Xalatan eye drops 0.005%, 2.5 ml No. 3

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

As with the use of 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 opening located at the inner corner of the eye on the lower eyelid. This must be done within 1 minute.

Eye drops

1 ml

latanoprost 50 mcg

excipients: sodium chloride; sodium dihydrogen phosphate (monohydrate); sodium hydrogen phosphate (anhydrous); benzalkonium chloride; water for injections

in dropper bottles of 2.5 ml; in a pack of cardboard 1 or 3 bottles.

• Hypersensitivity to latanoprost or other components of the drug;

• age up to 18 years.

Carefully:

aphakia, pseudoaphakia with rupture of the posterior capsule of the lens;

patients with known risk factors for macular edema (cases of macular edema, including cystoid edema, have been described during treatment with latanoprost); inflammatory, neovascular or congenital glaucoma (due to lack of sufficient experience with the drug).

pharmachologic effect

An antiglaucoma drug, an analogue of prostaglandin F2?, is a selective agonist of FP (prostaglandin F) receptors and reduces intraocular pressure (IOP) by increasing the outflow of aqueous humor, mainly by the uveoscleral route, as well as through the trabecular network. It was found that latanoprost has no significant effect on the production of aqueous humor and on the blood-ophthalmic barrier. When used in therapeutic doses, latanoprost does not have a significant pharmacological effect on the cardiovascular and respiratory systems. A decrease in IOP begins approximately 3-4 hours after drug administration, the maximum effect is observed after 8-12 hours, the effect lasts for at least 24 hours.

Side effect

The following adverse reactions related to the use of the drug have been reported. From the side of the organ of vision: eye irritation (burning sensation, feeling of sand in the eyes, itching, tingling and foreign body sensation); blepharitis; hyperemia of the conjunctiva; Pain in the eyes; increased pigmentation of the iris; transient point erosion of the corneal epithelium, edema of the eyelids, periorbital edema, edema and erosion of the cornea; conjunctivitis; lengthening, thickening, increasing the number and intensification of eyelash and vellus hair pigmentation; iritis / uveitis; keratitis; macular edema (including cystoid); a change in the direction of eyelash growth, sometimes causing eye irritation; the growth of an additional row of eyelashes above the meibomian glands, changes in the periorbital region and in the area of ??the eyelashes, leading to a deepening of the groove of the upper eyelid; blurred vision, photophobia, dryness of the mucous membrane of the eyes.On the part of the skin: rash, darkening of the eyelid skin and local skin reactions on the eyelids, toxic epidermal necrolysis. From the nervous system: 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 invasions: herpetic keratitis. Others: nonspecific chest pain. There have also been cases of retinal artery embolism, retinal detachment and vitreous hemorrhage 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 XalatanЃ in children did not differ from the safety profile in adults. Compared to the adult population, nasopharyngitis and fever were most common in children.

Application during pregnancy and lactation

There have been no adequate controlled studies in pregnant women. The drug should be prescribed during pregnancy only in cases where the expected benefit to the mother outweighs the possible risk to the fetus. Latanoprost and its metabolites can be excreted in breast milk, therefore, the drug should be used with caution during breastfeeding.

Application in children

Contraindicated for use in children under 1 year of age.

special instructions

XalatanЃ should be prescribed no more than 1 time / day, because 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 concomitantly with other classes of topical ophthalmic drugs to lower IOP. If the patient is using other eye drops at the same time, then they should be applied at intervals of at least 5 minutes. XalatanЃ contains benzalkonium chloride, which can be absorbed by contact lenses.

Before instilling drops, contact lenses must be removed and reinstalled after 15 minutes. Latanoprost can cause a gradual increase in the brown pigment content in the iris. The change in eye color is due to an increase in the content of melanin in the stromal melanocytes of the iris, and not an increase in the number of melanocytes themselves. Typically, brown pigmentation appears around the pupil and spreads concentrically to the periphery of the iris. In this case, the entire iris or parts of it become brown.

In most cases, discoloration is minor and may not be clinically apparent. Increased pigmentation in the iris of one or both eyes is observed mainly in patients with a mixed iris color with a brown base.

The drug has no effect on nevi and iris lentigo; pigment accumulation in the trabecular meshwork or in the anterior chamber of the eye was not observed. When determining the degree of pigmentation of the iris for more than 5 years, no undesirable consequences of increased pigmentation were revealed 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 iris pigmentation. Such patients should be monitored regularly and, depending on the clinical situation, treatment may be discontinued.

Increased iris pigmentation is usually observed within 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 progression of pigmentation decreases over time and stabilizes after 5 years. In more distant terms, the effects of increased iris pigmentation have not been studied. After stopping 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 eyelid skin have been described, which can be reversible. Latanoprost can cause gradual changes in eyelashes and vellus hair, such as lengthening, thickening, increased pigmentation, increased density and a change in the direction of eyelash growth. Eyelash changes are reversible and disappear after stopping treatment. In patients using drops in only one eye, heterochromia may develop.

Influence on the ability to drive vehicles and mechanisms

Eye drops may cause transient blurred vision. Drive a car or use complex equipment while using the drug with caution.

Overdose

Symptoms: in addition to irritation of the mucous membrane of the eyes, hyperemia of the conjunctiva or episclera, there were no other undesirable changes on the part of the organ of vision with an overdose of latanoprost. In case of accidental ingestion of latanoprost inside, the following information should be taken into account: one bottle with 2.5 ml of solution contains 125 ?g of latanoprost. More than 90% of the drug is metabolized during the 'first pass' through the liver. Intravenous infusion at a dose of 3 ?g / kg in healthy volunteers did not cause any symptoms, however, when a dose of 5.5-10 ?g / kg was administered, 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: carrying out symptomatic therapy.

Drug interactions

With the simultaneous instillation of two prostaglandin analogs into the eyes, a paradoxical increase in IOP has been described, therefore the simultaneous use of two or more prostaglandins, their analogs or derivatives is not recommended. Pharmaceutical interactions XalatanЃ is incompatible with eye drops containing thiomersal (precipitation occurs).