Travaxal, eye drops 0.04 mg/ml 2.5ml

Pharmacotherapeutic group: Antiglaucoma agent – synthetic prostaglandin F2-alpha analogue.

ATX code: S01EE04

Pharmacological properties

Indications

Reduction of elevated intraocular pressure with:

• open-angle glaucoma;
• increased intraocular pressure.

Pharmacological effect

Pharmacotherapeutic group: Antiglaucoma agent – ​​synthetic prostaglandin F2-alpha analogue.

ATX code: S01EE04

Pharmacological properties

Special instructions

The drug may cause a gradual change in eye color by increasing the number of melanosomes (pigment granules) in melanocytes. This effect is detected mainly in patients with mixed iris color, for example, blue-brown, gray-brown, green-brown or yellow-brown. This effect was also noted in patients with brown irises. Typically, brown pigmentation extends concentrically around the pupil to the periphery of the iris, and all or part of the iris may become a more intense brown color. The long-term effect on melanocytes and the consequences of this influence are currently unknown. Changes in iris color occur slowly and may go unnoticed for months or years. Before starting treatment, patients should be informed about the possibility of permanent changes in eye color. If only one eye is treated, persistent heterochromia may develop. After completion of travoprost therapy, no further increase in brown pigmentation of the iris was observed.

Darkening of the skin of the eyelids and/or periorbital area has been reported in association with travoprost use in 0.4% of patients.

Travoprost may gradually change the structure of the eyelashes of the eye on which it is applied; During clinical studies, such changes were observed in approximately half of patients and included an increase in length, thickness, pigmentation and number of eyelashes. The mechanism of changes in the structure of eyelashes and the long-term consequences of this action are unknown today.

There is no experience with travoprost in inflammatory eye diseases, neovascular glaucoma, angle-closure glaucoma, narrow-angle or congenital glaucoma, and there is only limited experience in eye diseases caused by thyroid dysfunction, glaucoma in pseudophakic patients. with pigmentary or pseudoexfoliative glaucoma.

It is recommended to prescribe the drug with caution to patients with aphakia, pseudophakia, rupture of the posterior capsule of the lens, and with risk factors for the development of cystoid macular edema.

Contact of travoprost with skin should be avoided as studies in rabbits have shown transdermal absorption of travoprost.

The drug should be prescribed with caution to patients with risk factors for the development of iritis/uveitis.

Patients must remove contact lenses before instilling the drug. You must wait 15 minutes after instillation before reinserting contact lenses.

Impact on the ability to drive vehicles and machinery

Temporary blurred vision or other visual disturbances after using the drug may affect the ability to drive vehicles and machines. If blurred vision occurs after instillation of the drug, then the patient must wait until clear vision is restored before driving vehicles and machinery.

Active ingredient

Travoprost

Composition

1 ml of the drug contains:

Active ingredient:

Travoprost – 004 mg,

Excipients:

Mannitol – 46.0 mg,

Macrogol glyceryl hydroxystearate – 5.0 mg,

Boric acid – 3.0 mg,

Trometamol – 1.2 mg,

Benzalkonium chloride – 0.015 mg,

Disodium edetate dihydrate (Trilon B) – 0.1 mg,

8 M sodium hydroxide solution or
8 M hydrochloric acid solution – up to pH 5.5-7.0,

Water for injection – up to 1.0 ml.

Pregnancy

Pregnancy

There are no or limited data on the use of travoprost in pregnant women. Animal studies with travoprost have shown reproductive toxicity. Women during pregnancy, as well as women planning pregnancy, should avoid direct contact with substances containing prostaglandins. Prostaglandins and prostaglandin analogues are biologically active substances that can be absorbed through the skin.

Women during pregnancy, as well as women planning pregnancy, should take appropriate precautions to prevent direct contact of the contents of the bottle with the skin. If a significant portion of the contents of the bottle does come into contact with the skin (which is unlikely), the area of ​​skin on which the drug has come into contact should be immediately rinsed with water.

Breastfeeding period

There is no data on whether travoprost and/or metabolites pass into breast milk.

Fertility

No studies have been conducted to evaluate the effects of travoprost on human fertility. Animal studies have shown that travoprost has no effect on fertility at doses greater than 250 times the maximum recommended human dose.

Contraindications

Hypersensitivity to the components of the drug, children under 18 years of age, pregnancy and breastfeeding.

