Prolatan eye drops 0.005% vial 2.5 ml

Indications

- reduction of increased intraocular pressure (IOP) in adults and children (over the age of 1 year) with open-angle glaucoma or increased intraocular pressure.

Note: In children younger than 3 years old with primary congenital glaucoma, first-line therapy remains surgical treatment (trabeculotomy / goniotomy).

Dosage and administration

Have adults and children over 1 year - one drop in the affected eye (a) 1 time per day. The optimal effect is achieved with the use of 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 the installation 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 must be done within 1 minute.

Side effect

The following adverse reactions have been reported regarding the use of the drug:

Special senses: eye irritation (burning sensation, feeling of sand 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 epithelium, eyelid edema, perporbital edema, corneal edema and erosion; conjunctivitis; lengthening, thickening, increasing the number and strengthening of the pigmentation of eyelashes and vellus hair; iritis / uveitis; keratitis; macular edema, incl.cystoid; changing the direction of eyelash growth, sometimes irritating to the eyes; blurred vision, photophobia, dry eye mucosa.

Dermatological: a rash, darkening of the eyelid skin and local skin reactions on the eyelids, toxic epidermal scrolling.

Nervous system: dizziness, headache.

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

From the musculoskeletal and connective tissue: pain in muscles / joints.

General and local reactions: nonspecific chest pains.

Infections and invasions: herpetic keratitis.

Also noted were cases of retinal artery embolism, retinal detachment and vitreous hemorrhage in patients with diabetic retinopathy.

Children

The safety profile of Prolatan in children did not differ from the safety profile in adults. Compared with the adult population, nasopharyngitis and fever were most common in children.

Contraindications

- hypersensitivity to latanoprost or other components of the drug;

- Age up to 1 year (efficacy and safety have not been established).

Carefully

Afakiya, pseudo-ophakia with a rupture of the posterior lens capsule, patients with known risk factors for macular edema (in the case of latanoprost, cases of macular edema develop,including cystoid); inflammatory, neovascular or congenital glaucoma (due to the lack of sufficient experience with the drug); asthma; herpetic keratitis in history.

It is necessary to avoid the use of the drug Prolatan in patients with the active form of herpetic keratitis and recurrent herpetic keratitis, especially associated with the use of prostaglandin analogues. Prolatan should be used with caution in patients with iritis / uveitis risk factors. There are limited data on the use of the drug Prolatan in patients who are planning surgery for cataracts. In this regard, in this group of patients, Prolatan should be used with caution.

Use during pregnancy and lactation

Adequate controlled studies in pregnant women have not been conducted. The drug should be prescribed during pregnancy only in cases where the potential benefit to the mother outweighs the possible risk to the fetus.

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

Use in children

Contraindicated in children under 1 year, because efficacy and safety not established.

The safety profile of Prolatan in children older than 1 year did not differ from the safety profile in adults. Compared with the adult population, nasopharyngitis and fever were most common in children.

Special notes

The drug Prolatan should be used no more than once a day, as more frequent administration of latanoprost leads to a weakening of the effect of IOP-lowering.

When skipping a single dose, the next dose should be administered at the usual time.

The drug Prolatan can be used simultaneously with other classes of ophthalmic drugs for local use 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.

The drug Prolatan includes benzalkonium chloride, which can be absorbed by contact lenses. Before dropping the drops in contact lenses must be removed and re-installed them after 15 minutes.

Prolatan may cause a gradual increase in the brown pigment content in the iris. The change in eye color is due to an increase in the melanin content in the stromal melanocytes of the iris, and not an increase in the number of melanotses. In typical cases, brown pigmentation appears around the pupil and concentrically spreads to the periphery of the iris. In this case, the entire iris or its parts become brown. In most cases, the color change is minor and may not be established clinically. Increased pigmentation of the iris of one or both eyes is observed mainly in patients with mixed color of the iris, which is mainly based on brown color.The drug has no effect on nevi and lentigo iris; accumulation of pigment in the trabscular network or in the anterior chamber of the eye is not marked.

When determining the degree of pigmentation of the iris for more than 5 years, no undesirable effects of increased pigmentation were detected, even with continued treatment with latanoprost. In patients, the degree of IOP reduction was the same regardless of the presence or absence of increased iris pigmentation. Consequently, treatment with Prolatan 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 pigmentation of the iris is usually observed during the first year after the start of treatment, rarely during the second or third year. After the fourth year of treatment, this effect was not observed. The rate to progress pigmentation decreases with time and stabilizes after 5 years. In more distant terms, the effects of increased pigmentation of the iris have not been studied. After cessation of treatment, the enhancement of brown pigmentation of the iris was not observed, however, the change in eye color may be irreversible.

In connection with the use of latanoprost, cases of darkening of the eyelid skin, which may be reversible, are described.

The drug Prolatan can cause gradual changes in eyelashes and hair, such as lengthening, thickening, increased pigmentation, increase in thickness and change in the direction of growth of eyelashes. Changes to the eyelashes are reversible and disappear after cessation of treatment.

Heterochromia may develop in patients using only one eye drop.

The use of eye drops can cause transient blurred vision.

Influence on ability to drive a car and other mechanisms

It is necessary to drive a car or use a complicated technique while using the drug.

Overdosage

In addition to irritation of the mucous membrane of the eyes, hyperemia of the conjunctiva or episclera, other undesirable changes on the part of the organ of vision in case of an overdose of latanoprost are not known.

In case of accidental intake of Prolatan, the following information should be taken into account: one bottle with 2.5 ml of solution contains 125 μg of latanoprost, 5 ml - 250 μg of latanoprost. More than 90% of the drug is metabolized during the first passage through the liver. Intravenous infusion at a dose of 3 µg / kg in healthy volunteers did not cause any symptoms, but nausea, abdominal pain, dizziness, fatigue, hot flashes and sweating were observed with a dose of 5.5-10 µg / kg. In patients with moderate bronchial asthma, the administration of latanoprost in the eye at a dose 7 times the therapeutic one did not cause bronchospasm.

In case of overdose, symptomatic treatment is carried out.

Drug interaction

When two prostaglandin analogues are instilled into the eyes at the same time, a paradoxical increase in IOP is described; therefore, the simultaneous use of two or more prostaglandins, their analogs or derivatives, is not recommended.

Pharmaceutically incompatible with thiomersal-containing eye drops - precipitation.

Terms and conditions of storage

Store at a temperature of 2-8 ° C, protected from light. The opened vial should not be stored for more than 45 days at a temperature not higher than 25 ° С. Keep out of the reach of children.