Xalatan eye drops 0.005% 2.5ml, 1pc

Composition

Eye drops 0.005% in the form of a clear, colorless solution.

1 ml latanoprost 50 mcg

Auxiliary substances:

sodium chloride-4.1 mg,

sodium dihydrogen phosphate (monohydrate) – 4.6 mg,

sodium hydrophosphate (anhydrous) – 4.74 mg,

benzalkonium chloride-0.2 mg,

water d / i-995 mg

Pharmacological action

Latanoprost is an analog of prostaglandin F2a and a selective agonist of FP receptors.

Reduces intraocular pressure by increasing the outflow of watery moisture and has an anti-glaucoma effect.

The main mechanism of action of latanoprost is associated with an increase in uveoscleral outflow.

It has no significant effect on the production of aqueous humor and does not affect the blood-ophthalmic barrier.

A decrease in intraocular pressure begins 3-4 hours after use of the drug, the maximum effect is noted after 8-12 hours, and the effect lasts for at least 24 hours.

Indications

Prevention and complex therapy (reduction of intraocular pressure) in open-angle glaucoma and increased ophthalmotonus.

Use during pregnancy and lactation

No adequate controlled trials have been conducted in pregnant women. The drug should be prescribed during pregnancy only in cases where the expected benefit to the mother exceeds the possible risk to the fetus.

Latanoprost and its metabolites can be excreted in breast milk, so the drug should be used with caution during breast-feeding.

Use in children

It is contraindicated for use in children under 1 year of age.

Contraindications

• age up to 1 year (efficacy and safety have not been established);
• hypersensitivity to latanoprost or other components of the drug.

The drug should be used with caution in patients with aphakia, pseudoaphakia with rupture of the posterior lens capsule, in patients with risk factors for macular edema (cases of macular edema, including cystoid edema, have been described during treatment with latanoprost); in patients with inflammatory, neovascular glaucoma (due to lack of sufficient experience with the drug); in patients with bronchial asthma, herpetic keratitis in the anamnesis.

Xalatan should be avoided in patients with active herpetic keratitis and recurrent herpetic keratitis, especially associated with the use of prostaglandin F2a analogues.

Xalatan should be used with caution in patients with risk factors for iritis/uveitis.

There are limited data on the use of Xalatan in patients who are planning cataract surgery. Therefore, Xalatan should be used with caution in this group of patients.

Side effects

The following adverse reactions have been reported with the use of the drug.

From the side of the visual organ: eye irritation (burning sensation, sand sensation in the eyes, itching, tingling and foreign body sensation); blepharitis; conjunctival hyperemia; pain in the eyes; increased pigmentation of the iris; transient point erosion of the corneal epithelium, eyelid edema, periorbital edema, corneal edema and erosion; conjunctivitis; lengthening, thickening, increasing the number and strengthening of pigmentation of eyelashes and downy hair; iritis/uveitis; keratitis; macular edema (including cystoid edema); changes in the direction of eyelash growth, sometimes causing eye irritation; growth of an additional row of eyelashes over the Meibomian glands, changes in the periorbital area and in the area of the eyelashes, leading to a deepening of the furrow of the upper eyelid; blurred vision, photophobia, dryness of the eye mucosa.

From the skin: rash, darkening of the skin of the eyelids and local skin reactions on the eyelids, toxic epidermal necrolysis.

Nervous system disorders: dizziness, headache.

From the respiratory system: bronchospasm (including acute attacks or exacerbation of the disease in patients with a history of bronchial asthma), shortness of breath.

From the musculoskeletal system: muscle pain, joint pain.

Infections and infestations: herpetic keratitis.

Other: non-specific chest pain.

Retinal artery embolism, retinal detachment, and vitreous hemorrhage have also been reported in patients with diabetic retinopathy.

In some patients with significant corneal damage, very rare cases of corneal calcification have been reported due to the use of phosphate-containing eye drops.

The safety profile of Xalatan in children did not differ from that of adults. Compared to the adult population, children were most frequently diagnosed with nasopharyngitis and fever.

Interaction

When two prostaglandin analogues are simultaneously instilled into the eyes, a paradoxical increase in IOP has been described, so the simultaneous use of two or more prostaglandins, their analogues or derivatives is not recommended.