With caution

The drug should be used with caution in patients with aphakia; in patients with pseudophakia due to rupture of the posterior capsule of the lens or in patients with an anterior chamber intraocular lens; in patients at risk of developing cystoid macular edema.

The drug should be used with caution in patients with acute inflammatory phenomena of the organ of vision, as well as in patients with risk factors predisposing to iritis and uveitis.

Side Effects

The overall profile of adverse reactions from clinical studies showed that the most frequently encountered adverse events were conjunctival injection and iris hyperpigmentation, with an incidence of 20% and 6%, respectively.

Adverse reactions identified during post-registration use of the drug were classified as follows: very often (≥1/10); often (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); very rare (< 1/10000) and frequency unknown (cannot be estimated from available data). Within each group, adverse events are presented in order of decreasing severity. Information about adverse events was obtained during clinical trials and post-registration surveillance.

System-organ class
Frequency of occurrence
Adverse event
Infectious and parasitic diseases
Rarely
Eye infection caused by Herpes simplex, herpetic keratitis
Immune system disorders
Uncommon
Hypersensitivity, seasonal allergies
Mental disorders
With unknown frequency
Depression, anxiety, insomnia
Nervous system disorders
Uncommon
Headache, dizziness, loss of visual fields
Rarely
Dysgeusia
Visual disorders
Very often
Conjunctival injection
Often
Iris hyperpigmentation, eye pain, eye discomfort, dry eye syndrome, eye itching, eye irritation
Uncommon
Corneal erosion, uveitis, iritis, keratitis, punctate keratitis, photophobia, blepharitis, eye discharge, eyelid erythema, periorbital edema, eyelid itching, decreased visual acuity, blurred vision, lacrimation, conjunctivitis, ectropion, cataracts, crusts on the edges of the eyelids, increased eyelash growth, eyelash discoloration, asthenopia, inflammation of the anterior chamber of the eye
Rarely
Photopsia, eczema of the eyelids, conjunctival edema, the appearance of rainbow circles around light sources, conjunctival folliculosis, eye hypoesthesia, meibomianitis, pigment dispersion in the anterior chamber of the eye, mydriasis, thickening of eyelashes, trichiasis, iridocyclitis, inflammation of the eye
With unknown frequency
Macular edema, sunken eyeballs
Disorders of the hearing organ and labyrinth
With unknown frequency
Vertigo, tinnitus
Heart disorders
Uncommon
Feeling of heartbeat
Rarely
Irregular heartbeat, decreased heart rate
With unknown frequency
Chest pain, bradycardia, tachycardia, arrhythmia
Vascular disorders
Rarely
Decreased diastolic blood pressure, increased systolic blood pressure, hypotension, hypertension
Respiratory, thoracic and mediastinal disorders
Uncommon
Dyspnea, asthma, nasal congestion, throat irritation
Rarely
Respiratory dysfunction, pain in the oropharynx, cough, dysphonia, allergic rhinitis
With unknown frequency
Worsening of bronchial asthma, nosebleeds
Gastrointestinal disorders
Rarely
Constipation, dry mouth, exacerbation of stomach ulcers, disruption of the gastrointestinal tract
With unknown frequency
Diarrhea, abdominal pain, nausea, vomiting
Skin and subcutaneous tissue disorders
Uncommon
Increased skin pigmentation in the periorbital area, skin discoloration, changes in the structure of vellus hair, hypertrichosis
Rarely
Allergic dermatitis, contact dermatitis, erythema, rash, discoloration of vellus hair, madarosis
With unknown frequency
Itching, abnormal growth of vellus hair
Musculoskeletal and connective tissue disorders
Rarely
Musculoskeletal pain
With unknown frequency
Arthralgia
Renal and urinary system disorders
With unknown frequency
Dysuria, urinary incontinence
General violations
Rarely
Asthenia
Laboratory abnormalities
With unknown frequency
Increased total prostate specific antigen

Profile of adverse events in pediatric practice

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

The most commonly reported 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 the pediatric population (n=77) during a 3-month clinical trial similar to that of adult patients (n=185), with an overall incidence of adverse events of 1.3% compared with 0.0% in the adult population.

Overdose

Toxicity from overdose when applied topically is unlikely. Treatment for accidental ingestion is symptomatic and supportive.

In case of local overdose of the drug, rinse the eyes with warm water.

Storage conditions

At temperatures from 2 to 8 °C.

Store the opened bottle at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life

3 years. After opening the bottle – 1 month.

Do not use after the expiration date!

Manufacturer

Grotex LLC, Russia