macular edema; acute inflammatory phenomena of the visual organ and patients with risk of iritis, uveitis should use the drug with caution.

Side effects

According to clinical studies, the most frequent adverse events were conjunctival injection and iris hyperpigmentation, with an incidence of 20% and 6%, respectively.

The incidence of adverse reactions is given according to the following classification: very common (≥1/10), common (≥1/100 to < 1/10), infrequent (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1000), very rare (< 1/10,000), frequency unknown. In each group of adverse events by frequency, the adverse events are presented in decreasing order of severity. Information on adverse events is obtained from clinical studies and post-registration surveillance.

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

Immune system disorders: infrequent hypersensitivity and seasonal allergy.

Mental disorders: frequency unknown – depression, anxiety.

Nervous system disorders: infrequent – headache, dizziness; rarely – dysgeusia.

An organ of vision: very common – conjunctival injection; common – iris hyperpigmentation, eye pain, eye discomfort, dry eye syndrome, eye irritation; infrequent – corneal erosion, uveitis, iritis, keratitis, pitting keratitis, photophobia, blepharitis, ocular discharge, erythema of eyelids, periorbital edema, itching of eyelids, decreased visual acuity, blurred vision, lacrimation, conjunctivitis, ectropion, cataracts, crusts on margins of eyelids, increased lash growth, discolored lashes, asthenopy; rarely – photopsia, eczema of eyelids, conjunctival edema, iridescent circles around light sources, conjunctival folliculosis, eye hypoesthesia, meibomitis, pigment dispersion in the anterior chamber of the eye, mydriasis, thickened eyelashes; frequency unknown – macular edema, retraction of the eyeballs.

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

Cardiovascular system: infrequent – sensation of palpitations; rare – irregular heartbeat, decreased heart rate; rare – decreased diastolic BP, increased systolic BP, hypotension, hypertension; frequency unknown – chest pain, bradycardia, tachycardia.

Respiratory system: infrequent – dyspnea, asthma, nasal congestion, throat irritation; rarely – impaired airway function, oropharyngeal pain, cough, dysphonia; frequency unknown – worsening of bronchial asthma.

The digestive system: rare – constipation, dry mouth, aggravation of gastric ulcer, GI disturbances; frequency unknown – diarrhea, abdominal pain, nausea.

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

Muscular system: rare – musculoskeletal pain; frequency unknown – arthralgia.

The urinary system: frequency unknown – dysuria, urinary incontinence.

Laboratory data: frequency unknown – increase in total PSA.

Others: rare – asthenia.

The adverse event profile in pediatric practice

In a 3-month phase III study and a 7-day pharmacokinetic study involving 102 pediatric patients, the adverse event profile was consistent with that in 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 at rates of 11.4% and 0.0%, respectively. Additionally, in the pediatric population (n=77), a 3-month clinical trial similar to that of adults (n=185) reported a single case of erythema, keratitis, lacrimation, and photophobia with an overall adverse event rate of 1.3% compared to 0.0% in the adult population.

Overdose

Toxicity in overdose with topical administration is unlikely.

Treatment: in case of accidental ingestion – symptomatic and supportive therapy. In case of overdose of the drug during topical administration the eyes should be rinsed with warm water.

Similarities

Travapress, Travoprost-Optic