Xalatan, eye drops 0.005% 2.5ml

Latanoprost is a prostaglandin F2α analog and a selective FP receptor agonist.

Latanoprost reduces intraocular pressure by increasing aqueous humor outflow and has an anti-oglaucoma effect.

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

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

The decrease of intraocular pressure starts 3-4 hours after the drug administration with maximal effect noted after 8-12 hours and the effect lasts for at least 24 hours.

Indications

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

Active ingredient

Composition

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

1 mLatanoprost50 mcg

Ancillary substances:

Sodium chloride – 4.1 mg,

sodium dihydrophosphate (monohydrate) – 4.6 mg,

sodium hydrophosphate (anhydrous) – 4.74 mg,

benzalkonium chloride – 0.2 mg,

water d/i – 995 mg.

How to take, the dosage

Adults and children over 1 year of age – 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 drop, in order to reduce the possible systemic effect of the drug, immediately after instillation of each drop it is recommended that pressure be applied to the lower lacrimal point located at the inner corner of the eye on the lower eyelid. This should be done within 1 minute.

Interaction

Paradoxical elevation of IOP has been described when two prostaglandin analogues are put into the eyes at the same time, so the simultaneous use of two or more prostaglandins, their analogues or derivatives is not recommended.

Pharmaceutical interactions

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

Special Instructions

Xalatan® should not be administered more than once daily because the IOP-lowering effect is diminished with more frequent use of latanoprost.

If a dose is missed, the next dose should be given at the usual time.

Latanoprost can be used concomitantly with other classes of ophthalmic drugs for topical use to reduce IOP. If the patient uses other eye drops at the same time, they should be used at least 5 minutes apart.

The product Xalatan® contains benzalkonium chloride which may be absorbed by contact lenses. Contact lenses should be removed and reinserted after 15 minutes before the drops are placed.

Latanoprost may cause a gradual increase in brown pigment in the iris. The change in eye color is due to an increase in melanin in the stromal melanocytes of the iris, not an increase in the number of melanocytes themselves. In typical cases, brown pigmentation appears around the pupil and spreads concentrically to the periphery of the iris. In this case the entire iris or its parts take on a brown color. In most cases, the color change is subtle and may not be detected clinically. Increased iris pigmentation of one or both eyes is seen mostly in patients with mixed iris color, containing brown at the core. The drug has no effect on iris nevi and lentigos; no accumulation of pigment in the trabecular network or in the anterior chamber of the eye.

In determining the degree of iris pigmentation over 5 years, there were no adverse effects of increased pigmentation even with continued latanoprost therapy. The degree of IOP reduction was similar in patients regardless of the presence or absence of iris pigmentation enhancement. Therefore, treatment with latanoprost may be continued in cases of increased iris pigmentation. These patients should be monitored regularly, and treatment may be discontinued depending on the clinical situation.

Augmentation of iris pigmentation is usually seen within the first year of treatment, rarely in the second or third year. This effect is not seen after the fourth year of treatment. The rate of progression of pigmentation decreases with time and stabilizes after 5 years. The effects of increased iris pigmentation have not been studied in the longer term. No increase in brown iris pigmentation has been observed after discontinuation of treatment, but the change in eye color may be irreversible.

Latanoprost has been associated with cases of darkening of the eyelid skin, which may be reversible.

Latanoprost can cause gradual changes to eyelashes and downy hair, such as lengthening, thickening, increasing pigmentation, increasing density, and changing the direction of eyelash growth. Eyelash changes are reversible and go away after treatment is discontinued.

In patients using drops in only one eye, heterochromia may develop.

Impact on driving and operating machinery

The use of eye drops may cause transient blurring of vision. Caution should be exercised while using the drug to drive a vehicle or operate complex machinery.

Contraindications

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

The use of Xalatan should be avoided in patients with active herpetic keratitis and recurrent herpetic keratitis, especially those associated with the use of prostaglandin F2α analogues.

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

There are limited data on the use of Xalatan in patients scheduled for cataract surgery. Because of this, Xalatan must be used with caution in this group of patients.

Side effects

The following adverse reactions have been reported when using the drug.

An organ of vision: Eye irritation (burning sensation, sensation of sand in the eyes, itching, tingling and sensation of foreign body); blepharitis; conjunctival hyperemia; eye pain; increased iris pigmentation; transient pitting erosions of corneal epithelium, eyelid edema, periorbital edema, corneal edema and erosions; conjunctivitis; lengthening, thickening, increasing the number and increasing pigmentation of eyelashes and downy hair; iritis/veitis; keratitis; macular edema (including cystoid edema); macular edema; andincluding cystoid); 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 eyelash area leading to deepening of the upper eyelid furrow; blurred vision, photophobia, dry eye mucous membrane.

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

Nervous system disorders: dizziness, headache.

Respiratory system disorders: bronchospasm (including acute attacks or exacerbation of the disease in patients with bronchial asthma in anamnesis), shortness of breath.

Muscular system disorders: 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 Xalatan in children did not differ from that of adults. Compared to the adult population, nasopharyngitis and fever were most common in children.

Overdose

Symptoms: Apart from ocular mucosal irritation and conjunctival or episcleral hyperemia, no other adverse effects on the visual organ have been reported with latanoprost overdose.

In case of accidental oral administration of latanoprost, the following information should be considered: one vial of 2.5 ml solution contains 125 mcg of latanoprost. More than 90% of the drug is metabolized during “first passage” through the liver. An intravenous infusion of 3 mcg/kg in healthy volunteers caused no symptoms, but nausea, abdominal pain, dizziness, fatigue, hot flashes, and sweating were observed with doses of 5.5-10 mcg/kg.

In patients with moderately severe bronchial asthma, administration of latanoprost to the eye at a dose 7 times the therapeutic dose did not cause bronchospasm.

Treatment: administration of symptomatic therapy.

Pregnancy use

An adequate controlled study in pregnant women has not been conducted. The drug should be administered during pregnancy only when the expected benefits to the mother exceed the possible risk to the fetus.

Latanoprost and its metabolites can be excreted with the breast milk, therefore the drug should be used with caution during breastfeeding.

Pediatric use

The drug is contraindicated in children under 1 year of age.

Similarities