Pharmaceutical interaction

Xalatan is incompatible with eye drops containing thiomersal (precipitation occurs)

How to take, course of use and dosage

Adults and children older than 1 year – 1 drop in the affected eye (s) 1 time/day. The optimal effect is achieved when using the drug in the evening.

As with any eye drops, in order to reduce the possible systemic effect of the drug, immediately after instillation of each drop, it is recommended to press on the lower lacrimal point located at the inner corner of the eye on the lower eyelid. This should be done within 1 minute.

Overdose

Symptoms: in addition to irritation of the eye mucosa, conjunctival or episcleral hyperemia, no other undesirable changes on the part of the visual organ were observed with an overdose of latanoprost.

In case of accidental ingestion of latanoprost, the following information should be taken into account: one bottle with 2.5 ml of the solution contains 125 mcg of latanoprost. More than 90% of the drug is metabolized during the” first pass ” through the liver. IV infusion at a dose of 3 mcg / kg in healthy volunteers did not cause any symptoms, but with a dose of 5.5-10 mcg/kg, nausea, abdominal pain, dizziness, fatigue, hot flashes and sweating were observed.

In patients with moderate bronchial asthma, the introduction of latanoprost into the eyes at a dose 7 times higher than the therapeutic dose did not cause bronchospasm.

Treatment: performing symptomatic therapy.

Special instructions

Xalatan® should be prescribed no more than 1 time / day, since more frequent use of latanoprost leads to a weakening of the IOP-lowering effect.

If one dose is missed, the next dose should be administered at the usual time.

Latanoprost can be used simultaneously with other classes of topical ophthalmic medications to reduce IOP. If the patient is using other eye drops at the same time, they should be applied at intervals of at least 5 minutes.

Xalatan® contains benzalkonium chloride, which can be absorbed by contact lenses. Before instilling drops, the contact lenses must be removed and re-installed after 15 minutes.

Latanoprost can cause a gradual increase in the content of brown pigment in the iris. The change in eye color is caused by an increase in the content of melanin in the stromal melanocytes of the iris, and not by an increase in the number of melanocytes themselves. In typical cases, brown pigmentation appears around the pupil and extends concentrically to the periphery of the iris. In this case, the entire iris or parts of it turn brown. In most cases, the discoloration is minor and may not be detected clinically. Increased pigmentation of the iris of one or both eyes is observed mainly in patients with mixed iris color, containing brown in the base. The drug does not affect the nevi and lentigo of the iris; pigment accumulation in the trabecular network or in the anterior chamber of the eye was not noted.

When determining the degree of pigmentation of the iris for more than 5 years, there were no undesirable consequences of increased pigmentation, even with continued therapy with latanoprost. In patients, the degree of IOP reduction was the same regardless of the presence or absence of increased iris pigmentation. Therefore, treatment with latanoprost can be continued in cases of increased pigmentation of the iris. Such patients should be monitored regularly and, depending on the clinical situation, treatment may be discontinued.

Increased iris pigmentation is usually observed during the first year after starting treatment, rarely during the second or third year. After the fourth year of treatment, this effect is not observed. The rate of pigmentation progression decreases over time and stabilizes after 5 years. In the longer term, the effects of increased iris pigmentation have not been studied. After discontinuation of treatment, there was no increase in brown pigmentation of the iris, but the change in eye color may be irreversible.

In connection with the use of latanoprost, cases of darkening of the skin of the eyelids, which can be reversible, have been described.

Latanoprost can cause gradual changes in the eyelashes and downy hair, such as lengthening, thickening, increasing pigmentation, increasing density, and changing the direction of lash growth. Changes to the eyelashes are reversible and disappear after treatment is stopped.

Patients who use drops in only one eye may develop heterochromia.

Influence on the ability to drive motor vehicles and manage mechanisms

The use of eye drops may cause temporary blurred vision. Drive a car or use complex equipment during the use of the drug should be used with caution.

Form of production

Eye drops

Storage conditions

In a dark place, at a temperature of 2-8 °C

Shelf life

3 years

Active ingredient

Latanoprost

Conditions of release from pharmacies

By prescription

Dosage form

eye drops