Travoprost (Drops) Instructions for Use

ATC Code

S01EE04 (Travoprost)

Active Substance

Travoprost (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiglaucoma drug – synthetic prostaglandin F2α analogue

Pharmacotherapeutic Group

Drugs used in ophthalmology. Antiglaucoma drugs and miotic agents. Prostaglandin analogues

Pharmacological Action

Antiglaucoma agent. Synthetic analogue of prostaglandin F_2α.

It is a highly selective agonist of prostaglandin FP receptors. Reduces intraocular pressure by increasing uveoscleral outflow of aqueous humor.

Intraocular pressure decreases approximately 2 hours after application of the drug, with the maximum effect achieved after 12 hours.

Pharmacokinetics

Travoprost is absorbed through the cornea of the eye, where travoprost is hydrolyzed to its biologically active form – travoprost acid. The C_max of travoprost in blood plasma is reached within 30 minutes after topical application and is 25 pg/ml or less.

Travoprost is rapidly eliminated from plasma; the concentration decreases below the detection limit (< 10 pg/ml) within an hour. It is excreted as inactive metabolites mainly with bile (61%), the remainder is excreted by the kidneys.

Indications

Reduction of elevated intraocular pressure in open-angle glaucoma, elevated ophthalmotonus.

ICD codes

Dosage Regimen

Instill one drop into the conjunctival sac of the affected eye(s) once daily.

Administer the dose in the evening to maximize therapeutic effect and minimize potential side effects.

Do not exceed the recommended once-daily dosage; more frequent administration may decrease the intraocular pressure-lowering effect.

If using other topical ophthalmic medications, maintain an application interval of at least 5 minutes between instillations.

Prior to instillation, remove contact lenses; reinsert them no sooner than 20 minutes after administration.

To prevent contamination, avoid contact between the dropper tip and the eye, eyelids, or any other surface.

Close the container tightly immediately after use.

Treatment is typically long-term; continue therapy as prescribed unless directed otherwise by a physician.

Report any significant ocular irritation, conjunctival hyperemia, or changes in iris pigmentation or eyelashes to your healthcare provider.

Adverse Reactions

Ophthalmic disorders very common – transient mild conjunctival hyperemia, which resolves spontaneously; common – decreased visual acuity, sensation of discomfort and foreign body, pain, itching, burning in the eyes, visual disturbances, blepharitis, “haze” before the eyes, cataract, conjunctivitis, conjunctival dryness, changes in iris color, keratitis, crusting on the eyelids, photophobia, subconjunctival hemorrhages, and increased lacrimation.

Cardiovascular system disorders common – increase or decrease in BP, bradycardia, angina pectoris, chest pain, hypercholesterolemia.

CNS disorders common – general anxiety, headache, depression.

Urinary system disorders common – urinary incontinence and urinary system infections.

Musculoskeletal system disorders common – arthritis, back pain.

Other common – flu-like syndrome, sinusitis, bronchitis, dyspepsia.

Contraindications

Childhood and adolescence under 18 years of age, hypersensitivity to travoprost.

Use in Pregnancy and Lactation

Use during pregnancy is contraindicated.

There is insufficient experience with use during lactation. Use during breastfeeding is possible only under medical supervision and only if the potential benefit of therapy for the mother outweighs the possible risk of side effects for the breastfed infant.

Pediatric Use

Contraindicated in childhood and adolescence under 18 years of age.

Special Precautions

Use with caution in the presence of risk factors for the development of macular edema (aphakia, pseudophakia, rupture of the posterior lens capsule), and in acute iritis, uveitis.

During use, a gradual change in eye color may occur due to an increase in the amount of brown pigment in the iris. This effect is detected mainly in patients with mixed-color irises, for example, blue-brown, gray-brown, green-brown, or yellow-brown, which is explained by an increase in melanin content in the stromal melanocytes of the iris.

Usually, brown pigmentation spreads concentrically around the pupil to the periphery of the iris, and the entire iris or its parts may become more intensely brown.

In patients with uniformly colored blue, gray, green, or brown eyes, changes in eye color after two years of using the drug were observed very rarely. The color change is not accompanied by any clinical symptoms or pathological changes.

After discontinuation of therapy, no further increase in the amount of brown pigment was observed, but the already developed color change may be irreversible.

Before starting treatment, patients should be informed about the possibility of a change in eye color.

Treatment of only one eye may lead to permanent heterochromia.

No changes in nevi or lentigo on the iris have been noted under the influence of travoprost.

Travoprost may cause darkening, thickening, and lengthening of eyelashes and/or an increase in their number; rarely – darkening of the skin of the eyelids.

It can be used in combination with other topical antiglaucoma drugs. In this case, the interval between their applications should be at least 5 minutes.

When wearing contact lenses, the lenses should be removed before instillation and reinserted no earlier than 20 minutes after the procedure.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.