Travapress (Drops) Instructions for Use

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

ATC Code

S01EE04 (Travoprost)

Active Substance

Travoprost

Dosage Form

Travapress

Eye drops 40 mcg/1 ml: bottle 2.5 ml 1 pc. with dropper cap

Dosage Form, Packaging, and Composition

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

Excipients: boric acid – 3 mg, trometamol – 1.2 mg, macrogol glycerol hydroxystearate (cremophor RH40) – 5 mg, mannitol – 46 mg, disodium edetate dihydrate – 0.1 mg, benzalkonium chloride – 0.15 mg, 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 6.2±0.1, purified water – to 1 ml.

2.5 ml – polyethylene bottles with a capacity of 5 ml (1) with a dropper cap – cardboard packs.

Clinical-Pharmacological Group

Antiglaucoma drug – synthetic prostaglandin F2α analogue

Pharmacotherapeutic Group

Antiglaucoma agent – synthetic prostaglandin F_2α analogue

Pharmacological Action

Antiglaucoma agent. Synthetic prostaglandin F_2α analogue.

It is a highly selective agonist of prostaglandin FP receptors. It 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, with the concentration falling 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.

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 different products.

Before instillation, wash hands thoroughly.

To avoid contamination, do not let the dropper tip touch any surface, including the eye, eyelids, or fingers.

Immediately after instillation, apply gentle pressure to the lacrimal sac (at the inner corner of the eye) for approximately one minute to reduce systemic absorption.

This simple technique minimizes potential systemic side effects.

If you wear contact lenses, remove them before application.

You may reinsert contact lenses 20 minutes after instillation of the drops.

Adverse Reactions

From the organ of vision very common – transient mild conjunctival hyperemia, which resolves on its own; 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, crust formation on the edges of the eyelids, photophobia, subconjunctival hemorrhages and increased lacrimation.

From the cardiovascular system common – increase or decrease in blood pressure, bradycardia, angina pectoris, chest pain, hypercholesterolemia.

From the central nervous system common – general anxiety, headache, depression.

From the urinary system common – urinary incontinence and urinary system infections.

From the musculoskeletal system 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 predominantly 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 very rare. 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 change in color that has already developed 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 observed 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 eyelid skin.

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.